Two pharmaceutical companies are now administering doses of zandelisib to the first patients in an international phase 2 clinical trial. The drug is being assessed as a possible treatment option for marginal zone and follicular lymphomas.
MEI Pharma and Kyowa Kirin, the two companies that are manufacturing the drug candidate, said the tests are aimed at determining the efficacy of the treatment, which could save a lot of lives.
There is currently no cure for relapsed and refractory marginal zone lymphoma, and there are very limited therapeutic options for patients. Currently available treatments and therapies have proven to be ineffective, which is why companies are hopeful for the outcome of the latest rounds of tests.
"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," Dr. Pier Luigi Zinzani from the Institute of Hematology Seràgnoli at the University of Bologna said.
In the latest clinical trials, there will be about 180 patients expected to participate. The trial is expected to be completed by December 2025. The study's main goal is to measure the objective response rate of the drug, including partial and complete responses to the treatment. The other goals of the study will be to measure the duration of the response and the progression-free survival times, which is the time during and after treatment when patients continue to be disease-free.
Patients who will be involved in the latest trial are those diagnosed with the disease above 18 years of age. They will also need to pass blood, kidney, and liver screenings to ensure a consistent baseline.
Patients with a history of known lymphomatous involvement of the central nervous system and those with a history of drug-induced pneumonitis will be excluded. Patients with gastrointestinal conditions and a history of HIV infections will also be excluded.
The two companies are actively recruiting patients with marginal zone and follicular lymphomas for the global study. The tests will be conducted in 19 cancer treatment centers in the U.S. and around the world.
