- Overall survival rate estimated at 24 months was 52.4%
with generally tolerated safety profile
- Completed a Type B End-of-Phase 2 (EOP2) meeting with the
US FDA for the combination (ASP-1929 photoimmunotherapy and
anti-PD-1) in the first-line recurrent HNSCC setting and reviewed
the key details of a multi-regional registrational
study
- Rakuten Medical plans to initiate the global Phase 3
clinical trial with a primary endpoint of OS in 2H
2024
SAN
DIEGO, May 24, 2024 /PRNewswire/ -- Rakuten
Medical, Inc., a global biotechnology company developing and
commercializing precision, cell-targeting photoimmunotherapy based
on its proprietary Alluminox™ platform, today announced the
updated safety and efficacy findings from an interim evaluation of
an open-label Phase 1b/2 study
(ASP-1929-181/ClinicalTrials.gov Identifier: NCT04305795) of
photoimmunotherapy using ASP-1929 in combination with anti-PD-1 for
recurrent and/or metastatic head and neck squamous cell carcinoma
(HNSCC). The data will be presented in a poster at the 2024
American Society of Clinical Oncology Annual Meeting (ASCO 2024) on
June 2, 2024.
The updated interim evaluation (data cut-off: August 31, 2023) of 19 enrolled patients in
ASP-1929-181 study suggests that the novel treatment approach of
ASP-1929 photoimmunotherapy in combination with anti-PD-1 showed
promising early results in patients with locoregional and/or
metastatic HNSCC. Median overall survival (OS) was not reached at
data cut-off, with an estimated survival rate of 52.4% at 24
months, and an objective response rate (ORR) of 35.3%. Adverse
events were generally manageable, and the combination therapy was
generally tolerated with an absence of synergistic serious adverse
events.
The encouraging early efficacy and safety outcomes warrant
additional clinical studies to substantiate and reinforce these
interim findings. Rakuten Medical recently completed a Type B
End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug
Administration (FDA) for the combination of ASP-1929
photoimmunotherapy and anti-PD-1 in the first-line recurrent HNSCC
setting and discussed the key details for a multi-regional
registrational study. Based on these results, Rakuten Medical
plans to initiate this global phase 3 clinical trial with a primary
endpoint of OS in the second half of 2024.
Disclaimer: These interim findings may change upon completion
of follow-up and final data analysis.
Key findings
[Efficacy]
- Clinically meaningful activity was observed
- Median Overall Survival (OS) was not reached, with an estimated
survival rate of 52.4% (95% CI: 25.9-73.4) at 24 months
- The objective response rate (ORR) was 35.3% (6 patients, 95%
CI: 14.2-61.7), which included 4 complete responses (CR) (23.5%,
95% CI: 6.8-49.9) and 2 partial responses (PR) (11.8%, 95% CI:
1.5-36.4)
- Median time to response of 1.4 months
- Median progression-free survival (PFS) was at 2.9 months (95%
CI 1.4-14.6)
[Safety]
- Adverse events were manageable and generally
tolerated
- No fatal serious adverse events (SAEs)
- Two Grade 4 SAEs: laryngeal edema related to photoimmunotherapy
and tumor hemorrhage unrelated to study treatment, both of which
resolved
- No synergistic SAEs due to ASP-1929 and anti-PD-1
Upcoming Rakuten Medical's Poster Presentation at
ASCO
- Abstract Title: Recent safety and efficacy findings from
a phase 1b/2 open-label combination
study of ASP-1929 photoimmunotherapy with anti-PD-1 therapy in
EGFR-expressing advanced head and neck squamous cell carcinoma
(HNSCC)
- Abstract Number: 6083
- Abstract Link:
https://meetings.asco.org/abstracts-presentations/234832
- Session Name: Poster Session – Head and Neck Cancer
- Session Date: Sunday, June 2,
2024
- Session Time: 9:00 a.m. –
12:00 p.m., CDT
- First Author: David M. Cognetti, Department of
Otolaryngology – Head and Neck Surgery, Thomas
Jefferson University, US
- Location: Exhibit Hall A, Poster Board #399
About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a global biotechnology company
developing and commercializing precision, cell targeting therapies
based on its proprietary Alluminox™ platform, which, in
pre-clinical studies, has been shown to induce rapid and selective
cell killing and tumor necrosis. Alluminox therapies have not yet
been approved outside of Japan.
