Ono Pharmaceutical Co., Ltd. announced it will present promising clinical data for two investigational cancer therapies at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, in Chicago, Illinois.
The Japanese pharmaceutical company will showcase positive results from the Phase 2 PROSPECT study evaluating tirabrutinib (ONO-4059) in patients with relapsed or refractory primary central nervous system lymphoma (PCNSL) during a rapid oral presentation session. Additionally, data on ONO-4578, an EP4 antagonist being studied in combination with nivolumab for locally advanced resectable rectal cancer, will be featured in a poster session.
"We are fully committed to developing innovative drugs for cancer patients. This announcement is an important step forward in demonstrating that we can potentially provide new value to patients," said Tatsuya Okamoto, Corporate Officer and Executive Director of Clinical Development at Ono Pharmaceutical. "We aim to offer new treatment options in cancer care globally and contribute to improving patients' quality of life."
Tirabrutinib Shows Promise in Difficult-to-Treat Lymphoma
The Phase 2 PROSPECT study evaluated tirabrutinib in U.S. patients with relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma that affects the brain and spinal cord. PCNSL has historically been challenging to treat due to the blood-brain barrier limiting drug penetration.
Tirabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor designed to target B-cell malignancies. The drug's ability to cross the blood-brain barrier makes it a potentially valuable treatment option for PCNSL patients who have limited therapeutic alternatives after relapse.
Dr. Lakshmi Nayak from Dana-Farber Cancer Institute will present the efficacy and safety findings from the PROSPECT study on May 31, 2025, from 3:00-4:30 PM CDT during the Central Nervous System Tumors session. The abstract submission ID for this presentation is 487376.
Novel Combination Approach for Rectal Cancer
In a separate poster presentation, Ono will share data on ONO-4578, an investigational EP4 antagonist, used in combination with nivolumab after chemoradiation therapy in patients with locally advanced resectable rectal cancer.
The EP4 receptor has emerged as a promising target in cancer immunotherapy, as its inhibition may enhance anti-tumor immune responses. This neoadjuvant approach combining ONO-4578 with nivolumab, an established PD-1 inhibitor, represents a novel strategy for improving outcomes in rectal cancer patients.
Dr. Yusuke Takahashi from the National Hospital Organization Osaka National Hospital will present the poster (Abstract #3588, Poster Board 257) on May 31, 2025, from 9:00 AM-12:00 PM CDT during the Gastrointestinal Cancer – Colorectal and Anal poster session.
Expanding Oncology Portfolio
These presentations highlight Ono Pharmaceutical's growing presence in oncology drug development. The company has been strategically expanding its pipeline to address unmet needs in difficult-to-treat cancers.
Ono Pharmaceutical, headquartered in Osaka, Japan, has a corporate philosophy of being "Dedicated to the Fight against Disease and Pain." The company focuses on areas with significant unmet medical needs, including oncology, immunology, and neurology.
Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the United States and Europe to drive global business expansion and strengthen its commitment to patient care.
The upcoming ASCO presentations represent important milestones in Ono's clinical development programs and underscore the company's dedication to advancing innovative therapies for cancer patients worldwide.
