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
SAN
DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today 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.
Halozyme is headquartered in San
Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations
facility.
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.
