RAPT Therapeutics Announces Positive Data, Including Objective Response Rates and Progression-Free Survival, from its Phase 2 Trial of FLX475 in Combination with a Checkpoint Inhibitor in Patients with Advanced NSCLC
04 November 2023 - 3:00AM
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 Phase 2
trial of FLX475 (tivumecirnon) in patients with advanced non-small
cell lung cancer (NSCLC) who had no prior checkpoint inhibitor
therapy. The trial evaluated FLX475, an oral small molecule CCR4
antagonist designed to block the migration of regulatory T cells,
in combination with the checkpoint inhibitor pembrolizumab. In this
cohort of NSCLC patients, 36 patients were evaluable for efficacy,
of which 20 were PD-L1 positive. In these PD-L1 positive patients,
the combination of FLX475 and pembrolizumab showed a 40% (8/20)
confirmed ORR and a median PFS of 6.3 months as of the data cut off
date, with seven patients continuing on study. For comparison,
historical pembrolizumab monotherapy activity in checkpoint
inhibitor-naïve and previously-treated NSCLC patients showed a
confirmed ORR of 18% and a median PFS of 4.0 months. The confirmed
ORR for the combination of FLX475 and pembrolizumab in PD-L1 low
and high subsets were 38% (6/16) and 50% (2/4), respectively. For
comparison, the ORR for pembrolizumab monotherapy in the PD-L1 low
and high subsets has been previously reported as 10% and 30%,
respectively.
The data were presented today in a poster at the Society for
Immunotherapy of Cancer (SITC) 38th Annual Meeting being held in
San Diego. The presenting author was Julie Brahmer, M.D.,
Co-director of the Upper Aerodigestive Department and Professor of
Oncology, Johns Hopkins University.
“We are excited by the response rates and PFS data for FLX475 in
combination with a checkpoint inhibitor in this cohort of NSCLC
patients. The data from this cohort, which will continue to mature
and potentially improve, met our criteria to advance development of
FLX475,” said Brian Wong, M.D., Ph.D., President and Chief
Executive Officer of RAPT. “We are particularly intrigued to see
differentiating efficacy in patients with cool (PD-L1 low) tumors,
which are typically poorly responsive to checkpoint inhibitors and
checkpoint inhibitor combinations, such as those with anti-TIGIT
antibodies. Along with RPT193, we now have two internally
discovered compounds that have demonstrated clinical proof of
concept in large, commercially attractive indications.”
Phase 2 Data Summary in CPI-naïve NSCLC Patients
(n=20)
PD-L1 Status |
Confirmed Responses (n) |
Confirmed ORR |
Positive (TPS ≥1%) |
8/20 |
40% |
Low (TPS 1-49%) |
6/16 |
38% |
High (TPS ≥50%) |
2/4 |
50% |
At the time of data cut off, there was one additional response
among the PD-L1 low patients awaiting confirmation.
The combination of FLX475 and pembrolizumab was well tolerated
in this Phase 2 NSCLC cohort. The most common treatment-emergent
adverse event deemed related to study treatment was QT prolongation
that was asymptomatic and reversible. FLX475 has now been dosed in
more than 300 patients with various advanced cancers and has been
generally well tolerated, and the combination with pembrolizumab
has not increased immune-related toxicity beyond that expected with
pembrolizumab alone.
In previous disclosures, FLX475 showed durable objective
responses as monotherapy in an EBV+ lymphoma, as well as in
combination with pembrolizumab in EBV+ gastric cancer.
Webcast Conference Call Information RAPT will
host a webcast conference call today, November 3, 2023 at 10:00
a.m. PT. To join the conference call via phone and participate in
the live Q&A session, please pre-register online here to
receive a telephone number and unique passcode required to enter
the call. The live webcast and audio archive of the presentation
may be accessed on the RAPT Therapeutics website at
https://investors.rapt.com/events-and-presentations.
About FLX475 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. FLX475 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, RPT193 (zelnecirnon) and FLX475
(tivumecirnon), 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 FLX475,
plans to advance clinical development of FLX475 and RPT193, plans
to seek a partner to accelerate development of FLX475 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 may not be predictive
of future data or results, 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-Q for the quarter
ended June 30, 2023 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
RAPT Therapeutics (NASDAQ:RAPT)
Historical Stock Chart
From Apr 2024 to May 2024
RAPT Therapeutics (NASDAQ:RAPT)
Historical Stock Chart
From May 2023 to May 2024