Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies, today announced initial data from pivotal Cohort 4
and updated long-term data from Cohort 2 in the C-144-01 study of
lifileucel in advanced melanoma.
“We are very pleased to announce our pivotal Cohort 4 early data
from the C-144-01 clinical study in advanced melanoma today,” said
Maria Fardis, Ph.D., President and Chief Executive Officer of
Iovance Biotherapeutics. “The data from the first 68 patients in
Cohort 4, with a 32.4% overall response rate (ORR) at 5.3 months of
median study follow up, is highly consistent with what we have
observed in Cohort 2 with comparable study follow up. For Cohort 2,
median duration of response has not been reached at 18.7 months of
study follow up. Available care for metastatic melanoma patients
enrolled into our program is chemotherapy, which has been reported
to offer a 4-10% response rate with a very short median duration of
response. Together, these early data continue to support the
potential benefit of the one-time administration of lifileucel TIL
therapy in advanced melanoma patients.”
Interim Pivotal Cohort 4 ResultsInitial results
from the pivotal Cohort 4 in the C-144-01 clinical study is
available for 68 patients with two radiological assessments, as
determined by investigator. Primary endpoint for the C-144-01
Cohort 4 study is ORR by independent review committee and secondary
endpoint is ORR by investigator. Lifileucel shows a 32.4% overall
response rate (1 complete response and 21 partial responses, 2 of
which are yet to be confirmed with follow up visits) and a disease
control rate of 72.1% as of the data cut off of 16 Mar 2020. This
data is consistent with what was noted in Cohort 2 at 6 months of
median study follow up. The ORR was 33% as reported in SITC 2018
abstract.
The Cohort 4 metastatic melanoma patients have a similar patient
characteristic profile to Cohort 2 with high baseline disease
burden. They have progressed on multiple prior therapies, including
anti-PD-1 and BRAF/MEK inhibitors. The adverse event profile was
consistent with Cohort 2 and with the underlying advanced disease,
lymphodepletion and IL-2 regimens. Cohort 4 dosed a total of 89
patients, and additional updates on Cohort 4 will be presented at
upcoming medical meetings. Iovance remains on track to submit a
biologics licensing application (BLA) for lifileucel in late
2020.
Updated Cohort 2 ResultsUpdated results from
Cohort 2 will be presented at the ASCO20 Virtual Scientific Program
during an oral abstract session titled, “Long-term follow up of
lifileucel (LN-144) cryopreserved autologous tumor infiltrating
lymphocyte therapy in patients with advanced melanoma progressed on
multiple prior therapies.” In this Cohort 2 data, lifileucel shows
a 36.4% overall response rate (2 complete responses and 22 partial
responses) and a disease control rate of 80% (n=66) as assessed by
investigators. Median duration of response (DOR) was not reached at
18.7 months of median study follow up (2.2 to 26.9+ months).
Durable responses have been observed across a wide age range in
metastatic melanoma patients who have received prior anti-CTLA-4
and BRAF targeted treatments, regardless of BRAF mutation status,
and equally in patients with PD-L1 high and low status.
The Cohort 2 melanoma patients are heavily pretreated with high
baseline disease burden. They have progressed on multiple prior
therapies (3.3 mean prior therapies), including anti-PD-1 and
BRAF/MEK inhibitors. The adverse event profile was consistent with
the underlying advanced disease, lymphodepletion and IL-2
regimens.
The oral abstract session at ASCO20 will be available on demand
in the ASCO Meeting Library at https://meetinglibrary.asco.org/.
Details of the presentation are as follows:
Title: Long-term follow up of lifileucel
(LN-144) cryopreserved autologous tumor infiltrating lymphocyte
therapy in patients with advanced melanoma progressed on multiple
prior therapiesAuthors: Amod Sarnaik, et
al.Session Title: Melanoma/Skin
CancersSession Type: Oral Abstract
SessionAbstract Number:
10006Location: ASCO20 Virtual Scientific Program
at
https://meetings.asco.org/am/virtual-programDate/Time: available
for on-demand viewing starting at 8:00am ET on May 29,
2020 Furthermore,
Iovance will provide results from Cohort 4 as well as Cohort 2 of
the C-144-01 study in metastatic melanoma as part of the BLA
package. Based on the pooled analysis of Cohort 2 plus 4 (n=134),
the overall response rate was 34.3%, including three complete
responses, 43 partial responses (two of which are yet to be
confirmed with follow up visits) and a disease control rate of
76.1%. Median DOR was not reached at 10.6 months of median
study follow up.
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. After infusion, TIL reach tumor tissue, where
they attack tumor cells. The company has completed dosing in the
pivotal study in patients with metastatic melanoma and is currently
conducting a pivotal study in patients with advanced cervical
cancer. In addition, the company’s TIL therapy is being
investigated for the treatment of patients with locally advanced,
recurrent or metastatic cancers including head and neck and
non-small cell lung cancer. A clinical study to investigate Iovance
T cell therapy for blood cancers called peripheral blood lymphocyte
(PBL) therapy is open to enrollment. 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, filings with the Securities and Exchange
Commission (“SEC”), reports to stockholders and in meetings with
investors and analysts, 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.
These forward-looking statements include, but are not limited to,
statements regarding 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 strength of the Company’s product pipeline; and
the guidance provided for the Company’s future cash, cash
equivalents, short term investment and restricted cash balances.
