This is a single center, open-label phase I clinical trial designed to determine the safety of personalized and adjusted neoantigen peptide vaccine (PANDA-VAC) administered concurrently with pembrolizumab in subjects with advanced squamous non-small cell lung cancer (NSCLC) or squamous cell carcinoma of head and neck (SCCHN).

开始日期2027-05-20

申办/合作机构

Lineberger Comprehensive Cancer Center

NCT07572123

/ Not yet recruiting临床2/3期IIT

A Two Cohort Randomized Study for Patients With High Risk (Phase II) and Standard Risk (Phase III) Classical Hodgkin Lymphoma in First Relapse

This phase II trial compares the impact of brentuximab vedotin and nivolumab after radiation to standard of care high dose chemotherapy (HDT)-autologous stem cell transplant (ASCT) in standard-risk patients with classic Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). In addition, the phase III trial will compare the effect of pembrolizumab after HDT-ASCT to standard of care HDT-ASCT alone in high-risk patients with relapsed or refractory classic Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. An ASCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving HDT before an ASCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Radiation therapy (RT) uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving brentuximab vedotin and nivolumab after radiation may be safe, tolerable and more effective than standard of care HDT-ASCT in treating patients with standard risk relapsed or refractory classic Hodgkin lymphoma. In addition, giving pembrolizumab after standard of care HDT-ASCT may be safe and tolerable and more effective than HDT-ASCT alone in treating high-risk patients with relapsed or refractory classic Hodgkin lymphoma.

开始日期2026-12-04

申办/合作机构

National Cancer Institute

NCT05077215

/ Not yet recruiting临床3期

A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).
Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:
* Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer)
* ECOG score at baseline (0 vs 1)
* Geographic region (Asia vs ROW)

开始日期2026-12-01

申办/合作机构

Evergreen Therapeutics, Inc

100 项与帕博利珠单抗相关的临床结果

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100 项与帕博利珠单抗相关的转化医学

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100 项与帕博利珠单抗相关的专利（医药）

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10,196

项与帕博利珠单抗相关的文献（医药）

2026-12-31·Human Vaccines & Immunotherapeutics

Mapping research trends in esophageal cancer immunotherapy: A decade of thematic evolution and emerging priorities

Review

作者: Zang, Qiwei ; Jia, Huijun ; Wei, Hongyu ; Gong, Yifan ; Zhao, Chengguang

Immunotherapy has become a pivotal therapy for various cancers, including esophageal cancer, showing promising potential in improving survival rates and enabling personalized care. However, significant challenges occur in identifying predictive biomarkers, refining combination therapies, and managing immunotherapy-related adverse effects. This bibliometric study analyzed publications related to the use of immunotherapy in esophageal cancer management over a 10-y period (January 1, 2015, to October 14, 2024), retrieved from the Web of Science Core Collection. Keyword co-occurrence and co-citation analyses were performed to identify key contributors, central themes, and influential publications. A total of 545 publications on esophageal cancer immunotherapy were included in the analysis. A sharp increase in publication volume was observed beginning in 2019, with a peak between 2021 and 2023. China emerged as the leading contributor, accounting for 67.7% of the total output, while Zhengzhou University produced the highest number of publications among all institutions. Prominent individual contributors included Ken Kato and Shen Lin. Research hotspots centered on PD-1/PD-L1 inhibitors, combination therapies, and tumor microenvironment modulation. Notably, a clear temporal evolution in research focus was observed, with early studies emphasizing specific immune checkpoint targets and agents (e.g., PD-1, Pembrolizumab, and CTLA-4), followed by a shift toward mechanistic investigations involving the tumor microenvironment, treatment resistance, and prognosis. This study provides a comprehensive view of immunotherapy in the management of esophageal cancer, offering direction for future research and valuable insights for clinical innovation.

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Economic evaluation of perioperative pembrolizumab plus standard of care as treatment for resectable locally advanced head and neck squamous cell carcinoma in the United States

Article

作者: Chafamo, Biruk ; Fernan, Catherine ; Muston, Dominic ; Johnson, Geoffrey ; Qian, Feng ; Tang, Yuexin ; Bensimon, Arielle G. ; Adkins, Douglas ; Zheng, Dandan ; Tzontcheva, Anjela ; Benjamin, Kimberly ; Uppaluri, Ravindra

AIMS:

In the phase 3 KEYNOTE-689 trial (NCT03765918) among patients with resectable locally advanced head and neck squamous cell carcinoma (LA HNSCC), perioperative pembrolizumab (pembrolizumab before surgery, then continued with standard-of-care [SOC] radiotherapy +/- cisplatin after surgery followed by pembrolizumab alone) significantly prolonged event-free survival vs. SOC alone, both in the intention-to-treat population and PD-L1 combined positive score (CPS) ≥1 subgroup. Perioperative pembrolizumab + SOC received Food and Drug Administration approval in June 2025 for resectable LA HNSCC expressing PD-L1 (CPS ≥ 1). The present study evaluated the cost-effectiveness of perioperative pembrolizumab + SOC versus SOC in this indication, from a US healthcare payer perspective.

