Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies (tumor-infiltrating lymphocyte, TIL, and
peripheral-blood lymphocyte, PBL), today announced that the Journal
of Clinical Oncology has published a manuscript of clinical data
for Cohort 2 in the C-144-01 study of lifileucel TIL therapy in
metastatic melanoma. Online open access to the publication is
available at https://ascopubs.org/doi/full/10.1200/JCO.21.00612.
Amod Sarnaik, Associate Professor of Cutaneous Oncology and
Immunology at H. Lee Moffitt Cancer Center stated, “Effective
treatment options are limited for patients with advanced melanoma
who progress after immune checkpoint inhibitors and targeted
therapies. Lifileucel represents a significant improvement in the
treatment of advanced melanoma, particularly in the expanding
post-immune checkpoint inhibitor patient population. The results
from the C-144-01 clinical study, as well as the advancement of
lifileucel using a centralized TIL manufacturing process, offer a
new opportunity for accessible treatment for the most challenging
to treat patients with metastatic melanoma.”
“With this publication we have summarized several years of our
clinical development and TIL manufacturing as we strive to make TIL
a broadly accessible cell therapy for patients with advanced
melanoma,” said Maria Fardis, PhD, MBA, President and Chief
Executive Officer of Iovance. “At the time of the data extract for
publication, the overall response rate (ORR) was 36%, median
duration of response (DOR) had not been reached at 18.7 months of
median study follow up and median overall survival (OS) was 17.4
months. As a reference, patients treated with chemotherapy are
expected to have an OS of approximately 7 months. I believe these
results demonstrate the durability of one-time treatment with
lifileucel. Importantly, durable responses were seen across all
patient subgroups regardless of prior treatment or mutation status,
including patients who were primary refractory to anti−PD-1
therapy. I would like to thank the investigators who contributed to
this manuscript as well as the patients who participated in Cohort
2 of the C-144-01 clinical study.”
Publication SummaryIn Cohort 2 of the C-144-01
clinical study, 66 patients received a mean of 3.3 prior therapies.
As of the data extract for the publication (April 23, 2020), the
ORR was 36% (2 complete responses and 22 partial responses),
meeting the study primary endpoint in a patient population that had
failed frontline anti−PD-1 therapy, the current standard of care.
The median DOR was not reached after a median of 18.7 months of
study follow-up (range 0.2 to 34.1 months) and 69% of patients had
DOR of at least one-year. The median OS was 17.4 months, and
one-year survival was 38% in patients with stable disease and 92%
in patients with a partial or complete response.
Lifileucel also demonstrated similar ORR across Cohort 2
subgroups, including patients who were primary refractory to
anti−PD-1 or anti−PD-L1 therapy (41%); patients who received
anti−PD-1 or anti−PD-L1 combination as a frontline therapy (33%) or
after failing frontline therapy (32%); and patients with primary
resistance or acquired resistance to anti−PD-1 plus anti−CTLA-4
combination therapy (35% and 27%, respectively).
Responses to lifileucel were agnostic of PD-L1 status, BRAF
mutation status, or prior anti−CTLA-4 therapy. Safety profile was
consistent with known adverse events associated with advanced
disease, non-myeloablative lymphodepletion, and IL-2.
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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