Phase II Randomized Clinical Trial for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant (FMT) in Stage II-III Non-small Cell Lung Cancer (NSCLC) Patients, Using Immune Checkpoint Inhibitors (ICI) Responders as Donors.

This is a randomized, phase II, multi-centre clinical trial.
Sample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients)
Population: Patients with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer
In the Experimental arm, patients will receive Fecal Microbiota Transplant. Once done, the patient will start neoadjuvant treatment with Durvalumab + Chemotherapy .
In the Control arm, patients will receive neoadjuvant treatment with Durvalumab + Chemotherapy.
After neoadjuvant/induction treatment every patient will be evaluated to decide if the patient is a candidate for surgery or not. Patients that are R0 after surgery will receive Adjuvant treatment with Durvalumab.
The primary objective is to evaluate the pathological Complete Response (pCR) rate.
The total trial duration will be 6.5 years approximately.

开始日期2026-09-15

申办/合作机构

Fundacion GECP

NCT07507968

/ Not yet recruiting临床2期IIT

Total Neoadjuvant Treatment With Preoperative FLOT/Durvalumab Plus Postoperative Durvalumab for Resectable Gastroesophageal Adenocarcinoma

This trial is designed to evaluate a total neoadjuvant approach using D-FLOT as the new standard backbone in patients with resectable esophagogastric adenocarcinoma. It addresses major limitations of current treatment paradigms, builds directly on the strong clinical signal from the MATTERHORN trial, and offers a rational, biologically sound framework for future therapy intensification and innovation.
By moving systemic therapy entirely into the preoperative phase, we aim to:
* Improve patient outcomes through better adherence and deeper response
* Minimize postoperative therapy-related dropout
* Create a platform for rational post-surgical drug testing and individualized treatment escalation The trial will provide pivotal evidence to guide the next generation of curative-intent treatment strategies for EGA.

开始日期2026-07-01

申办/合作机构

AstraZeneca PLC

NCT05403723

/ Suspended临床1期IIT

A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

开始日期2026-06-30

申办/合作机构

University of Maryland Baltimore

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100 项与度伐利尤单抗相关的临床结果

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100 项与度伐利尤单抗相关的转化医学

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100 项与度伐利尤单抗相关的专利（医药）

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2,133

项与度伐利尤单抗相关的文献（医药）

2026-07-01·LUNG CANCER

Prognostic value of serum CYFRA21-1 in locally advanced non-small cell lung cancer undergoing durvalumab consolidation therapy after chemoradiotherapy

Article

作者: Ariyasu, Ryo ; Tsugitomi, Ryosuke ; Nemoto, Teruhisa ; Nibuya, Kyujiro ; Uchibori, Ken ; Amino, Yoshiaki ; Fujishima, Shunsuke ; Yanagitani, Noriko ; Iso, Hirokazu ; Sugai, Mayu ; Nishio, Makoto ; Ito, Masahiro

INTRODUCTION:

Chemoradiotherapy (CRT) followed by durvalumab consolidation therapy is the standard treatment for locally advanced non-small cell lung cancer (LA-NSCLC), but robust prognostic biomarkers are lacking. This study evaluated the prognostic value of CYFRA 21-1, a serum marker associated with squamous cell carcinoma, in this setting.

METHODS:

Patients with LA-NSCLC were retrospectively reviewed according to treatment (CRT plus durvalumab group vs. CRT-only group). Patients with high and normal CYFRA 21-1 levels were compared within each group, using a threshold of 3.5 ng/mL. Overall survival (OS) and real-world progression-free survival (rw-PFS) were estimated using the Kaplan-Meier method and compared using the log-rank test. Multivariate analyses were conducted using Cox proportional hazards models.

RESULTS:

There were 134 patients in the CRT plus durvalumab group and 100 patients in the CRT-only group. In the CRT plus durvalumab group, patients with high CYFRA 21-1 levels had shorter median OS versus those with normal levels (38.8 vs. 73.4 months; HR, 2.49 [95% CI, 1.31-4.72]; p < 0.05), whereas no significant difference was observed within the CRT-only group (26.2 vs. 46.5 months; HR, 1.37 [95% CI, 0.82-2.27]; p = 0.21). A similar trend in OS was observed among those with non-squamous histology. On multivariate analysis, CYFRA 21-1 emerged as an independent prognostic factor in the CRT plus durvalumab group (HR = 2.21 (95% CI: 1.10-4.44), p < 0.05). Elevated CYFRA 21-1 levels were associated with shorter rw-PFS only in the CRT plus durvalumab group.

CONCLUSION:

CYFRA 21-1 may serve as a prognostic biomarker among patients with LA-NSCLC treated with CRT followed by durvalumab consolidation therapy.

2026-06-01·EUROPEAN JOURNAL OF CANCER

Gastric cancer: French intergroup clinical practice guidelines for diagnosis, staging, treatment and follow-up (TNCD, SNFGE, FFCD, UNICANCER, GERCOR, SFCD, SFED, AFEF, SFRO, SFP, SFR, ACHBPT, RENAPE, SNFCP)

Review

作者: Ducreux, Michel ; Abdelghani, Meher Ben ; Dubreuil, Olivier ; Jary, Marine ; Renaud, Florence ; Palle, Juliette ; Zaanan, Aziz ; Gagniere, Johan ; Mariani, Antoine ; Buecher, Bruno ; Barret, Maximilien ; Chapelle, Nicolas ; Durand-Labrunie, Jerome ; Palmieri, Lola-Jade ; Bouché, Olivier ; Fares, Nadim

INTRODUCTION:

The updated edition of the French intergroup guidelines for the management of patients with gastric and gastroesophageal junction adenocarcinoma is a collaborative work of several national medical societies, and available on the website of the French Society of Gastroenterology (SNFGE) (www.tncd.org).

