Adding Camrelizumab to First-Line Chemotherapy Improves Survival in Advanced Squamous NSCLC

The addition of camrelizumab to first-line carboplatin and paclitaxel is associated with improved progression-free survival (PFS) among patients with advanced squamous non-small cell lung cancer (NSCLC) with a manageable safety profile, according to results from a phase 3 trial.

“Camrelizumab, a humanized immunoglobulin G4-κ monoclonal antibody against programmed cell death protein 1, has exhibited antitumor activity and tolerability across various tumors, including lung cancers,” wrote lead author Shengxiang Ren, MD, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China, and coauthors.

This double-blind, randomized phase 3 trial aimed to examine the efficacy and safety of camrelizumab in combination with chemotherapy for advanced squamous NSCLC. A secondary aim of the trial was to analyze the predictive value of circulating tumor DNA (ctDNA).

The trial was conducted in 53 centers in China and included 389 patients. Patients were randomized in a 1:1 ratio to receive  4 to 6 cycles of carboplatin plus paclitaxel with camrelizumab (n = 193) or placebo (n = 196) every 3 weeks, followed by maintenance therapy with camrelizumab or placebo. Researchers collected peripheral blood ctDNA samples at baseline and after 2 cycles of treatment.

Camrelizumab plus chemotherapy significantly prolonged PFS and overall survival (OS). Median PFS was 8.5 months for the camrelizumab group vs 4.9 months with placebo (P <.0001). Median OS was not reached vs 14.5 months, respectively (P <.0001).

“The PFS benefits for camrelizumab plus chemotherapy were driven by a high objective response rate (64.8%) and remarkable response durability (median, 13.1 months)… [and]… were not limited to patients with positive PD-L1…Although we observed a trend toward greater efficacy with PD-L1 enrichment…the benefits among patients with negative PD-L1 expression were also substantial with camrelizumab plus chemotherapy (HR, 0.49 [95% CI 0.35–0.68] for PFS and 0.62 [95% CI 0.41-0.94] for OS),” wrote Dr Ren and co-authors.

At data cutoff, 64% of patients in the camrelizumab plus chemotherapy group had disease progression or died, compared with 85% of subjects in the placebo group. Findings from biomarker analysis suggested that ctDNA clearance after 2 cycles of treatment with camrelizumab plus chemotherapy was independently associated with dramatically longer PFS (P <.0001) and OS (P <.0001).

Treatment-related adverse events (TEAEs) were reported for 100% of patients treated with camrelizumab plus chemotherapy, and 99% of those in the placebo group. Grade 3 or higher TEAEs occurred in 74% of patients in the camrelizumab group, compared with 72% of participants in the placebo group, none of them unexpected in either group.

Source:
Ren S, Chen J, Xu X, et al. Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial. J Thorac Oncol. Published Dec. 16, 2021. doi:10.1016/j.jtho.2021.11.018