Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced additional clinical data for
lifileucel alone and in combination with pembrolizumab in patients
with advanced melanoma. The data are available in two ASCO
abstracts, with additional updates to be provided at the upcoming
ASCO 2021 Annual Meeting, to be held June 4-8, 2021.
Maria Fardis, Ph.D., President and Chief Executive
Officer of Iovance Biotherapeutics, stated, “We are very excited
that our latest clinical datasets demonstrate the broad potential
for lifileucel in advanced melanoma. For the first time we are
reporting results for lifileucel as an earlier treatment for
advanced melanoma in combination with pembrolizumab, demonstrating
an overall response rate (ORR) of 86% in patients who are naïve to
anti-PD-1 therapy. We are impressed with the results for this
combination regimen, particularly since pembrolizumab alone
demonstrated a 33% ORR in a comparable patient population. In
addition, in a post-PD1 advanced melanoma patient population in
Cohort 2 in the C-144-01 study, shorter duration of prior anti-PD-1
therapy maximizes Duration of Response (DOR) to lifileucel
treatment.”
Lifileucel in Combination with
Pembrolizumab in Advanced Melanoma (IOV-COM-202
Study)Early data suggest the response rate of lifileucel
plus pembrolizumab may be additive in patients with immune
checkpoint inhibitor (ICI)-naïve advanced melanoma. Cohort 1A in
the IOV-COM-202 study is evaluating lifileucel in combination with
pembrolizumab in up to 12 patients who are naïve to ICI, or
anti-PD-1, therapy. Six of the initial seven patients had a
confirmed objective response, representing an 86% ORR (1 Complete
Response (CR) and 5 Partial Responses (PR), with one best response
of stable disease (abstract data extraction: February 2021). The
longest duration of response was 16.8 months.
The Treatment-Emergent Adverse Event (TEAE) profile
was consistent with the underlying disease and known Adverse Event
(AE) profiles of pembrolizumab, NMA-LD and IL-2. These encouraging
data confirm the potential feasibility and activity of lifileucel
in combination with pembrolizumab in early-line treatment of
patients with advanced melanoma. Updated results for the initial
seven patients will be available in the upcoming ASCO poster.
Lifileucel Following anti-PD-1 therapy in
Advanced Melanoma (C-144-01 clinical study)As previously
reported, the long-term follow-up data for Cohort 2 in the C-144-01
clinical study continue to demonstrate durability and depth of
lifileucel TIL therapy response. DOR was not reached at 28.1 months
of median study follow up and ORR remained at 36.4 percent.
New data in the ASCO abstract suggest that DOR was
positively associated with shorter cumulative duration of prior
anti-PD-1 therapy. In responders, the median cumulative duration
and median prior lines of anti-PD-1 therapy was 4.4 months (range:
1.4-22.5 months) and 1.5 lines (range: 1-4). These results support
earlier use of lifileucel following anti-PD-1 therapy instead of
retreatment with anti-PD-1 based - regimens.
All patients in Cohort 2 had high baseline disease
burden and were heavily pretreated (3.3 mean prior therapies),
including anti-PD1 and BRAF/MEK inhibitors if BRAFV600 mutation
positive. The adverse event profile was consistent with the
underlying advanced disease, lymphodepletion and IL-2 regimens,
with no new adverse events emerging over time. Updated results for
Cohort 2 with longer duration of follow up will be part of the oral
presentation during ASCO 2021.
Iovance Presentation and Poster at ASCO
2021
Title: Lifileucel (LN-144), a cryopreserved
autologous tumor infiltrating lymphocyte (TIL) therapy in patients
with advanced melanoma: Evaluation of impact of prior anti-PD-1
therapy.Authors: James M. G. Larkin, et
al.Session Title: Melanoma/Skin
CancersSession Type: Oral Abstract
SessionAbstract Number:
9505Location: ASCO Meeting Library at
https://meetinglibrary.asco.org/ and
https://www.iovance.com/our-science/publications/ Session
Date and Time: Sunday, June 6, 2021 from 8:00 – 11:00 a.m.
ET
Title: Safety and efficacy of lifileucel
(LN-144), an autologous, tumor infiltrating lymphocyte cell therapy
in combination with pembrolizumab for immune checkpoint inhibitor
naïve patients with advanced melanoma.Authors:
Sajeve Samuel Thomas, et al.Session Title:
Melanoma/Skin CancersSession Type: ePoster
SessionAbstract Number:
9537Location: ASCO Meeting Library at
https://meetinglibrary.asco.org/ and
https://www.iovance.com/our-science/publications/ePoster
Viewing: on demand beginning Friday, June 4, 2021 at 9:00
a.m. ET
About Iovance Biotherapeutics,
Inc.
Iovance Biotherapeutics 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) therapy uses a patient’s own
immune cells to attack cancer. TIL cells 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 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 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”). 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 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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