Abstract 12P
Background
In the phase III CameL-sq trial, Cam-chemo as 1L treatment significantly prolonged PFS vs placebo (PBO)-chemo in patients (pts) with advanced sqNSCLC. Here, we report updated outcomes 5 y after enrollment of the last pt.
Methods
Eligible pts with previously untreated advanced sqNSCLC were randomized 1:1 to receive Cam (200 mg) or PBO plus carboplatin (AUC 5) and paclitaxel (175 mg/m2) Q3W for 4–6 cycles, followed by maintenance with Cam or PBO. Pts allocated to the PBO arm were allowed to cross over to Cam upon disease progression. Maximum treatment duration for Cam was 2 y.
Results
389 pts were randomized and treated (Cam-chemo, n=193; PBO-chemo, n=196). As of Dec 20, 2024, median time from randomization to DCO was 65.6 mo (range 59.7–73.2). Median OS was significantly extended with Cam-chemo vs PBO-chemo (27.4 vs 15.5 mo; HR 0.57, 95% CI 0.46–0.72; 1-sided p < 0.0001). OS benefits with Cam-chemo were sustained overtime, with a 5y OS rate of 27.8% (95% CI 21.4–34.6) vs 12.5% (95% CI 8.2–17.8). 97 (49.5%) pts in the PBO-chemo arm crossed over to receive Cam monotherapy; OS benefits with Cam-chemo were more pronounced after adjustment for cross-over effect with the RPSFT model (HR 0.38, 95% CI 0.29–0.50). Consistent OS benefits were observed with Cam-chemo across baseline subgroups, including those defined by PD-L1 expression; median OS was 19.8 vs 14.4 mo (HR 0.62, 95% CI 0.45–0.86) and 38.4 vs 20.1 mo (HR 0.60, 95% CI 0.43–0.85) in pts with PD-L1 TPS
Conclusions
Addition of Cam to chemo continued to show clinically meaningful survival benefits with manageable toxicities after long-term follow-up. Over a quarter of pts were estimated to be alive at 5y, further supporting this regimen as a standard-of-care 1L treatment for advanced sqNSCLC.
Clinical trial identification
NCT03668496.
Legal entity responsible for the study
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
C. Zhou: Financial Interests, Personal, Other, Honoraria as a speaker: Lily China, Sanofi, BI, Roche, MSD, Qilu, Hengrui, Innovent Biologics, C-Stone, LUYE Pharma, TopAlliance Biosciences Inc.; Financial Interests, Personal, Advisory Role: Amoy Diagnositics, Innovent Biologics, Hengrui, Qilu, TopAlliance Biosciences Inc. Z. Wang, X. Lu: Financial Interests, Personal, Full or part-time Employment: Hengrui. All other authors have declared no conflicts of interest.