预约演示
更新于：2025-05-31
Loperamide Hydrochloride
盐酸洛哌丁胺
更新于：2025-05-31
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (1976-12-28), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C29H34Cl2N2O2 |
InChIKeyPGYPOBZJRVSMDS-UHFFFAOYSA-N |
CAS号34552-83-5 |
关联
68
项与 盐酸洛哌丁胺 相关的临床试验NCT06424522
Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management
This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.
开始日期2025-06-01 |
CTIS2024-515531-29-00
- N-LOP-24-289
开始日期2024-11-05 |
申办/合作机构- |
ISRCTN18843536
Impact of 20% phenytoin and 5% loperamide cream on neuropathic pain: a prospective double-blind randomized controlled study
开始日期2024-03-13 |
申办/合作机构- |
100 项与 盐酸洛哌丁胺 相关的临床结果
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100 项与 盐酸洛哌丁胺 相关的转化医学
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100 项与 盐酸洛哌丁胺 相关的专利（医药）
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3,693
项与 盐酸洛哌丁胺 相关的文献（医药）2025-12-31·PHARMACEUTICAL BIOLOGY
Article
作者: Choi, Yu-Jin ; Wang, Jing-Hua ; Hwang, Seung-Ju ; Lee, Jin-Seok ; Woo, Tae-Wook ; Kim, Dong-Seon ; Son, Chang-Gue ; Seo, Chang-Seob ; Baek, Dong-Cheol ; Gu, Ji-Yeon
CONTEXT:
WDJ-S4, a standardized herbal formula, has been prescribed for refractory functional dyspepsia (FD) in Korea, but the detailed mechanisms are lacking.
OBJECTIVE:
The present study investigates the acceleration of gastrointestinal (GI) motility by WDJ-S4 and its potential mechanisms.
MATERIALS AND METHODS:
For five days, WDJ-S4 (50, 100 and 200 mg/kg) or mosapride (3 mg/kg) was orally given to BALB/c mice. After 20 h of fasting, loperamide (10 mg/kg, i.p.) was given to the mice except for normal group. To assess gastric emptying or intestinal propulsion, 500 μL of 0.05% phenol red or 200 μL of 5% charcoal diet was given once orally.
RESULTS:
Loperamide delayed gastric emptying and intestinal propulsion, while WDJ-S4 ameliorated peristaltic dysfunction, evidenced by reductions of remaining phenol red in the stomach and a marked increase of charcoal propulsion in the intestine. WDJ-S4 also normalized levels of acetylcholine and acetylcholine-related enzymes, including choline acetyltransferase (ChAT) and acetylcholinesterase (AChE), in the gastric antrum and jejunum. C-kit level and smooth muscle contraction-related genes were elevated by WDJ-S4 in both the gastric antrum and jejunum.
CONCLUSION:
Overall, WDJ-S4 can effectively promote GI motility. The efficacy is associated with modulation of acetylcholine pathway and the interstitial cells of Cajal (ICCs) activation. All the results provide scientific evidence supporting the clinical usage of WDJ-S4 for FD.
2025-09-01·FOOD AND CHEMICAL TOXICOLOGY
Loperamide-induced constipation is associated with excessive accumulation of bile acids and cholesterol in the liver of mice; attenuation by hesperidin
Article
作者: Nie, Ya ; Lei, Yuting ; Lei, Zili ; Rong, Hedong ; Yu, Siping ; Bi, Dan ; Li, Jiahui ; Yang, Yanhong ; Wu, Huijuan
Loperamide, a widely used antidiarrheal agent, frequently induces constipation alongside other adverse effects. This study explored hesperidin's therapeutic potential in alleviating loperamide-induced constipation and its underlying mechanisms. Constipation models were established in HFD- or NFD-fed mice via loperamide administration (5 mg/kg/day). Hesperidin (100 mg/kg/day) significantly increased fecal weight and moisture in constipated mice. Biochemical analyses revealed elevated cholic acid/chenodeoxycholic acid ratios in serum and liver tissues of loperamide-treated HFD mice, indicating bile acids dysregulation. qRT-PCR and Western blot results demonstrated that hesperidin downregulated hepatic expression of cholesterol/bile acids biosynthesis genes (e.g., Hmgcr, Cyp7a1, Ch25h), which were overexpressed in constipated mice. Concurrently, hesperidin enhanced the expression of transporters (Abcg5, Abcb11, Abcc2) responsible for biliary cholesterol and bile acids efflux. Furthermore, hesperidin upregulated hepatic nuclear receptors (FXR/SHP), key regulators of bile acids homeostasis. Hesperidin alleviates loperamide-induced constipation through two parallel mechanisms: decreasing hepatic cholesterol accumulation and enhancing bile acids excretion. This dual action results from coordinated regulation of biosynthesis enzymes and transport proteins. This study highlights hesperidin's potential as an adjunct therapy to counteract loperamide-related constipation.
2025-07-01·BIOMEDICAL CHROMATOGRAPHY
Stability‐Indicating RP‐HPLC Method Development and Validation for Quantification of Butylated Hydroxyanisole Content in Loperamide Oral Solid Dosage Form
Article
作者: Sambu, Pranitha ; Myneni, Rama Krishna ; Divadari, Hareesh ; Lankalapalli, Prasanna Kumar ; chollety, Vijaykumar ; Kasa, Srinivasulu ; Kamireddy, Teja
ABSTRACT:
The present study discusses the development of a simple, rapid, and specific high‐performance liquid chromatography (HPLC) method for the estimation of butylated hydroxyanisole (BHA) in loperamide HCl capsule dosage formulations. The developed HPLC method was validated in accordance with current ICH guidelines. Chromatographic separation was achieved using a phosphate buffer (pH 6.8) as mobile phase A and a mixture of acetonitrile and buffer in a ratio of 80:20 (v/v) as mobile phase B. The flow rate was 0.8 mL/min, and column temperature was maintained at 35°C. Detection of the component was performed at 290 nm for BHA. The optimized HPLC method was validated as per current ICH guidelines and demonstrated high specificity with a linearity range of 13–83 μg/mL for BHA, with a correlation coefficient greater than 0.999. The method showed accuracy exceeding 97%. Stress studies revealed that BHA is sensitive to peroxide stress conditions. The results highlight the successful applicability of the current method for estimating BHA in marketed formulations, which can be further utilized to evaluate other formulation systems. The developed method was validated according to international ICH guidelines concerning specificity, linearity, precision, and accuracy. The method was developed and validated in a quality control lab for stability analysis.
