Updated Results of Studies in Advanced Cervical Cancer and Melanoma Support Long-Term Efficacy of Iovance Tumor Infiltrating ...
May 31 2019 - 7:00AM
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel cancer immunotherapies based
on tumor-infiltrating lymphocyte (TIL) technology, today announced
updated data from studies of TIL therapy LN-145 in patients with
advanced cervical cancer and TIL therapy lifileucel in advanced
melanoma. At 7.4-month median follow-up in the ongoing study of
LN-145 in advanced cervical cancer, an 11 percent complete response
rate (CR) was seen. Furthermore, the median duration of response
(DOR) had not been reached. At 8.8-month median follow-up in the
ongoing study of lifileucel in advanced melanoma, median duration
of response had not been reached. Updated data from the ongoing
innovaTIL-04 and innovaTIL-01 studies will be presented at the 55th
Annual Meeting of the American Society of Clinical Oncology (ASCO).
“As we continue to observe the effects of Iovance
TIL therapy, we have not yet reached a median DOR for our TIL
product in either our melanoma or cervical trial,” commented Maria
Fardis, Ph.D., president and chief executive officer of Iovance
Biotherapeutics. “We are also extremely encouraged to see CRs in
our cervical cancer study as the study continues over time,
demonstrating the potential for deep responses after one treatment.
The same phenomenon was noted in our melanoma trial as well with
two CRs now being reported at ASCO in a heavily pre-treated
melanoma patient population.”
“The duration of response of current second line
treatments for advanced cervical cancer are in the range of three
to five months and options are limited,” commented Emese Zsiros,
M.D., Ph.D., faculty researcher at the Department of Gynecologic
Oncology of the Roswell Park Comprehensive Cancer Center and
Iovance LN-145 study investigator. “The observation in the study of
LN-145 that median DOR has not yet been reached at a median of 7.4
months following treatment provides evidence that this therapy
could provide a clinically meaningful improvement over currently
available options for patients with advanced cervical cancer.”
As of May 14, 2019, data from the innovaTIL-04
study in 27 patients with recurrent, metastatic or persistent
cervical cancer demonstrated an objective response rate of 44
percent (3 complete responses and 9 partial responses) and a
disease control rate of 85 percent. At 7.4-month median follow-up,
10 patients maintained a response and the median DOR had not been
reached (range 2.6+ to 9.2+ months). The mean patient age was 45
years and study participants had experienced a mean of 2.4 prior
lines of therapy. Study data will be presented on Saturday, June 1
(Abstract #2538, Poster 182).
As of May 8, 2019, results from Cohort 2 in the
ongoing innovaTIL-01 study demonstrated an ORR of 38 percent (2
complete responses and 23 partial responses) in 66 consecutively
dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma.
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. The disease control rate
was 80 percent. At 8.8-month median follow-up, median DOR had not
been reached (range 1.4+ to 19.8+ months). Study data will be
presented on Saturday, June 1 (Abstract #2518, Poster 162).
About Iovance Biotherapeutics,
Inc. Iovance Biotherapeutics intends to commercialize
lifileucel, an autologous cell therapy product using TIL technology
that amplifies the body’s own immune response to eradicate solid
tumors or attack blood cancers. The company is currently conducting
the pivotal study innovaTIL-01 in patients with metastatic
melanoma. In addition, the company’s TIL therapies are being
investigated for the treatment of patients with locally advanced,
recurrent or metastatic cancers including cervical, head and neck,
and non-small cell lung cancer. 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 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; 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 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, including efficacy and safety results, from
ongoing Phase 2 studies may not be reflected in the final analyses
of these trials, including new cohorts within these trials, and may
not be supportive of product approval; the FDA or other regulatory
authorities may potentially delay the timing of their approval of,
or other action with respect to, the Company’s product candidates;
the Company’s ability to address FDA or other regulatory authority
requirements relating to its clinical programs and registrational
plans, such requirements including, but not limited to, clinical
and safety requirements as well as manufacturing and control
requirements; risks related to the Company’s ability to maintain
and benefit from accelerated FDA review designations, including BTD
and RMAT, which may not ultimately result in a faster development
process or review of the Company’s product candidates (and which
may later be rescinded by the FDA if such product candidates no
longer meet the conditions for qualification for the program), and
does not in any way 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; and the ability of
the Company to manufacture its therapies using third party
manufacturers. 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
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