Investigational Cancer Treatment Being Evaluated in B-Cell Malignancies

The first patient with marginal zone lymphoma has been dosed in an international phase 2 clinical trial assessing zandelisib as a treatment option for marginal zone and follicular lymphomas in patients who have received at least two prior therapies, according to MEI Pharma and Kyowa Kirin, the manufacturers of the agent.

“Relapsed and refractory marginal zone lymphoma is an incurable disease for which there are limited available therapeutic options for patients who may not have responded to conventional therapies,” said Dr. Pier Luigi Zinzani, a professor at the Institute of Hematology Seràgnoli University of Bologna, in a news release. “Given the positive and encouraging results to date with zandelisib, we are eager to further evaluate the potential benefit zandelisib may offer patients with marginal zone lymphoma.”

The expected enrollment for the study is 180 patients and it is estimated to be finished in December 2025. Measuring the objective response rate (the percentage of patients whose disease partially or completely responds to the treatment) is the main goal of the study. Moreover, other goals of the study include evaluating the duration of treatment response, as well as progression-free survival (time during and after treatment when the patient lives without disease progression) and overall survival (time that a patient with cancer is still alive).

To be considered for enrollment, patients must be aged at least 18 years, have at least one measurable nodal lesion, confirmed marginal zone or follicular lymphoma, as well as adequate blood, kidney and liver parameters at screening.

Patients would be excluded from participating in the trial if they have a history of known lymphomatous involvement of the central nervous system, an uncontrolled clinically significant illness, an ongoing case or history of drug-induced pneumonitis, as well as a history of a significant gastrointestinal condition or a known history of or active HIV infection.

“I am delighted that this important milestone was achieved for zandelisib in the marginal zone lymphoma study arm of the global TIDAL study,” Yoshifumi Torii, an executive officer, vice president and head of the R&D Division at Kyowa Kirin said in the release. “Under the partnership with MEI, we continue to work with medical professionals and patients to demonstrate zandelisib's potential to help those in need with B-cell malignancies.”

Patients with marginal zone and follicular lymphomas are being actively recruited to join the trial which is taking place at 19 cancer centers in the United States, and other international locations.

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