更新于：2024-09-20
Retlirafusp alfa
瑞拉芙普-α
更新于：2024-09-20
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
序列信息
Sequence Code 13388069L
来源: *****
Sequence Code 524307712H
来源: *****
关联
51
项与 瑞拉芙普-α 相关的临床试验An Open-Label Phase I/II Study of SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
SHR-1701 in combination with albumin paclitaxel and carboplatin for advanced head and neck squamous cell carcinoma
SHR-A1811联合用药治疗HER2表达晚期胃或胃食管结合部腺癌的Ib/II期临床研究
100 项与 瑞拉芙普-α 相关的临床结果
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100 项与 瑞拉芙普-α 相关的转化医学
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100 项与 瑞拉芙普-α 相关的专利（医药）
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6
项与 瑞拉芙普-α 相关的文献（医药）2023-12-15Human vaccines & immunotherapeutics
Long-lasting complete response to SHR-1701 plus famitinib in refractory advanced gallbladder cancer: A case report
Article
作者: Yi, Lixia ; Zhu, Xiaoyan ; Meng, Zhiqiang ; Xie, Jing
Biliary tract cancer (BTC) is an aggressive malignancy with few options for advanced-stage treatment. The combination of PD-1/PD-L1 inhibitors with famitinib, a receptor tyrosine kinase (RTK) inhibitor, has demonstrated improved clinical outcomes in several clinical trials. We herein reported a case of a gallbladder cancer (GBC) patient with liver metastases, previously resistant to traditional chemotherapy. Remarkably, the patient achieved a complete response (CR) with a long-lasting survival benefit exceeding 3 years. This was achieved using a novel regimen combining SHR-1701, an anti-PD-L1/TGF-βR fusion protein, and famitinib, even though the patient had proficient mismatch repair (pMMR) and tested negative for PD-L1. Adverse events were limited and manageable. This is the first report of such a treatment regimen being applied in a clinical setting, suggesting that the SHR-1701 and famitinib combination may be a promising immunotherapeutic approach for patients with refractory advanced GBC.
2022-12-15Clinical cancer research : an official journal of the American Association for Cancer Research
Bifunctional Blockade: A Novel Immunotherapy Approach for Cervical Cancer
Communications
作者: Friedman, Claire F. ; Miller, Kathryn M.
Summary:
SHR-1701, a bispecific fusion protein directed against PD-L1 and TGFβ, demonstrates promising clinical activity in advanced/recurrent cervical cancer. A recent study serves as a proof of principle that the TGFβ pathway may be successfully targeted, and that bispecific antibodies offer a novel therapeutic approach to do so.See related article by Feng et al., p. 5297
2022-12-15Clinical cancer research : an official journal of the American Association for Cancer Research
SHR-1701, a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, for Recurrent or Metastatic Cervical Cancer: A Clinical Expansion Cohort of a Phase I Study
Article
作者: Chen, Hongmin ; Feng, Jifeng ; Sun, Yuping ; Zhou, Qi ; Zou, Jianjun ; Yang, Junqin ; Lou, Hanmei ; Wang, Linna ; Peng, Jin ; Tang, Dihong ; Wang, Jing ; Liu, Pan ; Cai, Yunlang
Abstract:
Purpose::
Patients with recurrent or metastatic cervical cancer have limited treatment options after platinum-containing treatment. We initiated a phase I study to assess SHR-1701, a novel bifunctional fusion protein composed of a mAb against programmed death ligand 1 (PD-L1) fused with the extracellular domain of TGFβ receptor II, in solid tumors (NCT03774979). Here, results from the cervical cancer cohort are presented.
Patients and Methods::
Patients with recurrent or metastatic cervical cancer who progressed during or after platinum-based therapy were enrolled to receive SHR-1701 at 30 mg/kg every 3 weeks. Primary endpoint was objective response rate (ORR) per RECIST v1.1.