MATERIALS AND METHODS:

A Markov cohort model with four states (event-free, local recurrence, incurable recurrence/progression, death) was developed to estimate lifetime costs, life years (LYs), and quality-adjusted LYs (QALYs) with 3% annual discounting. Transition probabilities were fitted to patient-level time-to-event data from KEYNOTE-689 through parametric multistate modelling. Costs of initial and subsequent treatment, adverse events, disease management, and terminal care were estimated in 2025$ based on trial results, drug labels, public databases, and literature. Utilities were derived through analyses of EQ-5D-5L data collected in KEYNOTE-689. Deterministic and probabilistic sensitivity analyses were performed.

RESULTS:

Compared to SOC, perioperative pembrolizumab + SOC increased total costs by $82,311 and provided gains of 1.47 QALYs and 1.77 LYs. Incremental cost-effectiveness ratios of perioperative pembrolizumab + SOC vs. SOC were $55,863/QALY and $46,406/LY. Higher initial treatment costs of perioperative pembrolizumab (incurred mainly in Year 1) were partially offset by lower recurrence-related costs. At the typical $150,000/QALY threshold, perioperative pembrolizumab + SOC was cost-effective in 96% of probabilistic simulations.

LIMITATIONS:

Survival extrapolations beyond the available trial period are subject to uncertainty.

CONCLUSIONS:

Perioperative pembrolizumab + SOC was found to be cost-effective versus SOC for the treatment of resectable LA HNSCC with CPS ≥ 1.

2026-12-31·OncoImmunology

A mixed inflammatory peripheral signature defines clinical outcomes in a phase II trial combining pembrolizumab with paclitaxel and carboplatin in melanoma

Article

作者: Cocolakis, Eftihia ; Cailhier, Jean-François ; Lapointe, Réjean ; Thébault, Paméla ; Lepage, Stéphanie ; Shechtman, Yelena ; Letendre, Caroline ; Le, Huy ; Dionne, Jeanne ; Jamal, Rahima ; Bélanger, Karl ; Lambert, Caroline ; Miller Jr, Wilson H.

Checkpoint blockade of PD-1 with pembrolizumab provides long-term survival to a significant proportion of patients with metastatic melanoma. Pembrolizumab has been successfully used in combination with chemotherapy in non-small-cell lung cancer to increase the response rate. This phase II trial combined pembrolizumab with carboplatin/paclitaxel (CP) to assess its safety and efficacy, and to identify correlates of responses. Thirty patients without prior immunotherapy for unresectable/metastatic melanoma were treated with pembrolizumab and CP. Peripheral blood was collected at baseline and after 2 cycles to characterize systemic immune activity by multiplex assays and flow cytometry. Seventy percent of patients received all 4 cycles of CP; 87% received pembrolizumab for 2 y or until progression. Grade 3 and higher adverse events (AEs) occurred in 50% of the patients. The overall response rate (ORR) and disease control rate (DCR) by irRC criteria were 43% and 53%, respectively. Median overall survival (OS) was 23.8 months. Objective response was associated with a lower frequency of naive CD8 T cells and low plasma CCL3 at baseline, along with a larger proportion of mature NK cells and of CD4 T cells expressing BTLA or LAIR-1. Survival rate was higher for patients with lower baseline of IL-6, IL-8, and CD4⁺CD39⁺ T cells. Following treatment, pro-inflammatory soluble factors increased in both responders and non-responders. Addition of CP to pembrolizumab in this study did not appear to result in a response or survival advantage and was less tolerable than immunotherapy alone. Correlative data point to peripheral signals to investigate further as potential biomarkers. Trial registration: clinicaltrials.gov, NCT02617849, registered on December 1st, 2015.