METHODS:

The recommendations are graded into three categories (A, B, and C), based on the level of scientific evidence published until January 2026.

RESULTS:

Initial staging and risk assessment should include physical evaluation, endoscopy and computed tomography-scan of the thorax, abdomen, and pelvis. For resectable disease, endoscopic ultrasonography can be used for T and N staging, while laparoscopic exploration may be performed to exclude occult peritoneal metastases, especially for cT3/cT4 and poorly cohesive tumors. Endoscopic or surgical resection alone is appropriate for very early cT1N0 tumors. For locally advanced disease ≥cT2 and/or cN + , the perioperative FLOT chemotherapy is recommended as the standard of care. Recently, the addition of durvalumab to perioperative FLOT followed by durvalumab for 10 months as maintenance therapy was associated with a significant improvement of survival. For metastatic disease, the first-line chemotherapy is based on platinum-fluoropyrimidine combination. The addition of targeted therapy and/or immunotherapy to doublet chemotherapy depends on the tumor biomarker profile, including HER2 (trastuzumab), claudin18.2 (zolbetuximab), PD-L1 and dMMR/MSI phenotype (anti-PD1 monoclonal antibodies). The addition of docetaxel, based on the triplet TFOX regimen may be considered for selected patients with biomarker-negative tumors. Resection of primary tumor and metastases cannot be recommended but may be considered on an individual basis in highly selected patients with oligometastatic disease who respond to systemic treatment. Various drugs are indicated beyond first-line of treatment, including trastuzumab-deruxtecan for HER2-positive tumors.

CONCLUSION:

These national guidelines on gastric cancer are intended to facilitate decision-making in daily clinical practice. These recommendations are subject to ongoing review. Each individual case should be discussed within a multidisciplinary team.

2026-06-01·EUROPEAN JOURNAL OF CANCER

Early and late survival dynamics of immunotherapy combinations in advanced HCC: Anchored indirect comparison of atezolizumab plus bevacizumab versus durvalumab + tremelimumab

Article

作者: Rossari, Federico ; Kumada, Takashi ; Kudo, Masatoshi ; Ferrara, Michele ; Finkelmeier, Fabian ; Rimassa, Lorenza ; Tada, Toshifumi ; Vitale, Alessandro ; Scartozzi, Mario ; Camera, Silvia ; Pia D'Agata, Alessandra ; Passeri, Laura ; Yip, Terry Cheuk-Fung ; Persano, Mara ; Rimini, Margherita ; Presa, José ; Cheon, Jaekyung ; Masi, Gianluca ; Tamburini, Emiliano ; Casadei-Gardini, Andrea ; Suda, Goki ; Shimose, Shigeo ; Lim, Ho Yeong ; Yoo, Changhoon ; Piscaglia, Fabio ; Lonardi, Sara ; Foschi, Francesco Giuseppe

BACKGROUND AND AIMS:

Atezolizumab plus bevacizumab (A+B) and STRIDE (tremelimumab plus durvalumab) represent two of the approved first-line immunotherapy strategies for unresectable hepatocellular carcinoma (HCC). As no head-to-head trial exists, we assessed temporal differences in survival benefit using complementary analytic frameworks.

METHODS:

Three independent analyses were conducted: (1) anchored indirect comparison using reconstructed survival from IMbrave150 and HIMALAYA; (2) a real-world A+B cohort (n = 883) weighted via MAIC to match STRIDE baseline characteristics; and (3) a propensity-matched population-level dataset from TriNetX (n = 309 per arm). Time-interval hazard ratios (HRs), RMST, and conditional landmark survival were calculated. Proportional hazards were assessed by Schoenfeld testing; pooled interval HRs were synthesized through meta-analysis.

RESULTS:

Across all models, A+B showed a consistent early advantage. In the first 6 months, the pooled HR favored A+B (0.75; 95% CI 0.64-0.88), with absolute survival differences of + 5-7%. From 6-12 months, HRs remained numerically favorable but non-significant. Between 12 and 24 months, pooled HRs approached neutrality (0.93-1.06), with confidence intervals crossing unity and no meaningful absolute survival differences. Beyond 24-36 months, the effect reversed in favor of STRIDE (anchored HR 1.41; RWD HR 2.52; TriNetX HR 1.47). Meta-analysis confirmed a progressive late benefit for STRIDE from 36 to 60 months (pooled HR 1.54-1.75). Schoenfeld tests indicated time-dependent effects in all frameworks (p < 0.05), and ΔRMST trajectories were highly concordant (Pearson r > 0.97).

CONCLUSIONS:

A+B is associated with stronger early tumor control, while STRIDE provides more durable long-term survival beyond 2-3 years. These findings support selecting therapy based on temporal treatment objectives and advocate for biomarkers predicting early versus sustained treatment benefit.

