Iovance Biotherapeutics Announces Regulatory and Clinical Updates for TIL Therapy in Advanced Non-Small Cell Lung Cancer
10 Julho 2023 - 8:00AM
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, today announced positive regulatory and
clinical updates related to its registrational single-arm Phase 2
IOV-LUN-202 trial in post-anti-PD-1 NSCLC.
NSCLC Regulatory and Clinical Update: At a Type
B Pre-Phase 3 meeting held between Iovance and the U.S. Food and
Drug Administration (FDA), the FDA provided positive regulatory
feedback that the design of the IOV-LUN-202 trial may be acceptable
for accelerated approval of LN-145 TIL therapy for patients who
have progressed on or after chemotherapy and anti-PD-1 therapy for
advanced (unresectable or metastatic) NSCLC without EGFR, ROS or
ALK genomic mutations and had received at least one line of an
FDA-approved targeted therapy if indicated by other actionable
tumor mutations. Based on this FDA feedback, Iovance completed a
preliminary analysis of the IOV-LUN-202 trial. This recent data
cut1 included 23 NSCLC patients treated with LN-145. An ORR of
26.1% by RECIST v1.1 (n=6, one complete response and five partial
responses) was observed, with a disease control rate of 82.6%.
While still early on study, the median duration of response (DOR)
was not reached. The DOR ranged from 1.4+ months to 9.7+ months.
Treatment-emergent adverse events were consistent with the
underlying disease and known adverse event profiles of
non-myeloablative lymphodepletion and interleukin-2. Based on the
regulatory discussions, Iovance plans to enroll a total of
approximately 120 patients into the registrational IOV-LUN-202
trial. Enrollment is expected to be complete during the second half
of 2024. As previously announced, Iovance is also preparing to meet
with the FDA this year to discuss a randomized confirmatory trial
of LN-145 in frontline advanced NSCLC patients. This confirmatory
trial in frontline advanced NSCLC is expected to be well underway
at the time of a potential approval in advanced post-anti-PD-1
NSCLC.
Lifileucel BLA Submission on Track in Advanced
Melanoma: The FDA’s Priority Review of Iovance’s Biologics
License Application (BLA) for lifileucel in advanced melanoma
remains on track and continues to progress well. The Prescription
Drug User Fee Act target action date for the BLA is November 25,
2023.
_____________
1Data cut date of July 6, 2023.
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,
that 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: preliminary and
interim clinical results, which may include efficacy and safety
results, from ongoing clinical trials or cohorts, including but not
limited to our IOV-LUN-202 trial, 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; 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, including the risk
that the planned single-arm Phase 2 IOV-LUN-202 trial may not
support registration; 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 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
and/or regarding our prior meetings with the FDA regarding our
NSCLC clinical trials); 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 regarding the
successful integration of the recent Proleukin acquisition; 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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