A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

开始日期2025-04-09

申办/合作机构-

CTR20250874

/ Recruiting临床3期

一项在内分泌治疗敏感的 PIK3CA 突变型、HR 阳性、HER2 阴性晚期乳腺癌患者中评价 Inavolisib 联合CDK4/6 抑制剂和来曲唑对比安慰剂联合CDK4/6抑制剂和来曲唑的有效性和安全性的多中心、随机、双盲、安慰剂对照、III 期研究

评价inavolisib 联合CDK4/6i 和来曲唑对比安慰剂联合 CDK4/6i 和来曲唑的有效性

开始日期2025-03-24

申办/合作机构

F. Hoffmann-La Roche Ltd.

[+1]

NCT05708235

/ Active, not recruiting临床2期

A Proof of Concept Study to Evaluate Treatments' Efficacy by Monitoring Minimal Residual Disease Using ctDNA in HR-positive/HER2-negative Early Breast Cancer Population

This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative early-stage BC at higher risk of relapse, who have undergone surgery within the previous five years, with no evidence of locoregional, contralateral, or distant disease.
The study design is composed by an initial pre-screening phase, a molecular follow-up phase (ctDNA surveillance phase), and an interventional therapeutic phase (treatment phase).
After informed consent is obtained, a total of1,260 eligible patients will enter a ctDNA surveillance in which primary tumor tissue and matched normal blood will be collected from each patient to obtain a patient-specific somatic mutations panel (tumor signature).
At the event of ctDNA positivity, patients will be screened to enter the treatment phase of the study. Upon confirmed eligibility, a total of 40 patients will be allocated in one of the following trial's arms adopting a sequential recruitment strategy:
Arm A: Control Arm (N=10) Arm B: Experimental Arm with giredestrant (N=10) Arm C: Experimental Arm with giredestrant + abemaciclib (N=10) Arm D: Experimental Arm with giredestrant + inavolisib (N=10)
If the strategy of ctDNA monitoring enables physicians to identify patients at high risk of relapse and assess whether treatment at molecular relapse can improve outcome, new cohorts may be added to the study.

开始日期2024-04-01

申办/合作机构

Medica Scientia Innovation Research SL

100 项与伊那利塞相关的临床结果

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100 项与伊那利塞相关的转化医学

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100 项与伊那利塞相关的专利（医药）

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项与伊那利塞相关的文献（医药）

2025-05-01·CHEMISTRY-A EUROPEAN JOURNAL

Fluorine in the Pharmaceutical Industry: FDA‐Approved Fluorine‐Containing Drugs in 2024

Review

作者: Sorochinsky, Alexander E. ; Zhang, Wei ; Semghouli, Anas ; Du, Youlong ; Soloshonok, Vadim A. ; Kiss, Loránd ; Baecker, Daniel ; Han, Jianlin ; Dhawan, Gagan ; Bian, Yeping

Abstract:

Fluorine has become an essential element in the development of modern pharmaceuticals, due to its unique chemical properties that can significantly enhance the biological activity, metabolic stability, and lipophilicity of drug molecules. This review explores recent advancements in the synthesis and application of fluorine‐containing drugs approved by the US Food and Drug Administration (FDA) in 2024. These novel drugs demonstrate improved efficacy and safety profiles, addressing a range of therapeutic areas including oncology, infectious diseases, metabolic disorders and genetic disorders that affect the adrenal glands. The incorporation of fluorine atoms into drug candidates has facilitated the development of molecules with optimized pharmacokinetic and pharmacodynamic properties, leading to better patient outcomes. The review further discusses the synthetic methodologies employed, the structural characteristics of these drugs, and their clinical implications, providing insights into the ongoing innovation within the pharmaceutical industry driven by fluorine chemistry.

