Abstract 62P
Background
In the phase III CameL-sq trial, camrelizumab + chemo as 1L treatment significantly extended PFS vs placebo + chemo in patients (pts) with advanced sqNSCLC. Here we report the outcomes 4 yrs after enrollment of the last pt.
Methods
Eligible pts with previously untreated advanced sqNSCLC were randomized 1:1 to receive camrelizumab (200 mg) or placebo plus carboplatin (AUC 5) and paclitaxel (175 mg/m2) Q3W for 4-6 cycles, followed by maintenance therapy with camrelizumab or placebo. Pts allocated to the placebo arm were allowed to cross over to camrelizumab upon disease progression.
Results
389 pts were randomized and treated (camrelizumab + chemo, n=193; placebo + chemo, n=196). As of Dec. 15, 2023, median time from randomization to data cutoff was 53.5 mo (range 47.5-61.0). Median OS was substantially prolonged with camrelizumab + chemo vs placebo + chemo (27.4 mo vs 15.5 mo; HR 0.56 [95% CI 0.45-0.72]); the OS benefit with camrelizumab + chemo was sustained, with a consistent improvement in OS rate of ∼20% at 2, 3, and 4 yrs (Table). 97 (49.5%) pts in the placebo + chemo arm crossed over to camrelizumab; analyses adjusted for cross-over effect with the Rank Preserving Structural Failure Time model further confirmed the OS benefits with camrelizumab + chemo (HR 0.35, 95% CI 0.27-0.47). Improvement in OS with camrelizumab + chemo vs placebo + chemo was seen regardless of baseline demographic and clinical characteristics; median OS was 19.8 mo vs 14.4 mo (HR 0.62, 95% CI 0.45-0.86) in the PD-L1 TPS <1% subgroup and 38.4 mo vs 20.1 mo (HR 0.56, 95% CI 0.40-0.81) in the PD-L1 TPS ≥1% subgroup. No new safety signals were identified. Table: 62P
OS outcomes
| Camrelizumab + chemo (n=193) | Placebo + chemo (n=196) | |
| Median OS* (95% CI), mo | 27.4 (22.1-33.5) | 15.5 (13.4-18.4) |
| HR (95% CI) †; p-value‡ | 0.56 (0.45-0.72); p <0.0001 | |
| OS rate* (95% CI), % | ||
| 1 yr | 75.0 (68.2-80.5) | 62.0 (54.8-68.4) |
| 2 yr | 53.4 (46.0-60.2) | 34.4 (27.8-41.1) |
| 3 yr | 41.6 (34.4-48.6) | 20.2 (14.8-26.2) |
| 4 yr | 33.9 (27.1-40.9) | 14.3 (9.7-19.9) |
* Kaplan-Meier method. † Stratified Cox proportional-hazards model stratified by smoking history (≥400 cigarette-yr vs <400 cigarette-yr or never), presence of liver or brain metastases at baseline (yes vs no), and sex (men vs women). ‡ One-sided p-value was calculated based on stratified log-rank test.
Conclusions
The addition of camrelizumab to chemo continued to demonstrate clinically meaningful survival benefits with manageable toxicities after long-term follow-up; 4-yr OS rate was ∼20% higher in pts receiving camrelizumab + chemo, 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, Speaker’s Bureau: Amoy Diagnostics, Boehringer Ingelheim, C-stone, Eli Lilly China, Hengrui, Innovent Biologics, LUYE Pharma, Merck Sharp & Dohme, Qilu, Roche, Sanofi, TopAlliance Biosciences Inc; Financial Interests, Personal, Advisory Role: Hengrui; Financial Interests, Personal, Invited Speaker: Innovent Biologics, 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.