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Background <p>We aimed to evaluate the efficacy and safety of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) plus TPC chemotherapy (NAB-paclitaxel, cisplatin or lobaplatin, and capecitabine) in patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) who failed to PD-1 inhibitor-containing regimens.</p> Methods <p>In this single-arm, open-label, phase 2 study, RM-NPC patients who failed to at least one line of systemic chemotherapy and anti-PD-1 immunotherapy were enrolled and received cadonilimab plus TPC chemotherapy every 3&#xa0;weeks for up to 6 cycles, followed by cadonilimab plus capecitabine every 3&#xa0;weeks for a maximum of 2&#xa0;years. The primary endpoint was the objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety.</p> Results <p>Twenty-five patients were enrolled (84% male; median age 44&#xa0;years (range, 24–60)), with a median follow-up of 10.2&#xa0;months. The ORR was 68%, with 3 complete responses, 14 partial responses, and 6 stable diseases. The median DoR was 9.1&#xa0;months (95% CI, 3.8–14.5&#xa0;months). The median PFS was 10.6&#xa0;months (95% CI, 5.2–16.0&#xa0;months). The 12-month OS was 75.6%. Treatment was well tolerated. Grade 3 or 4 treatment-related adverse events occurred in 12 (48%) patients. Fourteen patients (56%) experienced potentially immune-related adverse events (irAEs). One patient experienced a grade 3 immune-related rash and another patient had grade 3 immune-related lipase increased. No treatment-related death occurred.</p> Conclusions <p>Cadonilimab in combination with TPC chemotherapy demonstrated promising antitumoral efficacy and manageable toxicities in patients with RM-NPC who failed frontline immunotherapy. Further trials are warranted to confirm and expand these findings.</p> Trial registration <p>This trial was registered at chictr.org.cn (ChiCTR2200067057).</p>

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Efficacy and safety of cadonilimab (PD-1/CTLA-4 bispecific) in combination with chemotherapy in anti-PD-1-resistant recurrent or metastatic nasopharyngeal carcinoma: a single-arm, open-label, phase 2 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月11日

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  • Yaofei Jiang,
  • Weixin Bei,
  • Lin Wang,
  • Nian Lu,
  • Cheng Xu,
  • Hu Liang,
  • Liangru Ke,
  • Yanfang Ye,
  • Shuiqing He,
  • Shuhui Dong,
  • Qin Liu,
  • Chuanrun Zhang,
  • Xuguang Wang,
  • Weixiong Xia,
  • Chong Zhao,
  • Ying Huang,
  • Yanqun Xiang,
  • Guoying Liu

摘要

Background

We aimed to evaluate the efficacy and safety of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) plus TPC chemotherapy (NAB-paclitaxel, cisplatin or lobaplatin, and capecitabine) in patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) who failed to PD-1 inhibitor-containing regimens.

Methods

In this single-arm, open-label, phase 2 study, RM-NPC patients who failed to at least one line of systemic chemotherapy and anti-PD-1 immunotherapy were enrolled and received cadonilimab plus TPC chemotherapy every 3 weeks for up to 6 cycles, followed by cadonilimab plus capecitabine every 3 weeks for a maximum of 2 years. The primary endpoint was the objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety.

Results

Twenty-five patients were enrolled (84% male; median age 44 years (range, 24–60)), with a median follow-up of 10.2 months. The ORR was 68%, with 3 complete responses, 14 partial responses, and 6 stable diseases. The median DoR was 9.1 months (95% CI, 3.8–14.5 months). The median PFS was 10.6 months (95% CI, 5.2–16.0 months). The 12-month OS was 75.6%. Treatment was well tolerated. Grade 3 or 4 treatment-related adverse events occurred in 12 (48%) patients. Fourteen patients (56%) experienced potentially immune-related adverse events (irAEs). One patient experienced a grade 3 immune-related rash and another patient had grade 3 immune-related lipase increased. No treatment-related death occurred.

Conclusions

Cadonilimab in combination with TPC chemotherapy demonstrated promising antitumoral efficacy and manageable toxicities in patients with RM-NPC who failed frontline immunotherapy. Further trials are warranted to confirm and expand these findings.

Trial registration

This trial was registered at chictr.org.cn (ChiCTR2200067057).