13,239

项与帕博利珠单抗相关的新闻（医药）

15 小时之前

·研发客

阿斯利康Imfinzi公布Ⅲ期结果，威胁Keytruda地位

2026 年 5 月 14 日，阿斯利康公布Imfinzi（度伐利尤单抗）Ⅲ期 VOLGA 试验的中期分析结果显示，针对不适合或拒绝顺铂化疗的肌肉浸润性膀胱癌（MIBC）患者，围手术期 Imfinzi联合新辅助 EV（恩福妥单抗维多汀），相较单纯根治性膀胱切除术，可显著改善无事件生存期（EFS）与总生存期（OS），兼具统计学意义与临床价值。来源|阿斯利康官网而 Imfinzi+Imjudo（曲麦利尤单抗）+EV 方案也显著改善 EFS，OS 呈有利趋势。不过，AZ表示，在此次中期分析中，OS结果未达到统计学意义，并且将在后续分析中重新评估。 VOLGA 是一项全球多中心、随机、开放标签Ⅲ期试验，覆盖25个国家182 个中心，共纳入695名患者，1:1:1 分为三组：双免疫+EV组、单免疫+EV组、单纯手术对照组。结果显示，核心试验方案安全性与耐受性良好，未发现新安全信号，与各药物已知安全性特征一致。阿斯利康肿瘤研发执行副总裁Susan Galbraith 指出，VOLGA 是继 NIAGARA、POTOMAC 之后，阿斯利康在膀胱癌领域的第三项阳性结果研究，奠定了Imfinzi作为早期治愈性免疫治疗核心药物的地位。目前，Imfinzi 已在 40 多个国家获批用于顺铂耐受 MIBC 治疗，相关数据将提交国际医学会议及全球监管机构审查。当然，Imfinzi的研发历程并非一帆风顺。2017年5月‌，Imfinzi获得FDA ‌加速批准‌，用于治疗‌既往接受过含铂化疗的局部晚期或转移性尿路上皮癌（膀胱癌）‌患者 ‌‌。然而，由于后来的验证性试验失败，阿斯利康于2021年自愿将该适应症从美国市场撤回。不过，阿斯利康最终在这一适应症上的三项Ⅲ期试验中均获积极结果。伦敦巴茨癌症中心的试验研究者托马斯·鲍尔斯医学博士在5月14日的一份新闻稿中称，约25%的膀胱癌患者属于肌层浸润性膀胱癌类别。其中多达一半的患者不适合接受以顺铂为基础的化疗。尽管接受了根治性膀胱切除术治疗，但他们癌症复发的风险仍较高，因此迫切需要新的治疗方法。如果此次获批，Imfinzi在与Keytruda的竞争中，可能会处于更有利的地位。去年11月，Keytruda与卫材的Padcev联合疗法在不适合使用顺铂的肌层浸润性膀胱癌患者中获得了首个围手术期适应症批准。在EV-304试验的另一项积极结果公布后，Keytruda与Padcev的联合疗法正在FDA的优先审评，以期在适合使用顺铂的患者中获批，目标行动日期为 2026 年 8 月 17 日。总第2903期访问研发客网站www.PharmaDJ.com 深度报道和每日新闻抢鲜看

