medwireNews: Interim analysis of the CameL trial indicates that progression-free survival (PFS) for Chinese patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) is improved with the first-line use of the PD-1 inhibitor camrelizumab alongside chemotherapy.
“Based on our findings, camrelizumab plus carboplatin and pemetrexed was approved as a new standard first-line therapeutic option for Chinese patients,” say Caicun Zhou, from Tongji University in Shanghai, China, and co-authors in The Lancet Respiratory Medicine.
After a median 11.9 months, the prespecified interim analysis indicated that median PFS was 11.3 months for the 205 patients who were randomly assigned to receive camrelizumab 200 mg every 3 weeks with four to six cycles of carboplatin AUC 5 mg/mL per minute and pemetrexed 500 mg/m2.
This was significantly longer than the median 8.3 months achieved by the patients given only the carboplatin–pemetrexed chemotherapy, resulting in a hazard ratio for progression or death of 0.60 in favor of camrelizumab use.
And PFS favored the camrelizumab arm across all subgroups, including patients with or without brain metastases, and regardless of PD-L1 tumor proportion score.
“Although the overall survival is continued to be followed up, a clear trend toward improvement in overall survival was observed with camrelizumab plus chemotherapy over chemotherapy alone,” the researchers report.
Kaplan–Meier estimates at time of interim analysis gave a median overall survival of unreached and 20.9 months, respectively, giving a hazard ratio for death of 0.73 in favor of the camrelizumab combination.
Safety analysis identified a higher rate of grade 3 or worse treatment-related adverse events (TRAEs) in camrelizumab-treated patients than those given only chemotherapy (69 vs 47%), including a higher rate of serious TRAEs (36 vs 13%).
Neutrophil count decreases were the most common grade 3 or more severe TRAE among camrelizumab-treated patients, affecting 38% versus 30% of controls, followed by reduced white blood cell count (20 vs 14%), anemia (19 vs 11%), and reduced platelet count (17 vs 12%).
The most frequent serious TRAEs at grade 3 or worse were platelet count decreases (9 vs 2%) and bone marrow toxicity (4 vs <1%).
In addition, 91% of camrelizumab-treated patients experienced immune-related AEs of any grade, most commonly reactive cutaneous capillary endothelial proliferation (78%). Grade 3 or more severe immune-related AEs were reported by 21% of patients, including two (<1%) cases of grade 3 reactive cutaneous capillary endothelial proliferation.
“[A]mong Chinese patients with treatment-naive advanced non-squamous NSCLC without EGFR and ALK alterations, camrelizumab plus carboplatin and pemetrexed resulted in an improved progression-free survival benefit than with chemotherapy alone, supporting its application as an additional first-line treatment option,” Zhou et al conclude.
“Based on the recommendations of the independent data monitoring committee, the trial is being continued to determine further outcomes, including the final progression-free survival in PD-L1–positive population and overall survival in all patients.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group