Three-year follow-up data from the phase 2 L-MIND study demonstrated that tafasitamab-cxix in combination with lenalidomide induces sustainable response in relapsed/refractory diffuse large B-cell lymphoma.
Three-year follow-up data from the phase 2 L-MIND study demonstrated that tafasitamab-cxix (Monjuvi) in combination with lenalidomide induces sustainable response in relapsed/refractory diffuse large B-cell lymphoma (DLBCL).1
As of the October 30, 2020, data cutoff, the best objective response rate (ORR) was 57.5% (95% CI, 45.9-68.5) at a median follow up of at least 35 months. Overall, 40% of patients experienced a complete response (CR) and 17.5% had partial response (PR).
Median duration of response (DOR) was 43.9 months (95% CI, 26.1-NR).
“The results of this long-term analysis of the L-MIND study demonstrate that tafasitamab plus lenalidomide followed by extended tafasitamab monotherapy provided durable responses in transplant-ineligible patients with relapsed or refractory DLBCL,” said coauthor Johannes Düll, MD, with Germany’s University Hospital Wurzburg. He presented the findings in a poster during the 2021 ASCO Annual Meeting.
“These data suggest that this chemotherapy-free combination treatment may have the potential to achieve prolonged remission and survival benefit in this patient population, especially at first relapse.”
In the open-label, multinational, single-arm phase 2 L-MIND study (NCT02399085), investigators assigned 81 patients with relapsed/refractory DLBCL to 12 mg/kg IV tafasitamab plus and 25 mg daily oral lenalidomide for up to 12 28-day cycles. Patients with stable disease or better then received the same dose of tafasitamab, an FC-modified humanized anti-CD19 monoclonal antibody, as monotherapy until disease progression.
Düll said that the best ORR was 67.5%, with a CR rate of 47.5% in patients who received 1 prior treatment. The ORR was 47.5% with a CR rate of 32.5% in patients who received 2 or more prior treatments.
The median progression-free survival (PFS) was 11.6 months and the overall survival (OS) of 33.5 months.
Düll noted that patients who had CR had better outcomes. The median DOR was not reached in this subgroup. Similarly, PFS (95% CI, 45.7-NR) and OS (95% CI, 45.7-NR) were not reached.
“Concerning safety, long-term follow up in the L-MIND study shows that tafasitamab plus lenalidomide was tolerated with no unexpected toxicities or new safety signals,” Düll said. “Similar to the primary analysis, the most common treatment emergent adverse events of grade 3 or higher severity during the extended follow-up phase were neutropenia, thrombocytopenia, and febrile neutropenia.”
Forty (49.4%) patients had grade ≥3 treatment-emergent neutropenia. Fourteen (17.3%) had grade ≥3 thrombocytopenia, while 10 (12.3%) had grade ≥3 febrile neutropenia.
“The 3-year efficacy data, combined with the safety and tolerability profile of tafasitamab, further support a therapeutic option for patients with relapsed or refractory DLBCL who are ineligible for transplant—a traditionally difficult-to-treat population,” lead investigator Gilles Salles, MD, PhD, chief of the lymphoma service at Memorial Sloan Kettering Cancer Center, said in a news release.2
“I am encouraged to see the confirmed favorable outcome of patients in the L-MIND study, which suggest that this combination treatment regimen could potentially offer a paradigm shift and long-term disease control,” he added.
The FDA approved the tafasitamab/lenalidomide combination in July 2020 for the treatment of adult patients with relapsed/refractory DLBCL, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant. The approval was based on previous data from L-MIND, which showed an ORR of 55%. The CR rate was 37% with a PR rate of 18%. The median DOR was 21.7 months.3
Findings from L-MIND later published in Lancet Oncology demonstrated even greater efficacy. At a median follow-up of 13.2 months 60% (48/80; 95% CI, 48-71) of 80 patients who received the combination had an objective response with 34 (43%) CRs and 14 (18%) PRs.4