Topline results from Re-MIND, an observational retrospective study, demonstrated that the combination of tafasitamab with lenalidomide had a statistically significant and superior objective response rate compared with lenalidomide monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma who were not eligible for high-dose chemotherapy and stem cell transplant, announced MorphoSys AG, the manufacturer of tafasitamab, in a press release.
Pier Luigi Zinzani, MD, PhD
Topline results from Re-MIND, an observational retrospective study, demonstrated that the combination of tafasitamab (MOR208) with lenalidomide (Revlimid) had a statistically significant and superior objective response rate (ORR) compared with lenalidomide monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who were not eligible for high-dose chemotherapy and stem cell transplant, announced MorphoSys AG, the manufacturer of tafasitamab, in a press release.1
“I’m very excited about this real-world data approach of the Re-MIND trial to isolate a single-agent contribution of tafasitamab in combination with lenalidomide in a matched patient population in relapsed/refractory DLBCL,” said study investigator Pier Luigi Zinzani, MD, PhD, professor of Hematology and Head of the Lymphoma Group at the Institute of Hematology, in a statement. “This study further strengthens the synergistic effect of tafasitamab and lenalidomide, as already observed in the L-MIND trial.”
In the single-arm, open-label phase II L-MIND trial, 81 patients who had at least 1 to 3 prior lines of systemic treatment were treated with a combination of tafasitamab, a novel Fc-enhanced CD19-targeted antibody, plus lenalidomide. Tafasitamab was administered intravenously weekly at 12 mg/kg, and lenalidomide was given at 25 mg daily for 3 of the 4 weeks of each cycle for up to 12 cycles, or until disease progression or unacceptable toxicity.2
Efficacy data was collected from 490 patients with relapsed/refractory DLBCL who were transplant-ineligible and were treated with single-agent lenalidomide in the real-world setting for the Re-MIND study. Seventy-six patient from the trial were matched 1:1 to patients from the L-MIND trial based on baseline characteristics, such as relevant prognostic factors, laboratory characteristics, and patient demographics.1
The primary end point of Re-MIND was ORR. Secondary end points included complete response (CR) rate and overall survival (OS). The goal was to compare the effectiveness of lenalidomide monotherapy to the combination based on real-world efficacy outcomes.
The ORR in patients that received the combination regimen was 67.1% (95% CI, 55.4%-77.5%) versus 34.2% (95% CI, 23.7%-46.0%) in those that received lenalidomide alone (P<.0001). The CR rates were 39.5% (95% CI, 28.4%-51.4%) and 11.8% (95% CI, 5.6%-21.3%; P<.0001) in the combination and monotherapy arms, respectively. The OS had not yet been reached in those treated with the combination, but the OS in those treated with lenalidomide alone was 9.3 months (HR, 0.47; 95% CI, 0.30-0.73; P<.0008).
Preliminary findings from the L-MIND trial, presented at the 2018 ASH Annual Meeting,3demonstrated an ORR of 58% with the combination. CRs were observed in 33% of the patients, while partial responses were observed in 25% of patients. The median progression-free survival was 16.2 months at a median follow-up of 1 year (95% CI, 6.3-not reached). Neither duration of response nor median OS were met at the time of data cutoff, but the 1-year OS rate was 73% (95% CI, 63%-85%).
The most common treatment-emergent adverse events (TRAEs) of any grade included neutropenia (48%), thrombocytopenia (32%), anemia (31%), diarrhea (30%), pyrexia (22%), and asthenia (20%). The most common grade 3 or greater TRAEs were neutropenia (43%), thrombocytopenia (17%), and anemia (9%). Additionally, 42% of patients required a lenalidomide dose reduction.
"Encouraged by the results we achieved with the real-world data approach, we re-affirm our plans to pursue advancement of tafasitamab to market in combination with lenalidomide as a potential, chemo-free treatment option for patients with r/r DLBCL, subject to FDA approval,” Malte Peters, MD, chief development officer at MorphoSys AG, said in a press release. “The data announced today complement the previously published data of the single-arm L-MIND study.”
Rolling submission of a biologics license application has begun for the combination of tafasitamab plus lenalidomide with expected completion by the end of 2019, based on data from the L-MIND trial, according to MorphoSys.