Iovance Biotherapeutics Announces Clinical Data for LN-145 in Non-Small Cell Lung Cancer
June 29 2021 - 6:30AM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced clinical data for its tumor
infiltrating lymphocyte (TIL) therapy LN-145 in patients with
metastatic non-small cell lung cancer (mNSCLC) who enrolled in
Cohort 3B of the ongoing basket study IOV-COM-202. Cohort 3B
enrolled patients that had progressed on prior immune checkpoint
inhibitor (ICI) therapy, including patients with oncogene-driven
tumors who received prior tyrosine kinase inhibitor therapy. The
initial clinical results are available in a slide presentation on
the Iovance website here.
The overall response rate (ORR) by investigator per RECIST 1.1
was 21.4% (n=28, one complete response and five partial responses)
and the disease control rate (DCR) was 64.3% following one-time
treatment with LN-145 monotherapy, including two responders with
PD-L1 negative tumors. Median duration of response was not reached
at a median study follow up of 8.2 months. The treatment-emergent
adverse event profile was consistent with the underlying disease
and known adverse event profiles of non-myeloablative
lymphodepletion and IL-2. All patients treated in Cohort 3B
received prior anti-PD-1/L1 therapy and all six responding patients
also received prior chemotherapy. Historically, ORRs of
approximately 20% were reported with ICIs as second-line therapy in
ICI-naïve patients who progressed on front-line chemotherapy.
Iovance anticipates presenting additional Cohort 3B data at a
medical meeting in the second half of 2021.
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of
Iovance, stated, “There remains a very significant unmet need to
increase response rates and prolong survival in the second line
non-small cell lung cancer treatment setting. The initial data for
LN-145 in this difficult to treat patient population is very
promising.”
The Cohort 3B data using Iovance’s TIL cell therapy are the
first reported clinical data on TIL administered as a one-time
monotherapy in mNSCLC from a prospective, multi-center study, and
add significantly to the existing scientific data previously
reported by Iovance’s collaborator H. Lee Moffitt Cancer
Center.
Iovance also announced today that it dosed the first patient in
IOV-LUN-202. Iovance previously opened the IOV-LUN-202 trial to
investigate LN-145 in second-line mNSCLC where patients have
progressed on one prior ICI and chemotherapy. This trial is
designed to be supportive of registration.
Dr. Graf Finckenstein also stated: “We are excited to share our
initial results for LN-145 in non-small cell lung cancer, a new
potential indication for Iovance TIL cell therapy, which show
positive outcomes in patients with high unmet medical need. We see
a substantial opportunity to advance LN-145 in the post-ICI setting
for patients with lung cancer. These data also have the potential
to drive momentum with enrollment in our registration supporting
study, IOV-LUN-202, as well as in two additional non-small cell
lung cancer cohorts in IOV-COM-202, and we move ahead with great
enthusiasm.”
About Iovance Biotherapeutics, Inc.Iovance
aims to improve patient care by making T cell-based immunotherapies
broadly accessible for the treatment of patients with solid tumors
and blood cancers. Tumor infiltrating lymphocyte (TIL) cell therapy
uses a patient’s own immune cells to attack cancer. TIL are
extracted from a patient’s own tumor tissue, expanded through a
proprietary process, and infused back into the patient. Upon
infusion, TIL reach tumor tissue, where they attack cancer cells.
The company has completed dosing in pivotal programs in patients
with metastatic melanoma and cervical cancer. In addition, the
company’s TIL cell therapy is being investigated in a
registration-supporting study for the treatment of patients with
locally advanced, recurrent or metastatic non-small cell lung
cancer (NSCLC). Clinical studies are also underway to evaluate TIL
in earlier stage cancers in combination with currently approved
treatments, and to investigate Iovance peripheral blood lymphocyte
(PBL) T cell therapy for blood cancers. 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; preliminary and interim clinical
results, which may include efficacy and safety results, from
ongoing clinical trials may not be reflected in the final analyses
of our ongoing or subsequent clinical trials or subgroups within
these trials; 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 new version of the protocol which
further defines the patient population to include more advanced
patients in our cervical cancer trial may have an adverse effect on
the results reported to date; 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; 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 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,
IRCVice President, Investor Relations & Public
Relations650-260-7120 ext. 264Sara.Pellegrino@iovance.com
Solebury Trout:Zara
Lockshin646.378.2960zlockshin@soleburytrout.com
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