Bristol-Myers Squibb's programmed cell death protein-1 (PD-1)-targeting immunotherapy Opdivo (nivolumab) failed to benefit patients with non-small cell lung cancer (NSCLC) in a first-line setting compared with chemotherapy. The treatment failed regardless of PD-L1 (PD-1 ligand) protein expression used as a exploratory predictive biomarker measured on patients' tumor cells. The company presented the phase 3 CHECKMATE-026 trial data in October at the European Society for Molecular Oncology (ESMO) annual meeting in Copenhagen. At the same meeting, favorable results in NSCLC released by competitors prompted a 10%, or $9.4-billion; drop in the New York–based firm's stock valuation. Opdivo had previously received approval from the US Food and Drug Administration as a second-line therapy in NSCLC, that is, for use in patients with metastatic disease that has progressed during or following initial treatment. The approval is for all patients regardless of PD-L1 (PD-1 ligand) expression—unlike rival Merck's Keytruda (pembrolizumab), for example, also approved as a second-line lung cancer treatment. Bristol-Myers Squibb disclosed in August that Opdivo had not improved progression-free survival in CHECKMATE-026 when compared with chemotherapy in patients with more than 5% PD-L1 protein expression on tumor cells. An analysis presented at ESMO showed the drug did not even benefit patients whose tumors expressed more than 50% PD-L1 and, in some groups, the patients did less well on Opdivo than with chemotherapy. At the same time, Kenilworth, New Jersey–based Merck showed 10.3 months median progression-free survival with Keytruda in first-line NSCLC compared with six months on chemotherapy. The US Food and Drug Administration (FDA) is expected to approve before year-end.

Another challenger to Opdivo's aspirations in the lung cancer market is anti PD-L1 antibody Tecentriq (atezolizumab). The drug, owned by S. San Francisco–based Genentech, received FDA approval October 18 to treat patients with metastatic NSCLC, regardless of PD-L1 expression, whose disease has progressed during or following platinum-containing chemotherapy or in some cases after a targeted therapy. Phase 3 data presented at the conference in October showed median progression-free survival of 13.8 months for Tecentriq versus 9.6 months for Taxotere/Docefrez (docetaxel) chemotherapy, with better overall results in trial participants with high PD-L1 expression on tumor cells or tumor-infiltrating cells.