Full Press Release Details
Iovance Biotherapeutics Submits Marketing Authorization
Application to European Medicines Agency for Lifileucel in Advanced Melanoma
Multiple Planned Global Submissions for Lifileucel in 2024 and 2025
Expansion to Address >20,000 Patients Annually with Previously Treated Advanced Melanoma
SAN CARLOS, Calif., June 28,
2024 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing,
and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, submitted a marketing authorization
application (MAA) to the European Medicines Agency (EMA) for lifileucel, a TIL cell therapy, for the treatment of adult patients with
unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor
with or without a MEK inhibitor. If approved, lifileucel will be the first and only approved therapy in this treatment setting in all
European Union (EU) member states.
Raj K. Puri, M.D., Ph.D., Executive Vice President, Regulatory Strategy
and Translational Medicine, stated, "This EU regulatory submission is the first step toward expanding lifileucel into global markets
with a high prevalence of advanced melanoma. The unmet need and strength of the clinical data will support approval of lifileucel as
the first and only approved therapy for advanced melanoma patients in the EU who have progressed following standard of care therapies.
Following the accelerated approval in the U.S., our global expansion strategy can more than double the number of patients with significant
unmet need who may access lifileucel."
The MAA submission for lifileucel is
supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma.
If the MAA for lifileucel is validated, which is anticipated in the third quarter of 2024, the Committee for Medicinal Products for Human
Use (CHMP) is expected to issue a scientific opinion for the European Commission to adopt in 2025. Additional marketing submissions for
lifileucel are on track in Canada and the United Kingdom during the second half of 2024 and in Australia in 2025. Each year, more than
20,000 people die from advanced melanoma in the U.S., EU, United Kingdom, Canada, and Australia.1
1. World Health Organization
International Agency for Research on Cancer (IARC) GLOBOCAN 2022.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics,
Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) 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. The Iovance TIL platform has demonstrated promising clinical data across multiple solid
tumors. Iovance's Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication. 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.
Amtagvi and its accompanying design marks, Proleukin ,
Iovance , and IovanceCares are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries.
All other trademarks and registered trademarks are the property of their respective owners.
Forward-Looking Statements
Certain 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"). 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," "can," "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 U.S. 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 risks related to our ability to successfully
commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration ("FDA")
approval, and Proleukin, for which we have obtained FDA and European Medicines Agency ("EMA") approval; the risk that
the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application
submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and
their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other
international markets and whether such acceptance is sufficient to support continued commercialization or development of our
products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may
adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our
therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such
third party manufacturers and our own facility, may adversely affect our 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 the successful development or commercialization of our
products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable
in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain
FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial
results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support
registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the
planned single arm Phase 2 IOV-LUN-202 trial may not support registration; 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 risk that 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, EMA, or
other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA,
EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory
authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that
clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may
not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash
balances and forecasts and increase our estimated capital requirements; the effects of the COVID-19 pandemic; and other factors,
including general economic conditions and regulatory developments, not within our control.
Iovance Biotherapeutics, Inc:
Sara Pellegrino, IRC
Senior Vice President, Investor Relations & Corporate Communications
650-260-7120 ext. 264
Senior Director, Investor Relations & Corporate Communications