medwireNews: Treatment-naïve patients with advanced squamous non-small-cell lung cancer (NSCLC) derive a significant progression-free survival (PFS) and overall survival (OS) benefit with the addition of camrelizumab to chemotherapy, indicates the Chinese CameL-sq study.
The risk for disease progression or death, as assessed by blinded independent review, was reduced by a significant 63% for participants who received the PD-1 inhibitor alongside platinum-based chemotherapy, while the risk for death was a significant 45% lower, report Caicun Zhou (Tongji University School of Medicine, Shanghai, China) and co-investigators.
“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,” they write in the Journal of Thoracic Oncology, noting that the combination has already been approved in China in the first-line nonsquamous setting.
In the double-blind, phase 3 CameL-sq trial, 389 patients with untreated stage IIIB–IV squamous NSCLC lacking sensitizing EGFR or ALK alterations were randomly assigned to receive camrelizumab 200 mg or placebo alongside four to six cycles of carboplatin AUC 5 mg/mL per min plus paclitaxel 175 mg/m2. All the treatments were given on the first day of each 3-week cycle and were followed by maintenance camrelizumab or placebo.
After a median follow-up of 13.5 months in the camrelizumab group and 11.6 months in the placebo group, the median PFS was significantly longer and the 12-month PFS rate was significantly higher with camrelizumab than placebo, at 8.5 versus 4.9 months and 37.9% versus 9.2%, respectively.
OS was similarly significantly better among camrelizumab- than placebo-treated patients, with the median unreached and 14.5 months, respectively, and corresponding 12-month survival rates of 75.1% and 61.5%.
The OS benefit offered by camrelizumab was observed “despite the cross-over of 47% [of] patients from the placebo plus chemotherapy group after disease progression,” and was confirmed using the rank preserving structural failure time model that accounted for crossover (hazard ratio=0.50), say Zhou and team.
The independently assessed objective response rate was also significantly improved in the camrelizumab compared with the placebo group, at 64.8% and 36.7%, respectively, and the median duration of response also favored the PD-1 inhibitor, at 13.1 versus 4.4 months.
“The safety profile of camrelizumab plus carboplatin-based chemotherapy was generally consistent with the previous reports in non-squamous NSCLC […] and there was no evident increase in adverse events associated with chemotherapy with the addition of camrelizumab,” note the study authors.
Treatment-related adverse events (TRAEs) of grade 3 or worse occurred in a comparable 74% of patients in the camrelizumab arm and 72% of those in the placebo arm, with decreased neutrophil count the most frequent TRAE of this severity in both groups (55 vs 59%).
A total of 12% of participants given camrelizumab plus chemotherapy discontinued any treatment component due to TRAEs, as did 4% of those given placebo plus chemotherapy. The respective rates of deaths possibly attributable to TRAEs were 3% and 2%.
Zhou et al report that the most common immune-related AE in the camrelizumab group was reactive cutaneous capillary endothelial proliferation, occurring in 69% of patients, but they highlight that the majority (67%) of cases were of grade 1 or 2.
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J Thorac Oncol 2021; doi:10.1016/j.jtho.2021.11.018