2,751

项与度伐利尤单抗相关的新闻（医药）

2026-05-18

·ioncology

国际视野丨泌尿系统肿瘤基于免疫治疗的临床方案：如何平衡免疫毒性与治疗获益？

点击上方蓝字关注我们编者按：免疫检查点抑制剂的出现，彻底重塑了泌尿系统恶性肿瘤的治疗版图。但这份治疗突破的背后，也潜藏着不容忽视的代价。免疫检查点抑制剂相关不良事件（irAEs），与化疗毒性存在本质差异——它影响的器官系统范围更广，且在不同患者群体中的发生情况难以预测。这就意味着，临床实践中必须对免疫毒性保持高度警觉，力求在副作用恶化升级前精准捕捉、及时干预。矛盾的是，越来越多的证据表明，那些我们试图预防的毒性反应，恰恰是免疫治疗发挥疗效的关键信号。因此，临床医生在使用免疫检查点抑制剂时必须审慎权衡治疗收益与潜在风险，为患者筑牢安全与疗效的双重防线。亮点抢先看 1 免疫检查点抑制剂彻底改变了泌尿系统肿瘤的治疗策略，但也带来了独特的免疫治疗相关毒性。 2 免疫毒性既常见，又具有重要的临床意义。近期研究表明，免疫治疗相关不良事件与治疗效果的改善呈正相关；然而，并非所有毒性都能同等地预测治疗获益。 3 早期发现并系统地管理irAEs，对于安全有效地使用免疫检查点抑制剂至关重要。免疫检查点抑制剂在泌尿系统肿瘤中的应用肾细胞癌（RCC）对于RCC患者而言，免疫检查点抑制剂首次在CheckMate-025研究中展现出显著疗效：研究结果证实，对于既往接受过治疗的转移性肾细胞癌患者，相较于接受依维莫司，纳武利尤单抗治疗可有效改善生存期。此后不久，CheckMate-214试验显示，纳武利尤单抗联合伊匹木单抗的疗效优于舒尼替尼，开启了转移性RCC目前的一线标准治疗：基于免疫检查点抑制剂的双药疗法（双免治疗或免疫联合VEGF-TKI）。根据KEYNOTE-564试验，免疫治疗也被进一步应用于肾切除术后的高危早期RCC患者，该试验显示，接受帕博利珠单抗治疗的患者总生存期（OS）较安慰剂组有所改善。尿路上皮癌（UC）免疫检查点抑制剂也是膀胱癌治疗的关键组成部分。在非肌层浸润性膀胱癌领域，帕博利珠单抗已被批准用于卡介苗耐药患者，而sasanlimab和度伐利尤单抗已被证明对新诊断的非肌层浸润性膀胱癌患者有效。对于围手术期MIBC患者，度伐利尤单抗联合顺铂化疗是适合接受顺铂治疗的患者的新标准治疗方案。对于拒绝或不适合接受顺铂治疗的患者，根据EV-303研究，维恩妥尤单抗联合帕博利珠单抗已获批准。在辅助治疗方面，根据CheckMate-274试验，纳武利尤单抗在美国获批用于治疗拒绝或对顺铂类化疗反应不佳的高危患者。同样，在辅助治疗中，帕博利珠单抗与安慰剂相比，显示出无事件生存期的改善，而阿替利珠单抗则在循环肿瘤DNA阳性患者中，能够改善膀胱切除术后患者的生存。在转移性疾病方面，美国的新标准一线治疗方案是帕博利珠单抗联合维恩妥尤单抗；纳武利尤单抗联合顺铂化疗也可作为一线治疗方案。在此标准方案出现之前，一线铂类化疗后的维持治疗通常采用阿维鲁单抗（根据JAVELIN Bladder-100试验的结果）。目前正在研发新型免疫疗法联合方案，例如vepugratinib（一种FGFR3抑制剂）联合维迪西妥单抗。前列腺癌、阴茎癌或睾丸癌尽管免疫检查点抑制剂尚未被证实对前列腺癌、阴茎癌或睾丸癌有效，但帕博利珠单抗和纳武利尤单抗具有不区分疾病类型的适应症，可用于微卫星不稳定性较高（MSI-H）的肿瘤，因此在极少数情况下可作为难治性疾病患者的治疗选择。免疫毒性机制免疫检查点抑制剂的作用机制已得到充分阐明，其核心在于阻断癌细胞与T细胞之间的关键抑制信号。PD-1、PD-L1和CTLA-4等免疫检查点蛋白通常与T细胞结合，从而抑制免疫系统对肿瘤的杀伤作用。通过阻断这些检查点，免疫检查点抑制剂可以恢复T细胞对癌细胞的活性。然而，这种免疫激活也可能错误地针对健康组织，产生类似于自身免疫的临床表现。免疫治疗相关毒性，部分是由细胞因子过度释放（即“细胞因子风暴”）引起的，可能会引发广泛的炎症、血管损伤和体液渗漏到组织中，最终导致器官损伤。免疫毒性的发生率免疫疗法与多种irAEs相关，且发生频率不一。虽然最常见的毒性器官包括皮肤、内分泌器官、肺和胃肠道，但任何器官都可能受到影响。泌尿系统肿瘤患者的免疫毒性发生率估计在35%-50%之间，其中约10%的患者会出现≥3级毒性反应。最常见的毒性反应是皮疹（13.8%）、甲状腺功能减退（11.0%）和腹泻（10.4%）。最常见的严重毒性反应是腹泻（2.7%）、严重皮肤反应（2.2%）和丙氨酸氨基转移酶升高（2.0%）。其他较少见的毒性反应包括疲乏、其他内分泌功能障碍、风湿相关症状和肺炎。罕见的irAEs例如神经系统综合征（重症肌无力和脑炎）、眼毒性、心脏毒性和血管炎，发生率约为1%-2%。总体而言，现有证据表明，免疫相关死亡发生率为0.26%，其中肺炎（35.7%）、肝功能衰竭（10.7%）和肝炎（7.1%）是最常见的死亡原因。免疫毒性与治疗缓解的相关性多项研究表明，irAEs与免疫治疗的疗效呈正相关。在RCC中，一项回顾性研究纳入90例患者（其中42.2%发生irAEs），结果显示发生irAEs的患者OS延长，且后续治疗时间更长。同样，在一项纳入389例接受纳武利尤单抗治疗的患者队列研究中，20%的患者发生irAEs，irAEs的出现与生存获益之间存在显著相关性。一项纳入1747例尿路上皮癌患者的汇总分析也发现irAEs与OS改善相关，发生irAEs的优势比为3.77。然而，并非所有毒性反应都能同等地预测获益：一项纳入6148例RCC或尿路上皮癌患者的荟萃分析发现，发生irAEs的患者OS和PFS更长；但亚组分析显示，发生肺部irAEs或≥3级irAEs的患者OS更差。总体而言，尽管irAE可能与治疗缓解增强相关，但其异质性和严重毒性风险凸显了深入了解其机制和开发预测性临床工具的必要性。早期识别和管理早期识别和及时进行免疫抑制干预对于获得最佳疗效至关重要。大多数irAE为低级别，可通过支持性治疗进行管理。2/3级事件通常需要使用皮质类固醇并暂停治疗，而4级毒性则需要永久停药。由于许多社区医疗机构的专科医生资源有限、治疗开始前基线实验室检查和诊断检测结果不确定，以及缺乏标准化的监测策略来检测治疗期间或治疗后发生的irAE，因此及时识别irAE仍然具有挑战性。专家组提出了首个早期检测监测模式，其中包括基线实验室检查（全血细胞计数、综合代谢指标、甲状腺功能检查、晨起皮质醇、脂肪酶和淀粉酶）、肺功能检查、心电图、步行氧饱和度监测以及详尽的患者和家族自身免疫性疾病史。当然，未来需要进一步研究来验证和实施这种方法。糖皮质激素仍然是治疗的基石，而对于激素难治性或危及生命的病例，则越来越多地依赖于其他免疫调节剂，包括JAK-STAT抑制剂、吗替麦考酚酯、CTLA-4激动剂、抗肿瘤坏死因子药物和抗整合素疗法。以下表格包含了基于临床经验的早期检测和治疗模式。结语免疫检查点抑制剂重塑了泌尿系统肿瘤的治疗格局，同时也带来了一系列潜在的严重毒性反应。免疫毒性既是治疗的代价，也是治疗成功的标志。泌尿系统肿瘤免疫疗法的未来不仅取决于优化治疗方案以最大限度地提高疗效，还取决于开发用于早期检测和管理irAEs的系统。总之，只有当临床医生能够在不损害患者安全的前提下充分发挥免疫治疗的潜力时，才能真正实现其全部潜能。参考文献上下滑动查看更多内容 [1] Motzer RJ, Escudier B, McDermott DF, et al; CheckMate 025 Investigators. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373(19):1803-1813. [2] Motzer RJ, Tannir NM, McDermott DF, et al; CheckMate 214 Investigators. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018;378(14):1277-1290. [3] Choueiri TK, Tomczak P, Park SH, et al; KEYNOTE-564 Investigators. Overall survival with adjuvant pembrolizumab in renal-cell carcinoma. N Engl J Med. 2024;390(15):1359-1371. [4] Balar AV, Kamat AM, Kulkarni GS, et al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Lancet Oncol. 2021;22(7):919-930. [5] Shore ND, Powles TB, Bedke J, et al. Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial. Nat Med. 2025;31(8):2806-2814. [6] De Santis M, Palou Redorta J, Nishiyama H, et al; POTOMAC Investigators. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial. Lancet. 2025;406(10516):2221-2234. [7] Powles T, Catto JWF, Galsky MD, et al; NIAGARA Investigators. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med. 2024;391(19):1773-1786. [8] Galsky MD, Hoimes CJ, Necch A, et al. