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BMS Moves Closer To Subcutaneous Opdivo With Phase III Trial Success

 
• By Joseph Haas

A Phase III trial testing subcutaneous nivolumab versus the intravenous product hits pharmacokinetic and efficacy endpoints. BMS, Roche and Merck & Co. all are seeking subcutaneous versions of their anti-PD-1/L1 blockbusters.

Chemical process
Bristol makes progress in formulating a subcutaneous version of Opdivo • Source: Shutterstock

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

  • Bristol Myers Squibb met pharmacokinetic and efficacy endpoints in a Phase III renal cell cancer study of subcutaneous Opdivo.

In the open-label, 495-patient CheckMate-67T study, subcutaneous nivolumab demonstrated non-inferiority to I.V. nivolumab on two co-primary pharmacokinetic endpoints and on...

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