Cytotoxic agents may potentiate immune-checkpoint inhibitors with immunological effects. Camrelizumab plus pemetrexed and platinum is a current standard of care for Chinese patients (pts) with advanced non-squamous NSCLC and negative EGFR/ALK mutation. Here we evaluated first-line camrelizumab plus chemotherapy (chemo) for pts with squamous NSCLC.
In this double-blind, multicenter, phase III trial, previously untreated pts with histologically or cytologically confirmed stage IIIB-IV 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. The primary endpoint was PFS per IRC. Cross-over after disease progression was allowed for pts allocated placebo plus chemo
Totally, 389 pts (camrelizumab plus chemo, n = 193; placebo plus chemo, n = 196) were included. As of Nov. 06, 2020, pts treated with camrelizumab plus chemo were associated with significantly prolonged IRC-assessed PFS versus placebo plus chemo (median, 8.5 [95% CI 6.9–10.4] vs 4.9 [95% CI 4.2–5.5] months; HR, 0.37 [95% CI 0.29–0.47], one-sided P < 0.0001), with benefit observed in pts with both PD-L1 TPS <1% (HR, 0.49 [95% CI 0.35–0.68]) and ≥1% (HR, 0.34 [95% CI 0.24–0.49]). There was also significant improvement in OS for the camrelizumab plus chemo group (median, NR [18.4–NR] vs 14.5 [95% CI 13.2–16.6] months; HR, 0.55 [95% CI 0.40–0.75], one-sided P < 0.0001). Consistently, confirmed ORR (64.8% [95% CI 57.6%–71.5%] vs 36.7% [95% CI 30.0%–43.9%], P < 0.0001) and DoR (median, 13.1 [95% CI 9.3–15.7] vs 4.4 [95% CI 4.2–4.9] months) per IRC favored the camrelizumab plus chemo group. Grade ≥3 treatment-related adverse events occurred in 73.6% of pts in the camrelizumab plus chemo group and 71.9% in the placebo plus chemo group, with no unexpected adverse effects.
The addition of camrelizumab to chemotherapy significantly prolonged PFS and OS in the first-line setting with an acceptable safety profile, supporting this combination as an additional first-line treatment option for pts with advanced squamous NSCLC.
NCT03668496.
Jiangsu Hengrui Medicine Co., Ltd.
Jiangsu Hengrui Medicine Co., Ltd.
C. Zhou: Honoraria (self): Roche; Honoraria (self): Lily China; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Merck; Honoraria (self), Advisory/Consultancy: Hengrui; Honoraria (self), Advisory/Consultancy: Qilu; Honoraria (self): Sanofi; Honoraria (self): Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Innovent Biologics; Honoraria (self): C-Stone; Honoraria (self): Luye Pharma; Honoraria (self), Advisory/Consultancy: TopAlliance Biosciences; Honoraria (self): Amoy Diagnositics. Z. Yang: Full/Part-time employment: Jiangsu Hengrui Medicine. L. Wang: Full/Part-time employment: Jiangsu Hengrui Medicine. All other authors have declared no conflicts of interest.