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Dako, Ono Pharmaceutical Working on Potential CDx for Opdivo in NSCLC

NEW YORK (GenomeWeb) – Agilent subsidiary Dako and Ono Pharmaceutical are working together to investigate and advance a diagnostic test that will identify which non-small cell lung cancer patients are likely to respond to Opdivo (nivolumab).

"This test is being investigated for its diagnostic utility," the companies said, in order to identify best responders to Opdivo. The drug works by inhibiting PD-1, a protein that impedes the body's ability to launch an immune attack against cancer cells.

The US Food and Drug Administration in December granted accelerated approval of Opdivo as a treatment for advanced or unresectable melanoma patients who are no longer responding to other drugs. Additionally, Ono also received regulatory approval in Japan for Opdivo for the same indication in July.

In the US, Bristol-Myers Squibb sells Opdivo. BMS holds global development and commercialization rights to Opdivo, except in Japan, South Korea, and Taiwan, where Ono retains all rights for the compound.

In January, BMS announced that an open-label, randomized Phase III trial comparing Opdivo to docetaxel in previously treated advanced squamous cell NSCLC patients showed that Opdivo-treated patients lived longer than those in the comparator arm. The trial was stopped early by an independent data monitoring committee because the trial met its survival endpoint.

Ono and Dako didn't disclose the financial details of the deal.