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Intermittent dosing of zandelisib for patients with R/R FL: Results from the phase II TIDAL trial
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The global, multicenter, open-label, single-arm, phase II TIDAL trial (NCT03768505) assessed the safety and efficacy of zandelisib, an oral PI3Kδ inhibitor, in 121 adult patients with R/R FL who had received ≥2 prior lines of therapy, including an anti-CD20 antibody and chemotherapy, and were PI3Kδ inhibitor-naïve.1 Patients were treated with zandelisib daily continuously for 8 weeks followed by intermittent dosing until disease progression or intolerability. The primary efficacy endpoint was ORR and the secondary endpoints included DoR, PFS, OS, and safety. Results from this trial were published in Hemasphere by Zelenetz, et al.1
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| Key learnings |
| Response rates were high and durable, with an ORR of 73%, including a CR rate of 38% and a median DoR of 16.4 months. |
| With a median follow-up of 14.3 months, the median PFS was 11.6 months and the median OS was not reached. |
| Intermittent dosing of zandelisib was associated with a relatively low incidence of severe toxicities compared with continuous dosing, with dose interruptions and discontinuations due to AEs occurring in 49% and 17% of patients, respectively. |
| Grade 3–4 AEs of special interest for PI3Kδ inhibitors included diarrhea (6%), colitis (3%), pneumonia (4%), stomatitis (3%), cutaneous reactions (3%), ALT elevation (2%), non-infectious pneumonitis (1%), and PJP infections (1%). |
| Zandelisib treatment resulted in high rates of durable response in patients with R/R FL, and the intermittent dosing may offer improved tolerability over continuous PI3Kδ inhibition. |
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; CR, complete response; DoR, duration of response; FL, follicular lymphoma; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PI3K; phosphoinositide 3-kinase; PJP, Pneumocystis jirovecii pneumonia; R/R, relapsed/refractory.
- Zelenetz AD, Jurczak W, Ribrag V, et al. The PI3Kδ inhibitor zandelisib on intermittent dosing in relapsed/refractory follicular lymphoma: Results from a global phase 2 study. 2024;8(8):e138. DOI: 10.1002/hem3.138
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