Analysts react to Bristol-Myers Squibb's update on nivolumab, Yervoy development

Bristol-Myers Squibb indicated that it is not yet planning a Phase III trial investigating its PD-1 inhibitor nivolumab with Yervoy (ipilimumab) in patients with lung cancer, but will continue with earlier-stage studies. "Many investors expected Bristol-Myers to rapidly advance the nivo-Yervoy combo to Phase III, with the plans for such a move perhaps being announced as early as [January 24]," remarked BMO analyst Alex Arfaei.

The company's head of R&D, Francis Cuss, noted that "based on our assessment of the preliminary data, we will continue the cohorts of patients before beginning a registrational study." Bristol-Myers Squibb is expected to release results from the CheckMate 012 trial, which is investigating nivolumab and Yervoy in lung cancer, at the ASCO annual meeting later this year. "We’ll certainly know a lot more about nivolumab a year from now," Cuss added.

Arfaei remarked that the drugmaker's slower timetable might be seen as a sign of caution or suggest a lack of "synergy" between the two drugs in patients with lung cancer. The analyst added that the "news is incrementally positive for Merck & Co," which is developing the PD-1 inhibitor MK-3475. However, Leerink Partners analyst Seamus Fernandez said that comments from Bristol-Myers Squibb "about how they move forward before beginning registrational studies is far from a failed outcome."

Yervoy was approved in 2011 in the US and Europe for the treatment of patients with late-stage melanoma.

For related analysis, see ViewPoints: Bristol-Myers Squibb looks for biomarker benchmark in immunotherapy race and FirstWord Lists – The drug trial results that will shape 2014.

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