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

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). 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. 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. 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.