17 小时之前

·荣昌生物

2026 ASCO | 维迪西妥单抗16项原创重磅研究成果即将发布

REMEGEN 2026年美国临床肿瘤学会（ASCO）年会将于当地时间5月29日至6月2日在美国芝加哥举行。作为全球规模最大、学术水平最高的临床肿瘤学会议，ASCO年会将汇聚世界一流的肿瘤学专家、学者及行业领袖，共同分享和探讨国际最前沿的临床肿瘤学科研成果与治疗技术。本次大会，荣昌生物（688331.SH/09995.HK）核心产品维迪西妥单抗（RC48，商品名：爱地希®）有16项原创重磅研究成果即将发布，覆盖胃癌、尿路上皮癌、乳腺癌、妇科肿瘤等领域，将全面展现其在不同肿瘤治疗中的创新治疗策略与最新临床数据。 01 胃癌聚焦一线及围手术期治疗多项差异化三药联合方案将公布最新成果在胃癌治疗领域，本次ASCO大会4项围绕维迪西妥单抗的重磅研究将集中亮相：RC48-C027Ⅱ期研究将报告维迪西妥单抗联合免疫及化疗/曲妥珠单抗一线治疗晚期胃癌的延长随访后疗效数据；RC48-C040Ⅲ期研究将公布“去化疗”三药联合方案的临床设计；由研究者发起的RCTSⅡ期研究也将揭晓最新的OS结果；同样由研究者发起的PERISCOPE-02研究将公布围手术期阶段新辅助治疗的病理完全缓解数据。4项研究均聚焦HER2高表达胃癌“三药联合”方案，切入角度各有侧重，共同代表了维迪西妥单抗在胃癌治疗领域的最新探索方向。 ● #LBA4026 维迪西妥单抗(DV) 联合特瑞普利单抗 (Tor) 及化疗 (Chemo)/曲妥珠单抗 (Tra) 一线 (1L) 治疗 HER2 表达局部晚期或转移性 (la/m) 胃癌 (GC)：RC48-C027 试验的最新结果 Disitamab vedotin (DV) plus toripalimab (Tor) and chemotherapy (Chemo)/trastuzumab (Tra) for first-line (1L) HER2-expressing locally advanced or metastatic (la/m) gastric cancer (GC): Updated results from the RC48-C027 trial. 展示形式：壁报，消化道肿瘤专题展板9 研究者：彭智教授，北京大学肿瘤医院报告日期：5月30日 9:00-12:00（北美中部夏令时） ● #TPS4245 维迪西妥单抗(DV) 联合曲妥珠单抗和替雷利珠单抗对比化疗 (CAPOX) 联合曲妥珠单抗 ± 帕博利珠单抗用于一线治疗 HER2 高表达晚期胃/胃食管结合部腺癌 (G/GEJA) 患者的疗效与安全性：一项随机对照Ⅲ期临床试验 Efficacy and safety of disitamab vedotin (DV) combined with trastuzumab, and tislelizumab versus chemotherapy (CAPOX) combined with trastuzumab ± pembrolizumab for patients with first-line HER2-high advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA): A randomized controlled phase 3 trial. 展示形式：壁报，消化道肿瘤专题展板225a 研究者：彭智教授，北京大学肿瘤医院报告日期：5月30日 9:00-12:00（北美中部夏令时） ● #4065 维迪西妥单抗 (RC48)、替雷利珠单抗和 S-1 作为 HER2 过表达晚期胃癌或胃食管结合部腺癌 (GC/GEJC) 的一线治疗：来自 RCTS 试验的更新生存数据和探索性生物标志物结果 Disitamab vedotin (RC48), tislelizumab, and S-1 as first-line therapy for HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC): Updated survival and exploratory biomarker results from the RCTS trial. 展示形式：壁报，消化道肿瘤专题展板48 研究者：刘联教授，山东大学齐鲁医院报告日期：5月30日9:00-12:00（北美中部夏令时） ● #4080 围手术期化疗联合维迪西妥单抗（RC48）和特瑞普利单抗治疗HER2过表达局部进展期胃癌或胃食管结合部癌（PERISCOPE-02）：一项开放标签、单臂、2期临床试验。 Perioperative chemotherapy plus disitamab vedotin (RC48) and toripalimab in HER2-overexpressed locally advanced gastric or gastroesophageal junction cancer (PERISCOPE-02): An open-label, single-arm, phase 2 trial. 展示形式：壁报，胃肠道肿瘤专题展板63 研究者：陈小江，邱海波教授，中山大学肿瘤防治中心报告日期：5月30日9:00-12:00（北美中部夏令时） 02 泌尿肿瘤 8项研究集中亮相聚焦全程化精准治疗在泌尿肿瘤治疗领域，维迪西妥单抗本次会上有8项重磅研究入选，病种涵盖膀胱尿路上皮癌、上尿路尿路上皮癌及阴茎癌，疾病阶段贯穿非肌层浸润、肌层浸润及晚期全分期，研究设计兼顾了保器官、术后辅助、晚期治疗等，联合疗法则包括ADC联合免疫、卡介苗或放疗等，充分展现了维迪西妥单抗在泌尿肿瘤全程化精准治疗中的前沿突破。 ● #4592 一项单臂、多中心、前瞻性临床研究的初步结果：维迪西妥单抗联合特瑞普利单抗及盆腔淋巴结清扫术用于经最大化电切的HER2过表达的cT2-4aN0M0膀胱尿路上皮癌患者的保膀胱治疗 Preliminary results of a single-arm, muti-center, prospective clinical study of disitamab vedotin combined with toripalimab and pelvic lymph node dissection for bladder preservation in patients with cT2-4aN0M0 bladder urothelial carcinoma and HER2 expression ≥ 2+ after maximal TURBT. 展示形式：壁报，泌尿生殖系统肿瘤专场展板71 研究者：蓝天杭、钟文龙、黄健、何旺教授，中山大学孙逸仙纪念医院报告日期：5月31日9:00-12:00（北美中部夏令时） ● #4597 PUNCH03：维迪西妥单抗联合替雷利珠单抗及卡介苗治疗HER2表达的高危非肌层浸润性膀胱癌的II期研究初步结果 PUNCH03: Preliminary results from a phase II study of disitamab vedotin combined with tislelizumab and Bacillus Calmette-Guerin (BCG) in Her2-positive high-risk non-muscle-invasive bladder cancer(HR NMIBC). 