Results::
In total, 32 patients were recruited. ORR was 15.6% [95% confidence interval (CI), 5.3–32.8], and disease control rate was 50.0% (95% CI, 31.9–68.1). Responses were still ongoing in 80.0% of the responders; 6-month duration of response rate was 80.0% (95% CI, 20.4–96.9). Median progression-free survival (PFS) was 2.7 months (95% CI, 1.4–4.1). Of note, as assessed by immune-modified RECIST, median PFS was 4.1 months (95% CI, 1.6–4.3). Overall survival rate at 12 months was 54.6% (95% CI, 31.8–72.7). Treatment-related adverse events of grade 3 or 4 were reported in 11 (34.4%) patients. No treatment-related deaths occurred. No difference in ORR was found between patients with PD-L1 combined positive score ≥1 or <1; patients with high phosphorylated SMAD2 level in immune cells or tumor cells had numerically higher ORR.
Conclusions::
SHR-1701 exhibits encouraging antitumor activity and controllable safety in patients with recurrent or metastatic cervical cancer after platinum-based regimens, and therefore might provide another treatment option for this population.See related commentary by Miller and Friedman, p. 5238
100 项与 瑞拉芙普-α 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 子宫颈转移癌 | 临床3期 | 中国 | 2022-02-26 | |
| 局部进展期胃癌 | 临床3期 | 中国 | 2022-01-26 | |
| 非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2022-01-24 | |
| 宫颈癌 | 临床3期 | 中国 | 2022-01-10 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | - | 2021-12-30 | |
| 胃食管交界处恶性肿瘤 | 临床3期 | 中国 | 2021-12-06 | |
| 转移性胃食管结合部腺癌 | 临床3期 | 中国 | 2021-12-06 | |
| 胃食管交界处癌 | 临床3期 | 中国 | 2021-12-01 | |
| 结直肠癌 | 临床3期 | 中国 | 2021-06-22 | |
| 转移性结直肠癌 | 临床3期 | 中国 | 2021-06-22 |
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临床结果
临床结果
适应症
分期
评价
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临床1/2期 | 胰腺癌 一线 | 56 | 願獵獵獵鏇遞憲構繭蓋(願構餘繭夢網淵鹽簾顧) = 製糧選選製願簾糧壓糧 膚憲齋壓衊憲網憲遞憲 (憲築範築餘構膚範製製, 20.3 ~ 46.0) 更多 | 积极 | 2024-09-16 | ||
(PD-L1 TPS≥1%) | 願獵獵獵鏇遞憲構繭蓋(願構餘繭夢網淵鹽簾顧) = 獵艱範積鬱觸鏇繭糧鑰 膚憲齋壓衊憲網憲遞憲 (憲築範築餘構膚範製製 ) 更多 | ||||||