118
项与 盐酸洛哌丁胺 相关的新闻（医药）2025-05-23
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ASCENT-03 study of Trodelvy® (sacituzumab govitecan-hziy). The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1/PD-L1 inhibitors, meaning they are PD-L1 negative or are ineligible to receive immunotherapy.
“Almost half of the patients diagnosed with metastatic triple-negative breast cancer do not receive treatment beyond first-line, demonstrating an urgent need for innovative treatment options in this early setting,” said Dr. Javier Cortes, Head of the International Breast Cancer Center in Spain and principal investigator of the ASCENT-03 study. “Traditional chemotherapy has been the standard of care for early treatment of metastatic triple-negative breast cancer, and we know that therapeutic advances in this disease area serve a critical unmet need for patients and the broader oncology community.”
Together with the recently announced positive results from the ASCENT-04 study evaluating Trodelvy plus Keytruda® in patients with previously untreated PD-L1+ metastatic TNBC, Trodelvy now has the potential to be the backbone treatment for all patients across first-line mTNBC. Detailed data from the ASCENT-04 study will be shared during the American Society of Clinical Oncology (ASCO) meeting taking place May 30 – June 3, 2025.
“The ASCENT-03 outcome represents the first clinically meaningful advance for this patient population in over 20 years versus chemotherapy,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “By addressing this aggressive and difficult to treat disease earlier, we can potentially improve treatment options for the high unmet need that patients with metastatic triple-negative breast cancer face.”
The safety profile of Trodelvy in the ASCENT-03 study was consistent with prior studies, and no new safety signals were identified in this patient population. Overall survival (OS) is a key secondary endpoint and was not mature at the time of PFS primary analysis. No OS detriment was observed. Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analysis planned.
Detailed results from the ASCENT-03 study will be presented at a future medical meeting and discussed with regulatory authorities. The use of Trodelvy in first-line mTNBC is investigational, and the safety and efficacy of this use have not been established.
Healthcare professionals have well-established experience with Trodelvy, which has shown generally consistent outcomes across both clinical trials and real-world studies in 60,000+ patients across 50+ countries over approximately five years. It is the only antibody-drug conjugate (ADC) with four positive Phase 3 trials in HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) metastatic breast cancer (mBC), and remains the only approved Trop-2-directed ADC that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers: 2L mTNBC and pre-treated HR+/HER2- mBC.
Trodelvy is a Category 1 preferred treatment for both currently approved indications per the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelinesi) and the only ADC with an ESMO Magnitude of Clinical Benefit Scale (MCBS) rating of 5 for mTNBC. Trodelvy also has an MCBS rating of 4 for women with HR+/HER2- mBC.
Currently, Gilead has additional ongoing Phase 3 studies investigating Trodelvy across HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer including the ASCENT-07 pivotal trial in patients with HR+/HER2- mBC who have received endocrine therapy, and the ASCENT-05 pivotal trial in patients with early-stage TNBC (eTNBC). Trodelvy is also being evaluated in additional Phase 3 studies across a range of tumor types, including in lung and gynecologic cancers.
Gilead would like to thank the patients, families, investigators and advocates who have contributed and continue to contribute to this important research. We remain committed to advancing care to address the unmet needs for the breast cancer community.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Triple-Negative Breast Cancer (In Patients Who Are Not Candidates for PD-1/PD-L1 inhibitors)
Triple-negative breast cancer (TNBC) is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionately impacts younger, pre-menopausal as well as Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.
Chemotherapy remains the mainstay of treatment in first-line mTNBC patients who are not candidates for PD-1/PD-L1 inhibitors, and the need to improve outcomes continues to be high. In mTNBC overall, ~50% of patients do not receive treatment beyond 1L setting, demonstrating a need for additional effective earlier-line treatment options.
About the ASCENT-03 Study
The ASCENT-03 study is a global, open-label, randomized Phase 3 trial evaluating the efficacy and safety of sacituzumab govitecan compared with treatment of physician’s choice in patients with previously untreated, locally advanced, inoperable, or metastatic triple-negative breast cancer (mTNBC) whose tumors do not express PD-L1, or who are PD-L1 positive and previously treated with a PD-(L)1 inhibitor in the curative setting. ~540 patients were enrolled across multiple study sites worldwide.
Patients were randomized 1:1 to receive either sacituzumab govitecan (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) or treatment of physician’s choice, which included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel. Treatment continued until blinded independent central review (BICR)-verified disease progression or unacceptable toxicity. Patients randomized to chemotherapy were eligible to crossover to sacituzumab govitecan upon disease progression.
The primary endpoint of the study is progression-free survival (PFS) as assessed by BICR according to RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to onset of response (TTR), patient-reported outcomes (PROs), and safety.
More information about ASCENT-03 is available at ClinicalTrials.gov: NCT05382299.
About Trodelvy
Trodelvy® (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.
Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.
Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.
