Now a New Companion Diagnostic for Nivolumab in Non-Squamous NSCLC

Three months ahead of review deadline, nivolumab received an expanded approval end of last week for use in patients with non-squamous non-small cell lung cancer (NSCLC) who have advance on platinum-based chemotherapy. Today, the diagnostics company Dako announced the approval of its companion diagnostic test for nivolumab for use in lung cancer patients.

Dako has developed PD-L1 IHC 28-8 pharmDx in collaboration with Bristol-Myers Squibb, the makers of nivolumab, to quantitate expression of PD-L1 on the surface of non-small cell lung cancer cells (NSCLC) and provide information on the survival benefit of patients with NSCLC treated with nivolumab. Nivolumab is a monoclonal antibody that inhibits the PD-1/PD-L1 pathway, thereby providing an immune boost to the patient. The diagnostic was used to assess PD-L1 expression in the phase 3 CheckMate 057 trial, in which nivolumab demonstrated superior overall survival in patients with previously treated metastatic non-squamous NSCLC compared with chemotherapy.

“We are proud to announce the recent FDA approval of OPDIVO based upon overall survival in an expanded indication for all appropriate patients with previously treated metastatic non-small cell lung cancer,” said Michael Giordano, senior vice president and head of Development, Oncology, at Bristol-Myers Squibb. “Our collaboration with Dako underscores our leadership in cancer innovation and our commitment to advancing research evaluating the potential role of PD-L1 in multiple tumor types.”

The concern with the new breed of immuno-oncology agents, among providers and payers alike, has been choosing the right patient population to treat with these agents. Although results presented this year at the annual meeting of the American Society of Clinical Oncology provided hints of being able to select the right population based on PD-1/PD-L1 expression, the results have been mixed. In addition to exposing non-responders to unnecessary treatment, the high cost of these agents has also created anxiety among stakeholders.

Today’s announcement follows the approval of pembrolizumab—the PD-1 inhibitor developed by Merck—for patients with advanced NSCLC who are refractory to treatment. Dako has also collaborated with Merck to develop the companion diagnostic PD-L1 IHC 22C3 pharmDx that can define the patient population expressing PD-L1 who will respond to pembrolizumab.