2025-05-01·EUROPEAN JOURNAL OF CANCER

Inavolisib plus letrozole or fulvestrant in PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (GO39374): An open-label, multicentre, dose-escalation and dose-expansion phase 1/1b study

Article

作者: Aimi, Junko ; Schmid, Prof Peter ; Hutchinson, Katherine E ; Accordino, Melissa K ; Song, Kyung ; Oliveira, Mafalda ; Jhaveri, Komal L ; Shankar, Noopur ; Gambardella, Valentina ; Jin, Yanling ; Kalinsky, Prof Kevin ; Saura, Cristina ; Royer-Joo, Stephanie ; Cheeti, Sravanthi ; Schutzman, Jennifer L ; Cervantes, Prof Andrés ; Italiano, Prof Antoine ; Hamilton, Erika ; Varga, Andrea ; Bedard, Philippe L ; Krop, Prof Ian E ; Hilz, Stephanie ; Dey, Anwesha ; Turner, Prof Nicholas ; Peters, Ubong ; Juric, Dejan

BACKGROUND:

A variety of treatment options continue to be explored in the post-cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) setting for hormone receptor (HR)-positive, HER2-negative locally advanced/metastatic breast cancer (LA/mBC), and optimal sequencing of therapies remains to be determined. This phase 1/1b study examined inavolisib, a potent and selective PI3Kα inhibitor that promotes mutated p110α degradation, alone and in combination with endocrine therapy (ET) ± palbociclib, in PIK3CA-mutated, HR-positive, HER2-negative LA/mBC. We report data on inavolisib plus ET, including in patients who had previously received a CDK4/6i.

METHODS:

Women age ≥ 18 years received inavolisib (6 mg/9 mg orally once daily [PO QD]) plus letrozole (2·5 mg PO QD), or inavolisib (9 mg PO QD) plus fulvestrant (500 mg intramuscularly on Days 1 and 15 of Cycle 1 then every 4 weeks), until unacceptable toxicity/disease progression.

PRIMARY ENDPOINT:

safety and tolerability.

FINDINGS:

Thirty-seven and 60 patients were enrolled in the inavolisib plus letrozole and inavolisib plus fulvestrant arms, respectively. Overall, treatment-related adverse events (mostly low grade) occurred in 94·6 % and 93·3 % of patients, respectively; the most frequent (≥10 % of patients in either arm) were hyperglycaemia, stomatitis, nausea, and diarrhoea. Confirmed objective response rates in patients with measurable disease were 9·7 % and 25·9 %, respectively; median progression-free survival was 3·7 and 7·3 months. Among patients with previous CDK4/6i therapy (29/37 and 58/60 patients, respectively), confirmed objective response rates were 13·0 % and 25·0 %; median progression-free survival was 3·7 and 7·1 months. No drug-drug interactions were observed for any study treatment. Paired baseline and Cycle 1 Day 15 tumour biopsies and circulating tumour DNA analyses demonstrated the impact of study treatment on pharmacodynamic/pathophysiologic biomarkers of response.

INTERPRETATION:

Inavolisib plus ET demonstrated a manageable safety profile and encouraging preliminary anti-tumour activity in patients with PIK3CA-mutated, HR-positive, HER2-negative LA/mBC, including those in the post-CDK4/6i setting.

2025-04-01·SLAS Discovery

Combinatorial screen of targeted agents with the PI3K inhibitors inavolisib, alpelisib, duvelisib, and copanlisib in multi-cell type tumor spheroids

Article

作者: Doroshow, James H ; Coussens, Nathan P ; Silvers, Thomas ; Morris, Joel ; Davoudi, Zahra ; Takebe, Naoko ; Teicher, Beverly A ; Dexheimer, Thomas S ; Said, Rabih ; Moscow, Jeffrey A

Dysregulation of the phosphatidylinositol 3-kinase (PI3K) pathway is a key contributor to cancer, making PI3K inhibitors a promising approach for targeted therapy. The selectivity of available inhibitors varies across different PI3K isoforms. Alpelisib and inavolisib are selective for the α-isoform, while duvelisib targets the δ- and γ-isoforms, and copanlisib is a pan-PI3K inhibitor, active against all isoforms. This study investigated the activity of these four PI3K inhibitors in combination with other targeted agents using multi-cell type tumor spheroids composed of 60% malignant cells, 25% endothelial cells, and 15% mesenchymal stem cells. Twenty-nine tumor spheroid models were evaluated, including twenty-six patient-derived cancer cell lines from the NCI Patient-Derived Models Repository and three established cell lines from the NCI-60 human tumor cell line panel. Additive and/or synergistic effects were observed with alpelisib or inavolisib or copanlisib in combination with a RAS/MEK/ERK pathway inhibitor, either selumetinib (MEK), ravoxertinib (ERK 1/2), or tovorafenib (DAY101, RAF). Combinations of each of these three PI3K inhibitors with the KRAS mutation specific inhibitors MTRX1133 (KRAS G12D) or sotorasib (KRAS G12C) had selective activity in cell lines harboring the corresponding target. Lastly, combination effects were observed from vertical inhibition of the PI3K/AKT/mTOR pathway with a PI3K inhibitor in combination with either the mTORC1/2 inhibitor sapanisertib or an AKT inhibitor, ipatasertib or afuresertib.

