Zandelisib promising in relapsed/refractory indolent B-cell NHL

Zandelisib displayed a high response rate in heavily pre-treated patients with relapsed/refractory indolent B-cell non-Hodgkin’s lymphoma (RR iB-NHL), including patients with poor prognoses. The safety analysis revealed a low rate of grade ≥3 adverse events of special interest.

Zandelisib is a selective oral PI3Kδ inhibitor that has been studied in patients with RR follicular lymphoma, chronic lymphocytic leukaemia, and marginal zone lymphoma [1–3].

Dr Takahiro Kumode (Kindai University, Japan) presented the findings of the current phase 2 MIRAGE trial (NCT04384770), which evaluated the efficacy and safety of zandelisib, administered by intermittent dosing, in 61 Japanese participants with RR iB-NHL [4]. The primary endpoint was the overall response rate (ORR).

The ORR was 75.4%, with a complete response rate of 24.6% and a partial response rate of 50.8%. Dr Takahiro added that the ORRs were also high in participants who were refractory to their last therapy (ORR 70.0%), participants who had a bulky disease (ORR 62.5%), or those who had ‘progression of disease within 2 years’ (ORR 65.5%). Furthermore, the median time-to-response was 58 days.

The most common adverse events were a decreased neutrophil count (43%) and diarrhoea (36%). Grade ≥3 adverse events of special interest, such as pneumonia, increased AST (aspartate aminotransferase) and ALT (alanine aminotransferase), or hepatic function abnormalities were all below 5%. Finally, the discontinuation rate due to adverse events was 14.8%.

These data demonstrate favourable safety and efficacy profiles of zandelisib in Japanese patients with RR iB-NHL.

1. Pagel JM, et al. Lancet Oncol. 2022;23(8):1021─1030
2. Goto H, et al. Int J Hematol. 2022;116(6):911─921
3. Zelenetz AD, et al. JCO. 2022;40.16_suppl.7511
4. Kumode T, et al. Efficacy and safety of zandelisib administered by intermittent dosing in patients with relapsed/refractory indolent B-cell non-Hodgkin’s lymphoma: primary analysis of the phase 2 study MIRAGE. P1086, EHA 2023 Annual Congress, 8─11 June, Frankfurt, Germany

 

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Posted on 2 August 202318 March 2024