Full Press Release Details
Iovance Reports Pivotal Cohort 4 Data
for Tumor Infiltrating Lymphocyte (TIL) Therapy Lifileucel from
C-144-01 Clinical Study in Advanced Melanoma
4 Early Data Shows 32.4% ORR by Investigator Assessment at 5.3 Months of Median Study Follow up
2 Median Duration of Response Not Reached at 18.7 Months of Median Study Follow Up and 36.4% ORR
SAN CARLOS, Calif., May 27, 2020 -- 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 Results
Initial 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
Updated Cohort 2 Results
Updated 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
Title: Long-term follow up of lifileucel (LN-144)
cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior
Authors: Amod Sarnaik, et al.
Session Title: Melanoma/Skin Cancers
Session Type: Oral Abstract Session
Abstract Number: 10006
Location: ASCO20 Virtual Scientific Program
Date/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
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