INDICATIONS
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:
Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: NEUTROPENIA AND DIARRHEA
CONTRAINDICATIONS
Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.
Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.
Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.
ADVERSE REACTIONS
In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).
In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.
DRUG INTERACTIONS
UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.
UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.
Please see full Prescribing Information, including BOXED WARNING.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Trodelvy (such as ASCENT-03, ASCENT-04, ASCENT-05 and ASCENT-07); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
i
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
临床结果临床3期ASCO会议上市批准免疫疗法
2025-05-23
点击上方蓝字 关注我们编者按乳腺癌是女性最常见的恶性肿瘤之一，2024年2月1日，根据世界卫生组织（WHO）下属国际癌症研究机构（IARC）发布的最新数据，2022年全球乳腺癌新发例数高达230万，仅次于肺癌。其中HER2阳性乳腺癌进展快、复发风险高，曾是预后最差的乳腺癌类型。近20年，随着抗HER2治疗的出现及发展，HER2阳性早期乳腺癌患者预后明显提高。但是即使在标准的化疗联合抗HER2靶向的（新）辅助治疗之后，局部复发与远处转移仍是患者不得不面对的严峻挑战：经曲妥珠单抗治疗1年的患者10年复发率为31%[1]，经曲妥珠单抗联合帕妥珠单抗双靶治疗1年的淋巴结阳性亚组患者6年复发率为12%[2]；新辅助后疾病残留的患者接受T-DM1治疗后，3年和7年疾病复发率分别近12%和20%[3]。并且HER2阳性乳腺癌在诊断后的1-3年内存在复发高峰，即使应用曲妥珠单抗治疗之后，复发风险仍持续存在。在此背景下，Ⅲ期ExteNET研究探索了曲妥珠单抗后的序贯治疗模式。该研究评估了HER2阳性乳腺癌患者完成1年曲妥珠单抗辅助治疗后使用奈拉替尼辅助强化的价值。研究结果显示，ITT人群2年、5年的复发风险分别降低了33%和27%，淋巴结阳性亚组患者和HR阳性患者5年复发风险分别降低30%和42%[4,5]。其中高危人群获益更为显著：激素受体阳性/完成曲妥珠单抗辅助治疗≤1年（HR+/≤1年）且新辅助non-pCR的患者较安慰剂组，5年iDFS绝对获益达到7.4%，8年OS绝对获益达到9.1%[5]。基于以上结果，奈拉替尼分别于2017、2018年在美国和欧盟上市。2020年4月27日，奈拉替尼在中国上市，获批用于HER2阳性早期乳腺癌强化辅助治疗。随着2021年被纳入国家医保，奈拉替尼的可及性大大增加，也得到了国内指南的大力推荐。尤其对于淋巴结阳性的患者，属于复发高危人群，《CACA-CBCS指南》2025版推荐高危（任何pN+）患者在初始的辅助化疗联合抗HER2治疗后，使用奈拉替尼进行后续的强化治疗。对于淋巴结阴性并且pT1c及以上的中危患者，也推荐考虑使用奈拉替尼进行辅助强化治疗，以尽量降低癌症复发的可能性。病例分享专家简介孙哲昆明医科大学第一附属医院乳腺外科主治医师云南省医学分会乳腺疾病分会委员云南省医学会日间医疗分会肿瘤日间化疗学组委员中国解剖学会临床神经解剖分会委员中国研究型医院学会整形分会青年委员主要从事以乳腺疾病为主的临床及科研研究，主要研究方向为乳腺癌术后整形、乳腺癌综合治疗曾发表SCI及核心期刊文章多篇，参与多项国自然及省级科研基金研究2018“赫然新声”全国中青年演讲赛西南赛区冠军病例介绍患者基本信息患者：女年龄：40岁主诉：发现左乳肿物1年现病史：患者1年前无意中发现左乳肿物，约2cmx2cm大小，无局部红肿，无发热，无乳头溢液，无明显疼痛，无咳嗽咳痰，无腹痛腹泻。于2023年6月24日在我院门诊就诊，行超声提示：左乳4点方向实性结节（BI-RADS 4C类），门诊以“左乳肿物（乳腺癌可能）”收入我科，患者患病期间，精神可，睡眠、食欲欠佳，大小便无明显异常，体重无明显变化。既往史：无特殊个人史：出生于云南昆明，无烟酒史，无疫水疫区等接触史。既往体健，无其他基础疾病。家族史：无特殊体格检查视诊：双乳大小、位置基本对称，乳晕区无明显色素沉着，皮肤无明显红肿、破溃、橘皮样改变（-）、酒窝征（-）触诊：左乳4点钟见一肿物，大小约2.0x2.0cm的不规则肿物，质硬，活动度差，表面欠光滑，边界不清，无压痛，右乳未触及明显肿物，左侧腋窝及双侧锁骨上未触及明显肿大淋巴结。影像学检查· 乳腺彩超2023-06-26彩色多普勒超声宽景成像+术前体表定位: 1、左乳4点钟方向实性肿块(乳腺Ca可能，BI-RADS 4C类)，已体表定位，此次定位仅供手术医生参考。2、双乳乳腺增生症。3、双侧腋窝探及多个淋巴结。图1. 2023年6月24日乳腺彩超辅助检查· 乳腺MR图2. 2023年6月28日乳腺MR结果1、左乳外下象限肿块，考虑恶性。(BI-RADS 5)2、左侧乳头凹陷并强化，左乳下份皮肤结节样强化，请结合临床及其他检查。3、右乳外份条带样异常信号，硬化性腺病与其他待鉴别，必要时活检。(BI -RADS 4A)4、双乳多发点结状强化灶。(BI-RADS 3)· 乳腺DR图3. 2023年6月27日乳腺DR结果1、左乳外下象限前中带肿块，恶性可能。(BI-RADS 4C)2、右乳外上象限中后带局限性非对称致密，建议进一步检查。(BI-RADS 0）· CT图4. 2023年6月27日CT结果1、双肺肺气肿并散在肺大疱。2、双肺多发微小结节，多为磨玻璃结节，密切随诊。3、左乳外份肿块，建议乳腺相关检查。· 穿刺病理图5. 2023年6月28日穿刺病理结果免疫组化及相关检查：P63（部分+），SMMHC（部分＋），CK5/6（部分+），ER（+，约90%强），PR（+，1% -2%强），HER-2（2+），AR（+，约80%-90%强），Ki-67（+，约20%-30%），P120（+），E-cad（+），Syn（-），CgA（-），GATA-3（+），CD34（血管+）。病理诊断：（左乳穿刺组织）浸润性乳腺癌，NST，2级（腺管形成3分，核级3分，核分裂1分，总分7分），伴导管原位癌（中核级，无坏死）。