Abstract 135P
Background
The phase 3 CameL and CameL-sq studies have proven the superiority of first-line camrelizumab plus chemotherapy (camre-chemo) vs chemo for progression-free survival (PFS) in patients (pts) with advanced non-squamous and squamous NSCLC, respectively. Here, we report pooled outcomes of pts from the two trials with long-term follow-up.
Methods
Pts with stage IIIB–IV NSCLC, no EGFR/ALK alterations, ECOG PS of 0 or 1, and no prior systemic therapy for metastatic disease were randomized to 4–6 cycles of carboplatin-pemetrexed ± camre followed by maintenance pemetrexed ± camre (non-squamous) or carboplatin-paclitaxel + placebo/camre followed by placebo/camre (squamous). Crossover from chemo to camre was permitted at radiographic progression, and RPSFT model was used to adjust for crossover. Total camre exposure was up to 2 yrs.
Results
801 pts were included (camre-chemo, N=398; chemo, N=403). Baseline characteristics were well balanced between the two groups (male, 82% with camre-chemo vs 82% with chemo; median age, 61 vs 61 yrs; ECOG PS of 1, 78% vs 80%; smoking history of ≥20 packs/yr, 73% vs 71%; PD-L1 TPS of ≥1%, 59% vs 52%). As of Jan 31, 2022, median follow-up was 21.6 mo (range 0.2–51.3) in camre-chemo group and 15.2 mo (range 0.5–48.6) in chemo group. Median PFS (mPFS) per investigator was 11.0 mo (95% CI 9.3–12.6) with camre-chemo vs 5.5 mo (95% CI 5.5–5.6) with chemo (HR 0.44 [95% CI 0.38–0.52]; 1-sided p <0.0001). Median overall survival (mOS) was 26.1 mo (95% CI 22.9–29.2) with camre-chemo vs 16.8 mo (95% CI 14.9–19.9) with chemo (HR 0.66 [95% CI 0.55–0.79]; 1-sided p <0.0001); the OS rate was 52.3% (95% CI 47.1–57.3) vs 37.7% (95% CI 32.8–42.6) at 24 mo, 31.9% (95% CI 25.6–38.4) vs 21.0% (95% CI 16.0–26.4) at 36 mo, and 26.8% (95% CI 19.5–34.7) vs 12.4% (95% CI 7.4–18.7) at 48 mo. Crossover-adjusted mOS was 14.5 mo (95% CI 12.9–16.5) with chemo (HR 0.52 [95% CI 0.43–0.63]; 1-sided p <0.0001). No new safety signals were observed.
Conclusions
With extended follow-up, camre plus chemo continued to provide clinically meaningful survival benefits over chemo with manageable safety in pts with previously untreated, advanced non-squamous and squamous NSCLC.
Clinical trial identification
NCT03134872 (First Posted: May 1, 2017) and NCT03668496 (First Posted: September 12, 2018).
Legal entity responsible for the study
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
C. Zhou: Financial Interests, Personal, Invited Speaker: Roche, Lily China, Boehringer Ingelheim, Merck, Hengrui, Qilu, Sanofi, Merck Sharp & Dohme, Innovent Biologics, C-Stone, Luye Pharma, TopAlliance Biosciences, and Amoy Diagnostics; Financial Interests, Personal, Advisory Role: Innovent Biologics, Hengrui, Qilu, and TopAlliance Biosciences. Y. Tai, X. Ma, X. Lu: Financial Interests, Personal, Full or part-time Employment: Hengrui. All other authors have declared no conflicts of interest.