Researchers studied the Fc-enhanced, humanized anti-CD19 antibody MOR208 combined with lenalidomide in relapsed/refractory large B-cell lymphoma.
The Fc-enhanced, humanized anti-CD19 antibody MOR208 combined with lenalidomide showed promising activity against relapsed/refractory large B-cell lymphoma (R/R DLBCL), even among patients with a poor prognosis, according to new results from the phase II L-MIND study (abstract 7521). The findings were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31–June 4 in Chicago.
The study included R/R DLBCL patients who had adequate organ function; received three or fewer lines of therapy, including at least 1 anti-CD20 therapy; and were ineligible for stem cell transplant. The regimen included a 28-day cycle of MOR208, and could be repeated up to a total of 12 cycles.
For the first 3 cycles, the regimen included 12 mg/kg of intravenous (IV) MOR208 q1w, with a loading dose on day 4 of the first cycle. For cycles 4 to 12, the regimen was q2w. In all 12 cycles, lenalidomide was given orally on days 1 to 21.
A total of 81 patients were included in the analysis (median age, 72 years). Of these, 42% were refractory to their last therapy, 26% had a diagnosis of non-germinal center B cell–like (GCB) disease, and 49% had GCB-DLBCL, with the remainder of unknown origin. In total, 52% of patients had an International Prognostic Index (IPI) of 3 to 5.
The majority of participants (72%) stayed on a lenalidomide dose of at least 20 mg/day; 17% of patients experienced treatment-related serious adverse events, most commonly infections (10%) and neutropenic fever. Complete response rate was 33% and partial response rate was 25% based on investigator assessment for an overall response rate (ORR) of 58%. These numbers were comparable to numbers obtained via the IRC assessment (ORR, 54%; complete response, 32%).
Patients who had two or more prior therapies had an ORR of 46%. ORR was 59% in rituximab-refractory patients, 56% in last-treatment refractory patients, 58% in early-relapse patients, 57% in baseline IPI 3-5 patients, 71% in non–GCB-DLBCL, and 53% in GDB-DLBCL.
The median time to response was 1.8 months, and median time to complete response was 3.4 months. The median duration of response was not reached, but the median 12-month duration of response rate was 87% in patients who achieved a complete response.
Asked to comment on the results, Catherine Diefenbach, MD, said, “This is an exciting study. We have a monoclonal antibody, which appears to have quite substantial activity, even as a single agent. It really suggests that this combination (with lenalidomide) has a place in the treatment of these patients. The fact it was so well-tolerated suggests a strategy for people who are less fit, who are not going to be a candidate for autologous stem cell transplant or CAR T-cell therapy.” Dr. Diefenbach is an assistant professor and clinical director of lymphoma at Perlmutter Cancer Center at New York University.
The study also showed reassuring, broad applicability of the regimen. “Even though lenalidomide is historically far more active in non-germinal center patients, the germinal center patients in this study were deriving substantial benefit along with the non-germinal center patients,” Diefenbach added.