|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
The PI3Kδ inhibitor ME-401 achieved a high rate of durable responses in patients with relapsed or refractory follicular lymphoma, according to the results of a phase 1b study presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. However, more research on the use of a continuous schedule or intermittent schedule of administration will be needed.
The study was designed to test the efficacy of ME-401 in patients with relapsed or refractory B-cell malignancies. Of the 70 treated patients, 48 had follicular lymphoma. Patients were enrolled in a dose-escalation phase examining doses from 60 mg to 180 mg, and then in 60 mg expansion cohorts as monotherapy (39 individuals) or in combination with rituximab (9 individuals).
ME-401 was given first as a daily continuous schedule until disease progression or unacceptable toxicity, and then evaluated as an intermittent schedule on days 1-7 of a 28-day after 2 cycles (18 patients) or more than or equal to 3 cycles (9 patients).
With a median follow-up of 9.3 months, 28 patients remained on therapy. Of the 20 patients who discontinued, there were 9 with disease progression, 4 who withdrew because of adverse events, 4 who withdrew consent, and 3 patients who withdrew to undergo stem cell transplant.
Responses were noted in 79% of patients. Similar rates of response were seen in patients assigned monotherapy and those assigned to ME-401 plus rituximab.
Delayed grade 3 immune-related adverse events occurred in about one-third (30%) of patients assigned to the continuous schedule and 11% of patients that switched to the intermittent schedule. Four patients who had grade 3 immune-related adverse events had a break from treatment and were given corticosteroids, but resumed ME-401 on an intermittent schedule with no adverse event recurrence.
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Zelentz AD, Jagadeesh D, Reddy NM, et al. Results of the PI3Kδ inhibitor ME-401 alone or with rituximab in relapsed/refractory (R/R) follicular lymphoma (FL). Presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 3, 2019. Abstract 7512.