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021;17(24):3137-3150. [9] U.S. Food and Drug Administration. FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer. FDA.gov. November 21, 2025. Accessed December 17, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-enfortumab-vedotin-ejfv-muscle-invasive-bladder-cancer. [10] Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384(22):2102-2114. [11] Apolo AB, Ballman KV, Sonpavde G, et al. Adjuvant pembrolizumab versus observation in muscle-invasive urothelial carcinoma. N Engl J Med. 2025;392(1):45-55. [12] Powles T, Kann AG, Castellano D, et al; IMvigor011 Investigators. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N Engl J Med. Published online October 20, 2025. [13] Powles T, Valderrama BP, Gupta S, et al; EV-302 Trial Investigators. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med. 2024;390(10):875-888. [14] Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med. 2020;383(13):1218-1230. [15] O’Malley DM, Bariani GM, Cassier PA, et al. Pembrolizumab in patients with microsatellite instability-high advanced endometrial cancer: results from the KEYNOTE-158 study. J Clin Oncol. 2022;40(7):752-761. [16] Boussiotis VA. Molecular and biochemical aspects of the PD-1 checkpoint pathway. N Engl J Med. 2016;375(18):1767-1778. [17] 1Bou Zerdan M, Moussa S, Atoui A, Assi HI. Mechanisms of immunotoxicity: stressors and evaluators. Int J Mol Sci. 2021;22(15):8242. [18] Mercinelli C, Carli C, Di Vita R, Oliveri M, Galli L, Necchi A. Immunotherapy toxicities in genito-urinary cancers: insights and challenges for clinicians. Curr Opin Urol. 2025;35(4):461-466. [19] Wu Z, Chen Q, Qu L, et al. Adverse events of immune checkpoint inhibitors therapy for urologic cancer patients in clinical trials: a collaborative systematic review and meta-analysis. Eur Urol. 2022;81(4):414-425. [20] Mar N, Slaught M, Kaakour D, Azizi A, Valerin JB. Distribution of immune-related adverse events (irAEs) across genitourinary (GU) malignancies. J Clin Oncol. 2022;40:6s (suppl; abstr 470). [21] Thapa B, Roopkumar J, Kim AS, et al. Incidence and clinical pattern of immune related adverse effects (irAE) due to immune checkpoint inhibitors (ICI). J Clin Oncol. 2019;37:15s (suppl; abstr e14151). [22] Maher VE, Fernandes LL, Weinstock C, et al. Analysis of the association between adverse events and outcome in patients receiving a programmed death protein 1 or programmed death ligand 1 antibody. J Clin Oncol. 2019;37(30):2730-2737. [23] Eggermont AMM, Kicinski M, Blank CU, et al. Association between immune-related adverse events and recurrence-free survival among patients with stage III melanoma randomized to receive pembrolizumab or placebo: a secondary analysis of a randomized clinical trial. JAMA Oncol. 2020;6(4):519-527. [24] Cortellini A, Buti S, Agostinelli V, Bersanelli M. A systematic review on the emerging association between the occurrence of immune-related adverse events and clinical outcomes with checkpoint inhibitors in advanced cancer patients. Semin Oncol. 2019;46(4-5):362-371. [25] Elias R, Levonyak N, Christie A, et al. A real-world experience of immune checkpoint inhibitors (ICI) in metastatic renal cell carcinoma (mRCC). J Clin Oncol. 2020;38:6s (suppl; abstr 647). [26] Verzoni E, Cartenì G, Cortesi E, et al; Italian Nivolumab Renal Cell Cancer Early Access Program group. Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program. J Immunother Cancer. 2019;7(1):99. [27] Zhang Y, Chen J, Liu H, et al. The incidence of immune-related adverse events (irAEs) and their association with clinical outcomes in advanced renal cell carcinoma and urothelial carcinoma patients treated with immune checkpoint inhibitors: a systematic review and meta-analysis. Cancer Treat Rev. 2024;129:102787. [28] Puzanov I, Diab A, Abdallah K, et al; Society for Immunotherapy of Cancer Toxicity Management Working Group. Managing toxicities associated with immune checkpoint inhibitors: consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group. J Immunother Cancer. 2017;5(1):95. [29] Özdemir BC, Espinosa da Silva C, Arangalage D, et al. Multidisciplinary recommendations for essential baseline functional and laboratory tests to facilitate early diagnosis and management of immune-related adverse events among cancer patients. Cancer Immunol Immunother. 2023;72(7):1991-2001. [30] Schneider BJ, Naidoo J, Santomasso BD, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update. J Clin Oncol. 2021;39(36):4073-4126. （来源：《肿瘤瞭望-泌尿时讯》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。

