Iovance Biotherapeutics Announces Results of a Subgroup Analysis of Patients in the Lifileucel Metastatic Melanoma Study who ...
November 21 2019 - 7:00AM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced results of a subgroup analysis of
Cohort 2 of the Phase 2 lifileucel metastatic melanoma study
C-144-01 in patients who were primary refractory to prior
anti-PD-1/L1 therapy. An abstract with details of the analysis was
accepted as a late-breaking poster at the 16th International
Congress of the Society for Melanoma Research (SMR) being held Nov.
20-22 in Salt Lake City.
Highlights from the poster, presented by study investigator Omid
Hamid, M.D., Chief of Translational Research and Immunotherapy and
Director of Melanoma Therapeutics at the Angeles Clinic and
Research Institute of Los Angeles, on Thursday, Nov. 21, 2019,
include:
- In 42 primary refractory patients enrolled in Cohort 2 of
C-144-01 study, defined as having had the best response of
progressive disease (PD) on their first anti-PD-1/L1 treatment, an
objective response rate (ORR) of 41 percent, as assessed by the
investigator, was observed
- Median duration of response (DOR) was not reached at 12 months
of study follow-up (range: 2.8+ to 21.2+ months)
- 71 percent of responders who are primary refractory to anti
PD-1/L1 therapy remain on study
“Patients who are primary refractory to prior anti-PD-1/L1
therapy have very limited therapeutic options and yet form a large
population of diagnosed metastatic melanoma patients,” commented
Maria Fardis, Ph.D., MBA, president and chief executive officer of
Iovance. “Tumor infiltrating lymphocyte (TIL) therapy developed by
Iovance has shown strong efficacy for patients with relapsed or
refractory metastatic melanoma. In the subgroup analysis conducted
for primary refractory patients in our Cohort 2 of the C-144-01
study, TIL demonstrates excellent efficacy and durability of
response thus far. We are very pleased to see that the Iovance TIL
may offer a therapeutic option for this patient population.”
Cohort 2 in the ongoing C-144-01 study includes consecutively
dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma
who also have received BRAF/MEK therapy if clinically indicated. In
this study, patients had experienced a mean of 3.3 lines of prior
therapy including anti-PD1 blocking antibody, and the patients had
a high baseline tumor burden. Primary refractory patients included
42 of the 66 dosed patients in Cohort 2 who had a best response of
progressive disease to the first anti-PD-1/L1.
About the Society for Melanoma Research (SMR) 2019
Congress
SMR 2019 is a global congress that unites melanoma clinicians
and researchers to focus on multidisciplinary management of
melanoma/skin cancer. This is the leading meeting for cutting edge
data in melanoma.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends 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. After infusion, TIL reach tumor
tissue, where they attack tumor cells. The company is currently
conducting pivotal studies in patients with metastatic melanoma and
advanced cervical cancer. In addition, the company’s TIL therapies
are being investigated for the treatment of patients with locally
advanced, recurrent or metastatic cancers including head and neck
and non-small cell lung cancer. Clinical studies of T cell therapy
for blood cancers called peripheral blood lymphocyte (PBL) therapy
are being planned. 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”). We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “continue,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should” or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements. The
forward-looking statements include, but are not limited to, risks
and uncertainties relating to the success, timing, projected
enrollment, manufacturing and production capabilities, and cost of
our ongoing clinical trials and anticipated clinical trials for our
current product candidates (including both Company-sponsored and
collaborator-sponsored trials in both the U.S. and Europe),
such as statements regarding the timing of initiation and
completion of these trials; the timing of and our ability to
successfully submit, obtain and maintain FDA or other
regulatory authority approval of, or other action with respect to,
our product candidates, including those product candidates that
have been granted breakthrough therapy designation (“BTD”) or
regenerative medicine advanced therapy designation (“RMAT”) by
the FDA and new product candidates in both solid tumor
and blood cancers; the strength of the Company’s product pipeline;
the successful implementation of the Company’s research and
development programs and collaborations; the Company’s ability to
obtain tax incentives and credits; the guidance provided for the
Company’s future cash, cash equivalent, and short term investment
positions; the success of the Company’s manufacturing, license or
development agreements; the acceptance by the market of the
Company’s product candidates, if approved; and other factors,
including general economic conditions and regulatory developments,
not within the Company’s control. The factors discussed herein
could cause actual results and developments to be materially
different from those expressed in or implied by such statements.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in the
Company’s business, including, without limitation: the preliminary
clinical results, which may include efficacy and safety results,
from ongoing Phase 2 studies may not be reflected in the final
analyses of these trials or subgroups within these trials; a slower
rate of enrollment may impact the Company’s clinical trial
timelines; enrollment may need to be adjusted for the Company’s
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 the Company’s cervical cancer trial may have
an adverse effect on the results reported to date; the data within
these trials may not be supportive of product approval; changes in
patient populations may result in changes in preliminary clinical
results; the Company’s ability or inability to address FDA or
other regulatory authority requirements relating to its clinical
programs and registrational plans, such requirements including, but
not limited to, clinical, safety, manufacturing and control
requirements; the Company’s interpretation of communications with
the FDA may differ from the interpretation of such
communications by the FDA; risks related to the Company’s ability
to maintain and benefit from accelerated FDA review
designations, including BTD and RMAT, which may not result in a
faster development process or review of the Company’s product
candidates (and which may later be rescinded by the FDA), and
does not assure approval of such product candidates by
the FDA or the ability of the Company to obtain FDA
approval in time to benefit from commercial opportunities; the
ability or inability of the Company to manufacture its therapies
using third party manufacturers or its own facility may adversely
affect the Company’s potential commercial launch; and additional
expenses may decrease our estimated cash balances and increase our
estimated capital requirements. A further list and description of
the Company’s risks, uncertainties and other factors can be found
in the Company’s most recent Annual Report on Form 10-K and the
Company’s subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online
at www.sec.gov or www.iovance.com. The
forward-looking statements are made only as of the date of this
press release and the Company undertakes no obligation to publicly
update such forward-looking statements to reflect subsequent events
or circumstances.
Investor Relations Contacts: Annie
ChangSolebury Trout646-378-2972achang@troutgroup.com
Chad RubinSolebury Trout646-378-2947crubin@troutgroup.com
Media Relations Contact: Rich AllanSolebury
Trout646-378-2958rallan@troutgroup.com
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Sep 2023 to Sep 2024