BMS in discussions with health authorities
regarding next steps for submission and approval of subcutaneous
nivolumab in multiple indications
SAN
DIEGO, Oct. 19, 2023 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
Bristol Myers Squibb (BMS) reported positive topline results from
the Phase 3 CheckMate-67T trial evaluating a subcutaneous (SC)
formulation of Opdivo (nivolumab) with ENHANZE® in patients with
advanced or metastatic clear cell renal cell carcinoma (ccRCC) who
have received prior systemic therapy. The study met its co-primary
pharmacokinetics endpoints and key secondary endpoint.
CheckMate-67T Data Highlights
- Co-primary endpoints met; the study demonstrated noninferiority
of Cavgd28 (time-averaged Opdivo serum concentration over 28 days)
and Cminss (trough serum concentration at steady state) compared to
intravenous (IV) Opdivo.
- Subcutaneous nivolumab showed noninferiority of objective
response rate (ORR) by Blinded
Independent Central Review (BICR) vs. IV Opdivo, a key secondary
endpoint.
- The safety profile of SC nivolumab was consistent with IV
Opdivo.
"We are pleased that the positive topline results from BMS'
trial of subcutaneous nivolumab with ENHANZE support a shorter
treatment time, as a single injection administered in less than
five minutes, potentially making it a more convenient treatment
option for patients," said Dr. Helen Torley, president and
chief executive officer of Halozyme. "This is the fifth positive
phase 3 data readout from our Wave 3 products in the last 19
months, supporting the high success rate in the translation of
phase 1/2 ENHANZE SC pharmacokinetic data into positive phase 3
data."
BMS will share detailed results from the CheckMate-67T trial at
an upcoming medical meeting and work with health authorities on
next steps for SC nivolumab across multiple indications.
About CheckMate-67T
CheckMate-67T is a Phase 3 randomized, open-label trial
evaluating subcutaneous administration of Opdivo co-formulated with
Halozyme's proprietary recombinant human hyaluronidase rHuPH20, or
subcutaneous nivolumab (nivolumab and hyaluronidase) compared to
intravenous Opdivo, in patients with advanced or metastatic clear
cell renal cell carcinoma (ccRCC) who have received prior systemic
therapy. This trial presents an opportunity to potentially bring a
subcutaneous formulation of Opdivo to patients. A total of 495
patients were randomized to either subcutaneous nivolumab or
intravenous Opdivo. The co-primary endpoints of the trial include
time-averaged serum concentration over 28 days (Cavgd28) and trough
serum concentration at steady-state (Cminss) of subcutaneous
nivolumab vs. intravenous Opdivo. Objective response rate
(ORR) is a key secondary
endpoint.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. As the innovators of the
ENHANZE® drug delivery technology with the proprietary enzyme
rHuPH20, Halozyme's commercially-validated solution is used to
facilitate the delivery of injected drugs and fluids in order to
reduce the treatment burden to patients. Having touched more than
700,000 patient lives in post-marketing use in five commercialized
products across more than 100 global markets, Halozyme has licensed
its ENHANZE® technology to leading pharmaceutical and biotechnology
companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly,
Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV
Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, drug-device combination products using its
advanced auto-injector technology that are designed to provide
commercial or functional advantages such as improved convenience
and tolerability, and enhanced patient comfort and adherence. The
Company has a commercial portfolio of proprietary products
including XYOSTED® and TLANDO® and partnered commercial products
and ongoing product development programs with several
pharmaceutical companies including Teva Pharmaceutical 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
in this press release include forward-looking statements including,
without limitation, statements concerning the Company's ENHANZE®
drug delivery technology including the possible 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, facilitating more rapid
delivery of injectable medications through subcutaneous delivery
and certain other potential benefits of ENHANZE® including lowering
the treatment burden for patients. Forward-looking statements
regarding the Company's ENHANZE® business may include potential
growth and expansion of our collaboration opportunities driven by
our partners' development and commercialization efforts (including
anticipated discussions with healthcare regulatory authorities
regarding subcutaneous nivolumab). These forward-looking statements
are typically, but not always, identified through use of the words
"believe," "enable," "may," "will," "could," "intends," "estimate,"
"anticipate," "plan," "predict," "probable," "potential,"
"possible," "should," "continue," and other words of similar
meaning and involve risk and uncertainties that could cause actual
results to differ materially from those in the forward-looking
statements. Actual results could differ materially from the
expectations contained in these forward-looking statements as a
result of several factors, including unexpected results or delays
in the growth of the Company's business, or in the development,
regulatory review or commercialization of the Company's partnered
products (including subcutaneous nivolumab), regulatory approval
requirements, unexpected adverse events or patient outcomes and
competitive conditions. These and other factors that may result in
differences are discussed in greater detail in the Company's most
recent Annual Report on Form 10-K and Quarterly Reports on Form
10-Q 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
Dawn Schottlandt
Argot Partners
212-600-1902
Halozyme@argotpartners.com
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SOURCE Halozyme Therapeutics, Inc.