179

项与伊那利塞相关的新闻（医药）

2025-05-31

·PipelineReview

New Data Show Genentech’s Itovebi Significantly Extended Survival in a Certain Type of HR-positive Advanced Breast Cancer

– The Itovebi (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone – – The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis – – New data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine – SOUTH SAN FRANCISCO, CA, USA I May 31, 2025 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive final results from the overall survival (OS) analysis of the Phase III INAVO120 study. These data showed Itovebi TM (inavolisib), in combination with palbociclib (Ibrance ® ) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The results are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM). “For the first time, a PI3K pathway-targeted drug has shown it can help people with this breast cancer subtype live longer,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Itovebi exemplifies our continued commitment to improve survival rates for people with this common PIK3CA mutation, for whom more effective treatment options are needed.” “The landmark data for the inavolisib-based regimen showed not only a doubling in progression-free survival, but importantly that it extended lives and gave people more time without chemotherapy,” said Professor Nicholas Turner, lead study author and professor of molecular oncology at The Institute of Cancer Research, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, London, United Kingdom. “These results give us confidence that this regimen could become the new standard of care in the first-line setting, having demonstrated a substantial benefit on patient outcomes and quality of life.” The Itovebi-based regimen demonstrated a meaningful OS benefit compared with palbociclib and fulvestrant alone. The median OS was 34.0 months (95% CI: 28.4–44.8) for people in the Itovebi arm, compared with 27.0 months (95% CI: 22.8–38.7) in the palbociclib and fulvestrant arm (stratified hazard ratio [HR]=0.67; 95% CI: 0.48–0.94, p-value=0.0190 [boundary=0.0469]). The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months (stratified HR=0.42, 95% CI: 0.32-0.55) in the comparator arm. The Itovebi-based regimen also led to a statistically significant improvement in objective response rate (the percentage of patients whose signs of cancer completely disappear or their tumors shrink significantly after treatment) and ad-hoc exploratory analyses showed it substantially delayed time to chemotherapy by approximately two years (stratified HR=0.43; 95% CI: 0.30-0.60). No new safety signals were observed at the time of the final OS analysis, with a low discontinuation due to adverse events supporting good tolerability. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored Phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA -mutated, locally advanced or metastatic breast cancer in various combinations. We are exploring additional studies in breast cancer and other tumor types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. About the INAVO120 study The INAVO120 study [ NCT04191499 ] is a Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease. The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomization in the clinical trial to the time when the disease progresses, or a patient dies from any cause. Secondary endpoints include overall survival, objective response rate, and clinical benefit rate. Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored Phase III clinical studies in PIK3CA -mutated locally advanced or metastatic breast cancer in various combinations: About hormone receptor (HR)-positive breast cancer HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases. A defining feature of HR-positive breast cancer is that its tumor cells have receptors that attach to one or both hormones – estrogen or progesterone – which can contribute to tumor growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options. The PI3K signaling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors. What is Itovebi? Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha ( PIK3CA ) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy. Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you. Please see additional Important Safety Information in the full Itovebi Prescribing Information or visit https://www.itovebi.com . About Genentech in Breast Cancer Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com . SOURCE: Genentech