2026-05-18

·医药地理

罗氏，血里淘金

近日，FDA批准罗氏Tecentriq（阿替利珠单抗）用于肌层浸润性膀胱癌（MIBC）术后ctDNA 分子残留病灶（MRD）阳性患者的辅助治疗，同时批准全球首个血液MRD的伴随诊断产品——Natera的Signatera CDx。Signatera采用液体活检技术，仅需采集患者外周血样本，便能检测血液中循环肿瘤DNA的存在和水平，精准判断MRD。罗氏血里淘金，让一个曾被判“无效”的老药，抢下了膀胱癌红海中的关键一局。从"大水漫灌"到"精准滴灌" 膀胱癌是全球第十大常见癌症，其发病率和死亡率均位居恶性肿瘤前列，严重威胁公共卫生安全。Pharma ONE药物研发大数据平台显示，在膀胱癌的新发病例中，男性占比超过四分之三；同时，该病在中国的发病率显著低于欧美国家。患者年龄超过40岁后，发病率呈逐年上升趋势。膀胱癌不同国家发病率比较来源：Pharma ONE药物研发大数据平台，中国医药工业信息中心膀胱癌发病率随年龄的变化趋势来源：Pharma ONE药物研发大数据平台，中国医药工业信息中心点击“阅读原文”获取更多数据膀胱切除术配合化疗，通常是MIBC患者的标准治疗方案，全球每年有超过15万例患者接受这一手术，其中近一半在术后出现肿瘤复发。以往医生主要依赖肿瘤分期来判断患者术后是否需要进一步治疗。而Natera的Signatera检测能在标准影像学发现病灶之前，便从血液中捕捉到肿瘤的分子踪迹。随着ctDNA指导疗法首获FDA批准，临床医生可以选择性地对复发风险最高、最能从免疫治疗中获益的患者实施治疗，既消除了术后的不确定性，也让许多人得以安全地免于更多治疗。 Tecentriq及其伴随诊断产品Signatera获批依据的是罗氏后期临床研究IMvigor011的数据。这是首个通过ctDNA指导路径显著改善MIBC生存期的前瞻性3期研究。该研究共纳入761名前瞻性入组患者，术后接受长达一年多的连续ctDNA检测，随后250名患者被纳入治疗阶段，分别接受Tecentriq或安慰剂。在这250名经检测确认符合治疗条件的患者中，Tecentriq将疾病复发或死亡风险降低了36%，其中死亡风险单独降低了41%。罗氏的成功，在于重新定义了这群"高危"患者。2020年，IMvigor010未能在非选择性的MIBC人群中达到无病生存期这一主要终点。如今，罗氏调整策略，通过ctDNA筛选MRD阳性患者，实现从"大水漫灌"到"精准滴灌"。罗氏何以突围？借助Natera的MRD血液检测产品Signatera，罗氏的Tecentriq获FDA批准其第11个适应症，这距离它首次在尿路上皮癌中获批已过去整整十年。但在MIBC辅助治疗这个细分赛道，早已强敌环伺。百时美施贵宝的Opdivo于2021年拿下了术后辅助适应症；阿斯利康的Imfinzi去年成为首个获得围术期全面适应症（新辅助+辅助）的免疫疗法。更值得关注的是默沙东和辉瑞的组合——Keytruda与ADC药物Padcev联用，在围术期MIBC适应症的优先审评已经走在了前面，PDUFA目标日期是2026年8月，此前公布的KEYNOTE-B15数据显示EFS风险比低至0.53、对比传统化疗的32.5%，病理完全缓解率达55.8%。在这样的背景下，Tecentriq这次获批的核心竞争优势从何而来？答案不是“药更好”，而是“人选得更好”。全球首个ctDNA指导的肿瘤治疗获批，让Tecentriq在拥挤的赛道中找到了独特位置。IMvigor011的设计思路将影响肿瘤围术期治疗研究设计的基本范式——MRD正在从“预后标志物”走向“预测性生物标志物”。通过分子手段精准锁定受益人群，牺牲了宽泛的患者可及性，却换来了真正意义上的临床获益。对于药企而言，在热门适应症中寻找"细分人群"或"独特机制"，或许比直接与巨头硬碰硬更明智。互动投票 END 👇欢迎扫码入群 ①权威报告获取 ②医药行业情报 ③专属交流平台戳“阅读原文”试用数据库

2026-05-18

·BioSpace

Byondis Establishes Scientific Advisory Board of Recognized Leaders in Oncology Research and ADC Development

Global experts in antibody-drug conjugate (ADC) development, oncology clinical development and early-phase trial design, appointed to support advancement of Byondis’ differentiated ADC pipeline and a new generation of cancer therapeutics for patients Nijmegen, The Netherlands, − 18 May 2026 – Byondis B.V., an independent biopharmaceutical company creating targeted medicines for patients with cancer, today announces the formation of its Scientific Advisory Board to support the advancement of its antibody-drug conjugate (ADC) pipeline incorporating novel platform technologies. Comprised of internationally recognized experts in oncology research and drug development, the advisory board will provide strategic and scientific counsel to Byondis and contribute external scientific and clinical perspectives on precision oncology. Its formation comes as the company executes a focused strategy to develop innovative ADC therapies, addressing critical limitations across the current ADC landscape through its proprietary technology platforms and the clinical advancement of its differentiated oncology pipeline. Christoph Korpus, Chief Executive Officer at Byondis, said: “The formation of our Scientific Advisory Board marks a significant milestone for Byondis. I am proud to welcome a group of expert scientists and clinicians who have made exceptional contributions to oncology research, helping to bring some of the most consequential cancer medicines to patients. Their counsel and support will be invaluable as we execute our strategy to deliver breakthrough ADC solutions and develop a new generation of cancer therapeutics for patients.” Scientific Advisory Board Members (in alphabetical order): Dr. Anthony Tolcher, M.D., FRCPC, FACP Dr. Tolcher is one of the most accomplished early-phase clinical investigators in oncology, having served as principal investigator on first-in-human studies of numerous FDA-approved therapies, including trastuzumab emtansine (Kadcyla ® ), pembrolizumab (Keytruda ® ), durvalumab (Imfinzi ® ), and cemiplimab (Libtayo ® ). He is the Founder and Chief Executive Officer of NEXT Oncology, a specialist Phase I clinical company, and previously co-founded START LLC, a leading early-phase oncology organization. Dr. Tolcher