Camrelizumab Plus Famitinib versus Camrelizumab Alone and Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer: A Randomized, Phase II Study.

Methods

Patients with pretreated R/M CC were randomly assigned to receive camrelizumab (200 mg intravenously once every 3 weeks) plus famitinib (20 mg orally once daily), camrelizumab, or investigator's choice of chemotherapy.

对于接受过治疗的R/M CC患者，随机分配接受卡瑞利珠单抗（每3周静脉注射200毫克）联合法米替尼（每天口服20毫克）、单独卡瑞利珠单抗或研究者选择的化疗方案。

The primary end point was comparison of objective response rate(ORR) per blinded independent central review (BICR) for camrelizumab-famitinib versus camrelizumab in the intention-to-treatpopulation.

主要终点是比较盲法独立中心评审（BICR）下卡瑞利珠单抗-法米替尼与卡瑞利珠单抗在意向治疗人群中的客观缓解率（ORR）。

Results

Overall, 105, 54, and 35 patients received camrelizumab-famitinib, camrelizumab, and chemotherapy, respectively.

总体而言，分别有105名、54名和35名患者接受了卡瑞利珠单抗-法米替尼、卡瑞利珠单抗和化疗治疗。

As of April 21, 2023, ORR per BICR was significantly improved with camrelizumab-famitinib compared with camrelizumab (41.0% [95% CI, 31.5 to 51.0] v 24.1% [95% CI, 13.5 to 37.6]; difference, 16.9% [95% CI, 2.1 to 31.7]; one-sided P = .0181).

截至2023年4月21日，根据BICR评估，卡瑞利珠单抗-法米替尼的客观缓解率（ORR）显著优于卡瑞利珠单抗（41.0% [95% 置信区间, 31.5至51.0] 对比 24.1% [95% 置信区间, 13.5至37.6]；差异为16.9% [95% 置信区间, 2.1至31.7]；单侧P值为.0181）。

Per investigator, ORR with camrelizumab-famitinib was 42.9% (95% CI, 33.2 to 52.9), notably higher than 22.2% (95% CI, 12.0 to 35.6) with camrelizumab and 14.3% (95% CI, 4.8 to 30.3) with chemotherapy.

根据研究者评估，卡瑞利珠单抗-法米替尼的ORR为42.9%（95% 置信区间, 33.2至52.9），显著高于卡瑞利珠单抗的22.2%（95% 置信区间, 12.0至35.6）以及化疗的14.3%（95% 置信区间, 4.8至30.3）。

Median progression-free survivalper investigator was prolonged with camrelizumab-famitinib than camrelizumab and chemotherapy (8.1 months [95% CI, 6.2 to 12.4] vs 4.1 months [95% CI, 2.1 to 5.1] and 2.9 months [95% CI, 2.0 to 6.2]).

根据研究者评估，卡瑞利珠单抗-法米替尼组的中位无进展生存期较卡瑞利珠单抗组和化疗组延长（8.1个月 [95% 置信区间, 6.2至12.4] 对比 4.1个月 [95% 置信区间, 2.1至5.1] 和 2.9个月 [95% 置信区间, 2.0至6.2]）。

Median overall survivalwith camrelizumab-famitinib, camrelizumab, and chemotherapy, as of October 19, 2023, was 20.2 months (95% CI, 15.3 to not reached [NR]), 14.9 months (95% CI, 12.6 to NR), and 13.9 months (95% CI, 7.4 to 20.0), respectively.

截至2023年10月19日，卡瑞利珠单抗-法米替尼、卡瑞利珠单抗和化疗组的中位总生存期分别为20.2个月（95% 置信区间, 15.3至未达到[NR]）、14.9个月（95% 置信区间, 12.6至NR）和13.9个月（95% 置信区间, 7.4至20.0）。

Eighty-nine (84.8%), eight (15.1%), and 18 (60.0%) patients who received camrelizumab-famitinib, camrelizumab, and chemotherapy, respectively, experienced grade ≥3 treatment-related adverse events.

89名(84.8%)、8名(15.1%)和18名(60.0%)接受卡瑞利珠单抗-法米替尼、卡瑞利珠单抗和化疗的患者分别经历了≥3级的治疗相关不良事件。

Conclusions

Camrelizumab plus famitinib improved antitumor activity while exhibiting a manageable safety profile in patients with pretreated R/M CC, potentially offering a novel treatment option.

卡瑞利珠单抗联合法米替尼在既往接受治疗的R/M CC患者中提高了抗肿瘤活性，同时展现了可管理的安全性，可能提供了一种新的治疗选择。