medwireNews: An updated analysis of the CameL trial has shown a significant improvement in overall survival (OS) with the addition of camrelizumab to chemotherapy in treatment-naïve Chinese patients with advanced nonsquamous non-small-cell lung cancer (NSCLC).
The OS benefit was observed despite almost half the patients in the chemotherapy alone arm crossing over to receive the PD-1 inhibitor as monotherapy, say Caicun Zhou (Tongji University School of Medicine, Shanghai, China) and co-authors in the Journal of Thoracic Oncology.
They also note that “[d]espite longer follow-up with 22 additional calendar months, no new toxicity signals emerged.”
The team therefore believes that “the current analysis further [supports] the use of camrelizumab plus carboplatin and pemetrexed in [the] first-line treatment of advanced NSCLC without EGFR/ALK alterations.”
In the phase 3 study, 412 Chinese patients with stage IIIB–IV nonsquamous disease were randomly assigned to receive four to six cycles of camrelizumab 200 mg alongside carboplatin plus pemetrexed every 3 weeks or chemotherapy alone, followed by maintenance pemetrexed with or without camrelizumab.
A previous interim analysis, conducted at a median follow-up of 11.9 months, showed that progression-free survival (PFS) was significantly better with the addition of camrelizumab to chemotherapy, explain the investigators.
They now report that the present analysis – at a minimum follow-up of 43.9 months – also showed a significant prolongation of OS among patients who did versus did not receive camrelizumab, at a median of 27.1 and 19.8 months, respectively, and a hazard ratio (HR) for death of 0.72 in favor of the PD-1 inhibitor.
The OS rates in the camrelizumab and control groups were 54.0% versus 43.1% at 24 months, 39.3% versus 30.4% at 36 months, and 37.2% versus 25.6% at 48 months.
Zhou and colleagues highlight that “the survival benefit was more pronounced” after accounting for the 45.9% of patients in the chemotherapy group who crossed over to receive camrelizumab monotherapy at progression, at an HR of 0.55.
The significant PFS advantage offered by camrelizumab was maintained with longer follow-up, at a median duration of 11.0 months in the combination arm and 6.5 months in the control arm (HR=0.55), and the objective response rate was also significantly higher, at 55.1% versus 32.9%.
With regard to the safety, the investigators note that “[t]he safety profile of camrelizumab plus chemotherapy remained consistent with the interim analysis of this study and previous reports for this combination.”
Treatment-related adverse events (TRAEs) of grade 3 or worse occurred in 70.7% of camrelizumab-treated patients and 48.8% of controls, with the most frequent events of this severity being decreased neutrophil count (39.5 vs 30.9%), anemia (20.0 vs 11.1%), decreased white blood cell count (20.0 vs 4.5%), and decreased platelet count (16.6 vs 11.6%).
Six (2.9%) deaths in the camrelizumab plus chemotherapy group were attributed to TRAEs, as were three (1.4%) deaths in the chemotherapy alone group.
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