Rakuten Medical is committed to its mission to conquer cancer by
delivering its innovative treatments as quickly as possible to as
many patients as possible all over the world. The company has
offices in 5 countries/regions, including the United States, where it is headquartered,
Japan, Taiwan, Switzerland and India. For more information, visit
www.rakuten-med.com.
About Alluminox™ platform
The Alluminox™ platform is an investigational technology
platform based on a cancer therapy called photoimmunotherapy, which
was developed by Dr. Hisataka Kobayashi and team from the National
Cancer Institute in the United
States. Rakuten Medical is developing the Alluminox platform
as a technology consisting of a drug, device, and other related
components. The drug component of the platform consists of a
targeting moiety conjugated with one or more dyes leading to
selective cell surface binding. The device component consists of a
light source that locally illuminates the targeted cells with light
to transiently activate the drug. Pre-clinical data have shown that
this activation elicits rapid and selective necrosis of targeted
cells through a biophysical process that compromises the membrane
integrity of the targeted cells. Therapies developed on the
Alluminox platform may also result in local and systemic innate and
adaptive immune activation due to immunogenic cell death of the
targeted cancer cells and/or the removal of targeted
immunosuppressive cells within the tumor microenvironment. Outside
of Japan, Alluminox therapies have not yet been approved by any
regulatory authority.
About ASP-1929
Rakuten Medical's first pipeline drug developed on
its Alluminox™ platform is ASP-1929, an antibody-dye conjugate
comprised of the antibody cetuximab and IRDye® 700DX, a light
activatable dye. ASP-1929 binds to epidermal growth factor receptor
(EGFR), a cancer antigen expressed in multiple types of solid
tumors, including head and neck, breast, lung, colorectal, prostate
and pancreatic cancers. After binding to cancer cells, ASP-1929 is
locally activated by illumination with red light (690 nm), emitted
by a laser device system to produce a photochemical reaction. This
reaction is believed to cause damage to the membrane of cancer
cells, leading to selective necrosis of cancer cells. ASP-1929 has
received Fast Track designation from the U.S. Food and Drug
Administration (FDA) in January 2018,
and is currently under investigation in a global Phase 3 clinical
trial for recurrent head and neck cancer. In Japan, ASP-1929 received marketing approval
from the Japanese Ministry of Health, Labor, and Welfare for
unresectable locally advanced or recurrent head and neck cancer in
September 2020, under the Sakigake
Designation System and the Conditional Early Approval System.
Outside of Japan, ASP-1929 has not
yet been approved by any regulatory authority.
Forward Looking Statements
This press release contains forward looking statements that
correspond to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements include various
risks, uncertainties, and assumptions that may cause Rakuten
Medical's business plans and results to differ from the anticipated
results and expectations expressed in these statements. These
"forward looking statements" contain information about the status
and development of our products, including the Alluminox™ platform,
as well as other regulatory and marketing authorization efforts,
the potential benefits, efficacy, and safety of therapies created
using the Alluminox platform, and the status of regulatory filings.
The approval and commercial success of the product may not be
achieved. Forward looking statements relate to the potential
benefits, efficacy, and safety of our therapies, and the status of
regulatory filings. Such statements may include words such as
"expect," "believe," "hope," "estimate," "looks as though,"
"anticipate," "intend," "may," "suggest," "plan," "strategy,"
"will," and "do", and are based on our current beliefs. In
addition, this press release uses terms such as "important,"
"notable," and "abnormal" to express opinions about clinical trial
data. Ongoing clinical trial studies include various risks and
uncertainties, in particular, problems that arise during the
manufacturing stage of our therapies, the occurrence of adverse
safety events, situations in failure to demonstrate therapeutic
benefits, and other various risks and uncertainties, both
reasonable and unreasonable. For this reason, actual results,
including regulatory approvals and uncertainties in the
commercialization process of our therapies, may differ from
published information. Except to the extent required by applicable
law, we undertake no obligation to publicly update this or any
other forward-looking statement, whether because of new
information, future developments or events, changes in assumptions,
changes in the factors affecting forward-looking statements. If one
or more forward-looking statement(s) is updated, no inference
should be drawn that additional updates will be made to those or
other forward-looking statements.
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