Tafasitamab Cuts Progression-Free Survival in Follicular Lymphoma

The addition of tafasitamab to lenalidomide and rituximab for patients with recurrent or refractory follicular lymphoma (FL) resulted in significant improvement in progression-free survival (PFS), representing a 57 percent reduction in risk of progression, relapse, or death, according to a randomized Phase III trial. After a median follow-up of 14.1 months among patients who received the combination therapy, median PFS reached 22.4 months compared with 13.9 months among patients treated with placebo plus lenalidomide and rituximab (HR: 0.43). “This benefit was observed in all prespecified subgroups, including the high-risk subgroups of patients who are POD24 (disease progression within 24 months), those who are refractory to prior anti-CD20 monoclonal antibodies, and patients receiving multiple prior lines of therapy,” said Laurie H. Sehn, MD, MPH, a Clinical Professor at the BC Cancer Centre for Lymphoid Cancer and the University of British Columbia in Vancouver, Canada, during a press briefing before the late-breaking abstract session at the American Society of Hematology (ASH) annual meeting. “Tafasitamab plus lenalidomide and rituximab can be administered in community as well as academic settings and represents a potential new standard of care for patients with relapsed/refractory FL.” Several treatment options are available for FL, but none cure the disease. No clear standard of care currently exists for relapsed/refractory disease; however, the two-drug combination of lenalidomide and rituximab is the commonly used backbone in this setting, she said, adding that many patients treated are rituximab-refractory due to prior exposure from their chemoimmunotherapy and have high-risk features. Tafasitamab is currently approved by the FDA for use with lenalidomide to treat diffuse large B-cell lymphoma. Study Details At ASH, Sehn reported on the randomized, double-blind Phase III inMIND trial (Abstract LBA-1). It was conducted in more than two dozen countries and included 548 FL patients, median age 64 years. Some 55 percent were men, 79 percent had intermediate- or high-risk disease, and 83 percent had tumor burden. Nearly half (45%) had relapsed or refractory FL and had received more than one prior therapy. “This was a relatively high-risk cohort. One-third had progressed within 24 months of diagnosis,” said Sehn. She noted this study is the first to validate the approach of combining two antibodies (anti-CD19 with anti-CD20) for treatment of FL. “The simple addition of tafasitamab to the lenalidomide/rituximab backbone really did significantly improve PFS and I would say is clinically meaningful,” Sehn said. She also reported that among patients who received tafasitamab, 83.5 percent responded to treatment compared to 72.4 percent of those who received the placebo. In the tafasitamab group, 49.4 percent showed no evidence of cancer on a PET scan compared with 39.8 percent of those in the placebo group. Median duration of response was 21.2 months with tafasitamab compared with 13.6 months with placebo (HR: 0.47). In addition, median time to next treatment was not reached with tafasitamab compared with 28.8 months in the placebo group (HR: 0.45). Overall survival data was immature, but there was a trend favoring tafasitamab (HR: 0.59), she said. A subgroup analysis showed median PFS among patients with POD24 was 19.2 months with tafasitamab versus 11.3 months with placebo (HR: 0.43) and 23.6 months versus 16 months, respectively, among those who did not have POD24 (HR: 0.45). For patients who were refractory to anti-CD20 antibodies, median PFS was 15 months with tafasitamab versus 8.6 months with placebo (HR: 0.44), and 24 and 18.2 months, respectively, among those who were not refractory (HR: 0.44). Rates of adverse events were comparable in the two groups, and the safety profile was manageable and consistent with expected toxicities with these agents. The most common side effect was neutropenia (48.5% of tafasitamab patients, 45.2% placebo patients). The most common Grade 3 or 4 treatment-emergent adverse event (TEAE) was neutropenia (39.8% and 37.5%, respectively). Patients in the tafasitamab arm had a higher rate of Grade 3 or 4 pneumonia (8.4%) than in the placebo arm (5.1%). Sehn noted tafasitamab and placebo dose interruptions or discontinuations due to TEAEs were similar. Dose interruptions were 74 percent with tafasitamb and 70 percent with placebo, and discontinued study treatment due to TEAEs were 11 percent and 7 percent, respectively. Longer follow-up is needed to analyze overall survival, Sehn said. The investigators will continue to follow the patients in the study for 5 years. Mark L. Fuerst is a contributing writer.

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