Iovance Biotherapeutics Announces First Patient Randomized in Phase 3 TILVANCE-301 Trial in Frontline Advanced Melanoma
15 Junho 2023 - 8:01AM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology
company focused on innovating, developing, and delivering novel
polyclonal tumor infiltrating lymphocyte (TIL) therapies for
patients with cancer, announced that the first patient was recently
randomized in TILVANCE-301, a global, multicenter, registrational
Phase 3 trial comparing Iovance TIL therapy lifileucel in
combination with pembrolizumab versus pembrolizumab monotherapy in
frontline advanced (unresectable or metastatic) melanoma.
Friedrich Graf Finckenstein, M.D., Chief Medical
Officer of Iovance, stated, “Our strategy is to offer TIL therapy
across all lines of treatment for patients with advanced melanoma.
Randomizing the first patient in TILVANCE-301, our first Phase 3
trial at Iovance, is an important milestone. The trial offers TIL
therapy as part of an earlier treatment approach for frontline
advanced melanoma, while serving as a confirmatory trial to convert
an accelerated approval to full approval for lifileucel in
post-anti-PD-1 melanoma. TILVANCE-301 is expected to be well
underway at the time of potential accelerated approval in this
initial indication. This trial may also provide important insights
into the Iovance platform approach for TIL and anti-PD-1 therapy
combinations in additional solid tumors.”
TILVANCE-301 builds on Iovance clinical data and decades of
experience at the National Cancer Institute (NCI) on the use of TIL
therapy in early line advanced melanoma patients. An oral session
at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in
November 2021 highlighted positive results for Iovance TIL therapy
in combination with pembrolizumab in patients with advanced
melanoma, cervical and head and neck cancers who were naïve to
prior anti-PD-1 therapy. In April 2022, Iovance announced updated
positive results demonstrating a 67% ORR and durability of response
for lifileucel in combination with pembrolizumab in advanced
melanoma from Cohort 1A of the IOV-COM-202 trial, which have
remained consistent in nearly 20 patients treated to date.
The U.S. Food and Drug Administration (FDA) previously agreed
that dual primary endpoints of objective response rate (ORR) and
progression free survival (PFS) in TILVANCE-301 can support
accelerated and full approvals of lifileucel in frontline advanced
melanoma. The FDA also agreed that TILVANCE-301, which is expected
to be well underway at the time of a potential accelerated approval
of lifileucel in post-anti-PD-1 melanoma, can serve as the
confirmatory trial for full approval in this initial indication.
The FDA granted Priority Review for lifileucel in post-anti-PD-1
melanoma and assigned November 25, 2023, as the target action date
for a decision under the Prescription Drug User Fee Act
(PDUFA).
About TILVANCE-301TILVANCE-301 will
randomize approximately 670 patients to investigate the safety and
efficacy of lifileucel in combination with pembrolizumab
(experimental arm) compared with pembrolizumab monotherapy (control
arm). Trial sites are actively enrolling adult participants with
unresectable or metastatic melanoma who have not received prior
therapy for advanced disease. Participants randomized to the
control arm who experience disease progression may be treated with
lifileucel monotherapy in an optional crossover period. For more
information, eligibility criteria, and trial locations, please
visit www.clinicaltrials.gov (NCT05727904) or contact
clinical.inquiries@iovance.com.
About Iovance Biotherapeutics, Inc.Iovance
Biotherapeutics aims to be the global leader in innovating,
developing and delivering tumor infiltrating lymphocyte (TIL) cell
therapies for patients with cancer. We are pioneering a
transformational approach to cure cancer by harnessing the human
immune system’s ability to recognize and destroy diverse cancer
cells in each patient. Our lead late-stage TIL product candidate,
lifileucel for metastatic melanoma, has the potential to become the
first approved one-time cell therapy for a solid tumor cancer. The
Iovance TIL platform has demonstrated promising clinical data
across multiple solid tumors. We are committed to continuous
innovation in cell therapy, including gene-edited cell therapy,
which may extend and improve life for patients with cancer. For
more information, please visit www.iovance.com.
