|The following article features coverage from the 2021 Annual Meeting of the Society of Hematologic Oncology (SOHO). Click here to read more of Hematology Advisor‘s conference coverage.|
Tafasitamab plus lenalidomide may improve outcomes compared with therapies recommended by the National Comprehensive Cancer Network (NCCN)/European Society for Medical Oncology (ESMO) used in routine clinical care for treating patients with relapsed/refractory diffuse large-B cell lymphoma (DLBCL), according to study results presented at the Annual Meeting of the Society of Hematologic Oncology (SOHO).
The retrospective, observational RE-MIND2 study used data obtained from academic hospitals, public hospitals, and private practices in North America, Europe, and the Asia Pacific region between April 1, 2020, and November 13, 2020. Eligibility criteria were based on the L-MIND study and included patients aged ≥18 years with histologically confirmed DLBCL who had received ≥2 previous systemic therapies for R/R DLBCL, including ≥1 anti-CD20 therapy.
The study authors compared efficacy outcomes from the L-MIND cohort with those of the observational cohort of patients treated with NCCN/ESMO-listed treatment regimens in the RE-MIND2 database.
A total of 3454 patients were enrolled from 200 sites. Patients in the observational cohort who were eligible for autologous stem cell transplant (ASCT) were excluded. Nearest neighbor 1:1 matching led to strictly matched pairs of patients—tafasitamab + lenalidomide vs all systemic therapies pooled (n=76 pairs), tafasitamab + lenalidomide vs bendamustine + rituximab (BR; n=75 pairs), and tafasitamab + lenalidomide vs rituximab + gemcitabine + oxaliplatin (R-GemOx; n=74 pairs).
Overall survival (OS) was the primary endpoint, and secondary endpoints included objective response rate (ORR), complete response (CR) rate, progression-free survival (PFS), event-free survival, duration of response, and time to next treatment.
The median duration of follow-up in the matched cohorts was: 31.84 vs 33.25 months for tafasitamab + lenalidomide vs systemic therapies pooled, respectively; 32.92 vs 25.00 months for tafasitamab + lenalidomide vs BR, respectively; and 32.92 vs 33.18 months for tafasitamab + lenalidomide vs R-GemOx.
Tafasitamab + lenalidomide was associated with longer OS vs systemic therapies pooled (hazard ratio [HR], 0.553; P =.0076), BR (HR, 0.418; P <.0001), and R-GemOx (HR, 0.467; P =.0004). Significantly improved OS for second-line therapy was found for participants who received tafasitamab + lenalidomide compared with systemic therapies pooled (HR, 0.502, P =.0467), BR (HR, 0.287, P =.0002), and R-GemOx (HR, 0.403, P =.0067).
ORR and CR rates were significantly higher for patients who received tafasitamab + lenalidomide vs systemic therapies pooled and R-GemOx, and a numerical improvement was found for tafasitamab + lenalidomide vs BR. PFS was significantly improved in the tafasitamab + lenalidomide group vs systemic therapies pooled (12.1 vs 5.8 months; HR, 0.424; P <.0001), BR (12.1 vs 7.9 months; HR, 0.527; P =.0033), and R-GemOx (14.1 vs 5.1 months; HR, 0.433; P <.0001).
The treatment discontinuation rates due to adverse events with tafasitamab + lenalidomide were 14.5%, 14.5%, and 15.1% in the matched sets for systemic therapies pooled, BR, and R-GemOx, respectively.
“The primary endpoint of the study was met with a statistically significant improvement in OS for the tafasitamab + lenalidomide cohort versus matched observational cohorts of systemic therapies pooled, BR, and R-GemOx,” stated the study authors.
Disclosure: This study was funded by MorphoSys AG. Please see the original reference for a full list of authors’ disclosures.
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Nowakowski GS, Hyun Yoon D, Mondello P, et al. Overall survival with tafasitamab + lenalidomide versus routinely administered therapies for ASCT-ineligible relapsed or refractory diffuse large B-cell lymphoma: outcomes from the observational RE-MIND2 study. Paper presented at: Annual Meeting of the Society of Hematologic Oncology (SOHO); September 8-11, 2021. Abstract ABCL-346.