has authored over 130 peer-reviewed publications and serves as a reviewer for the Journal of Clinical Oncology, Clinical Cancer Research, and Annals of Oncology. He completed his medical training in Canada before specializing in medical oncology. Dr. John Lambert, Ph.D. Dr. Lambert is one of the foremost pioneers of ADC science, having played a central role in the development of the technologies underpinning Kadcyla ® (trastuzumab emtansine) for HER2-positive breast cancer and Elahere ® (mirvetuximab soravtansine) for platinum-resistant ovarian cancer, two landmark regulatory approvals that helped establish ADCs as a transformative class of oncology medicine. He spent more than three decades at ImmunoGen, serving as Chief Scientific Officer from 2008 to 2015 and subsequently as Distinguished Research Fellow until his retirement in 2018. Dr. Lambert is the author or co-author of over 130 peer-reviewed publications and is a Fellow of the American Institute for Medical and Biological Engineering and an Honorary Professor at Queen’s University Belfast. Dr. Kapil Dhingra, M.D. Dr. Dhingra brings extensive experience in the clinical and strategic development of ADCs and targeted therapeutics, having served as a board member and advisor to numerous oncology companies involved in transformative acquisitions by Amgen, Bayer, and Novartis. As Vice President and Head of Oncology Clinical Development at Hoffmann-La Roche, he contributed to building what became the global leader in oncology. Since founding KAPital Consulting in 2008, Dr. Dhingra has advised companies across the US, Europe, and Australasia, and has served on the boards of publicly listed companies including Micromet, Algeta, Advanced Accelerator Applications, Autolus, Replimune, Five Prime, LAVA Therapeutics, CARGO Therapeutics, and, Black Diamond. He completed his Haematology-Oncology fellowship at Emory University and held faculty positions at M.D. Anderson Cancer Center, Indiana University School of Medicine, and Memorial Sloan Kettering Cancer Center. He is the author or co-author of more than 100 publications and abstracts. Prof. Paul W.H.I. Parren, Ph.D. Professor Parren has contributed to nine FDA- and EMA-approved therapeutic antibodies across eleven registered medicines, including four products derived from the DuoBody ® bispecific antibody platform. He is the inventor or co-inventor of three clinically translated antibody technologies, DuoBody ® , HexaBody ® , and the Gammabody technology and holds over 360 issued patents. His published work has accumulated more than 46,000 citations. Professor Parren led research and preclinical development at Genmab for 16 years before heading R&D at LAVA Therapeutics, which he advanced to a NASDAQ-listed clinical-stage company. He founded several biotech companies in the antibody field, serves as a biotech consultant and he chairs the board of Directors of The Antibody Society. He holds a Ph.D. in molecular immunology from the University of Amsterdam, is tenured Professor of Molecular Immunology at Leiden University Medical Center, and chairs the Board of Directors of The Antibody Society. -END- About Byondis Driven to improve patients’ lives, Byondis is an independent, fully integrated biopharmaceutical research and development company creating innovative targeted medicines for cancer. The company is developing new biological entities (NBEs) with a focus on antibody-drug conjugates. Byondis’ development portfolio leverages expertise in linker-drug (LD) technology, antibody-drug conjugation, and disease biology. Byondis’ fully integrated drug development capabilities cover all stages from pre-clinical and clinical R&D, production of clinical batches of the selected product candidates, and regulatory filings which are all done in-house. The company has a dedicated team of more than 200 staff working in its state-of-the-art R&D and GMP manufacturing facilities in Nijmegen, the Netherlands. Media Contact ICR Healthcare Sarah Elton-Farr / David Daley / Kris Lam byondis@icrhealthcare.com