病理诊断：(左乳)浸润性乳腺癌;-NST，WHO 2级;-伴导管原位癌(约40%，中核级伴坏死)；-体积：2.5cmX2.0cmx2.0cm；-神经及脉管侵犯(-)；-乳头及各手术切缘(-)。最终诊断：左乳浸润性乳腺癌，pT2N0M0 WHO2级，三阳型治疗经过一、手术治疗入院后完善相关检查，排外穿刺禁忌，于2023-06-27日局麻下行左乳肿物空芯针穿刺活检术，穿刺结果：(左乳穿刺组织)初步考虑为浸润性癌。积极完善相关检查，排外手术禁忌症后，于2023-07-06日全麻下行左单侧乳房根治性切除术伴同侧腋窝前哨淋巴结活检术，术后患者恢复良好，术后病检：(左乳)浸润性乳腺癌，II级；免疫组化：Ki-67(15%+)，ER(85%，2+)，PR(-)，HER-2(2+)。HER-2基因有扩增，神经侵犯(-)，脉管癌栓(-)，LN (0/8)。· 术后病理图6. 2023年7月6日术后病理免疫组化及相关检查：Ki-67(15%+),CK5/6(-),ER(85%,2+),PR(-),AR(90%,2+),HER-2(2+),P120(+),E-cad(+),β-catenin(±), Syn(-), P53(-), P63(-), CK7(+), GATA-3(+)。2023年7月27日，HER2基因扩增FISH检测报告(MF230117)：HER2基因扩增。二、术后化疗2023年8月11日至2023年10月11日，予以辅助化疗，化疗方案EC-TH，化疗结束后，后继续靶向治疗1年，伴内分泌治疗（来曲唑+亮丙瑞林）。三、强化辅助治疗2024年11月4日，患者靶向治疗结束，门诊询问后续治疗，因该患者初始肿块大于2cm，且该患者较焦虑，担心复发，于2024年11月20日服用奈拉替尼，每日1次，每次3片，并予咯哌丁胺每日3次，每次2片预防腹泻。至2024年11月27日，奈拉替尼增量至每日4片，服用过程中腹泻2-3次左右，后逐渐缓解。2024年12月4日予奈拉替尼每日6片服用，至2024年12月31日，因患者服药过程中吃了小番茄，导致腹泻加重并引发痔疮、便血，与患者沟通后决定暂时停药，身体恢复后从低剂量（每日4片）开始服用奈拉替尼。至2025年1月24日患者大便次数正常，奈拉替尼增至每日6片。目前，患者耐受良好，大便次数正常。专家点评点评专家简介段文晶 教授昆明医科大学第一附属医院乳腺外科行政副主任 主任医师硕士生导师中华医学会云南省分会乳腺专业组委员云南省女医师协会外科学分会副主任委员云南省医师协会乳腺癌专业委员会委员云南省抗癌协会乳腺癌专业委员会常委云南省预防医学会乳腺癌专业委员会常委主要从事以乳腺疾病为主的临床、教学及科研研究，主要研究乳腺癌早期诊治、综合性治疗及乳腺癌术后整形修复（乳腺癌改良根治术、保留乳房的乳腺癌根治术、ⅠⅡ期乳房再造术）参与科研课题8项并获得2项云南省科学技术进步三等奖。发表专著《恶性肿瘤临床治疗与分析》1部，专业科研论⽂20余篇，北⼤核⼼5篇，SCI2篇奈拉替尼作为不可逆的泛HER酪氨酸激酶抑制剂（TKI），通过同时阻断HER1、HER2和HER4蛋白信号通路，持续抑制肿瘤细胞的增殖和存活，减少术后微小残留病灶[6-8]。ExteNET研究显示，对于HER2阳性早期乳腺癌患者，完成曲妥珠单抗治疗后序贯1年奈拉替尼，5年无浸润性疾病生存率（iDFS）提高至90.2%（对照组87.7%），远处转移风险降低40%。亚组分析显示，淋巴结阳性，激素受体阳性以及肿瘤＞2cm（T2/T3）患者从奈拉替尼的治疗中获益更大[5]。本例患者肿瘤大小为2.5cm（pT2N0M0），虽无淋巴结转移，但肿瘤体积较大，既往研究提示，原发肿瘤负荷≥pT2是HER-2阳性乳腺癌术后复发的独立危险因素[9]，因此该患者属于复发中高危。同时患者ER表达为85%，ExteNET研究数据也表明奈拉替尼对HR+/＜1年亚组的效果更优（5年iDFS绝对获益5.1%）。因此根据肿瘤大小和ER表达，判断该患者可能从奈拉替尼的治疗中获益。另外从机制上，奈拉替尼与曲妥珠单抗的作用位点和机制不同，可以发挥机制互补作用；奈拉替尼还可以弥补曲妥珠单抗等大分子难以入脑的局限性，利用分子量优势穿透血脑屏障，起到预防脑转移的作用[10]；最后曲妥珠单抗疗程结束后序贯使用奈拉替尼，可延长HER2通路抑制时间，减少“治疗空窗期”复发风险。CONTROL研究显示[11]，使用奈拉替尼剂量递增方案，并按需应用洛哌丁胺（如本例），并逐步递增剂量，通过个体化副作用管理来保障治疗连续性。本例患者通过剂量调整和腹泻预防，成功耐受治疗，体现了临床中“风险分层”与“精准管理”的结合。参考文献上下滑动查看更多内容[1]. Cameron, D., Piccart-Gebhart, M.J., Gelber, R.D., Procter, M., Goldhirsch, A., de Azambuja, E., Castro, G., Jr., Untch, M., Smith, I., Gianni, L., et al. (2017). 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet 389, 1195-1205. 10.1016/s0140-6736(16)32616-2.[2]. Piccart, M., Procter, M., Fumagalli, D., de Azambuja, E., Clark, E., Ewer, M.S., Restuccia, E., Jerusalem, G., Dent, S., Reaby, L., et al. (2021). Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol 39, 1448-1457. 10.1200/jco.20.01204.[3]. von Minckwitz, G., Huang, C.S., Mano, M.S., Loibl, S., Mamounas, E.P., Untch, M., Wolmark, N., Rastogi, P., Schneeweiss, A., Redondo, A., et al. (2019). Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med 380, 617-628. 10.1056/NEJMoa1814017.[4]. Chan, A., Delaloge, S., Holmes, F.A., Moy, B., Iwata, H., Harvey, V.J., Robert, N.J., Silovski, T., Gokmen, E., von Minckwitz, G., et al. (2016). Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 17, 367-377. 10.1016/s1470-2045(15)00551-3.[5]. Martin, M., Holmes, F.A., Ejlertsen, B., Delaloge, S., Moy, B., Iwata, H., von Minckwitz, G., Chia, S.K.L., Mansi, J., Barrios, C.H., et al. (2017). Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 18, 1688-1700. 10.1016/s1470-2045(17)30717-9.