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Sugemalimab offers PFS benefits for unresectable NSCLC

Presented by
Prof. Yi-Long Wu, Guangdong Provincial People’s Hospital, China
WCLC 2022
Phase 3, GEMSTONE-301
The final progression-free survival (PFS) analysis of the phase 3 GEMSTONE-301 trial demonstrated clinical benefits for patients with unresectable stage III non-small cell lung cancer (NSCLC) who were treated with sugemalimab after chemotherapy compared with those receiving placebo after chemotherapy. According to the investigators, sugemalimab presented itself as a new standard-of-care for the inoperable NSCLC population [1].

The phase 3 GEMSTONE-301 trial (NCT03728556) compared the efficacy of the PD-L1 inhibitor sugemalimab (n=255) with placebo (n=126) in patients with stage III, unresectable NSCLC who did not progress after either concurrent or sequential chemoradiotherapy (CRT). Sugemalimab displayed a significant PFS benefit over placebo in the pre-planned interim PFS analysis [2]. At the WCLC 2022, Prof. Yi-Long Wu (Guangdong Provincial People’s Hospital, China) presented the results of the final PFS analysis of this trial.

After a median follow-up of 27.1 months, the median PFS was significantly higher in patients who were treated with sugemalimab versus those treated with placebo (10.5 vs 6.2 months; HR 0.65; 95% CI 0.50–0.84; P=0.0012). In addition, the 3-year PFS rate was 26.1% in the experimental arm and 0% in the placebo arm. These results were consistent in patients who had received sequential CRT (8.1 vs 4.1 months; HR 0.57; 95% CI 0.38–0.87) and in those who were treated with concurrent CRT (15.7 vs 8.3 months; HR 0.71; 95% CI 0.50–1.00). Although the overall survival (OS) data were immature at the time of the analysis, they appear to favour sugemalimab over placebo (median OS not reached vs 25.9 months; HR 0.69; 95% CI 0.49–0.97). No new safety issues were reported in this final PFS analysis.

  1. Wu Y-L, et al. Sugemalimab vs placebo after cCRT or sCRT in pts with unresectable stage III NSCLC: final PFS analysis of a phase 3 study. OA02.05, WCLC 2022, Vienna, Austria, 06–09 August.
  2. Zhou Q, et al. Lancet Oncology. 2022;23(2):209-219


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