Tokyo - Results from the VALENTINE-PTCL01 phase 2 trial of Daiichi Sankyo's (TSE: 4568) EZHARMIA (valemetostat tosilate) showed clinically meaningful and durable responses in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

The data were presented today in an oral session (#302) at the 2023 American Society of Hematology (#ASH23) Annual Meeting. PTCL is a group of rare and aggressive blood cancers, which represent about 10 to 15% of all non-Hodgkin lymphomas (NHL).1 A majority of patients with PTCL experience disease progression following initial treatment with a multi-drug chemotherapy-based regimen and median overall survival following relapse is approximately 5.8 months.

An objective response rate (ORR) of 43.7% (95% CI: 34.6-53.1) was observed with EZHARMIA in 119 patients with relapsed or refractory PTCL as assessed by CT-based blinded independent central review (BICR). Seventeen complete responses (CRs) and 35 partial responses (PRs) were seen. Median duration of response (DoR) of 11.9 months (95% CI: 7.8-NE) was observed after a median follow-up of 9.7 months. Responses were observed across all PTCL subtypes. Median progression-free survival (PFS) of 5.5 months (95% CI: 3.5-8.3) was seen after a median followup of 11.3 months (95% CI: 11.1-13.8) and median overall survival (OS) of 17.0 months (95% CI: 13.5- NE) was observed after a median follow-up time of 12.3 months.

An exploratory analysis evaluating responses using PET-CT-based BICR assessment showed an ORR of 52.1% (n=62; 95% CI: 42.8-61.3) with 32 complete metabolic responses (CMRs). 'The high response rates and durability of responses observed with valemetostat in patients with relapsed or refractory peripheral T-cell lymphoma are very encouraging,' said Steven M. Horwitz, MD, Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York. 'Relapse is too frequent in PTCL and there is an acute need for new medicines beyond standard chemotherapy to better control the disease in the relapsed or refractory setting and improve patient outcomes.'

The safety profile of EZHARMIA in VALENTINE-PTCL01 (n=133) was consistent with previous clinical trials. Grade 3 or higher treatment emergent adverse events (TEAEs) occurred in 57.9% of patients. The most common grade 3 or higher TEAEs occurring in 10% of patients were thrombocytopenia (23.3%), anemia (18.8%) and neutropenia (17.3%). 'The results of VALENTINE-PTCL01 support the potential of EZHARMIA as a novel single agent therapy across subtypes of previously treated peripheral T-cell lymphomas,' said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. 'The response rate reported and duration of response of nearly one year seen in the study is impressive for this historically difficult-to-treat blood cancer with limited available treatment options.' Patients with PTCL enrolled in the study had received a median of two prior treatments (range, 1-12) and 35 patients (26.3%) received prior hematopoietic cell transplant (HCT). At the time of data cut-off of May 5, 2023, 32 patients (24.1%) remained on treatment.

About VALENTINE-PTCL01 Trial

VALENTINE-PTCL01 is a global, open-label, single-arm, two-cohort phase 2 study evaluating the efficacy and safety of EZHARMIA in patients with relapsed or refractory PTCL and adult T-cell leukemia/ lymphoma (ATLL) who received at least one systemic therapy and are ineligible for HCT at the time of screening. One cohort enrolled patients with PTCL and a second cohort enrolled patients with ATLL.

The primary endpoint of VALENTINE-PTCL01 is ORR based on CT-assessed BICR. Secondary endpoints include DoR, CR, PR, duration of CR and PFS - all assessed by both BICR and investigator assessment - as well as ORR assessed by investigator, OS, safety and pharmacokinetics. Exploratory endpoints include PET-CT-based BICR and biomarker mutational status. Patients were enrolled at approximately 60 sites in Asia, Europe, North America and Oceania.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need.

Contact:

Jennifer Brennan

Email: jbrennan2@dsi.com

Tel: +1 908 900 3183

Koji Ogiwara

Email: ogiwara.koji.ay@daiichisankyo.co.jp

Tel: +81 3 6225 1126

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