[6]. Rabindran, S.K., Discafani, C.M., Rosfjord, E.C., Baxter, M., Floyd, M.B., Golas, J., Hallett, W.A., Johnson, B.D., Nilakantan, R., Overbeek, E., et al. (2004). Antitumor activity of HKI-272, an orally active, irreversible inhibitor of the HER-2 tyrosine kinase. Cancer Res 64, 3958-3965. 10.1158/0008-5472.Can-03-2868.[7]. Tiwari, S.R., Mishra, P., and Abraham, J. (2016). Neratinib, A Novel HER2-Targeted Tyrosine Kinase Inhibitor. Clinical Breast Cancer 16, 344-348. 10.1016/j.clbc.2016.05.016.[8]. Wissner, A., and Mansour, T.S. (2008). The development of HKI-272 and related compounds for the treatment of cancer. Arch Pharm (Weinheim) 341, 465-477. 10.1002/ardp.200800009.[9]. Dall, P., Koch, T., Göhler, T., Selbach, J., Ammon, A., Eggert, J., Gazawi, N., Rezek, D., Wischnik, A., Hielscher, C., et al. (2017). Trastuzumab in Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: Results of a Prospective, Noninterventional Study on Routine Treatment Between 2006 and 2012 in Germany. Oncologist 22, 131-138. 10.1634/theoncologist.2016-0193.[10]. Li, J., Jiang, J., Bao, X., Kumar, V., Alley, S.C., Peterson, S., and Lee, A.J. (2022). Mechanistic Modeling of Central Nervous System Pharmacokinetics and Target Engagement of HER2 Tyrosine Kinase Inhibitors to Inform Treatment of Breast Cancer Brain Metastases. Clin Cancer Res 28, 3329-3341. 10.1158/1078-0432.Ccr-22-0405.[11]. Chan, A., Ruiz-Borrego, M., Marx, G., Chien, A.J., Rugo, H.S., Brufsky, A., Thirlwell, M., Trudeau, M., Bose, R., García-Sáenz, J.A., et al. (2023). Final findings from the CONTROL trial: Strategies to reduce the incidence and severity of neratinib-associated diarrhea in patients with HER2-positive early-stage breast cancer. Breast 67, 94-101. 10.1016/j.breast.2022.12.003.（来源：《肿瘤瞭望》编辑部）声 明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。
临床结果临床3期上市批准
2025-05-15
– Late-Breaking Data from the Phase 3 ASCENT-04/KEYNOTE-D19 Study Evaluating Trodelvy® plus Keytruda® in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer –
FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) will present more than 20abstracts across both Gilead and Kite at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting May 30 – June 3 and the 2025 European Hematology Association (EHA) Annual Congress June 12 – 15. The studies span breast cancer and other solid tumors (glioblastoma, endometrial cancer, lung cancer, gastric cancer), as well as multiple blood cancers (multiple myeloma, large B-cell lymphoma, indolent non-Hodgkin lymphoma, acute lymphoblastic leukemia).
At ASCO, Gilead will present detailed late-breaking results from the Phase 3 ASCENT-04 study showing a statistically significant and clinically meaningful benefit in progression-free survival for Trodelvy® plus Keytruda® versus Keytruda and standard of care chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (Abstract #LBA109). Additionally, Kite research collaborators at the University of Pennsylvania Perelman School of Medicine will present Phase 1 results evaluating a novel investigational CAR T-cell therapy using a dual-target approach in patients with recurrent glioblastoma during an oral session at ASCO (Abstract #102).
