BMS’ PD-1 Inhibitor for Lung Cancer Wins EC Nod

The European Commission has approved Bristol-Myers Squibb’s PD-1 inhibitor Nivolumab BMS for the treatment of advanced or metastatic squamous non-small cell lung cancer, the second indication approved for the drug in a month.

Nivolumab BMS — marketed as Opdivo in the U.S. — was approved on the basis of a Phase 3 trial showing 41 percent fewer deaths and an overall survival rate of 42 percent at one year — nearly twice the 24 percent OS rate for doxetaxel, the standard care.

The approval — the first major treatment advance for SQ NSCLC in more than a decade in Europe, according to BMS — follows the Commission’s June 19 approval of the drug for advanced melanoma.

BMS submitted two marketing authorization applications under the two different trade names — Nivolumab BMS and Opdivo — to accelerate availability of the drug for both indications. The company hopes to merge the two authorizations under the Opdivo name by the end of 2015.

In the U.S., Opdivo won FDA approval for advanced melanoma in December, followed by the SQ NSCLC indication in March.

On Monday, BMS halted a U.S. trial of Opdivo for the treatment of renal cell carcinoma after the drug met its primary endpoint of overall survival compared with everolimus.

Separately, Opdivo’s only competitor in the PD-1 inhibitor space, Merck’s Keytruda, received Commission approval last week for the treatment of advanced melanoma. The approval came after the drug showed a superior survival benefit over the monoclonal antibody ipilimumab — the current standard of care for the disease.

In the U.S., Keytruda won accelerated approval from the FDA last September for the same indication, but continued approval is contingent upon verification of clinical benefit in confirmatory trials, Merck said. — Kellen Owings