Iovance Biotherapeutics Announces Clinical Data Updates for Lifileucel in Advanced Melanoma During American Association for C...
April 09 2021 - 7:00AM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced data from Cohort 2 in the C-144-01
study of lifileucel in advanced melanoma. These data will be part
of an oral presentation in a Clinical Trials Plenary Session at the
upcoming American Association for Cancer Research (AACR) 2021
Annual Meeting.
“We are very excited to report our latest Cohort 2 melanoma data
in an oral presentation at AACR,” said Maria Fardis, Ph.D.,
President and Chief Executive Officer of Iovance Biotherapeutics.
“The long term follow up data show that median duration of response
was not reached at 28.1 months of median study follow up.
Furthermore, overall response rate remained at 36.4 percent and we
saw a continued deepening of response in 17 percent of the
patients. The data continue to demonstrate durability and depth of
our lifileucel TIL therapy response after a one-time treatment, in
a difficult to treat patient population with advanced melanoma. We
are honored that AACR has chosen our melanoma Cohort 2 data to be
featured in a clinical trials plenary session.”
Jason Chesney, M.D., Ph.D., Director, James Graham Brown Cancer
Center, University of Louisville and C-144-01 study investigator
stated, “Melanoma patients who have progressed on immune checkpoint
and BRAF/MEK inhibitors are among the most challenging patients for
oncologists to treat. The updated results of the C-144-01
study continue to demonstrate that autologous tumor infiltrating
lymphocytes (TILs; lifileucel) induce durable clinical responses in
36 percent of patients in the study. This study also creates
opportunities for additional trials of TILs in many other cancer
types and in combination with immunomodulatory agents.”
The Cohort 2 data are available in the abstract titled,
“Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating
lymphocyte (TIL) therapy in patients with advanced (unresectable or
metastatic) melanoma: durable duration of response at 28-month
follow up.” Data highlights as of the December 14, 2020 data cut
extract used for the abstract submitted to AACR were as
follows:
- Lifileucel showed a 36.4% overall
response rate (4.5% complete responses and 31.8% partial responses)
and median duration of response (DOR) was not reached at 28.1
months of median study follow up as assessed by investigators
(n=66).
- The Cohort 2 patients had heavily
pretreated metastatic melanoma with high baseline disease burden.
They have progressed on multiple prior therapies (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 additional adverse events emerging over
time.
The abstract is available in the AACR Online Meeting Planner at
www.aacr.org and on the Iovance website at
www.iovance.com/our-science/publications. The data from the
abstract will be highlighted in additional detail at the AACR 2021
Annual Meeting. Details of the oral presentation are as
follows:
|
Abstract Title: Lifileucel (LN-144), a
cryopreserved autologous tumor infiltrating lymphocyte (TIL)
therapy in patients with advanced (unresectable or metastatic)
melanoma: durable duration of response at 28-month follow up
Authors: Jason Alan Chesney, MD, PhD, et
al.Abstract Number: 5329Presentation
Number: CT008Session Title:
Immunooncology and Cell Therapy Trials Session Date and
Time: Saturday, April 10, 2021, 4:45 PM - 5:00 PM
ETLocation: AACR Virtual Annual Meeting 2021 at
www.aacr.org |
In addition to the oral presentation, three Iovance poster
presentations at AACR will highlight the design of clinical trials
in progress in solid tumors and chronic lymphocytic leukemia or
small lymphocytic lymphoma (CLL/SLL). These posters are intended to
educate physicians about study design and will not include clinical
data. Posters will be available from 8:30 a.m. ET on Saturday,
April 10 through Monday, June 21, 2021 in the Virtual ePoster Hall
at www.aacr.org and on the Iovance website at
www.iovance.com/our-science/publications.
- Abstract Title: A
Phase 2, multicenter study of autologous tumor infiltrating
lymphocytes (TIL) (LN-144/LN-145/LN-145-S1) in patients with solid
tumors (IOV-COM-202)Authors: Scott Gettinger, MD,
et al.Abstract Number: CT235
- Abstract Title: A
Phase 1/2 study evaluating the safety and efficacy of IOV-2001 in
patients with relapsed or refractory chronic lymphocytic leukemia
(CLL) or small lymphocytic lymphoma (SLL)
(IOV-CLL-01)Authors: Meixiao Long, MD, PhD, et
al.Abstract Number: CT244
- Abstract Title: A
phase 2 multicenter study of autologous tumor infiltrating
lymphocytes (TIL; LN-145) cell therapy in patients with metastatic
non-small cell lung cancer (IOV-LUN-202)Authors:
Erminia Massarelli, MD, PhD, et al.Abstract
Number: CT246
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. 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:Chad Rubin
(investors)646-378-2947crubin@soleburytrout.com
Zara Lockshin (media)646.378.2960zlockshin@soleburytrout.com
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