At EHA, Kite and its partner Arcellx will present updated findings from the Phase 2 registrational iMMagine-1 study of anitocabtagene-autoleucel (anito-cel) in relapsed/refractory multiple myeloma during an oral presentation (Abstract #S201).
Additional abstracts supporting pipeline therapies (e.g., KITE-363, a C19/20 dual-target CAR T) and results from collaborative studies will also be presented as orals across ASCO and EHA.
“Our oncology portfolio is broad and diverse by design, as we continue to innovate with next-generation therapies and combinations to deliver improved outcomes and ultimately seek to transform how cancer is treated,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “Data at ASCO and EHA will feature novel pipeline approaches with antibody-drug conjugate therapy and cell therapy, helping to drive oncology innovation and change medical practice.”
Summary of Presentations
Accepted abstracts at the 2025 ASCO Annual Meeting include:
Tumor Types
Abstract Title
Metastatic Triple-Negative Breast Cancer
Abstract #LBA109
May 31, 2025
3:35 – 3:47 PM CDT
(Oral Presentation)
Sacituzumab Govitecan (SG) + Pembrolizumab (Pembro) vs Chemotherapy (Chemo) + Pembro in Previously Untreated PD-L1 Positive Advanced Triple-Negative Breast Cancer (TNBC): Primary Results from the Randomized Phase 3 ASCENT-04/KEYNOTE-D19 Study
Abstract #511
June 1, 2025
8:12 – 8:18 AM CDT
(Oral Presentation)
A Phase 2 Study of Response-Guided Neoadjuvant Sacituzumab Govitecan and Pembrolizumab (SG/P) in Patients with Early-Stage Triple-Negative Breast Cancer: Results from the NeoSTAR Trial*
Lung Cancer
Abstract #8599
May 31, 2025
1:30 – 4:30 PM CDT
(Poster)
Longer Follow-up for Survival and Safety from the EVOKE-01 Trial of Sacituzumab Govitecan (SG) vs Docetaxel in Patients (pts) with Metastatic Non-small Cell Lung Cancer
Abstract #8522
May 31, 2025
1:30 – 4:30 PM CDT
(Poster)
Exploratory ctDNA Analyses for the EVOKE-1 Study in Metastatic Non-small Cell Lung Cancer
Abstract #11154
May 31, 2025
1:30 – 4:30 PM CDT
(Poster)
Characterizing Health Related Quality of Life Among Individuals Living with Non-Small Cell Lung Cancer in the United States: Findings from the Cancer Experience Registry
Endometrial Cancer
Abstract # e17624
May 22, 2025
4:00 PM CDT
(Online Publication Only)
Trop-2 Expression and its Prognostic Impact on Endometrial Cancer: A Real-world Data Analysis
Glioblastoma
Abstract #102
June 1, 2025
10:09 – 10:21 AM CDT
(Oral Presentation)
A Phase 1 Study of Intracerebroventricular Delivery of Bivalent CAR T-Cells Targeting EGFR and IL13Rα2 in Patients with Recurrent Glioblastoma**
Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomas
Abstract #4033
May 31, 2025
9:00 AM – 12:00 PM CDT
(Poster)
Real-world Analyses to Evaluate the Role of TIGIT as a Target in First-line (1L) Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomas
Head and Neck Squamous Cell Carcinoma (HNSCC)
Abstract # e18011
May 22, 2025
4:00 PM CDT
(Trial in Progress [TiP], Online Publication Only)
A Phase 2 Study of First-line Domvanalimab, Zimberelimab, and Chemotherapy in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Substudy-01 of the VELOCITY-HNSCC Platform Trial
B-cell Lymphoma
Abstract #7003
May 30, 2025
3:45 – 3:57 PM CDT
(Oral Presentation)
A Phase 1 Study of KITE-363 Anti-CD19/CD20 Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients (pts) with Relapsed/Refractory (R/R) B-cell Lymphoma
Large B-cell Lymphoma
Abstract #7023
June 1, 2025
9:00 AM – 12:00 PM CDT
(Poster)
Trends and Outcomes by Inpatient and Outpatient Infusion of Axicabtagene Ciloleucel (Axi-cel) in the US for Patients (Pts) with Relapsed / Refractory Large B-Cell Lymphoma
Secondary Central Nervous System Lymphoma
Abstract #2020
May 31, 2025
4:12 – 4:18 PM CDT
(Oral Presentation)
Using Single-Cell Transcriptomics to Reveal CD226 Upregulation and Enhancement of CD19-CAR-T Function in the Inhibitory CNS Microenvironment of Refractory CNS Lymphoma***
Abstract #7024
June 1, 2025
9:00 AM – 12:00 PM CDT
(Poster)
