Adding camrelizumab to carboplatin plus paclitaxel prolonged progression-free survival (PFS) and overall survival (OS) in patients with advanced squamous non-small cell lung cancer (NSCLC), according to phase 3 results published in the Journal of Thoracic Oncology.
The phase 3 CameL-sq trial (ClinicalTrials.gov Identifier: NCT03668496) included 389 patients with stage IIIB-IV squamous NSCLC treated at 53 centers in China. The patients had received no prior systemic therapy for metastatic disease.
The patients were randomly assigned to receive camrelizumab plus carboplatin and paclitaxel (193 patients) or placebo plus carboplatin and paclitaxel (196 patients) for 4-6 cycles. Patients then received maintenance therapy with camrelizumab or placebo.
Most patients were men (93% in the camrelizumab arm and 92% in the placebo arm). Most had a smoking history of at least 400 cigarette-years (84% and 80%, respectively), roughly half had a PD-L1 tumor proportion score of 1% or higher (49% and 47%, respectively), and 72% in each arm had stage IV disease.
At the data cutoff, the median follow-up was 13.5 months in the camrelizumab arm and 11.6 months in the placebo arm.
The objective response rate was higher in the camrelizumab arm than in the placebo arm — 64.8% and 36.7%, respectively (P <.0001). The median duration of response was 13.1 months and 4.4 months, respectively.
The median PFS was significantly longer in the camrelizumab arm than in the placebo arm — 8.5 months and 4.9 months, respectively (hazard ratio [HR], 0.37; 95% CI, 0.29-0.47; P <.0001). The 1-year PFS rate was 37.9% and 9.2%, respectively.
The median OS was significantly longer in the camrelizumab arm than in the placebo arm as well. The median OS was not reached and 14.5 months, respectively (HR, 0.55; 95% CI, 0.40-0.75; P <.0001). The 1-year OS rate was 75.1% and 61.5%, respectively.
Biomarker analysis showed that, among patients who received camrelizumab, those who had circulating tumor DNA clearance after 2 treatment cycles had significantly longer PFS and OS (P <.001 for both).
Grade 3 or higher treatment-related adverse events (AEs) were observed in 74% of patients in the camrelizumab arm and 72% of those in the placebo arm.
The most common of these AEs (in the camrelizumab and placebo arms, respectively) were decreased neutrophil count (55% vs 59%), decreased white blood cell count (30% vs 26%), and anemia (10% vs 7%).
In the camrelizumab arm, 77% of patients had immune-related AEs of any grade. The most common of these were reactive cutaneous capillary endothelial proliferation (69%), hypothyroidism (11%), and rash (6%).
“These findings support the application of camrelizumab plus carboplatin and paclitaxel as an additional standard first-line treatment option for patients with advanced squamous NSCLC,” the researchers concluded.
Disclosures: This research was supported by Jiangsu Hengrui Pharmaceuticals. Some study authors declared affiliations, including employment, with Jiangsu Hengrui Pharmaceuticals and other companies. Please see the original reference for a full list of disclosures.
Ren S, Chen J, Xu X, et al. Camrelizumab plus carboplatin and paclitaxel as first-line treatment for advanced squamous non-small-cell lung cancer (CameL-sq): A phase 3 trial. J Thorac Oncol. Published online December 16, 2021. doi:10.1016/j.jtho.2021.11.018