The data were presented today in an oral session (#302) at the 2023
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
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
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
About
Contact:
Email: jbrennan2@dsi.com
Tel: +1 908 900 3183
Email: ogiwara.koji.ay@daiichisankyo.co.jp
Tel: +81 3 6225 1126
(C) 2023 Electronic News Publishing, source