Posted: Tuesday, June 7, 2022
Findings from the global phase II TIDAL study, presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7511), suggest that treatment with the PI3Kδ inhibitor zandelisib may improve survival outcomes in some patients with relapsed or refractory follicular lymphoma. Andrew David Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues also found that the rate of treatment discontinuation, less than 10%, was comparable to results from the earlier phase Ib trial.
“This profile supports evaluation of zandelisib alone and in combination in various B-cell malignancies, both in relapsed disease and earlier lines of therapy,” concluded the authors.
The study’s primary efficacy population was the first 91 patients of the 121 enrolled to receive treatment. Eligible patients included those with grade 1 to 3A follicular lymphoma who had experienced disease progression after undergoing at least two previous therapies, none of which was a P13K inhibitor. Patients received 60 mg of daily zandelisib for two cycles followed by intermittent dosing on days 1 to 7 of 28-day cycles. The overall and complete response rates were 70.3% (n = 64) and 35.2% (n = 32), respectively. The majority of responses (87.5%, n = 56) occurred by the end of treatment cycle 2; the majority of complete responses (75%, n = 24) were observed by the end of cycle 4.
At a median follow-up of 9.4 months for all 121 enrolled patients, treatment-related adverse events led to treatment discontinuation in 9.9% (n = 12). Notable adverse events ≥ grade 3 included diarrhea (5%, n = 6), colitis (1.7%, n = 2), rash (3.3%, n = 4), stomatitis (2.5%, n = 3), alanine transaminase elevation (0.8%, n = 1), aspartate aminotransferase elevation (0.8%, n = 1), and noninfectious pneumonitis (0.8%, n = 1). A total of 83% of notable adverse events occurred in cycles 1 to 3.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.