RAPT Therapeutics Announces Promising Results from Phase 2 Trial of Tivumecirnon in Combination with Anti-PD-1 Immunotherapy in CPI-Experienced Head and Neck Cancer Patients
April 09 2024 - 12:00PM
RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage,
immunology-based therapeutics company focused on discovering,
developing and commercializing oral small molecule therapies for
patients with significant unmet needs in inflammatory diseases and
oncology, today announced safety and efficacy data from its ongoing
Phase 2 trial of tivumecirnon in combination with the anti-PD-1
checkpoint inhibitor (CPI) pembrolizumab in the cohort of patients
with advanced head and neck squamous cell carcinoma (HNSCC) whose
disease progressed despite previous treatment with CPI therapy
(CPI-experienced). The results were presented at the American
Association for Cancer Research (AACR) Annual Meeting in San Diego,
CA.
The AACR poster highlighted data from the 32-patient
CPI-experienced HNSCC cohort in the trial evaluating tivumecirnon,
an oral small molecule CCR4 antagonist designed to block the
migration of regulatory T cells, in combination with pembrolizumab.
Patients in this cohort had heavily pretreated disease, with 69% of
patients having received three or more (up to six) prior lines of
treatment. In the entire cohort, confirmed responses were observed
in 5/32 patients (15.6%) regardless of PD-L1 or HPV status. In the
23 patients known to have PD-L1+ disease (CPS ≥1), an ORR of 17.4%
(4/23) was observed, and in the 18 patients known to have HPV+
disease, an ORR of 22.2% (4/18) was observed. These findings
compare favorably to the expected ORR of anti-PD-1 monotherapy in
patients with recurrent or metastatic HNSCC who have progressed on,
or relapsed after, previous anti-PD-1 therapy, which is believed to
be <5-10%.
Phase 2 Data Summary in HPV+ CPI-experienced HNSCC
Patients (n=13)
PD-L1+ Status |
(n) |
Confirmed ORR |
All (regardless of PD-L1 or HPV status) |
5/32 |
15.6% (95% CI 6-32%) |
PD-L1+ (CPS ≥1) |
4/23 |
17.4% (5-39%) |
HPV+ |
4/18 |
22.2% (9-46%) |
These data complement previously reported clinical data for
tivumecirnon, which has now been dosed in more than 350 patients
with various advanced cancers either as monotherapy or in
combination with pembrolizumab. Findings to date have shown the
combination treatment to be well tolerated with no signal of
increased immune-related toxicity over that expected with
pembrolizumab alone.
“As the trial progresses and cohorts mature, we continue to be
impressed by the promise and expanded clinical activity of
tivumecirnon,” said Brian Wong, M.D., Ph.D., President and Chief
Executive Officer of RAPT. “These results add to the growing data
supporting the efficacy of tivumecirnon across a number of oncology
indications, including non-small cell lung cancer, head and neck
cancer, gastric cancer and non-Hodgkin lymphoma, and we are
evaluating the next steps to advance its development.”
Phase 1/2 Clinical Trial DesignThe ongoing
open-label Phase 1/2 study enrolled patients with multiple types of
cancer at leading cancer centers across the United States,
Australia and Asia. The Phase 2 portion is designed to evaluate the
degree of antitumor activity of tivumecirnon as monotherapy and in
combination with pembrolizumab specifically in patients with
several types of Treg and CCR4 pathway-enriched tumors. Changes in
the tumor microenvironment and other biomarkers are being evaluated
in both phases of the study. For more information please visit
clinicaltrials.gov identifier NCT03674567.
About Tivumecirnon (FLX475) Tivumecirnon is a
small molecule CCR4 antagonist designed to block the migration of
regulatory T cells (Treg) specifically into tumors, but not healthy
tissues. Treg represent a dominant pathway for downregulating
the immune response, generally correlate with poor clinical
outcomes and may limit the effectiveness of currently available
therapies such as checkpoint inhibitors. Tivumecirnon may restore
naturally occurring antitumor immunity alone and may synergize with
a variety of both conventional and immune-based therapies, such as
radiation, chemotherapy, checkpoint inhibitors, immune stimulators,
cancer vaccines and adoptive T cell therapy.
About RAPT Therapeutics, Inc. RAPT Therapeutics
is a clinical-stage, immunology-based therapeutics company focused
on discovering, developing and commercializing oral small molecule
therapies for patients with significant unmet needs in inflammatory
diseases and oncology. Utilizing its proprietary discovery and
development engine, the Company is developing highly selective
small molecules designed to modulate the critical immune drivers
underlying these diseases. RAPT has discovered and advanced two
unique drug candidates, zelnecirnon (RPT193) and tivumecirnon
(FLX475), each targeting C-C motif chemokine receptor 4 (CCR4), for
the treatment of inflammation and cancer, respectively. The Company
is also pursuing a range of targets that are in the discovery stage
of development.
Forward-Looking Statements This press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as
“anticipate,” “could,” “expect,” “look forward,” “plan,” “target,”
“will” and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances)
are intended to identify forward-looking statements. These
statements relate to future events and involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, performance or achievements to be materially different
from any future performances or achievements expressed or implied
by the forward-looking statements. Each of these statements is
based only on current information, assumptions and expectations
that are inherently subject to change and involve a number of risks
and uncertainties. Forward-looking statements include, but are not
limited to, statements about the therapeutic potential of
tivumecirnon to treat patients with lymphoma, non-small cell lung
cancer, head and neck cancer and gastric cancer; RAPT’s FLX475-02
Phase 1/2 clinical trial; plans for potential future development of
tivumecirnon and other statements that are not historical fact.
Many factors may cause differences between current expectations and
actual results, including unexpected safety or efficacy data
observed during clinical studies, preliminary data and trends that
may not be predictive of future data or results, clinical trial
results that may not demonstrate safety or efficacy or lead to
regulatory approval by the FDA or other regulatory agencies,
clinical trial site activation or enrollment rates that are lower
than expected, changes in expected or existing competition, changes
in the regulatory environment, the uncertainties and timing of the
regulatory approval process, the timing and results of unexpected
litigation or other disputes and the sufficiency of RAPT’s cash
resources. Detailed information regarding risk factors that may
cause actual results to differ materially from the results
expressed or implied by statements in this press release may be
found in RAPT’s Form 10-K for the year ended December 31, 2023
filed with the Securities and Exchange Commission on March 10, 2024
and subsequent filings made by RAPT with the Securities and
Exchange Commission. These forward-looking statements speak only as
of the date hereof. RAPT disclaims any obligation to update these
forward-looking statements.
Investor Contact:Sylvia
Wheelerswheeler@wheelhouselsa.com
Media Contact:Aljanae
Reynoldsareynolds@wheelhouselsa.com
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