Bristol-Myers Squibb reports positive clinical trial data for Opdivo

Bristol-Myers Squibb has announced new clinical trial data demonstrating the safety and efficacy of its new immuno-oncology agent Opdivo.

Data from the phase III Checkmate -067 study offered a positive evaluation of a combination regime of Opdivo plus Yervoy, or Opdivo monotherapy, compared to Yervoy monotherapy in patients with previously untreated advanced melanoma.

Both Opdivo-based treatment regimes showed superior progression-free survival and objective response rate versus Yervoy, while the combination regimen demonstrated improved outcomes compared to Opdivo monotherapy in PD-L1 non- and low-expressers.

This is the first phase III trial to demonstrate improved outcomes for a PD-1 immune checkpoint inhibitor, administered as monotherapy and in combination with another immuno-oncology agent, versus the standard of care for treatment of first-line patients with advanced melanoma.

Michael Giordano, senior vice-president and head of development for oncology at Bristol-Myers Squibb, said: "The findings of Checkmate-067 validate our strategy to combine immuno-oncology agents as the best approach to offer patients the potential for long-term survival."

The drug received a recommendation from Europe's Committee for Medicinal Products for Human Use last week for approval as a treatment for non-small cell lung cancer.