MEI Pharma and Kyowa Kirin have started dosing participants in the Phase III COASTAL clinical trial of zandelisib plus rituximab to treat relapsed or refractory (r/r) follicular lymphoma (FL) or marginal zone lymphoma (MZL).
The trial involves patients who have had at least one previous line of treatment, which should have comprised an anti-CD20 antibody, along with chemotherapy or lenalidomide.
Zandelisib is a selective inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ) being developed for oral once-daily use to treat B-cell malignancies.
The global, randomised, two-arm COASTAL trial will assess zandelisib in combination with rituximab compared with standard of care chemotherapy along with rituximab. It is set to enrol 534 patients.
Participants will receive zandelisib once a day for two 28-day cycles and then an intermittent regimen of once-daily dose for seven days of each consequent 28-day cycle for 24 months in total.
The drug will be given along with rituximab (R) in the initial six months only.
Meanwhile, the control arm will involve six cycles of the standard chemoimmunotherapy regimens R-CHOP or R-bendamustine.
The trial’s primary efficacy endpoint is progression-free survival. It will also assess secondary endpoints such as overall response rate, overall survival, patient-reported outcomes assessments, safety and tolerability.
Data from the trial is expected to support marketing applications in the US and other countries in r/r FL and MZL patients who have had at least one previous line of therapy.
In addition, COASTAL is meant to serve as the essential confirmatory study for the potential accelerated approval of zandelisib in the US, based on the ongoing Phase II TIDAL trial in r/r FL and MZL patients who have had two or more previous lines of therapy.
COASTAL principal investigator Wojciech Jurczak said: “Zandelisib has the potential to provide a best-in-class therapeutic profile that delivers a meaningful and improved clinical benefit to patients with relapsed or refractory follicular or marginal zone lymphomas.
“Because most patients diagnosed with follicular and marginal zone lymphomas will experience disease relapse or some may not respond well to initial treatments, additional chemotherapy-free therapeutic options are invaluable after first-line chemoimmunotherapy.”
In February 2021, Kyowa Kirin reported that the Phase II study of an investigational agent, KHK4083, in patients with atopic dermatitis, met the primary endpoint.