Dr. Martin led a team of researchers at Weill Cornell Medicine and centers from around the world in a retrospective study of patients with MCL who experienced disease progression while receiving ibrutinib. These researchers found that MCL patients who progressed during treatment with ibrutinib have a poor outcome. As there are no therapies that appear to be uniquely successful in the post-ibrutinib setting this represents an unmet need.
You can read about the full results from their study in the abstract.
Recently researchers from the Mayo Clinic presented data at the 2016 ASCO annual meeting suggesting that clinical trial participation might be associated with a survival benefit. The researchers used the Mayo Clinic Lymphoma Database to identify patients with relapsed Hodgkin lymphoma (HL), diffuse large B-cell lymphoma (DLBCL), or relapsed mantle cell lymphoma (MCL), and compared the characteristics and outcomes of those enrolled in clinical trials versus those who were eligible, but not enrolled in clinical trials. Between January 2001 and December 2014, 340 patients with DLBCL, 159 with MCL, and 115 patients with HL were identified. Over this same period 47 unique Phase 1-3 trials led to the FDA approval of 17 treatments.
94 of 340 (27%) DLBCL, 63 of 159 (41%) MCL and 66 of 115 (57%) HL patients were enrolled on a clinical trial at some point during therapy, with 38% of patients enrolled in more than 1 study. Researchers found that the median survival of patients treated in a clinical trial was roughly twice as long as patients not treated on a clinical trial in all 3 lymphoma subtypes. There are several possible sources of bias or confounding that might explain the difference, despite the researchers’ efforts to control for these variables. Clearly, more research in this areas is indicated. Nonetheless, the magnitude of benefit was striking and should be reassuring to patients considering clinical trial participation.
In this video Dr. Peter Martin describes the benefits of a recently opened clinical trial evaluating the efficacy and safety of copanlisib for mantle cell lymphoma (MCL) patients, who have failed or were unable to tolerate ibrutinib treatment. The purpose of this study is to to evaluate the efficacy and safety of copanlisib monotherapy in patients with MCL.
If you’re interested in participating in this trial please call 212-746-2919 for more information. A full listing of MCL trials at Weill Cornell Medicine can be found here.