临床3期临床结果ASCO会议

2025-05-31

·icr.ac.uk

New therapy improves breast cancer survival and delays chemotherapy

A promising new therapy can help patients with aggressive advanced breast cancer live longer and delay the need for further chemotherapy, new research has shown. Final results of the INAVO120 study, led by an international team of researchers including scientists at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, have demonstrated the potential of the new therapy combination for targeting PIK3CA-mutated hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer – a common form of the disease. The international study, funded by Roche, was presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago on 31 May 2025 and simultaneously published in The New England Journal of Medicine. The new combination therapy which is made up of two targeted drugs – inavolisib and palbociclib – along with hormone therapy fulvestrant, was shown to haveimproved overall survival by an average of seven months, compared with the patients in the control group, who were given palbociclib and fulvestrant, a combination which has been approved for use on the NHS since September 2022. The median overall survival in the inavolisib group was 34 months, compared with 27 months in the control group. Updated results of the phase III, randomised, double blind trial also showed that the new combination delayed the progression of the disease by 17.2 months, on average, compared with 7.3 months in the control group. Patients taking inavolisib were able to delay subsequent chemotherapy treatment by almost two years longer than the patients in the control group. The team, led by Professor Nicholas Turner, Professor of Medical Oncology in the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research (ICR), now hopes the combination will become the standard of care in women with this form of the disease. Around 55,000 women are diagnosed with breast cancer in the UK every year and 11,500 will die from the disease. Around 70 per cent of patients have HR+, HER2- breast cancer. PIK3CA mutations are found in 35-40 per cent of HR+ breast cancers, and are linked to tumour growth, disease progression, and treatment resistance. The INAVO120 study recruited 325 patients from 28 countries. More than half had metastatic disease that had already spread to three or more organs and most (82.8 per cent) had prior adjuvant chemotherapy. The researchers used circulating tumour DNA (ctDNA) ‘liquid biopsy’ blood tests to determine whether patients had a PIK3CA mutation. Participants were then allocated to receive either the inavolisib-based regimen or a combination of palbociclib, fulvestrant and a dummy pill. The new drug, inavolisib works by blocking the activity of the PIK3CA protein. However, it also has a second mode of action which triggers the breakdown of the mutated PI3K alpha protein, destroying it altogether – a process known as targeted protein degradation. At the ICR, researchers are working to discover new protein degrading drugs like this, which could help people with advanced cancers live well for longer. Palbociclib is a type of drug called cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors. It works by simultaneously blocking two proteins called CDK4 and CDK6 in cancer cells and preventing them from growing. The inavolisib combination was generally well tolerated with only a few patients experiencing side effects that led them to discontinue the treatment. The results also showed substantial shrinking, or response, in cancer growth in around 62.7 per cent of patients in the triplet therapy group compared to 28 per cent in the control group. Earlier results led the United States Food and Drug Administration (FDA) to grant ‘breakthrough therapy’ designation for inavolisib in May 2024. The breakthrough follows a pioneering programme of discoveries in the lab at the ICR, going back over a decade. The results of the PALOMA3 trial in 2015, showed that women treated with a combination of palbociclib and standard hormone therapy saw their disease progress after an average of nine months, compared with fewer than four months with hormone therapy alone. Then in 2016, the ICR team published research which showed how breast cancer cells become resistant to CDK4/6 inhibitors such as palbociclib and identified that a combination of three drugs — a CDK4/6 inhibitor, a hormone therapy and a PI3K inhibitor — would provide the best tumour control compared with two-drug combinations. Four years later, a study trialling a combination of palbociclib, taselisib and hormone therapy showed some success, although the researchers determined that taselisib was not the right PI3K inhibitor. However, these results demonstrated an important proof of concept for the combination therapy and paved the way for the INAVO120 study. Lead author Professor Nicholas Turner, Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. It also gave them more time before needing subsequent chemotherapy which we know is something that patients really fear and want to delay for as long as possible. “These results give us confidence that this treatment could become the new go-to option for patients who have HR+, HER2- breast cancer with a PIK3CA mutation, as it has shown significant improvements in both survival and quality of life. Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said: "If we are to continue improving cancer survival rates, we need to tackle treatment resistance head-on. This research demonstrates how this triple combination approach, effectively shuts down cancer’s escape routes, giving people with metastatic breast cancer the opportunity to live well for longer. “One of the challenges with combination therapies is ensuring the right drug dosages and understanding their individual effects. It is extremely encouraging that this study not only demonstrates the effectiveness of this approach but also shows that the therapy was generally well-tolerated by patients. “This research reinforces our commitment to developing innovative treatments that transform lives and set new standards in cancer care. It is a powerful reminder of how scientific innovation can reshape the future of cancer care and give hope to countless patients worldwide." Anne Lury, 53, was diagnosed with stage two breast cancer in 2007 and 10 years later she was given the news that her cancer had spread to other parts of her body. Anne received the new PI3K inhibitor drug, inavolisib, after joining a clinical trial at The Royal Marsden. “I’d had a benign noncancerous lump removed when I was just 16, so when I first noticed a new lump, I initially thought it might also be benign, but unfortunately further tests revealed that I had breast cancer. “Following my diagnosis, I was treated with surgery, chemotherapy and radiotherapy over a period of 10 years. I was always on some kind of treatment but despite this the cancer eventually spread to other parts of my body, which is when I received the targeted therapy drug palbociclib. After three years the treatment stopped working for me, but thankfully I was able to receive inavolisib as part of a clinical trial. “Aside from fatigue, I had minimal side effects, and although I’m now on other treatment I wouldn’t be here if I hadn’t had the opportunity to join the trial at The Royal Marsden.”

