Michael Wang, MD, discusses what led to the start of the phase 3 BRUIN MCL-321 trial for patients with mantle cell lymphoma.
Michael Wang, MD, a professor in the department of lymphoma and myeloma at MD Anderson Cancer Center, discusses what led to the start of the phase 3 BRUIN MCL-321 trial (NCT04662255) for patients with mantle cell lymphoma (MCL).
Previously in January 2023, the FDA approved pirtobrutinib for the treatment of patients with relapsed/refractory MCL based on findings from the phase 1/2 BRUIN trial (NCT03740529). This study evaluated the efficacy of pirtobrutinib at a dose of 200 mg given once a day until disease progression or unacceptable toxicity in 120 patients with MCL.
Now in this global, randomized, open-label, phase 3 study, investigators are comparing treatment with pirtobrutinib (Jaypirca) to investigator's choice of a Bruton’s tyrosine kinase (BTK) inhibitor, either acalabrutinib (Calquence), or zanubrutinib (Brukinsa), among patients with MCL who have received at least 1 line of therapy. Patients are also required to be BTK inhibitor naïve.
0:08 | At this ASCO, I presented a trial in progress, the phase 3 clinical trial with pirtobrutinib. [For] the trial design, this is a phase 3, international trial recruiting 500 patients. There are 2 arms. The experimental arm is the pirtobrutinib monotherapy vs the physicians choice of any covalent BTK inhibitors including acalabrutinib and zanabrutinib. The arm used to include the ibrutinib, and now, the ibrutinib [Imbruvica] has been withdrawn because of the most recent voluntary withdrawal, so there are [now] 2 arms.
0:56 | The reason we want to do it is because the preliminary phase 2 clinical trial showed that pirtobrutinib is really active when you have mantle cell lymphoma. It is even effective after resistance it has developed with a BTK inhibitor in patients with relapsed mantle cell lymphoma. The response rate was very impressive with refractory patients. Based on the phase 2 clinical trial, the FDA has approved pirtobrutinib for mantle cell lymphoma is the United States.