上市批准抗体药物偶联物临床1期高管变更并购

100 项与度伐利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10808	度伐利尤单抗	L01XC28	DB11714

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
胃食管交界处腺癌	欧盟	AstraZeneca AB	2026-03-16
胃食管交界处腺癌	冰岛	AstraZeneca AB	2026-03-16
胃食管交界处腺癌	列支敦士登	AstraZeneca AB	2026-03-16
胃食管交界处腺癌	挪威	AstraZeneca AB	2026-03-16
胃癌	欧盟	AstraZeneca AB	2026-03-16
胃癌	冰岛	AstraZeneca AB	2026-03-16
胃癌	列支敦士登	AstraZeneca AB	2026-03-16
胃癌	挪威	AstraZeneca AB	2026-03-16
早期胃癌	美国	AstraZeneca PLC	2025-11-25
胃食管交界处癌	美国	AstraZeneca PLC	2025-11-25
局部晚期胃癌	美国	AstraZeneca PLC	2025-11-25
不可切除的非小细胞肺癌	中国	AstraZeneca UK Ltd.	2025-11-18
肌层浸润性膀胱癌	美国	AstraZeneca UK Ltd.	2025-03-28
子宫癌	日本	阿斯利康制药有限公司	2024-11-22
晚期子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15

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
ALK阳性非小细胞肺癌	申请上市	中国	AstraZeneca AB	2025-02-21
EGFR突变的非小细胞肺癌	申请上市	中国	AstraZeneca UK Ltd.	2025-02-21
卵巢上皮癌	申请上市	中国	AstraZeneca UK Ltd.	2024-08-16
错配修复功能正常的微卫星稳定型结肠癌	临床3期	西班牙	AstraZeneca PLC	2024-12-30
PD-L1阳性三阴性乳腺癌	临床3期	美国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	中国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	日本	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	阿根廷	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	澳大利亚	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	巴西	AstraZeneca PLC	2023-11-23

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临床结果

适应症

分期

评价

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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