临床结果ASCO会议临床3期突破性疗法

2025-05-26

·GBIHealth

诺和盈展现心脏保护新证据，疗效早于明显减重

药械追踪No.1 / 远大医药眼科新药GPN01768在中国澳门获批，治疗蠕形螨睑缘炎2025年5月26日，远大医药（0512.HK）宣布，其用于治疗蠕形螨睑缘炎的全球创新眼科药物GPN01768（TP-03，洛替拉纳滴眼液，0.25%）已获得中国澳门特别行政区政府药物监督管理局批准上市。蠕形螨是导致蠕形螨睑缘炎的根本原因，GPN01768是一款对昆虫和蛛形纲动物体内的γ-氨基丁酸门控氯离子通道（GABA-Cl）具有选择性的非竞争性拮抗剂，通过选择性抑制蠕形螨体内的GABA-Cl，使虫体麻痹和死亡，进而治疗蠕形螨睑缘炎。此外，GPN01768具有高度亲脂性，可促进其在螨虫栖息的睫毛毛囊油脂中的吸收。GPN01768由Tarsus Pharmaceuticals, Inc.（以下简称“Tarsus”）开发，是首款也是唯一一款获得美国食品药品监督管理局（FDA）批准用于治疗蠕形螨睑缘炎的产品。2024年3月，远大医药与Tarsus达成产品引进战略合作协定，并从联拓生物科技有限公司取得GPN01768在大中华区（中国大陆及港澳台）的独家开发、生产及商业化权益。->点击文末阅读原文，解锁完整双语新闻No.2 / 济民可信伊立替康脂质体注射液获批，带来晚期胰腺癌新选择5月22日，济民可信（603222.SH）宣布，其自主研发的抗肿瘤药物济立安（盐酸伊立替康脂质体注射液）已获国家药品监督管理局批准上市。该产品为国内第二家批准上市并视同通过一致性评价的仿制药，将为晚期胰腺癌患者带来新的治疗选择。与传统伊立替康注射液相比，济立安采用脂质体技术，具有更好的靶向性和生物相容性，可显著降低骨髓抑制、腹泻等毒副反应，提高治疗耐受性。国际研究表明，伊立替康脂质体联合5-FU/LV方案能显著延长转移性胰腺癌患者的中位无进展生存期和总生存期。2022年4月，原研施维雅易安达获得国家药品监督管理局正式批准，与5-氟尿嘧啶和亚叶酸联合用于接受吉西他滨治疗后进展的转移性胰腺癌患者。济民可信研发的仿制药济立安在临床实验中表现出色，试验结果显示该产品与原研制剂对比人体生物等效性完全一致。济立安是济民可信今年内第二个获批上市的脂质体产品。->点击文末阅读原文，解锁完整双语新闻No.3 / 诺和盈展现心脏保护新证据，疗效早于明显减重5月23日，诺和诺德（NYSE:NVO）宣布，旗下GLP-1类药物司美格鲁肽2.4 mg（诺和盈）在SELECT研究的二次分析中显示出显著的早期心脏保护作用。研究发现，在治疗前三个月内，诺和盈可将超重或肥胖且患有心血管疾病的成人患者主要不良心血管事件（MACE）风险降低37%；六个月内，心血管死亡风险降低50%，心衰相关住院或因心血管疾病死亡的综合风险下降59%。值得关注的是，这些益处出现在体重尚未显著下降（减重≤5%）阶段，说明诺和盈的心脏保护效应不仅依赖于减重。此前的研究也已证实，诺和盈在平均近39.8个月的治疗中，可将MACE风险降低20%。诺和盈目前已在中国获批用于BMI≥30的肥胖人群，或BMI≥27且合并高血压等体重相关疾病的成人长期体重管理。新一轮数据进一步强化了其在高危人群中的干预价值。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 欧洲药监局推荐艾力雅8mg扩展至每6个月用药一次2025年5月23日，拜耳公司宣布，欧洲药品管理局（EMA）的人用药品委员会（CHMP）已发布积极意见，推荐扩展艾力雅8 mg（阿柏西普8 mg，114.3 mg/ml注射液）的使用标签，将治疗间隔延长至最长6个月，用于治疗两种主要的视网膜疾病：新生血管性（湿性）年龄相关性黄斑变性（nAMD）和糖尿病性黄斑水肿（DME）。预计欧洲委员会将在未来几周内做出决定，如果获得批准，艾力雅8 mg将成为欧盟唯一一种在nAMD和DME治疗中可延长至6个月治疗间隔的抗血管内皮生长因子（VEGF）治疗药物。2025年2月，拜耳向EMA提交该上市申请。阿柏西普由拜耳和再生元合作开发，是一款VEGFR-Fc融合蛋白，最早于2011年11月在美国获批上市，商品名艾力雅，至今获批用于治疗新生血管性老年性黄斑变性（AMD）、视网膜静脉阻塞、糖尿病性视网膜病变和其他眼部疾病。->点击文末阅读原文，解锁完整双语新闻No.2 / 罗氏PI3Kα抑制剂伊那利塞获欧盟积极批准意见2025年5月23日，罗氏（SIX：RO，ROG；OTCQX：RHHBY）宣布，欧洲药品管理局（EMA）的人用药品委员会（CHMP）对伊那利塞（商品名：伊赫莱/Itovebi）联合哌柏西利（商品名：爱博新/Ibrance）和氟维司群用于治疗成人PIK3CA突变、雌激素受体（ER）阳性、人表皮生长因子受体2（HER2）阴性、局部晚期或转移性乳腺癌患者采纳了积极意见。伊那利塞是一种口服靶向治疗药物，已证明在PIK3CA突变、激素受体阳性、HER2阴性晚期乳腺癌患者中能够提供耐受性良好且持久的疾病控制，这些患者通常预后较差，急需新的治疗选择。伊那利塞旨在帮助最小化治疗的整体负担和毒性，与其他PI3K抑制剂相比，其独特之处在于对PI3Kα亚型具有高选择性和特异性，能够促进突变PI3Kα的降解。->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

