Halozyme(HALO) Prnewswire·2024-12-30 11:30Core Insights - Halozyme Therapeutics announced FDA approval for Opdivo Qvantig, the first subcutaneously administered PD-1 inhibitor, co-formulated with Halozyme's ENHANZE drug delivery technology [1][3][13] Group 1: Product Efficacy and Approval - Opdivo Qvantig demonstrated consistent efficacy and a comparable safety profile to IV Opdivo in the Phase 3 CheckMate-67T trial [1][3] - The trial showed noninferiority for co-primary endpoints: time-averaged concentration over 28 days (Cavgd28) with a geometric mean ratio (GMR) of 2.10 (90% CI: 2.00-2.20) and minimum concentration at steady state (Cminss) with a GMR of 1.77 (90% CI: 1.63-1.93) [3] - The overall response rate (ORR) for Opdivo Qvantig was 24% (95% CI: 19-30) compared to 18% (95% CI: 14-24) for IV Opdivo [3] Group 2: Administration and Patient Experience - Subcutaneous administration of Opdivo Qvantig is faster, taking three to five minutes compared to 30 minutes for IV Opdivo, potentially offering greater flexibility for patients [2][5] - The approval represents Halozyme's ninth co-formulated product, showcasing the effectiveness of the ENHANZE technology in improving patient experiences [3][6] Group 3: Safety Profile - Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig, with the most frequent being pleural effusion and pneumonitis, each at 1.6% [4] - Common adverse reactions reported in ≥10% of patients included fatigue (20%), musculoskeletal pain (31%), and rash (15%) [4] - Fatal adverse reactions occurred in 1.2% of patients, including myocarditis and colitis complications, with 10% of patients discontinuing therapy due to adverse reactions [4]