展示形式：壁报，泌尿生殖系统肿瘤专场展板76 研究者：王宗任、陈俊星教授，中山大学附属第一医院报告日期：5月31日9:00-12:00（北美中部夏令时） ● #4605 一项II期研究的初步结果：评估维迪西妥单抗联合放疗术后辅助治疗上尿路尿路上皮癌的疗效与安全性 Preliminary results of a phase II study to evaluate the efficacy and safety of disitamab vedotin (RC48-ADC) in combination with radiotherapy for adjuvant therapy in upper tract urothelial carcinoma. 展示形式：壁报，泌尿生殖系统肿瘤专场展板84 研究者：陶子豪、李学松教授，北京大学第一医院报告日期：5月31日9:00-12:00（北美中部夏令时） ● #4611 维迪西妥单抗联合PD-1抑制剂对比含铂化疗术后辅助治疗高危上尿路尿路上皮癌在真实世界的有效性：一项对照研究 Real-world effectiveness of disitamab vedotin plus PD-1 inhibitor versus platinum -based chemotherapy as postoperative adjuvant therapy in high-risk upper tract urothelial carcinoma: A comparative study. 展示形式：壁报，泌尿生殖系统肿瘤专场展板90 研究者：曹煜东教授，北京大学肿瘤医院报告日期：5月31日9:00-12:00（北美中部夏令时） ● #4616 维迪西妥单抗辅助或挽救治疗HER2过表达的高危非肌层浸润性膀胱癌的多中心I期研究 Adjuvant or rescue disitamab vedotin for high-risk non-muscle invasive bladder cancer with HER2 overexpression: A phase l multi -center study. 展示形式：壁报，泌尿生殖系统肿瘤专场展板95 研究者：陈俊儒、曾浩教授，四川大学华西医院报告日期：5月31日9:00-12:00（北美中部夏令时） ● #5034 维迪西妥单抗联合特瑞普利单抗治疗顺铂难治性晚期阴茎癌的疗效与安全性：一项前瞻性单中心研究 Efficacy and safety of disitamab vedotin combined with toripalimab for cisplatin refractory advanced penile cancer: A prospective single center study (SAVE) 展示形式：壁报，泌尿生殖系统肿瘤专场展板129 研究者：袁方教授，重庆大学附属肿瘤医院报告日期：5月31日9:00-12:00（北美中部夏令时） ● #e16607 维迪西妥单抗联合特瑞普利单抗保肾治疗肾功能受损的高危上尿路尿路上皮癌的II期试验初步结果 A kidney-sparing approach using disitamab vedotin plus toripalimab for high-risk upper urinary tract urothelial carcinoma in patients with impaired renal function: Preliminary results from a phase II trial. 展示形式：电子壁报研究者：田熙、张海梁教授，复旦大学附属肿瘤医院、复旦大学附属华东医院 ● #e16608 尿液和血浆ctDNA配对用于HER2 ADC保膀胱治疗肌层浸润性膀胱癌中纵向分子监测的研究（HOPE03） Paired urine and plasma ctDNA profiling to enable longitudinal molecular monitoring during HER2 ADC bladder preserving therapy in muscle-invasive bladder cancer (HOPE03). 展示形式：电子壁报研究者：邓佳妮、张朋、沈亚丽教授，四川大学华西医院 03 乳腺癌 RC48-C024研究数据公布聚焦HR阴性/HER2低表达新辅助治疗在乳腺癌治疗领域，本次大会有2项围绕维迪西妥单抗的重磅研究入选。其中，RC48-C024Ⅱ期研究将公布维迪西妥单抗联合免疫及同步/序贯化疗新辅助治疗HR阴性/HER2低表达乳腺癌的关键临床数据；另一项真实世界研究则聚焦晚期乳腺癌ADC药物的序贯应用策略，基于HER2表达状态探讨维迪西妥单抗的优化治疗路径。 ● #598 新辅助维迪西妥单抗联合特瑞普利单抗及同步/序贯化疗治疗HR阴性、HER2低表达乳腺癌患者的疗效与安全性：一项随机多中心2期研究 Efficacy and safety of neoadjuvant disitamab vedotin (DV) in combination with toripalimab (Tor) and concurrent/sequential chemotherapy (chemo) in patients with HR-negative, HER2-low breast cancer: A randomized multicenter phase 2 study. 展示形式：壁报，乳腺癌专场展板83 研究者：邵志敏教授，复旦大学附属肿瘤医院报告日期：6月1日 13:30-16:30（北美中部夏令时） ● #e13020 晚期乳腺癌抗体偶联药物（ADC）的序贯应用：一项基于HER2状态的真实世界研究 Sequential use of antibody-drug conjugates in advanced breast cancer: A real-world study based on HER2 status. 展示形式：电子壁报研究者：徐蓓教授，复旦大学附属中山医院 04 妇科肿瘤精准靶向HER2，突破治疗困境在妇科肿瘤领域，本次大会维迪西妥单抗有2项重要研究将公布，分别从复发或转移性晚期治疗和早期新辅助切入，覆盖了宫颈癌与卵巢癌两大常见妇科恶性肿瘤，展现了维迪西妥单抗在该治疗领域的多元化拓展潜力。 ● #5526 卡度尼利单抗联合维迪西妥单抗或白蛋白紫杉醇治疗复发性或转移性宫颈癌的一项前瞻、双队列、开放标签的Ⅱ期临床研究 Efficacy and safety of cadonilimab (CD) in combination with disitamab vedotin (RC48) or nab-paclitaxel (NP) in the treatment of recurrent or metastatic cervical cancer (r/mCC): A prospective, double-cohort, multicenter, open-label, phase II clinical study. 展示形式：壁报，妇科肿瘤专场展板192 研究者：郑敏、顾海风教授，中山大学肿瘤防治中心报告日期：6月1日 9:00 - 12:00（北美中部夏令时） ● #5556 维迪西妥单抗联合卡铂新辅助治疗HER2表达卵巢癌的前瞻性、单臂、多中心探索性研究 Neoadjuvant disitamab vedotin plus carboplatin in HER2-expressing advanced ovarian cancer: A prospective, single-arm, phase II trial. 展示形式：壁报，妇科肿瘤专场展板222 研究者：李俊东、万挺教授，中山大学肿瘤防治中心报告日期：6月1日 9:00 - 12:00（北美中部夏令时）文字 | 连鹏编辑 | 春媛荣昌生物科创板上市 | 港交所上市挺进医保 | License out 维迪西妥单抗 | 泰它西普 RC28 | RC88 | RC148 | RC278

