Nivolumab fails as a superior 1st-line alternative to standard chemotherapy for NSCLC

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In this phase III study, presented at the ESMO 2016 Cancer Congress, nivolumab was compared to an investigator's choice comparator that consisted of a variety of platinum doublets, as 1st-line treatment for patients with advanced NSCLC. Patients were selected based on PD-L1 positivity; but the hopes for this immune checkpoint inhibitor as a more efficacious option than chemotherapy, were dashed.

This outcome is notable, given the successful testing of pembrolizumab in the same setting. Much of the commentary about this outcome has observed that the cut-off for PD-L1 positivity was >1%, whereas the cutoff for pembrolizumab was > 50%. So maybe the issue is that the lower PD-L1 expression threshold selected a patient population that was too diluted by the presence of non-responders. That's a plausible explanation and it's possible to test it formally. But there may be other factors at play here. Maybe the data set includes some high PD-L1 expressing patients who may provide preliminary support for this notion.