Halozyme Therapeutics, Inc announced that Bristol Myers Squibb received U.S. Food and Drug Administration (FDA) approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) co-formulated with Halozyme's ENHANZE® drug delivery technology for subcutaneous use in most previously approved adult, solid tumor intravenous (IV) Opdivo® indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor.
The subcutaneous administration of Opdivo Qvantig is faster, with a three- to five-minute administration time compared to 30 minutes for IV Opdivo.* Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their providers, may reduce steps required for preparation and time needed for administration.
"We are pleased Opdivo Qvantig, which is co-formulated with our ENHANZE drug delivery technology, is now FDA-approved as the first and only subcutaneously administered PD-1 inhibitor in the U.S.," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval represents our ninth co-formulated product and is yet another example of how Halozyme's innovative ENHANZE technology is enabling greater flexibility and optionality for patients."
The FDA approval is based on the results from the Phase 3 randomized, open-label CheckMate-67T trial, which was a noninferiority trial evaluating Opdivo Qvantig co-formulated with Halozyme's proprietary recombinant human hyaluronidase (rHuPH20), compared to intravenous Opdivo, in adult patients with advanced or metastatic clear cell renal cell carcinoma who received prior systemic therapy. In the trial, noninferiority was demonstrated for the co-primary endpoints of time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss) of Opdivo Qvantig vs. IV Opdivo. The geometric mean ratio (GMR) for Cavgd28 was 2.10 (90% CI: 2.00-2.20) and the GMR for Cminss was 1.77 (90% CI: 1.63-1.93). As a key powered secondary endpoint, the overall response rate (ORR) in the Opdivo Qvantig arm (n=248) was 24% (95% CI: 19-30) compared with 18% (95% CI: 14-24) in the IV Opdivo arm (n=247) showing that Opdivo Qvantig has similar efficacy compared to IV Opdivo as assessed by Blinded Independent Central Review (BICR).
Select Safety Profile from CheckMate-67T
Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig. The most frequent serious adverse reactions reported in >1% of patients who received Opdivo Qvantig were pleural effusion (1.6%), pneumonitis (1.6%), hyperglycemia (1.2%), hyperkalemia (1.2%), hemorrhage (1.2%) and diarrhea (1.2%). The most common adverse reactions (reported in ≥10% of patients) were fatigue (20%), musculoskeletal pain (31%), pruritus (16%), rash (15%), arthralgia (12%) and cough (11%). Fatal adverse reactions occurred in 3 (1.2%) patients who received Opdivo Qvantig; these included myocarditis, myositis, and colitis complications. Study therapy was discontinued in 10% of patients due to adverse reactions. The safety profile of Opdivo Qvantig was comparable with the safety profile of IV Opdivo.
*Refers to the injection time and does not include other aspects of treatment; actual clinic time may vary.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in nine commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals.
