Bristol Myers Squibb Company unveiled top-line Phase III data on 19 October that should aid its effort to obtain regulatory approval of a subcutaneous formulation of its blockbuster PD-1 inhibitor Opdivo (nivolumab), which currently is administered as an intravenous therapy in numerous cancer indications. The company has previously said successful data in one cancer setting would be sufficient for approval of the subcutaneous formulation in all monotherapy settings for which Opdivo is indicated.
Key Takeaways
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Bristol Myers Squibb met pharmacokinetic and efficacy endpoints in a Phase III renal cell cancer study of subcutaneous Opdivo.
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The pharma is partnered with Halozyme and its ENHANZE delivery technology to develop a subcutaneous formulation of the intravenously infused anti-PD-1 agent.
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Roche and Merck & Co
In the open-label, 495-patient CheckMate-67T study, subcutaneous nivolumab demonstrated non-inferiority to I.V