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The following is a summary of “Valemetostat monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma: a first-in-human, multicentre, open-label, single-arm, phase 1 study,” published in the December 2024 issue of Oncology by Maruyama et al.
Non-Hodgkin lymphoma (NHL) has limited treatment options for patients with relapsed or refractory disease, and outcomes remain poor.
Researchers conducted a prospective study evaluating the safety and efficacy of valemetostat in patients with relapsed or refractory NHL.
They conducted a phase 1, multicenter, open-label, single-arm study involving 90 patients who received oral valemetostat (150–300 mg per day) in a dose-escalation phase, followed by 200 mg per day in a dose-expansion phase. Participants were monitored for safety, pharmacokinetics, and preliminary antitumor activity over a median follow-up of 7.4 months.
The results showed 90 patients, 53 [59%] male, 37 [41%] female; 49 [54%] Asian, 33 [37%] White, and 8 [9%] Black received valemetostat, the overall response rate was 54.5% (48 of 88; 95% CI 43.6–65.2). Common treatment-emergent AEs included decreased platelet count (58%), dysgeusia (50%), and anemia (42%), with serious AEs like Pneumocystis jirovecii pneumonia in 4% of patients. The highest tolerated dose was not reached, and the recommended phase 2 dose was 200 mg daily.
They concluded valemetostat demonstrated an acceptable safety profile and favorable clinical activity in patients with relapsed or refractory NHL.
Source: thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00502-3/abstract
