3MO - First-line camrelizumab plus carboplatin and paclitaxel for advanced squamous non-small-cell lung cancer: Updated overall survival results from the phase 3 CameL-sq trial

Background

The phase 3 CameL-sq trial previously demonstrated a statistically significant improvement in progression-free survival with camrelizumab+chemotherapy (chemo) vs placebo+chemo as first-line treatment for advanced squamous non-small-cell lung cancer (NSCLC). Here we present an updated analysis of the overall survival (OS).

Methods

Patients without prior systemic treatment for advanced squamous NSCLC were randomized 1:1 to receive 4–6 cycles of carboplatin (AUC 5) plus paclitaxel (175 mg/m²) with camrelizumab (200 mg) or placebo every 3 weeks, followed by maintenance therapy with camrelizumab or placebo. Cross-over to second-line camelizumab after disease progression was allowed for patients in the placebo arm.

Results

As data cutoff of Dec 29, 2021, median follow-up was 23.7 mo in the camrelizumab+chemo group (n=193) and 15.2 mo in the placebo+chemo group (n=196). Camrelizumab+chemo improved OS vs placebo+chemo (median, 27.4 mo [95% CI 22.1-not reached (NR)] vs 15.5 mo [95% CI 13.4-18.4]; HR 0.57 [95% CI 0.44-0.75]; 1-sided log-rank P <0.0001); survival rate was 53.9% (95% CI 46.5-60.8) vs 35.0% (95% CI 28.3-41.7) at 24 mo and 42.8% (95% CI 34.0-51.4) vs 25.7% (95% CI 18.6-33.4) at 36 mo. The OS benefit was persistent when the cross-over effect was adjusted using the Rank Preserving Structural Failure Time model (HR 0.42, 95% CI 0.31-0.58). Further analysis showed generally consistent OS improvement with camrelizumab+chemo vs placebo+chemo across demographic and clinical subgroups; median OS was 19.8 mo (95% CI 14.0-26.3) vs 14.4 mo (95% CI 11.7-16.8) in patients with PD-L1 TPS <1% (HR 0.73, 95% CI 0.52-1.03) and NR (95% CI 29.1-NR) vs 20.1 mo (95% CI 14.5-24.5) in those with TPS ≥1% (HR 0.47, 95% CI 0.31-0.72), respectively. No new safety signals were observed.

Conclusions

The addition of camrelizumab to chemotherapy continued to demonstrate OS benefits after prolonged follow-up, further supporting this regimen as a new first-line treatment option for advanced squamous NSCLC.

Clinical trial identification

NCT03668496.

Editorial acknowledgement

Medical writing support was provided by Xiuzhi Wu (Hengrui Pharmaceuticals).

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; Financial Interests, Personal, Invited Speaker: Lily China; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Personal, Invited Speaker: Hengrui; Financial Interests, Personal, Invited Speaker: Qilu; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Innovent Biologics; Financial Interests, Personal, Invited Speaker: C-Stone; Financial Interests, Personal, Invited Speaker: Luye Pharma; Financial Interests, Personal, Invited Speaker: TopAlliance Biosciences; Financial Interests, Personal, Invited Speaker: Amoy Diagnositics; Financial Interests, Personal, Advisory Role: Innovent Biologics; Financial Interests, Personal, Advisory Role: Hengrui; Financial Interests, Personal, Advisory Role: Qilu; Financial Interests, Personal, Advisory Role: TopAlliance Biosciences. Z. Yang: Financial Interests, Personal, Full or part-time Employment: Hengrui Pharmaceuticals. All other authors have declared no conflicts of interest.