These statements involve risks, uncertainties and other factors
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,
including, without limitation, the following substantial known and
unknown risks and uncertainties inherent in the Company’s business:
the COVID-19 pandemic may have an adverse effect on the Company and
its clinical trials, including potential slower patient
recruitment, inability of clinical trial sites to collect data,
inability of the Company or its contract research organizations to
monitor patients, as well as U.S. Food and Drug Administration
(“FDA”) availability due to competing priorities; our ability to
achieve long-term profitability and successfully commercialize our
products alone or with third parties, as well as our history of
operating losses and our expectations that we will continue to
incur significant operating losses; our limited operating history
in our current line of business, which makes it difficult to
evaluate our prospects, our business plan or the likelihood of our
successfully implementing such business plan; risks related to the
timing of and our ability to successfully develop, submit, obtain
and maintain FDA or other regulatory authority approval of, or
other action with respect to, our product candidates (including
with respect to lifileucel for the treatment of metastatic
melanoma, for which we expect to submit a biologics licensing
application (“BLA”) to the FDA during 2020), and our ability to
successfully commercialize any product candidates for which we
obtain FDA approval; our limited history in conducting clinical
trials, on which our future profitability is substantially
dependent, and our need to rely on third parties, including
contract research organizations, contract manufacturing
organizations and consultants, in connection with the conduct,
supervision and monitoring of our clinical trials for our product
candidates; preliminary and interim clinical results, which may
include efficacy and safety results, from ongoing Phase 2 studies
may not be reflected in the final analyses of our ongoing clinical
trials or subgroups within these trials; the interim results for
Cohort 4 of our C-144-01 study in metastatic melanoma (“Cohort 4”)
speak only to data available as of March 16, 2020, and although
such data have been reviewed by an independent investigator, they
have not been reviewed by an institutional review board (“IRB”) and
are therefore unconfirmed (for example, the reported overall
response rate for Cohort 4 is based on unconfirmed partial response
rate data), and the IRB may ultimately disagree with the final data
for Cohort 4, when available and submitted to it for review; the
risk that a slower rate of enrollment may delay the Company’s
clinical trial timelines or otherwise adversely impact our clinical
development activities; the risk that 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 risk that the results obtained in our ongoing clinical trials
may not be indicative of results obtained in future clinical trials
or that data within these trials may not be supportive of product
approval, including that later developments with the FDA may be
inconsistent with already completed FDA meetings; the risk that the
FDA may not agree with our plan to combine the final results for
Cohort 4 with the final results for Cohort 2 of our C-144-01 study
in metastatic melanoma (“Cohort 2”), and that such combined data
will be sufficient to support a BLA filing for lifileucel for the
treatment of metastatic melanoma; the risk that the final data for
Cohort 4 will not be consistent with the final data for Cohort 2;
the risk that the FDA may not permit us to rely on duration of
response data from Cohort 2 in place of new data from Cohort 4, in
the event that patient follow-up is negatively impacted by the
global COVID-19 pandemic and we are unable to generate such new
data as a result; the risk that the FDA may not agree with our
approach to expand our cervical cancer trial to include Cohort 2 of
the C-145-04 trial; the risk that 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
risk that regulatory authorities may potentially delay the timing
of FDA or other regulatory approval of, or other action with
respect to, our product candidates, or 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 the Company’s interpretation of the
results of its clinical trials or communications with the FDA may
differ from the interpretation of such results or communications by
the FDA; our ability to obtain and maintain intellectual property
rights related to our product pipeline; our ability to successfully
implement our research and development programs and collaborations;
the acceptance by the market of our product candidates and their
potential reimbursement by payors, if approved; our ability to
obtain tax incentives and credits and the risk that our existing
net operating loss carryforwards and research tax credits may
expire or otherwise be limited in use; the success of our
manufacturing, license or development agreements; risks related to
the Company’s ability to maintain and benefit from accelerated FDA
review designations, including breakthrough therapy designation or
regenerative medicine advanced therapy designation, 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 which 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; the results of clinical
trials with collaborators using different manufacturing processes
may not be reflected in the Company’s sponsored trials; our
dependence on additional financing to fund our operations and
complete the development and commercialization of our product
candidates, and the risks that raising such additional capital may
restrict our operations or require us to relinquish rights to our
technologies or product candidates; the risk that additional
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
the Company’s control.
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
reports that we file or furnish with the SEC from time to time.
Copies of these reports are available online at www.sec.gov or
www.iovance.com. The forward-looking statements in this press
release should be considered in light of these risks and
uncertainties. All forward-looking statements made in this press
release are based solely on information available to us as of the
date of this press release and the Company undertakes no obligation
to publicly update or revise such forward-looking statements,
whether as a result of subsequent events, changed circumstances,
new information or otherwise.
CONTACTS:Iovance Biotherapeutics,
Inc:Sara Pellegrino, IRCVice President, Investor Relations
& Public Relations650-260-7120 ext.
264Sara.Pellegrino@iovance.com
Solebury Trout:Annie Chang
(investors)646-378-2972achang@troutgroup.com
Chad Rubin (investors)646-378-2947crubin@troutgroup.com
Rich Allan (media)646-378-2958rallan@troutgroup.com
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