Real-world Outcomes of Axicabtagene Ciloleucel (Axi-cel) for the Treatment of Relapsed/Refractory (R/R) Secondary Central Nervous System Lymphoma
*Collaborative study with Massachusetts General Hospital and Dana-Farber Cancer Institute
**Collaborative study with the University of Pennsylvania Perelman School of Medicine
***Collaborative study with Dana-Farber Cancer Institute
Summary of Presentations
Accepted abstracts at the EHA 2025 Annual Congress include:
Tumor Types
Abstract Title
Acute Lymphoblastic Leukemia
Abstract #PF374
June 13, 2025
6:30 – 7:30 PM CEST
(Poster)
Five-year Survival Outcomes of Patients (Pts) With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (R/R B-ALL) Treated with Brexucabtagene Autoleucel (Brexu-cel) In ZUMA-3
Large B-cell Lymphoma
Abstract #PF1168
June 13, 2025
6:30 – 7:30 PM CEST
(Poster)
Cost-effectiveness of Real-world Axicabtagene Ciloleucel Use in Relapsed/Refractory 2L LBCL Based on a Multi-center US Registry
Abstract #PF1002
June 13, 2025
6:30 – 7:30 PM CEST
(Poster)
Prognostic Value of Circulating Tumor DNA (ctDNA) Detection by PhasED-Seq after Axicabtagene Ciloleucel (Axi-cel) Therapy in Relapsed/Refractory Large B-cell Lymphoma
Abstract #PF1304
June 13, 2025
6:30 – 7:30 PM CEST
(Poster)
Health Impact of Chimeric Antigen Receptor T-Cell Vein-to-Vein Time in Second-Line Large B-Cell Lymphoma Patients: An Exploratory Modelling Analysis for Italy
Abstract #S237
June 13, 2025
5:00 – 6:15 PM CEST
(Oral Presentation)
Real-world Effectiveness and Safety Outcomes Among Key Subgroups of Second-line (2L) Axicabtagene Ciloleucel (Axi-cel) for Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL)
Abstract # PB3232
May 14, 2025
(Publication Only)
The Italian Commercial Axi-cel Manufacturing Performance: A Retrospective Analysis of an Efficient and Reliable Process Over Time
Abstract # PB3238
May 14, 2025
(Publication Only)
Clinical, Economic, and Humanistic Outcomes of First-line High-Risk Large B-Cell Lymphoma: A Series of Systematic Literature Reviews
Mantle Cell Lymphoma
Abstract #PF954
June 13, 2025
6:30 – 7:30 PM CEST
(Poster)
Real-world Outcomes of Brexucabtagene Autoleucel (Brexu-cel) in Patients (Pts) with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): A Systematic Literature Review (SLR) And Meta-analysis
Multiple Myeloma
Abstract #S201
June 14, 2025
5:00 – 6:15 PM CEST
(Oral Presentation)
Phase 2 Registrational Study of Anitocabtagene-Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1
Abstract #PF1294
June 13, 2025
6:30 – 7:30 PM CEST
(Poster)
Understanding Caregiver Challenges in Multiple Myeloma (MM): A Systematic Literature Review (SLR) of the Qualitative and Quantitative Literature
Anitocabtagene autoleucel is an investigational therapy. Neither Kite or Arcellx has received approval from any regulatory authority for any use of this therapy, and its safety and efficacy has not been established.
The use of Trodelvy plus Keytruda in patients with previously untreated PD-L1+ unresectable locally advanced or metastatic TNBC is investigational, and the safety and efficacy of this use have not been established. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for the approved U.S. Indications and additional Important Safety Information.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Trodelvy
Trodelvy® (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.
Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.
Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.
Indications for Trodelvy
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:
Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Important Safety Information for Trodelvy
BOXED WARNING: NEUTROPENIA AND DIARRHEA
TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS
Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.
Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.
Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting.Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.
ADVERSE REACTIONS
In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).
In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.