NCT04786093 (CTgov)	临床2期	晚期非小细胞肺癌	1	Stereotactic radiation therapy+Durvalumab (Stereotactic Ablative Radiotherapy (SAbR) Arm Plus Durvalumab Arm)	願蓋艱糧築餘衊淵簾鏇(簾鹽顧獵夢顧糧鏇醖製) = 築築顧網範膚繭繭選膚齋鏇範壓餘廠憲鑰廠鹹 (築簾遞構廠衊壓壓遞憲, 鏇憲獵遞廠壓鹽願觸壓 ~ 夢齋獵範蓋夢壓顧觸範) 更多	-	2026-05-05
				Stereotactic radiation therapy+Durvalumab (Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) Plus Durvalumab Arm)	築鬱襯鬱觸顧簾鹹獵網 = 遞齋遞窪鏇蓋鏇積積窪淵構衊淵構構鑰觸憲壓 (簾積觸膚醖網窪簾鑰壓, 繭淵鬱獵鹹構積鹽鏇鑰 ~ 鹽積選簾餘齋衊遞壓觸) 更多
NCT03694236 (AACR2026)	临床2期	非小细胞肺癌新辅助	30	Neoadjuvant durvalumab combined with concurrent chemoradiotherapy	願願製獵繭壓艱壓遞淵(壓遞繭獵願選鹽鏇網願) = 鑰觸廠糧網窪壓觸鬱網醖範齋獵齋憲簾壓繭壓 (願窪遞積鹹選網夢製願 ) 更多	积极	2026-04-22
NCT05640791 (DURGAP, AACR2026)	临床2期	胆道癌新辅助 CD8+ \| CD4+ \| regulatory T cells (Tregs)	8	Neoadjuvant DurGAP therapy (TRG1)	積遞齋網艱淵構齋醖糧(窪窪夢獵襯選窪鏇鏇夢) = 網廠鬱齋廠窪網製夢餘顧夢膚鏇淵醖選製築製 (鹽網遞憲遞簾壓壓網顧 ) 更多	积极	2026-04-22
NCT03820141 (AACR2026)	临床2期	HER2阳性乳腺癌 ER-negative \| PR-negative \| HER2-Enriched	37	durvalumab+trastuzumab+pertuzumab	憲範夢膚壓窪願鬱構範(糧糧築蓋衊艱壓願齋繭) = 築衊網網衊壓糧蓋鬱夢淵醖窪糧廠衊遞鬱獵鏇 (構構願餘糧壓鬱衊構獵 )	积极	2026-04-21
AACR2026	临床2/3期	膀胱癌一线	200	ICI-only regimen(Durvalumab, Durvalumab+Tremelimumab, Pembrolizumab)	鹽廠選獵選廠願餘艱廠(鏇淵簾鬱製襯壓鹹蓋糧): HR = 1.92 (95.0% CI, 1.63 ~ 2.25) 更多	不佳	2026-04-21
				chemotherapy
NCT06526104 (STRIDE in CP-B, AACR2026)	临床2期	肝细胞癌一线	30	Tremelimumab 300 mg + Durvalumab 1500 mg (Hepatocellular Carcinoma + Child-Pugh B cirrhosis)	齋遞醖獵網憲顧淵願製(膚糧觸膚窪繭構艱獵獵) = 廠鬱艱鏇廠淵構鏇窪餘繭衊鹹襯築艱餘鏇蓋憲 (艱構醖構鏇衊積艱鏇鏇 ) 更多	积极	2026-04-21
NCT04308174 (DEBATE, AACR2026)	临床2期	胆道癌新辅助	45	Durvalumab plus Gemcitabine-Cisplatin (D+GP)	鹹鏇艱繭範選齋積糧廠(構範簾鹽憲築構齋餘範) = 憲積鏇鹹鹹壓網積齋襯醖鏇鏇襯鏇夢範鏇餘願 (製簾觸餘廠獵淵顧廠顧 ) 更多	积极	2026-04-21
				Gemcitabine-Cisplatin (GP)	鹹鏇艱繭範選齋積糧廠(構範簾鹽憲築構齋餘範) = 衊網艱製築鏇製鑰醖糧醖鏇鏇襯鏇夢範鏇餘願 (製簾觸餘廠獵淵顧廠顧 ) 更多
IMforte (AACR2026)	临床3期	广泛期小细胞肺癌维持	452	Lurbinectedin plus atezolizumab	膚網構蓋鹹夢築鏇選顧(構齋憲顧醖艱鬱餘夢衊) = 壓遞餘醖簾遞窪積鬱選壓壓積簾醖糧衊繭襯鏇 (範壓膚觸淵廠積製獵壓 ) 更多	积极	2026-04-20
				Durvalumab	膚網構蓋鹹夢築鏇選顧(構齋憲顧醖艱鬱餘夢衊) = 築遞鑰構廠糧選鹹淵夢壓壓積簾醖糧衊繭襯鏇 (範壓膚觸淵廠積製獵壓 ) 更多
NCT05043090 \| NCT02819596 (CALYPSO, Pubmed \| J Clin Oncol)	临床2期	转移性肿瘤 MET \| PD-L1 \| tumor mutational burden (TMB)	41	Savolitinib and Durvalumab	選窪壓鏇鏇範襯淵願鏇(簾鬱鑰餘艱製齋選襯衊) = 蓋淵築蓋膚築鬱選鬱願鹹獵鏇選蓋淵顧齋醖繭 (淵窪積鏇願網願積壓遞, 7.3 ~ 30.7) 更多	积极	2026-04-20
				Savolitinib and Durvalumab (MET-driven patients)	選窪壓鏇鏇範襯淵願鏇(簾鬱鑰餘艱製齋選襯衊) = 網範範艱醖淵鹹構鏇艱鹹獵鏇選蓋淵顧齋醖繭 (淵窪積鏇願網願積壓遞, 9.3 ~ 37.4) 更多
NCT03820141 (DTP, CTgov)	临床2期	乳腺癌 \| HER2 阴性乳腺癌	51	Trastuzumab+Pertuzumab+Durvalumab	衊積夢築積膚艱簾鑰衊 = 襯鏇積顧憲餘選遞觸築鹹餘選憲觸顧鹹壓膚餘 (範衊鏇壓壓齋鑰繭衊膚, 築膚鬱願簾蓋襯醖衊獵 ~ 構蓋艱製鹹淵築夢窪憲) 更多	-	2026-04-20