Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel cancer immunotherapies based
on tumor-infiltrating lymphocyte (TIL) technology, today announced
updates from ongoing clinical trials including new interim data
from studies of TIL therapy LN-145 in patients with advanced
cervical cancer and with TIL therapy lifileucel in advanced
melanoma. These data will be presented at the 55th Annual Meeting
of the American Society of Clinical Oncology (ASCO) taking place
May 31 to June 4, 2019, in Chicago. In addition, the company
announced that the first PD-1/PD-L1 naive patient has been dosed
with TIL therapy and that it has entered into a collaboration with
Genocea to evaluate the potential for an improved TIL product.
Data from the innovaTIL-04 study in patients with recurrent,
metastatic or persistent cervical cancer showed an ORR of 44
percent (1 complete response, 9 partial responses and 2 unconfirmed
partial responses) and a disease control rate of 89 percent. At
3.5-month median study follow-up, 11 out of 12 patients maintained
a response. The mean patient age was 47 years and study
participants had experienced a mean of 2.6 prior lines of therapy.
The adverse event profile was generally consistent with the
underlying advanced disease and the profile of the lymphodepletion
and IL-2 regimens. These data will be presented on Saturday, June 1
(Abstract #2538). As a reference, ORR for Keytruda used in second
line cervical cancer patients is 14 percent.1
“As advanced cervical cancer is typically diagnosed at a
relatively young age and efficacy of existing treatment options is
extremely low, there is potential to significantly impact care with
an option that can bring about long-term remission and complete
responses,” said Amir Jazaeri, M.D., innovaTIL-04 study
investigator and associate professor of Gynecological Oncology and
Reproductive Medicine at the MD Anderson Cancer Center. “The
interim data from LN-145 present compelling evidence that TIL
therapy, provided as a single administration, could improve upon
current treatments.”
Updated results from Cohort 2 in the ongoing innovaTIL-01 study
demonstrated an ORR of 38 percent (2 complete responses, 18 partial
responses and 1 unconfirmed partial response) in 55 consecutively
dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma.
In this study, patients were heavily pretreated, with a mean of 3.1
lines of prior therapy including anti-PD1, and had high baseline
tumor burden. The disease control rate was 76 percent. At 7.4-month
median follow-up, responses were maintained in the majority of
patients (only 4 out of 21 responders had progressed at the time of
data analysis for the abstract). These data are consistent with
prior results from Cohort 2, presented at the Society for
Immunotherapy of Cancer (SITC) 2018 Annual Meeting, which
demonstrated a 38 percent ORR in a subset of 47 of the 55 patients
in Cohort 2. Adverse events resolved to baseline 2 weeks post TIL
infusion. These data will be presented on Saturday, June 1
(Abstract #2518).
“We are pleased to be sharing our broader melanoma data and now
Gen-2 cervical data at ASCO. The data are indicative of the
efficacy of TIL therapy in multiple indications. Further, we
believe that TIL therapy is a platform which may offer patients
with different advanced cancers a potential therapy,” said Maria
Fardis, Ph.D., president and chief executive officer of Iovance
Biotherapeutics. “We will provide further updates, including
duration of response data, at the ASCO meeting.”
The company today also announced that first melanoma patient has
been dosed in its Phase 2 IOV-COM-202 study. This represents the
first instance of a patient naive to checkpoint inhibitor treatment
receiving Iovance’s TIL therapy in combination with Keytruda.
“TIL therapy represents a promising approach to further advance
on the gains that have been made in cancer treatment thanks to
immunotherapy and combination approaches,” commented Sajeve Thomas,
M.D., Iovance study investigator and oncologist at the Orlando
Heath UF Health Cancer Center. “We are encouraged to be part of
evaluating new applications of Iovance TIL therapy with
combinations and additional tumor types and look forward to the
results in these areas.”
IOV-COM-202 is a Phase 2 global multicenter study evaluating the
safety and efficacy of Iovance autologous TIL therapy in
combination with pembrolizumab in patients who have not received
prior immunotherapy for treatment. The study is currently enrolling
in the U.S. and Europe. Additional information on this study is
available at https://clinicaltrials.gov/ct2/show/NCT03645928.
To support efforts to improve the potency of TIL, Iovance has
entered into a collaboration with Genocea to evaluate its ATLAS™
platform. As reported by the company at the American Association
for Cancer Research (AACR) 2019 Annual Meeting, melanoma patients
receiving lifileucel have a unique mutational landscape, suggesting
that high mutational load solid tumors such as melanoma may benefit
from treatment with a patient specific, polyclonal product such as
the Iovance TIL product. The company plans to utilize the ATLAS
platform to evaluate the potential for an improved TIL
product.
Conference call
Management will host a conference call and live audio webcast to
discuss these results on Thursday, May 16 at 8:00 a.m. EDT. To
participate in the conference call, please dial 1-844-646-4465
(U.S.) or 1-615-247-0257 (international) and reference the access
code 9291799. A live webcast can be accessed under “News &
Events: Investor Calendar” in the Investors section of the
Company’s website at www.iovance.com or at the link:
https://edge.media-server.com/m6/p/wgjz5xa7. An archived webcast
will be available in the Investors section of www.iovance.com for
thirty days following the call.
Details of ASCO Abstracts
- Abstract #2538. Amir Jazaeri et al. Safety and efficacy of
adoptive cell transfer using autologous tumor infiltrating
lymphocytes (LN-145) for treatment of recurrent, metastatic, or
persistent cervical carcinoma. Poster display Saturday, June 1,
8:00 a.m. - 11:00 a.m. CDT.
- Abstract #2518. Amod Sarnaik et al. Safety and efficacy of
cryopreserved autologous tumor infiltrating lymphocyte therapy
(LN-144, lifileucel) in advanced metastatic melanoma patients who
progressed on multiple prior therapies including anti-PD-1. Poster
display Saturday, June 1, 8:00 a.m. - 11:00 a.m. CDT; poster
discussion 1:15 p.m. - 2:45 p.m. CDT.
Additional information is available at the ASCO website and
at https://meetinglibrary.asco.org/.
1https://www.keytruda.com/hcp/advanced-cervical-cancer/
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 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 U.S. Food and Drug
Administration (“FDA”) or other regulatory authority approval of,
or other action with respect to, our product candidates; the
strength of Company’s product pipeline; the successful
implementation of the Company’s research and development programs
and collaborations; 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, including the Company’s studies in
advanced melanoma and advanced cervical cancer, may not be
reflected or maintained 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 accelerated FDA review
designations; 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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