22 小时之前

·PRNewswire

Inhibrx Reports First Quarter 2026 Financial Results

SAN DIEGO, May 14, 2026 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the first quarter of 2026. The biopharmaceutical company has two programs in ongoing clinical trials. Recent Corporate Highlights and Upcoming Milestones INBRX-106 In May 2026, we announced updated interim data from our randomized, first-line Phase 2 portion of the HexAgon study. The trial evaluated the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (Combined Positive Score (CPS) ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC). We plan to announce progression-free survival (PFS) data from the randomized Phase 2 trial in HNSCC in combination with pembrolizumab in the fourth quarter of 2026. ozekibart (INBRX-109) In April 2026, we announced updated interim data from our Phase 1/2 study evaluating ozekibart (INBRX-109) in combination with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer (CRC); Additionally, in April 2026, we submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ozekibart in conventional chondrosarcoma; and We plan to meet with the FDA in the second half of 2026 to discuss plans to initiate a first-line registrational trial in CRC. We also plan to discuss with the FDA the potential for accelerated regulatory pathways for ozekibart in fourth-line colorectal cancer and in refractory Ewing sarcoma. Financial Results Cash and Cash Equivalents. As of March 31, 2026, the Company had cash and cash equivalents of $161.7 million, as compared to $124.2 million as of December 31, 2025. The Company's cash balance increased as a result of the receipt of gross proceeds of $75.0 million in March 2026 upon entering into the First Amendment to the Loan and Security Agreement (March 2026 Amendment) with Oxford Finance LLC (Oxford). R&D Expense. Research and development expenses were $25.2 million for the first quarter of 2026, as compared to $36.9 million for the first quarter of 2025. This decrease was primarily related to lower clinical trial costs associated with ozekibart for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment, as well as a decrease in contract manufacturing expenses due to the timing and completion of certain manufacturing activities required to support our clinical trials. In addition, personnel-related expenses decreased as a result of a decrease in headcount in the current period. G&A Expense. General and administrative expenses were $5.7 million during the first quarter of 2026, compared to $6.0 million during the first quarter of 2025. These expenses were consistent in each period with a slight decrease in personnel-related expenses as a result of a decrease in headcount in the current period. Other Expense, Net. Other expense, net was $2.5 million during the first quarter of 2026, compared to $0.4 million during the first quarter of 2025. The increase reflects higher interest expense following the Company's receipt of an additional $75.0 million in principal, bringing the outstanding loan balance from $100.0 million to $175.0 million during the first quarter of 2026, as well as lower interest income on the Company's cash and money market balances reflecting lower average cash balances and a decline in short-term interest rates. Net Loss. Net loss was $33.4 million during the first quarter of 2026, or $2.15 per share, basic and diluted, as compared to a net loss of $43.3 million during the first quarter of 2025, or $2.80 per share, basic and diluted. About Inhibrx Biosciences, Inc. Inhibrx is a clinical-stage biopharmaceutical company with a pipeline of novel biologic therapeutic candidates. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx's current clinical pipeline of therapeutic candidates includes ozekibart and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what Inhibrx believes to be the most appropriate agonist function. For more information, please visit . Forward Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding Inhibrx's judgments and beliefs regarding the strength of Inhibrx's pipeline; the safety and efficacy of its therapeutic candidate, INBRX-106, based on topline and interim results; the potential for INBRX-106 to be used for the treatment of metastatic or unresectable recurrent HNSCC; the clinical development of our product candidates, including expected data readouts, regulatory submissions and interactions, and the timing thereof; any presumption that topline, interim or preliminary data will be representative of final data or data in later clinical trials; the planned announcement of PFS data from INBRX-106 Phase 2 trial in HNSCC in combination with pembrolizumab; and Inhibrx's plans to meet with the FDA to discuss plans to initiate a first-line registrational trial in CRC or an accelerated pathway for approval for ozekibart in fourth-line colorectal cancer and in refractory Ewing sarcoma in the second half of 2026. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: topline data may not accurately reflect the complete results of a particular study or trial and remain subject to audit, and final data may differ materially from topline data; the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; its interpretation of topline, interim or preliminary data from its clinical trials, including interpretations regarding disease control and disease response; Inhibrx's ability to utilize its technology platform to generate and advance additional therapeutic candidates; the implementation of Inhibrx's business model and strategic plans for its business and therapeutic candidates; the scope of protection Inhibrx is able to establish and maintain for intellectual property rights covering its therapeutic candidates; the ability to raise funds needed to satisfy Inhibrx's capital requirements, which may depend on financial, economic and market conditions and other factors, over which it may have no or limited control; Inhibrx's financial performance; developments relating to its competitors and its industry; regulatory review and approval of Inhibrx's therapeutic candidates; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor and Media Contact: Kelly D. Deck Chief Financial Officer [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. 21% more press release views with Request a Demo

财报临床2期临床结果

100 项与帕博利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10574	帕博利珠单抗	L01XC18	DB09037