临床3期 | 731 | SHR-1701+Chemo (ITT) | 繭繭壓簾憲襯衊築積觸(窪鏇鏇鹹糧構夢觸窪獵) = 範憲範獵繭夢醖糧糧齋 齋獵窪鬱繭鹹構鬱鑰齋 (鏇製憲鹹壓窪鬱製艱顧, 14.0 ~ 16.9) 更多 | 积极 | 2024-09-16 | ||
Placebo+Chemo (ITT) | 繭繭壓簾憲襯衊築積觸(窪鏇鏇鹹糧構夢觸窪獵) = 積簾衊構艱蓋鑰艱廠繭 齋獵窪鬱繭鹹構鬱鑰齋 (鏇製憲鹹壓窪鬱製艱顧, 9.4 ~ 12.1) 更多 | ||||||
临床2期 | 晚期鳞状细胞肺癌 一线 | 维持 | 23 | 範淵鏇窪夢觸網鹹壓繭(鬱鹽鹽淵觸製夢憲願壓) = 廠鏇鹹觸餘獵齋夢鏇顧 醖鹽壓築夢齋網衊獵蓋 (範繭餘觸憲窪艱鏇鑰獵 ) 更多 | 积极 | 2024-09-10 | ||
临床2期 | 非小细胞肺癌 III期 新辅助 | 107 | Neoadjuvant SHR-1701 + chemotherapy | 網積網簾鏇範壓願願蓋(遞簾憲蓋餘膚衊壓夢壓) = 選製餘鑰窪選遞繭襯築 顧餘遞製構範獵繭築衊 (衊糧醖鏇衊夢艱鬱觸觸, 45.2 ~ 66.5) 更多 | 积极 | 2024-05-24 | |
Neoadjuvant SHR-1701 alone | 網積網簾鏇範壓願願蓋(遞簾憲蓋餘膚衊壓夢壓) = 網簾淵糧製鹽淵糧遞獵 顧餘遞製構範獵繭築衊 (衊糧醖鏇衊夢艱鬱觸觸, 34.5 ~ 93.9) 更多 | ||||||
临床1期 | 晚期非小细胞肺癌 EGFR Mutation | PD-L1 Positive | 131 | SHR-1701 30 mg/kg (PD-L1 TPS≥1%) | 壓積衊膚艱餘壓範選遞(壓襯壓網膚夢顧淵膚繭) = 觸鹹繭淵顧遞齋製夢獵 製積築鑰製廠齋夢築醖 (壓艱繭顧鏇繭夢廠廠憲 ) 更多 | 积极 | 2023-12-11 | |
SHR-1701 30 mg/kg (EGFR突变) | 壓積衊膚艱餘壓範選遞(壓襯壓網膚夢顧淵膚繭) = 蓋艱簾繭範顧觸衊製齋 製積築鑰製廠齋夢築醖 (壓艱繭顧鏇繭夢廠廠憲 ) 更多 | ||||||
临床2期 | 21 | SHR-1701 30 mg/kg+ temozolomide 150 mg/m2 | 構鬱網顧觸觸膚艱憲鹽(鏇膚糧鏇範獵膚遞鑰衊) = 鹹鏇膚淵艱淵繭製衊繭 醖遞夢夢糧遞築襯獵遞 (願膚網糧壓衊鏇顧醖繭 ) 更多 | 积极 | 2023-10-22 | ||
临床1/2期 | HR阳性/HER2低表达实体瘤 PD-L1 CPS ≥1 | HER2 Negative | 67 | 鬱顧鏇積繭鬱遞範糧糧(衊範構蓋觸襯築廠鑰夢) = 衊憲築壓餘築窪鏇鬱齋 淵構鬱鹹壓願窪糧鬱鹹 (鏇膚鏇醖鬱鹽壓壓簾願 ) 更多 | 积极 | 2023-10-21 | ||
(GC/GEJC (1L)) | 構遞齋顧餘蓋衊繭繭繭(淵製艱夢衊鏇餘顧鹽窪) = 鹹願襯窪襯繭齋憲襯淵 簾夢鑰鹽膚鑰鬱範餘齋 (選憲繭鑰夢鏇夢顧壓憲, 6.1 ~ 45.6) 更多 | ||||||
临床1期 | 31 | SHR-1701+platinum-based chemotherapy+BP102 | 鏇衊網觸壓觸製壓願網(遞繭積壓網顧網築觸鹹) = 製襯夢蓋廠壓醖範窪簾 遞鏇願範淵夢築窪範憲 (蓋遞鹹願憲選範衊獵衊 ) 更多 | 积极 | 2023-05-31 | ||
临床1期 | 32 | 憲艱觸顧夢壓窪衊壓鹹(顧遞夢遞遞襯選壓醖鏇) = SHR2554 350mg bid plus SHR-1701 30mg/kg q3w 選構構鬱醖廠積鹹鹽積 (築積繭積壓糧願衊艱觸 ) 更多 | 积极 | 2023-05-31 | |||
临床2期 | 107 | chemotherapy+SHR-1701 (Arm A：PD-L1 TPS <50%，combo-therapy) | 鑰繭願蓋淵獵築顧憲鹹(顧選顧鏇積壓壓網簾鹹) = 築繭壓鏇製鏇簾艱醖鬱 遞願壓製顧齋夢築餘鏇 (築夢淵鹽鹽觸鑰鹹觸簾, 11.5 ~ NR) 更多 | 积极 | 2022-12-07 | ||
chemotherapy+SHR-1701 (Arm B：PD-L1 TPS ≥50%，combo-therapy) | 鑰繭願蓋淵獵築顧憲鹹(顧選顧鏇積壓壓網簾鹹) = 顧觸齋夢襯憲構顧鑰築 遞願壓製顧齋夢築餘鏇 (築夢淵鹽鹽觸鑰鹹觸簾, 3.3 ~ NR) 更多 |
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