Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced updated clinical data for
lifileucel from Cohort 2 in the C-144-01 clinical study in patients
with advanced melanoma. The data were presented in an oral
presentation at the ASCO 2021 Annual Meeting.
Omid Hamid, M.D., Chief of Research/Immuno-Oncology, The Angeles
Clinic & Research Institute, stated, “Anti-PD-1 therapy is a
mainstay class of treatment offering several therapeutic options
for metastatic melanoma. For patients who progress on anti-PD-1
therapy, there is an unfulfilled need for efficacious and durable
treatment options. The latest results with lifileucel suggest that
early intervention with lifileucel TIL therapy, immediately upon
progression on anti-PD-1 therapy, may offer better outcomes and
longer duration of response. These data offer evidence that
patients have had positive treatment experiences with lifileucel,
and I believe TIL therapy has the potential to become an important
option within the melanoma treatment landscape.”
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of
Iovance, stated, “Our latest data for Cohort 2 in the C-144-01
clinical study are very exciting and continue to support the
durability of responses after lifileucel in challenging to treat
patients with melanoma. Median DOR has still not been reached at 33
months of median study follow up. We are also reporting the
important observation that a shorter duration of prior anti-PD-1
therapy is associated with longer duration of response after
lifileucel. We are committed to bringing lifileucel to patients as
soon as we can.”
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. Median DOR was not reached at 33.1
months of median study follow up (range: 2.2 to 38.5+ months) and
Overall Response Rate, or ORR, remained at 36.4% (data extraction:
April 2021). Responses deepened over time and one patient converted
from partial to complete response at 24 months post lifileucel
infusion.
A multivariable model showed that for every six-month decrease
in cumulative duration of prior anti-PD-1 therapy, DOR to
lifileucel will be nearly doubled. These results suggest that early
intervention with lifileucel at the time of initial progression on
anti-PD-1 therapy may maximize benefit.
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 safety
risks identified for lifileucel during long-term follow-up.
Iovance Presentation 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
Cancers |
|
Session Type: Oral Abstract
Session |
|
Abstract Number: 9505 |
|
Location: 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 |
Webcast and Conference CallIovance will host a
webcast and conference call on Sunday, June 6, at 12:00 p.m. ET to
discuss ASCO clinical data updates for lifileucel alone and in
combination with pembrolizumab in patients with advanced melanoma.
Iovance senior leadership, together with Dr. Hamid, will present a
summary of the ASCO data from Cohort 1A in the IOV-COM-202 study as
well as the oral presentation of updated Cohort 2 data from the
C-144-01 clinical study.
The conference call dial-in numbers are 1-844-646-4465
(domestic) or 1-615-247-0257 (international) and the access code is
4858337. The live webcast can be accessed in the Investors section
of the company’s website at http://www.iovance.com. The archived
webcast will be available for a year in the Investors section at
www.iovance.com.
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) 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
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Apr 2023 to Apr 2024