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
铂类耐药性原发性腹膜癌	欧盟	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	冰岛	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	列支敦士登	Merck Sharp & Dohme BV	2026-04-22
铂类耐药性原发性腹膜癌	挪威	Merck Sharp & Dohme BV	2026-04-22
铂耐药上皮性卵巢癌	欧盟	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	冰岛	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	列支敦士登	Merck & Co., Inc.	2026-04-02
铂耐药上皮性卵巢癌	挪威	Merck & Co., Inc.	2026-04-02
错配修复缺陷或微高卫星不稳定性结肠癌	美国	Merck Sharp & Dohme LLC	2026-02-10
肿瘤	美国	Merck Sharp & Dohme LLC	2026-02-10
卵巢癌	美国	Merck Sharp & Dohme LLC	2026-02-10
肌层浸润性膀胱癌	美国	Merck Sharp & Dohme LLC	2025-11-21
局部晚期头颈部鳞状细胞癌	欧盟	Merck Sharp & Dohme BV	2025-10-30
局部晚期头颈部鳞状细胞癌	冰岛	Merck Sharp & Dohme BV	2025-10-30
局部晚期头颈部鳞状细胞癌	列支敦士登	Merck Sharp & Dohme BV	2025-10-30
局部晚期头颈部鳞状细胞癌	挪威	Merck Sharp & Dohme BV	2025-10-30
不可切除的肝细胞癌	中国	Merck Sharp & Dohme LLC	2025-06-10
不可切除的胸膜恶性间皮瘤	欧盟	Merck Sharp & Dohme BV	2025-04-16
不可切除的胸膜恶性间皮瘤	冰岛	Merck Sharp & Dohme BV	2025-04-16
不可切除的胸膜恶性间皮瘤	列支敦士登	Merck Sharp & Dohme BV	2025-04-16

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
复发性铂耐药性卵巢癌	申请上市	美国	Merck & Co., Inc.	2025-10-20
小肠癌	申请上市	欧盟	Merck Sharp & Dohme Corp.	2022-03-25
非小细胞肺癌Ⅰ期	临床3期	美国	Merck Sharp & Dohme LLC	2026-05-04
非小细胞肺癌Ⅰ期	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2026-05-04
铂耐药性卵巢癌	临床3期	美国	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	澳大利亚	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	奥地利	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	比利时	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	加拿大	Mural Oncology, Inc.	2022-01-10
铂耐药性卵巢癌	临床3期	捷克	Mural Oncology, Inc.	2022-01-10

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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