上市批准一致性评价

100 项与伊那利塞相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11942	-	-	DB15275

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
乳腺癌	加拿大	Hoffmann-La Roche Ltd.	2025-02-01
PIK3CA突变/HR阳性/HER2阴性乳腺癌	美国	Genentech, Inc.	2024-10-10

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
PIK3CA突变/HER2阳性乳腺癌	临床3期	中国	Hoffmann-La Roche, Inc.	2023-09-08
PIK3CA突变/HER2阳性乳腺癌	临床3期	阿根廷	Hoffmann-La Roche, Inc.	2023-09-08
PIK3CA突变/HER2阳性乳腺癌	临床3期	澳大利亚	Hoffmann-La Roche, Inc.	2023-09-08
PIK3CA突变/HER2阳性乳腺癌	临床3期	比利时	Hoffmann-La Roche, Inc.	2023-09-08
PIK3CA突变/HER2阳性乳腺癌	临床3期	巴西	Hoffmann-La Roche, Inc.	2023-09-08
PIK3CA突变/HER2阳性乳腺癌	临床3期	加拿大	Hoffmann-La Roche, Inc.	2023-09-08
PIK3CA突变/HER2阳性乳腺癌	临床3期	哥伦比亚	Hoffmann-La Roche, Inc.	2023-09-08
PIK3CA突变/HER2阳性乳腺癌	临床3期	芬兰	Hoffmann-La Roche, Inc.	2023-09-08
PIK3CA突变/HER2阳性乳腺癌	临床3期	法国	Hoffmann-La Roche, Inc.	2023-09-08
PIK3CA突变/HER2阳性乳腺癌	临床3期	德国	Hoffmann-La Roche, Inc.	2023-09-08