DRUG INTERACTIONS
UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.
UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.
Please see full Prescribing Information, including BOXED WARNING.
About Anitocabtagene autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.
About Arcellx and Kite Collaboration
Arcellx and Kite, a Gilead Company, formed a global strategic collaboration to co-develop and
co-commercialize anito-cel for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Anito-cel is currently being developed in a Phase 2 registrational study and a Phase 3 pivotal study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.
About Kite
Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing.
Forward-Looking Statements
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Trodelvy, anito-cel, KITE-363 and a Phase 1 candidate in recurring glioblastoma (such as the ASCENT-04, iMMagine-1 and any confirmatory studies); uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.
Trodelvy, Gilead, the Gilead logo, Kite and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies.
U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on X/Twitter (@KitePharma) and LinkedIn (Kite-Pharma).
Blair Baumwell, Gilead Media public_affairs@gilead.com
Jacquie Ross, Investors investor_relations@gilead.com
临床结果临床2期ASCO会议临床3期细胞疗法
100 项与 盐酸洛哌丁胺 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 急性腹泻 | 日本 | 1981-06-04 | |
| 腹泻 | 美国 | 1976-12-28 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 非小细胞肺癌 | 临床3期 | 美国 | 2013-04-01 | |
| 输卵管癌 | 临床2期 | 美国 | 2001-09-01 | |
| 输卵管癌 | 临床2期 | 加拿大 | 2001-09-01 | |
| 输卵管癌 | 临床2期 | 荷兰 | 2001-09-01 | |
| 输卵管癌 | 临床2期 | 斯洛伐克 | 2001-09-01 | |
| 输卵管癌 | 临床2期 | 英国 | 2001-09-01 | |
| 卵巢癌 | 临床2期 | 美国 | 2001-09-01 | |
| 卵巢癌 | 临床2期 | 加拿大 | 2001-09-01 | |
| 卵巢癌 | 临床2期 | 荷兰 | 2001-09-01 | |
| 卵巢癌 | 临床2期 | 斯洛伐克 | 2001-09-01 |
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临床结果
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
早期临床1期 | 34 | (5% Loperamide Gel) | 觸憲廠襯鏇餘顧網襯簾 = 窪醖憲壓廠願壓糧壓壓 壓憲餘衊夢積餘顧齋獵 (構選鬱鹽遞願廠築觸繭, 簾齋艱糧願願鏇艱憲憲 ~ 餘鏇鬱鹹膚製窪範窪鏇) 更多 | - | 2024-09-19 | ||
Drug, placebo gel (Placebo Gel) | 觸憲廠襯鏇餘顧網襯簾 = 選襯範獵廠選遞獵鹹淵 壓憲餘衊夢積餘顧齋獵 (構選鬱鹽遞願廠築觸繭, 壓簾齋觸廠顧選廠觸鏇 ~ 積繭鏇膚網夢齋鬱淵鏇) 更多 | ||||||
临床2期 | 50 | 蓋網簾網餘糧簾壓廠糧(憲鹽選鹽構積獵餘顧範) = 鏇鏇鏇遞淵憲艱憲廠醖 蓋壓繭簾淵糧積獵簾簾 (繭醖製顧範築齋糧夢窪 ) 更多 | 积极 | 2024-05-24 | |||
临床3期 | 300 | Anal exercises with biofeedback+Loperamide (Loperamide - Exercise Plus Biofeedback) | 遞膚製製積壓憲築壓艱(鹹網願淵範遞簾簾蓋鏇) = 蓋鹽積蓋簾衊積鬱鹹觸 簾淵願顧範壓衊鏇願夢 (繭餘鏇積構憲糧壓夢鹹, 餘鹹繭積醖糧網蓋簾鑰 ~ 構膚鹹鏇網顧夢獵窪選) 更多 | - | 2018-11-20 | ||
Placebo (Placebo - Exercise Plus Biofeedback) | 遞膚製製積壓憲築壓艱(鹹網願淵範遞簾簾蓋鏇) = 糧鏇鹹壓選簾顧鹹網簾 簾淵願顧範壓衊鏇願夢 (繭餘鏇積構憲糧壓夢鹹, 構遞觸製艱壓築襯鬱窪 ~ 鑰憲淵艱願觸鑰築衊築) 更多 | ||||||
临床2期 | HER2阳性乳腺癌 HER2 Positive | 186 | 鹹夢衊壓壓鑰獵遞遞簾(糧壓觸製鹽蓋膚窪窪鹽) = 窪艱網蓋齋鹽夢窪製艱 鏇鹽構選醖膚積構簾衊 (網齋糧廠廠觸願鹹壓醖 ) | 积极 | 2018-02-15 | ||
鹹夢衊壓壓鑰獵遞遞簾(糧壓觸製鹽蓋膚窪窪鹽) = 淵築觸範鏇鬱積願築夢 鏇鹽構選醖膚積構簾衊 (網齋糧廠廠觸願鹹壓醖 ) | |||||||
临床3期 | - | 12 | 鏇積網淵構願鹽廠網顧(夢壓衊觸選範糧繭蓋積) = 積膚艱鬱夢膚選蓋廠憲 淵製網夢構築膚蓋網鹹 (範廠鑰醖選遞蓋醖壓鹽 ) | - | 2017-12-01 | ||
N/A | 384 | 鑰憲觸艱淵壓鑰積膚壓(蓋構窪製夢鏇膚糧鹹襯) = 築製齋襯鹽顧願廠齋遞 廠範夢糧鏇衊願鑰艱鹹 (壓鏇壓簾積鑰廠膚構願 ) 更多 | - | 2017-11-29 | |||
鑰憲觸艱淵壓鑰積膚壓(蓋構窪製夢鏇膚糧鹹襯) = 壓廠鏇顧艱衊憲窪壓窪 廠範夢糧鏇衊願鑰艱鹹 (壓鏇壓簾積鑰廠膚構願 ) 更多 | |||||||
临床2期 | HER2阳性乳腺癌 HER2+ | 133 | 鏇觸範餘齋積齋繭鏇製(餘齋夢顧餘蓋遞糧夢簾) = 積範壓膚築淵鹽衊餘蓋 蓋遞夢觸餘艱鹹膚製構 (觸築壓繭鬱鏇鑰襯艱艱 ) 更多 | 积极 | 2017-02-15 | ||
鏇觸範餘齋積齋繭鏇製(餘齋夢顧餘蓋遞糧夢簾) = 廠簾夢製願構製糧壓範 蓋遞夢觸餘艱鹹膚製構 (觸築壓繭鬱鏇鑰襯艱艱 ) 更多 | |||||||
临床4期 | 5 | DMF (Control Group) | 醖憲積糧製簾襯餘鬱鑰(觸餘構蓋夢窪淵鑰構蓋) = 糧壓憲鏇艱蓋壓襯構壓 襯構齋顧簾範選鹹獵觸 (鏇衊廠窪膚製壓艱顧鬱, 憲醖積壓淵齋齋觸憲齋 ~ 繭艱積選襯廠築艱範齋) 更多 | - | 2017-01-06 | ||
(Treatment Arm) | 醖憲積糧製簾襯餘鬱鑰(觸餘構蓋夢窪淵鑰構蓋) = 鑰遞夢餘積艱襯夢餘壓 襯構齋顧簾範選鹹獵觸 (鏇衊廠窪膚製壓艱顧鬱, 鹽築獵鹽淵選壓鹹觸網 ~ 淵淵醖觸鹹構遞簾鹹齋) 更多 | ||||||
临床2/3期 | 9 | (Medications) | 蓋築齋鹹襯醖窪夢鑰積(願築顧糧網選鹹醖願艱) = 築範選觸簾範糧餘築築 壓願醖繭襯鬱獵築憲鏇 (鑰糧蓋鹽鬱夢觸憲願艱, 1.94) 更多 | - | 2016-07-15 | ||
placebo (Placebo) | 蓋築齋鹹襯醖窪夢鑰積(願築顧糧網選鹹醖願艱) = 衊範構願顧鏇構鹹製簾 壓願醖繭襯鬱獵築憲鏇 (鑰糧蓋鹽鬱夢觸憲願艱, 2.3) 更多 | ||||||
N/A | 大便失禁 一线 | 80 | 糧簾衊鏇壓獵醖積憲鹽(網蓋醖蓋廠蓋糧夢築遞) = Constipation occurred in 29% of participants for loperamide vs 10% for psyllium 繭願淵鬱鑰範顧鹹遞夢 (顧蓋觸構膚糧選獵憲積 ) | 不佳 | 2015-10-01 | ||
Psyllium |
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