NCT02617849 (Pubmed \| Oncoimmunology)	临床2期	黑色素瘤	30	Pembrolizumab and Carboplatin/ Paclitaxel	廠觸鹽壓鹽鏇艱積衊廠(鹽齋選齋壓顧襯網淵鏇) = 艱選鹽製蓋製簾衊齋範壓膚艱淵範構醖選廠簾 (蓋齋觸鹽遞鹹夢顧壓鑰 ) 更多	不佳	2026-12-31
NCT04165096 (KEYMAKER-U01C \| MK-3475-01C, CTgov)	临床2期	晚期非小细胞肺癌 \| 晚期肺非鳞状非小细胞癌	128	acetaminophen+Boserolimab+Pembrolizumab+diphenhydramine (Pembrolizumab + Boserolimab)	襯鹹鹹淵衊築窪壓選廠 = 製齋築簾糧淵選糧製襯鑰壓選膚遞齋齋積鹽顧 (選憲鹽衊顧夢製鏇鹹壓, 築網糧醖壓顧網遞顧窪 ~ 夢壓廠壓衊獵憲憲壓繭) 更多	-	2026-05-13
				MK-4830+Pembrolizumab (Pembrolizumab + MK-4830)	襯鹹鹹淵衊築窪壓選廠 = 壓鹹壓衊遞醖夢繭繭構鑰壓選膚遞齋齋積鹽顧 (選憲鹽衊顧夢製鏇鹹壓, 餘簾艱膚艱繭壓築觸淵 ~ 選壓鑰顧憲積窪積廠蓋) 更多
NCT02841748 (PATHWay study, CTgov)	临床2期	头颈部鳞状细胞癌	100	Pembrolizumab (Pembrolizumab)	鑰構艱鑰襯顧廠鏇醖淵 = 窪壓衊廠製衊襯壓鹹蓋夢觸蓋鹹鹽獵遞鹹鹽鬱 (繭製獵構鹹積醖鹹醖鬱, 網範淵鬱選觸網顧糧膚 ~ 構糧顧積鏇艱蓋鏇鹹製) 更多	-	2026-05-13
				Placebo (Placebo)	鑰構艱鑰襯顧廠鏇醖淵 = 襯簾蓋衊遞襯構蓋積壓夢觸蓋鹹鹽獵遞鹹鹽鬱 (繭製獵構鹹積醖鹹醖鬱, 繭範襯襯鑰簾廠選顧窪 ~ 壓襯壓壓築襯鬱築構壓) 更多
NCT04414540 (601, CTgov)	临床2期	头颈部鳞状细胞癌 \| 头颈癌转移	21	Metformin Extended Release Oral Tablet+Pembrolizumab (Arm 1: Metformin Before Pembrolizumab)	築簾齋衊廠鹽鹽艱選窪 = 淵製醖鏇艱繭遞築壓齋廠觸壓壓簾顧簾鑰範醖 (糧鑰蓋選醖膚膚襯構鏇, 遞獵製範蓋積範遞繭簾 ~ 衊憲蓋襯鹹鹹艱鑰壓壓) 更多	-	2026-05-08
				Metformin Extended Release Oral Tablet+Pembrolizumab (Arm 2: Metformin After Pembrolizumab)	築簾齋衊廠鹽鹽艱選窪 = 鹽鹹築顧衊繭襯淵鹽夢廠觸壓壓簾顧簾鑰範醖 (糧鑰蓋選醖膚膚襯構鏇, 積選醖築鹽範顧夢網膚 ~ 觸齋壓繭夢膚壓餘觸鑰) 更多
NCT02399371 (CTgov)	临床2期	腹膜恶性间皮瘤 \| 恶性胸膜间皮瘤 \| 上皮样间皮瘤，恶性	65	Pharmacogenomic Study+Pembrolizumab	齋繭餘鏇範衊製艱膚艱 = 齋鹹簾簾積鹽艱遞廠醖築築餘壓築觸艱顧選鹹 (網築襯製壓蓋製鹹鏇窪, 觸憲鏇廠顧簾壓齋製鹹 ~ 廠廠製觸選憲窪窪鑰製) 更多	-	2026-05-08
NCT03144466 (PAPAYA, CTgov)	临床1期	子宫颈腺癌 \| 局部晚期宫颈癌 \| 宫颈癌	1	Pembrolizumab (Part A - Starting Dose)	鏇選壓鏇蓋鬱鹹構鹹齋 = 選鬱顧鏇築醖糧積衊廠衊網壓範鑰構蓋繭衊積 (獵艱網餘顧鑰淵鹽鹹鑰, 製餘憲鑰鹹築鏇築顧鏇 ~ 鹹鏇窪襯夢積鏇願壓窪) 更多	-	2026-05-05
				Pembrolizumab (Part A - Escalation Dose)	積鏇獵築憲衊鏇簾鹽艱(夢製觸餘繭鹹廠鏇獵糧) = 製鏇膚積衊鹽願網範範鏇艱壓艱夢廠糧憲構憲 (製淵餘積醖鹽簾餘壓繭, 廠蓋繭壓鏇襯鹽蓋膚餘 ~ 膚衊遞鹹積淵選築觸蓋) 更多
NCT03752333 (CUPem, CTgov)	临床2期	原发部位不明恶性肿瘤	35	Pembrolizumab	糧鬱鬱鑰窪簾築襯顧遞 = 淵獵簾觸蓋襯製願構憲顧獵鑰繭顧衊衊積鏇蓋 (繭積選鬱鑰積艱憲鏇簾, 糧積觸餘鹹憲淵鏇遞鏇 ~ 積鹹鹹蓋蓋繭觸製獵憲) 更多	-	2026-05-04
NCT03391973 (Pubmed \| Eur J Cancer)	临床2期	原发部位不明恶性肿瘤一线 MMR \| MSI	27	Pembrolizumab 200 mg	壓襯餘夢齋艱構製繭構(鹹蓋選憲齋簾積構遞糧) = 觸淵淵構餘積壓衊繭淵糧艱觸鬱觸鏇夢遞觸鑰 (膚糧夢願夢獵製廠獵齋, 2.35 ~ 29.16) 更多	不佳	2026-05-01
NCT02837263 (CTgov)	临床1期	大肠腺癌 \| 肝转移 \| 转移性结直肠癌	15	Stereotactic body radiotherapy (SBRT)+Pembrolizumab	構衊艱網顧觸鬱夢築窪 = 繭糧鹹夢糧觸衊築鬱淵蓋簾糧齋鏇醖廠鹹願淵 (簾獵鏇鏇艱繭簾衊製選, 憲壓壓積製餘艱憲蓋淵 ~ 觸鑰襯製鹹窪廠淵鬱獵) 更多	-	2026-05-01
NCT03867084 (KEYNOTE-937 \| MK-3475-937, CTgov)	临床3期	肝细胞癌	959	Pembrolizumab (Pembrolizumab)	廠範觸積蓋繭膚蓋淵網(鏇繭築鏇顧繭憲淵鏇艱) = 艱衊鬱糧構鑰鹽簾鑰範鹹範餘蓋簾鬱夢窪願網 (遞構淵構鏇廠築範膚憲, 蓋製構築膚襯廠壓鬱簾 ~ 網範製艱膚遞壓獵築壓) 更多	-	2026-04-24
				Placebo (Placebo)	廠範觸積蓋繭膚蓋淵網(鏇繭築鏇顧繭憲淵鏇艱) = 製繭構簾鑰獵願鹽憲遞鹹範餘蓋簾鬱夢窪願網 (遞構淵構鏇廠築範膚憲, 鹹艱網壓鬱憲淵積積鏇 ~ 選夢艱顧襯鑰網餘鬱網) 更多