Kyowa Kirin and MEI Pharma have reported topline findings from the Phase II MIRAGE clinical trial of zandelisib in indolent B-cell non-Hodgkin’s lymphoma (iB-NHL) patients in Japan.

The open-label, multicentre, single-arm trial is designed to analyse zandelisib as a single agent in Japanese participants with relapsed or refractory (r/r) iB-NHL, who have previously received a minimum of two systemic therapies.

It enrolled 61 subjects with a median age of 70 years. 

These iB-NHL patients did not have small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and Waldenström’s macroglobulinemia.

Objective response rate (ORR) as evaluated by the Independent Review Committee (IRRC) using the modified Lugano criteria was the trial’s primary efficacy endpoint. 

According to the findings, the ORR was reported to be 75.4%.

In addition, 24.6% of subjects attained complete response (CR) as per the IRRC evaluation. 

A 14.8% discontinuation rate linked to any treatment-emergent adverse event was observed in the trial, with a median follow-up time of 9.5 months.

Kyowa Kirin R&D Division executive officer, vice-president and head Yoshifumi Torii said: “We continue to see a favourable profile of zandelisib with intermittent dosing that aims to balance efficacy and safety in Japanese patients who have been heavily pre-treated. 

“These results are consistent with the data of the similarly designed TIDAL study already announced in November 2021.”

An oral, investigational cancer therapy, zandelisib is an inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ).

Zandelisib received Orphan Drug designation from the Food and Drug Administration to treat follicular lymphoma in November last year.

MEI and Kyowa Kirin signed an international licence, development, and marketing agreement in April 2020 for the further development and commercialisation of zandelisib. 

Under the deal, the companies agreed to jointly develop and promote zandelisib in the US.

In August last year, MEI and Kyowa Kirin began dosing participants in the Phase III COASTAL trial of zandelisib plus rituximab for r/r follicular lymphoma or marginal zone lymphoma.