medwireNews: Avelumab has a “favourable” safety profile over docetaxel, but does not improve survival, when used to treat patients with programmed cell death ligand 1 (PD-L1)-positive advanced non-small-cell lung cancer (NSCLC), say researchers.
Overall survival in the JAVELIN Lung 200 study was 11.4 months for the 264 patients with stage IIIB or IV or recurrent NSCLC who were randomly assigned to receive avelumab 10 mg/kg every 2 weeks following disease progression after platinum-containing chemotherapy.
This was not significantly longer than the 10.3 months observed among the 265 patients randomly assigned to receive docetaxel 75 mg/m2 every 3 weeks, Keunchil Park (Sungkyunkwan University School of Medicine, Seoul, South Korea) and co-authors report in The Lancet Oncology.
However, the researchers note that “the high frequency of post-study use of checkpoint inhibitors […] might have affected overall survival findings in our study.” They say that 6% of patients in the avelumab group and 26% of those in the docetaxel arm received an immune checkpoint inhibitor after treatment with the study drug.
The team also found that when the cutoff for PD-L1 expression was raised from 1% of tumor cells to either 50% or 80% for a prespecified exploratory analysis, overall survival was significantly longer in the avelumab group than in the docetaxel group, at 13.6 versus 9.2 months and 17.1 versus 9.3 months, respectively.
And a similar pattern was seen for progression-free survival.
The rate of treatment-related adverse events was lower with avelumab than with docetaxel, at 64% versus 86%, while grade 3 or worse adverse events occurred in 10% and 49%, respectively.
Infusion-related reactions (2%) and increased lipase levels (1%) were the most common grade 3–5 treatment-related adverse events associated with avelumab, whereas neutropenia (14%), febrile neutropenia (10%), and decreased neutrophil counts (10%) were most common in the docetaxel group.
Twice as many patients discontinued docetaxel than avelumab because of a treatment-related adverse event (14 vs 7%) and there were four times as many treatment-related deaths (4 vs 1%) in the former group.
In an accompanying commentary, Rafael Rosell (Germans Trias i Pujol Research Institute and Hospital, Barcelona, Spain) and Niki Karachaliou (University Hospital Sagrat Cor, Barcelona) say that “[a]lthough overall survival […] did not differ between treatment groups in various patient subgroups, the results of post-hoc analyses suggest that further exploratory subanalysis should be done to identify specific patient populations who could benefit from anti-PD-1 or anti-PD-L1 antibodies.”
Park et al agree. They conclude that “the improved efficacy of avelumab relative to docetaxel in patients whose tumours had higher levels of PD-L1 expression could support the use of tumour-cell PD-L1 expression as a biomarker to identify patients more likely to obtain a clinical benefit with agents of this class.”
The results were also presented at the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer in Toronto, Ontario, Canada.
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group