Forward-Looking StatementsCertain matters
discussed in this press release are “forward-looking statements” of
Iovance Biotherapeutics, Inc. (hereinafter referred to as the
“Company,” “we,” “us,” or “our”) within the meaning of the Private
Securities Litigation Reform Act of 1995 (the “PSLRA”). All such
written or oral statements made in this press release, other than
statements of historical fact, are forward-looking statements and
are intended to be covered by the safe harbor for forward-looking
statements provided by the PSLRA. Without limiting the foregoing,
we may, in some cases, use terms such as “predicts,” “believes,”
“potential,” “continue,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,”
“could,” “might,” “will,” “should” or other words that convey
uncertainty of future events or outcomes and are intended to
identify forward-looking statements. Forward-looking statements are
based on assumptions and assessments made in light of management’s
experience and perception of historical trends, current conditions,
expected future developments and other factors believed to be
appropriate. Forward-looking statements in this press release are
made as of the date of this press release, and we undertake no duty
to update or revise any such statements, whether as a result of new
information, future events or otherwise. Forward-looking statements
are not guarantees of future performance and are subject to risks,
uncertainties and other factors, many of which are outside of our
control, that may cause actual results, levels of activity,
performance, achievements and developments to be materially
different from those expressed in or implied by these
forward-looking statements. Important factors that could cause
actual results, developments and business decisions to differ
materially from forward-looking statements are described in the
sections titled "Risk Factors" in our filings with the Securities
and Exchange Commission, including our most recent Annual Report on
Form 10-K and Quarterly Reports on Form 10-Q, and include, but are
not limited to, the following substantial known and unknown risks
and uncertainties inherent in our business: the effects of the
COVID-19 pandemic; risks related to the timing of and our ability
to successfully develop, submit, obtain and maintain U.S. Food and
Drug Administration (“FDA”) or other regulatory authority approval
of, or other action with respect to, our product candidates, and
our ability to successfully commercialize any product candidates
for which we obtain FDA approval; whether clinical trial results
from our pivotal studies and cohorts, and meetings with the FDA,
may support registrational studies and subsequent approvals by the
FDA; preliminary and interim clinical results, which may include
efficacy and safety results, from ongoing clinical trials or
cohorts may not be reflected in the final analyses of our ongoing
clinical trials or subgroups within these trials or in other prior
trials or cohorts; the risk that enrollment may need to be adjusted
for our trials and cohorts within those trials based on FDA and
other regulatory agency input; the changing landscape of care for
cervical cancer patients may impact our clinical trials in this
indication; the risk that we may be required to conduct additional
clinical trials or modify ongoing or future clinical trials based
on feedback from the FDA or other regulatory authorities; the risk
that our interpretation of the results of our clinical trials or
communications with the FDA may differ from the interpretation of
such results or communications by the FDA (including from the prior
pre-BLA meeting with the FDA); the risk that the FDA may not
approve our BLA submission for lifileucel in metastatic
melanoma; the acceptance by the market of our product candidates
and their potential reimbursement by payors, if approved; our
ability or inability to manufacture our therapies using third party
manufacturers or our own facility may adversely affect our
potential commercial launch; the results of clinical trials with
collaborators using different manufacturing processes may not be
reflected in our sponsored trials; the risk that unanticipated
expenses may decrease our estimated cash balances and forecasts and
increase our estimated capital requirements; and other factors,
including general economic conditions and regulatory developments,
not within our control.
CONTACTS
Iovance Biotherapeutics, Inc:Sara Pellegrino,
IRCSenior Vice President, Investor Relations & Corporate
Communications650-260-7120 ext. 264Sara.Pellegrino@iovance.com
Jen SaundersDirector, Investor Relations & Public
Relations267-485-3119Jen.Saunders@iovance.com
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