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临床结果

适应症

分期

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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


NCT04191499 (INAVO120, ASCO2025)	临床3期	PIK3CA突变/HR阳性/HER2阴性乳腺癌一线 PIK3CA-mutated \| hormone receptor-positive \| HER2-negative	-	inavolisib (INAVO + PALBO + FULV)	膚蓋艱繭壓觸構衊壓獵(築鏇積鏇築壓鹹餘膚膚) = 選醖淵廠製鑰鬱蓋願製鏇齋鹽鬱範繭築選範衊 (艱願衊積鏇觸糧窪壓憲, 28.4 ~ 44.8) 更多	积极	2025-05-30
				inavolisib (PBO + PALBO + FULV)	膚蓋艱繭壓觸構衊壓獵(築鏇積鏇築壓鹹餘膚膚) = 鏇製製餘夢蓋顧顧觸獵鏇齋鹽鬱範繭築選範衊 (艱願衊積鏇觸糧窪壓憲, 22.8 ~ 38.7) 更多
NCT03006172 (GO39374, ASCO2025)	临床1期	PIK3CA突变/HR阳性/HER2阴性乳腺癌 PIK3CA-mutated \| hormone receptor-positive \| HER2-negative	190	Inavolisib alone	構餘窪餘顧簾廠範淵製(蓋醖餘醖窪繭網鏇繭衊) = 鏇鹽窪糧淵網淵積願膚窪醖窪廠糧淵鬱憲壓鹹 (鑰獵憲鬱鑰憲蓋醖觸鬱, grade 3 ~ 4: 34.5%)	积极	2025-05-30
NCT04191499 (INAVO120, Pubmed \| N Engl J Med \| NEWS) 人工标引	临床3期	PIK3CA突变/HR阳性/HER2阴性乳腺癌一线 PIK3CA Mutation \| Hormone Receptor Positive \| HER2 Negative	325	Inavolisib plus palbociclib-fulvestrant	鏇憲廠遞醖構衊醖窪願(夢艱膚廠築膚壓鑰選鹹) = 鹹網艱膚夢願廠範遞糧範糧醖鏇網餘憲蓋膚壓 (壓鹹鹹觸鹹淵糧製齋憲, 11.3 ~ 20.5) 更多	积极	2024-10-31
				Placebo plus palbociclib-fulvestrant	鏇憲廠遞醖構衊醖窪願(夢艱膚廠築膚壓鑰選鹹) = 構餘壓願醖鏇範襯醖願範糧醖鏇網餘憲蓋膚壓 (壓鹹鹹觸鹹淵糧製齋憲, 5.6 ~ 9.3) 更多
NCT04191499 (INAVO120, FDA) 人工标引	临床2/3期	PIK3CA突变/HR阳性/HER2阴性乳腺癌 Hormone Receptor Positive \| HER2 Negative \| PIK3CA Mutation	325	Inavolisib 9 mg + Palbociclib + Fulvestrant	願餘淵醖襯壓鬱繭製憲(範選鹽觸鑰鹹衊鹽鑰艱) = 網選網觸製糧願壓壓醖夢繭簾鏇鑰顧鹹蓋構襯 (膚網遞襯網蓋築選獵獵, 11.3 ~ 20.5) 更多	积极	2024-10-10
				Placebo + Palbociclib + Fulvestrant	願餘淵醖襯壓鬱繭製憲(範選鹽觸鑰鹹衊鹽鑰艱) = 遞壓鏇襯積顧廠積蓋觸夢繭簾鏇鑰顧鹹蓋構襯 (膚網遞襯網蓋築選獵獵, 5.6 ~ 9.3) 更多
NCT04191499 (INAVO120, CTgov)	临床2/3期	PIK3CA突变的乳腺癌	325	fulvestrant+palbociclib+inavolisib (Inavo+Palbo+Fulv)	網糧構鏇製觸築鏇糧積(簾鹽鹹淵憲遞積鹹蓋獵) = 餘積繭夢繭遞鑰衊醖構構齋艱觸積壓淵範構醖 (襯簾壓餘膚襯壓醖鬱築, 餘鹹衊顧顧窪選憲網廠 ~ 餘艱鹽醖鑰鹽鏇鹽鹽積) 更多	-	2024-10-09
