Taiho Oncology Presents Data at the 2025 American Society of Clinical Oncology Annual Meeting

• Data will be shared in two oral presentations, a poster and two online abstracts
• Highlights include a potential novel, all-oral therapy for AML; and Phase 2 data for a novel treatment targeting NSCLC that harbors EGFR exon 20 insertion mutations

PRINCETON, N.J., May 22, 2025 /PRNewswire/ -- Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, today announced new data to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 through June 3 at McCormick Place in Chicago.

An oral presentation will highlight data describing the combination of decitabine and cedazuridine paired with venetoclax as a potential all-oral regimen for acute myeloid leukemia (AML).¹

"The design of an all-oral regimen for the treatment of AML is in line with our mission to improve the lives of patients with cancer, their families and their caregivers, giving patients access to anti-cancer agents that allow more flexibility in treatment," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology.

Another oral presentation will highlight positive safety and efficacy findings for the investigational drug candidate zipalertinib as a treatment for non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.²

Taiho Oncology will also present data from three real-world studies of two FDA-approved therapies.

"We're pleased to share these important data in several cancer types at the ASCO Annual Meeting," said Tim Whitten, President and CEO, Taiho Oncology. "Our purpose is grounded in ensuring we make a tangible impact for patients and their caregivers. These data continue to demonstrate our unwavering commitment to meaningful innovation across numerous disease states."

Oral regimen of decitabine and cedazuridine plus venetoclax in newly diagnosed AML¹

This Phase 1/2 trial evaluated the regimen of decitabine and cedazuridine plus venetoclax in 101 patients with newly diagnosed AML who were ineligible for first-line induction chemotherapy.

Complete remission (CR) and CR with incomplete hematologic recovery rates were 46.5% and 63.4%, respectively. Median time to CR was 2.4 months. Median CR duration was not reached; among patients who achieved CR, 80% maintained that status at 6 months and 75.3% at 12 months. Median OS was 15.5 months.

Ninety-eight percent of patients reported treatment-emergent adverse events of grade 3 or higher, most commonly febrile neutropenia (49.5%), anemia (38.6%) and neutropenia (35.6%). The 30- and 60-day mortality rates were 3% and 9%, respectively.

Zipalertinib in NSCLC harboring EGFR exon 20 insertion mutations²
The Phase 2b REZILIENT1 study of zipalertinib monotherapy in patients with NSCLC harboring the EGFR exon 20 insertion mutations who have received prior therapy met its primary endpoint of overall response rate.

The overall efficacy population (n=176) consisted of all patients who received at least one dose of 100 mg zipalertinib at data cutoff in December 2024. Patients had received a median of two prior therapies, and 38.6% of patients had a history of brain metastases.

With median follow-up of 9.3 months, zipalertinib demonstrated:

Among all patients treated, zipalertinib demonstrated a confirmed overall response rate (cORR) of 35.2%, with a median duration of response (mDOR) of 8.8 months.

In patients who had received previous chemotherapy only (n=125), the cORR was 40.0%. Among patients with brain metastases, the systemic cORR was 30.9%.

In patients with prior chemo and amivantamab (without the addition of other prior ex20ins-targeted therapy) (n=30), confirmed ORR was 30%. In a larger group of patients, including patients with prior chemo and amivantamab (with or without other ex20ins-targeted therapy) (n=51), ORR was 23.5 % with mDOR of 8.5 months.

The most common treatment-emergent AEs were paronychia, rash, anemia, diarrhea, dry skin, nausea and stomatitis and the majority of TEAEs were CTCAE grade 1 or 2.

Poster Presentation

Title: Real-world treatment patterns and outcomes with trifluridine/tipiracil monotherapy or in combination with bevacizumab in metastatic colorectal cancer
Abstract Number: 3580
Session Name: Gastrointestinal Cancer—Colorectal and Anal
Session Type: Poster Presentation
Session Date: May 31, 2025
Presentation Time: 9 a.m. – 12 p.m. CDT Location: Hall A - Posters and Exhibits | On Demand
Presenter: Donald Richards, MD, PhD, of Texas Oncology

Online Abstracts

Title: Real-world Clinical Outcomes of Patients with Metastatic Colorectal Cancer (mCRC) Treated with Trifluridine-Tipiracil + Bevacizumab by Performance Status
Abstract Number: E15606
Session Type: Publication Only
Publication Date: May 22, 2025
Publication Time: 5 p.m. EDT
Lead Author: Maliha Nusrat, MD, MS, Memorial Sloan Kettering Cancer Center

Title: Real-World patient characteristics and treatment patterns among cholangiocarcinoma patients treated with FGFR inhibitors
Abstract Number: E16262
Session Type: Publication Only
Publication Date: May 22, 2025
Publication Time: 5 p.m. EDT
Lead Author: Amit Mahipal, MD, University Hospitals Seidman Cancer Center and Case Comprehensive Cancer Center

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc. Cullinan Pearl Corp., which Taiho Pharmaceutical Co., Ltd., acquired from Cullinan Oncology, Inc. in 2022.

About Taiho Oncology, Inc.

The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada.

For more information, visit https://www.taihooncology.com/, and follow us on LinkedIn and X.

Taiho Oncology and the Taiho Oncology logo are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries.

Taiho Oncology Contact:

Leigh Labrie
(609) 664-9878
[email protected]

References:
1. Zeidan A et al. An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: Results from a Phase 2 cohort of 101 pts
2. Yu H et al. Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab

SOURCE Taiho Oncology