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Background <p>This single-center, open-label, exploratory trial aimed to investigate the efficacy and safety of envafolimab combined with lenvatinib and chemotherapy in previous treated advanced G/GEJ adenocarcinoma.</p> Methods <p>Eligible patients with HER2-negative, microsatellite stable (MSS) advanced G/GEJ adenocarcinoma who had progressed after first-line treatment were enrolled in this phase II trial. Patients without previously receiving PD-1/PD-L1 inhibitors were enrolled in Group <i>A</i>, and those who progressed on the first-line PD-1 inhibitors were included in Group <i>B</i>. Patients in both groups received envafolimab (200&#xa0;mg, subcutaneous injection (sc), days 1 and 15, Q4W) combined with lenvatinib and albumin-bound paclitaxel (100&#xa0;mg/m<sup>2</sup>, IV, days 1, 8 and 15, Q4W, up to 6 cycles) until disease progression, unacceptable toxicity, or refusal of continuation. The primary endpoint was objective response rate (ORR).</p> Results <p>A total of 30 patients were included for safety and efficacy analysis. As of data cutoff (Sep 14, 2024), the median follow-up was 17.0&#xa0;months (IQR: 8.0–18.8) in Group <i>A</i>. The ORR was 60.0%, and the DCR was 100.0%. The mPFS was 8.2&#xa0;months (95% CI 6.1–10.4) with mOS of 14.8&#xa0;months (95% CI 7.4–22.2). With a median follow-up of 9.0&#xa0;months (IQR: 6.1–16.2) in Group <i>B</i>, the ORR was 46.7%, and the DCR was 100.0%. The mPFS was 5.9&#xa0;months (95% CI 3.8–8.1), and the mOS was 11.5&#xa0;months (95% CI 3.1–19.9). The overall incidence of adverse events (AEs) of any grade was 100%. While Group <i>A</i> showed numerically better outcomes than Group <i>B</i>, there was no statistically significant difference in PFS (<i>P</i> = 0.629) or OS (<i>P</i> = 0.873) between the two groups.</p> Conclusions <p>Second-line envafolimab-based combination therapy demonstrated promising effects in previously treated advanced GC, particularly in those who have not previously received ICIs.</p>

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Envafolimab combined with lenvatinib and albumin-bound paclitaxel in previously treated advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma: a prospective, phase II, multi-cohort trial

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  • 发表日期：

    2026年4月21日

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  • Zhao Xiaoying,
  • Feng Wanjing,
  • Geng Qirong,
  • Huang Mingzhu,
  • Zhang Zhe,
  • Chen Jinsi,
  • Sheng Xuedan,
  • Zhu Xiaodong,
  • Guo Weijian

摘要

Background

This single-center, open-label, exploratory trial aimed to investigate the efficacy and safety of envafolimab combined with lenvatinib and chemotherapy in previous treated advanced G/GEJ adenocarcinoma.

Methods

Eligible patients with HER2-negative, microsatellite stable (MSS) advanced G/GEJ adenocarcinoma who had progressed after first-line treatment were enrolled in this phase II trial. Patients without previously receiving PD-1/PD-L1 inhibitors were enrolled in Group A, and those who progressed on the first-line PD-1 inhibitors were included in Group B. Patients in both groups received envafolimab (200 mg, subcutaneous injection (sc), days 1 and 15, Q4W) combined with lenvatinib and albumin-bound paclitaxel (100 mg/m2, IV, days 1, 8 and 15, Q4W, up to 6 cycles) until disease progression, unacceptable toxicity, or refusal of continuation. The primary endpoint was objective response rate (ORR).

Results

A total of 30 patients were included for safety and efficacy analysis. As of data cutoff (Sep 14, 2024), the median follow-up was 17.0 months (IQR: 8.0–18.8) in Group A. The ORR was 60.0%, and the DCR was 100.0%. The mPFS was 8.2 months (95% CI 6.1–10.4) with mOS of 14.8 months (95% CI 7.4–22.2). With a median follow-up of 9.0 months (IQR: 6.1–16.2) in Group B, the ORR was 46.7%, and the DCR was 100.0%. The mPFS was 5.9 months (95% CI 3.8–8.1), and the mOS was 11.5 months (95% CI 3.1–19.9). The overall incidence of adverse events (AEs) of any grade was 100%. While Group A showed numerically better outcomes than Group B, there was no statistically significant difference in PFS (P = 0.629) or OS (P = 0.873) between the two groups.

Conclusions

Second-line envafolimab-based combination therapy demonstrated promising effects in previously treated advanced GC, particularly in those who have not previously received ICIs.