Halozyme Announces FDA Approval of Bristol Myers Squibb's Opdivo Qvantig™ with ENHANZE® for Subcutaneous Use in Most Previously Approved Adult Solid Tumor Opdivo® (nivolumab) Indications
Halozyme (NASDAQ: HALO) announces FDA approval of Bristol Myers Squibb's Opdivo Qvantig™, the first and only subcutaneously administered PD-1 inhibitor co-formulated with ENHANZE® technology. The approval covers most previously approved adult solid tumor Opdivo® indications. The key advantage is faster administration time (3-5 minutes vs. 30 minutes for IV Opdivo).
The approval is based on the Phase 3 CheckMate-67T trial, which demonstrated noninferiority to IV Opdivo. The overall response rate was 24% for Opdivo Qvantig compared to 18% for IV Opdivo. The safety profile was comparable to IV Opdivo, with serious adverse reactions occurring in 28% of patients.
Halozyme (NASDAQ: HALO) annuncia l'approvazione della FDA per Opdivo Qvantig™ di Bristol Myers Squibb, il primo e unico inibitore PD-1 somministrato per via sottocutanea co-formulato con la tecnologia ENHANZE®. L'approvazione copre la maggior parte delle indicazioni per tumori solidi approvate in precedenza per Opdivo®. Il vantaggio principale è un tempo di somministrazione più rapido (3-5 minuti rispetto a 30 minuti per IV Opdivo).
L'approvazione si basa sullo studio di fase 3 CheckMate-67T, che ha dimostrato una non inferiorità rispetto a IV Opdivo. Il tasso di risposta complessivo è stato del 24% per Opdivo Qvantig rispetto al 18% per IV Opdivo. Il profilo di sicurezza è stato comparabile a quello di IV Opdivo, con reazioni avverse gravi che si sono verificate nel 28% dei pazienti.
Halozyme (NASDAQ: HALO) anuncia la aprobación de la FDA para Opdivo Qvantig™ de Bristol Myers Squibb, el primer y único inhibidor de PD-1 administrado subcutáneamente coformulado con la tecnología ENHANZE®. La aprobación cubre la mayoría de las indicaciones aprobadas previamente para tumores sólidos en adultos con Opdivo®. La ventaja clave es un tiempo de administración más rápido (3-5 minutos frente a 30 minutos para IV Opdivo).
La aprobación se basa en el ensayo de fase 3 CheckMate-67T, que demostró no ser inferior a IV Opdivo. La tasa de respuesta global fue del 24% para Opdivo Qvantig en comparación con el 18% para IV Opdivo. El perfil de seguridad fue comparable al de IV Opdivo, con reacciones adversas graves que ocurrieron en el 28% de los pacientes.
Halozyme (NASDAQ: HALO)는 Bristol Myers Squibb의 Opdivo Qvantig™에 대한 FDA 승인을 발표했습니다. 이는 ENHANZE® 기술로 공동 제형된 최초이자 유일한 피하 투여 PD-1 억제제입니다. 이번 승인은 대부분의 기존 성인 고형 종양 Opdivo® 적응증을 포함합니다. 주요 장점은 투여 시간이 더 빠르다는 것입니다 (3-5분 vs. IV Opdivo의 30분).
이번 승인은 IV Opdivo에 대한 비열등성을 입증한 3상 CheckMate-67T 시험에 기반하고 있습니다. Opdivo Qvantig의 전체 반응률은 24%였으며, IV Opdivo는 18%였습니다. 안전성 프로파일은 IV Opdivo와 유사했으며, 중대한 부작용은 환자의 28%에서 발생했습니다.
Halozyme (NASDAQ: HALO) annonce l'approbation par la FDA de Opdivo Qvantig™ de Bristol Myers Squibb, le premier et unique inhibiteur PD-1 administré par voie sous-cutanée coformulé avec la technologie ENHANZE®. L'approbation couvre la plupart des indications antérieures pour les tumeurs solides chez les adultes approuvées pour Opdivo®. L'avantage clé est un temps d'administration plus rapide (3-5 minutes contre 30 minutes pour IV Opdivo).
L'approbation est basée sur l'essai de phase 3 CheckMate-67T, qui a montré une non-infériorité par rapport à IV Opdivo. Le taux de réponse global était de 24 % pour Opdivo Qvantig contre 18 % pour IV Opdivo. Le profil de sécurité était comparable à celui d'IV Opdivo, avec des réactions indésirables graves survenues chez 28 % des patients.
Halozyme (NASDAQ: HALO) kündigt die FDA-Zulassung von Bristol Myers Squibbs Opdivo Qvantig™ an, dem ersten und einzigen subkutan verabreichten PD-1-Inhibitor, der mit ENHANZE®-Technologie koformuliert ist. Die Zulassung umfasst die meisten zuvor genehmigten Indikationen für solide Tumoren bei Erwachsenen für Opdivo®. Der Hauptvorteil ist eine schnellere Verabreichungszeit (3-5 Minuten im Vergleich zu 30 Minuten für IV Opdivo).
Die Zulassung basiert auf der Phase-3-Studie CheckMate-67T, die die Nichtunterlegenheit gegenüber IV Opdivo nachwies. Die Gesamtrücklaufquote betrug 24 % für Opdivo Qvantig im Vergleich zu 18 % für IV Opdivo. Das Sicherheitsprofil war mit dem von IV Opdivo vergleichbar, wobei ernsthafte Nebenwirkungen bei 28 % der Patienten auftraten.
- First-to-market subcutaneous PD-1 inhibitor approval, creating competitive advantage
- Marks Halozyme's ninth co-formulated product approval, demonstrating technology validation
- Significantly reduced administration time (3-5 minutes vs 30 minutes)
- Higher overall response rate compared to IV version (24% vs 18%)
- 28% of patients experienced serious adverse reactions
- 10% discontinuation rate due to adverse reactions
- Three fatal adverse reactions reported in trial (1.2% of patients)
Insights
Opdivo Qvantig represents the first and only subcutaneously administered PD-1 inhibitor
Opdivo Qvantig demonstrated consistent efficacy and showed a comparable safety profile to IV Opdivo in the Phase 3 CheckMate-67T trial
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
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 (
Select Safety Profile from CheckMate-67T
Serious adverse reactions occurred in
*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.
Halozyme is headquartered in
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including offering flexibility to receive treatment in more convenient locations and broadening the treatment options for the indications referred to in this press release and potentially decreasing the time spent by healthcare professionals preparing and administering treatment and potentially improving infusion chair capacity. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in launch or commercialization of our partner's product referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.
FAQ
What makes Opdivo Qvantig with ENHANZE different from regular Opdivo?
What were the efficacy results of Opdivo Qvantig in the CheckMate-67T trial?
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How many products has Halozyme (HALO) now co-formulated with ENHANZE technology?