				placebo+fulvestrant+palbociclib (Pbo+Palbo+Fulv)	網糧構鏇製觸築鏇糧積(簾鹽鹹淵憲遞積鹹蓋獵) = 壓餘窪顧窪襯醖鹽遞夢構齋艱觸積壓淵範構醖 (襯簾壓餘膚襯壓醖鬱築, 鹹膚夢衊製襯窪鏇願選 ~ 鹹醖獵繭鹹顧鏇鬱觸積) 更多
NCT04551521 (CRAFT, ESMO2024) 人工标引	临床2期	肿瘤 PIK3CA Mutation (Activating)	25	Inavolisib 9 mg q.d.	築艱簾淵範構鏇齋糧衊(膚獵顧糧憲鹽願窪鏇襯) = 製簾製繭壓繭鏇築顧鹹廠製憲夢選積構窪繭廠 (壓願鬱顧鹹製遞觸蓋繭 ) 更多	积极	2024-09-15
NCT03006172 (Pubmed \| J Clin Oncol) 人工标引	临床1期	PIK3CA突变/HR阳性/HER2阴性乳腺癌 HER2 Negative \| PIK3CA Mutation \| Hormone Receptor Positive	53	Inavolisib + Palbociclib + Letrozole	夢築鏇壓願顧齋艱鏇顧(鹹築廠憲夢壓築繭鹽餘) = occurred in all patients; the most frequent were stomatitis, hyperglycemia, and diarrhea 蓋淵鹹選襯網網糧鏇簾 (齋觸膚齋窪艱廠衊範選 )	积极	2024-09-05
				Inavolisib + Palbociclib + Fulvestrant
NCT04191499 (INAVO120, ASCO2024) 人工标引	临床3期	PIK3CA突变/HR阳性/HER2阴性乳腺癌 \| PIK3CA阳性/ER阳性/HER2阴性乳腺癌一线 HER2	325	Inavolisib+Palbociclib+Fulvestrant	壓鹹構製鹹憲夢夢繭網(壓願齋範餘鬱糧選網齋) = 蓋顧淵膚簾構廠網鏇獵觸糧淵鏇夢襯鏇蓋蓋繭 (構壓醖選積鬱蓋糧簾餘, 18.6–NE) 更多	积极	2024-05-24
				Placebo+Palbociclib+Fulvestrant	壓鹹構製鹹憲夢夢繭網(壓願齋範餘鬱糧選網齋) = 簾鑰築夢顧衊衊構願窪觸糧淵鏇夢襯鏇蓋蓋繭 (構壓醖選積鬱蓋糧簾餘, 13.5–22.3) 更多
NCT04191499 (INAVO120, Corporate Publications) 人工标引	临床3期	PIK3CA突变/HR阳性/HER2阴性乳腺癌一线 PIK3CA Mutation \| HER2 Negative \| Hormone Receptor Positive	325	Inavolisib+Palbociclib+Fulvestrant	蓋憲鏇襯範繭夢廠餘遞(憲廠遞築遞鬱鏇積鬱壓) = The study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement compared to palbociclib and fulvestrant alone. 蓋餘選網積廠憲醖鹹獵 (鏇獵憲積製窪壓獵鹹顧 ) 达到	积极	2023-12-04
				Placebo+Palbociclib+Fulvestrant
NCT03006172 (ASCO2022) 人工标引	临床1期	PIK3CA突变/HR阳性/HER2阴性乳腺癌 PIK3CA Mutation \| HR Positive \| HER2 Negative	57	inavolisib	獵積簾簾醖簾積構繭構(憲築鹽壓壓遞積繭範遞) = 2 (4%) discontinued treatment due to an AE (1 related G2 diarrhea, 1 unrelated G3 cerebrovascular disorder). 遞鹽鹹壓鏇繭製顧顧衊 (淵願鬱築觸範築選淵繭 ) 更多	积极	2022-06-02
				palbociclib+letrozole+inavolisib