Tafasitamab Results in Real-World Study on Par With Those in L-MIND

Patients receiving tafasitamab (Monjuvi; Incyte) in real-world settings to treat relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) had response rates that were on par with those seen in clinical trials, according to a new study published in The Oncologist.¹ The findings were encouraging, given that the patients in this real-world study were more likely to come from underrepresented groups, according to the authors, some of whom are employed by Incyte, which sponsored the study.¹

Tafasitamab is a humanized, Fc-modified anti-CD19 monoclonal antibody that eliminates CD19-expressing B cells through antibody-dependent cellular cytotoxicity and phagocytosis.^1,2 In July 2020, FDA granted the drug accelerated approval in combination with lenalidomide for adults with R/R DLBCL not otherwise specified—including DLBCL arising from low-grade lymphoma—who are ineligible for autologous stem cell transplant (ASCT).² That approval was based on the single-arm phase 2 L-MIND trial, which reported an overall response rate (ORR) of 60% but enrolled a population that was 89% White, leaving real-world effectiveness in racially and ethnically diverse patients poorly characterized.³

More recently, on June 18, 2025, the FDA approved a second indication: tafasitamab in combination with lenalidomide and rituximab for adults with R/R follicular lymphoma, based on the phase 3 inMIND trial. This chemotherapy-free regimen showed a median PFS of 22.4 vs 13.9 months and an ORR of 84% vs 72% favoring the tafasitamab arm.⁴

The retrospective, physician-abstracted medical chart review in The Oncologist set out to describe real-world characteristics, treatment patterns, and outcomes of tafasitamab-treated R/R DLBCL patients specifically by race and ethnicity—populations historically underrepresented in the trials supporting DLBCL drug approvals.¹

In their paper, the authors trace the historic challenge of enrolling underrepresented groups in clinical trials, despite efforts by the FDA to bring attention to this problem.

“In the United States, 25.2% of the population are a race other than White, and 20.0% are Hispanic or Latino,” they note. Despite this, trials that led to approvals for several treatments in R/R DLBCL treatments in second line or beyond “were primarily conducted in White patients or did not report race and ethnicity data.”¹ As noted, the L-MIND trial was among them.³

For this real-world evaluation, 23 community and academic oncologists across the US contributed data on 181 eligible adults who initiated tafasitamab, with or without lenalidomide, on or after October 21, 2020. The cohort was considerably more diverse than L-MIND: 64.1% White, 22.1% Black or African American, 7.7% categorized as Other race, and 6.1% unknown; by ethnicity, 17.1% of patients identified as Hispanic.¹

Baseline characteristics of the real-world cohort—median age (~71 years), ECOG performance status, R-IPI risk scores, and rates of primary refractory disease—were broadly similar across racial and ethnic subgroups, as were treatment patterns: most patients (71.8%) received tafasitamab in the second line, and almost all received it in combination with lenalidomide, with a median treatment duration of 11 months.

The key effectiveness finding was that real-world rates were high and statistically comparable across groups: 73.3% in White patients, 82.5% in Black or African American patients, 74.5% in non-Hispanic patients, and 67.7% in Hispanic patients. Median real-world progression-free survival (PFS) and overall survival (OS) likewise did not differ meaningfully by subgroup, and in multivariable Cox models, neither race nor ethnicity was independently associated with real-world PFS or real-world OS after adjusting for other clinical and treatment variables; a univariable signal for worse outcomes in Hispanic patients did not hold up in adjusted analysis.

The authors noted that the ORR observed here (73%) was substantially higher than both the pivotal L-MIND trial (60%) and a prior real-world academic-center study by Qualls et al. (31%), a difference the authors attribute partly to this study's predominantly community-oncology setting and differences in baseline characteristics and line of therapy. In fact, the paper highlights that 90% of the patients in the Qualls study were White.⁵

“This difference in effectiveness outcome may be partially due to the differences in baseline characteristics and line of therapy in which tafasitamab was received, potentially reflecting variations in clinical practice between community and academic centers,” with the authors noting that many of the patients were being treated in community settings.¹

Limitations include the retrospective design, physician-driven abstraction, small subgroup sizes (particularly for Hispanic and "Other" race patients), potential residual selection bias, censoring assumptions for patients who discontinued tafasitamab without documented progression, and the absence of collected safety data.

The study was funded by Incyte Corporation, which manufactures and markets tafasitamab; several co-authors are current or former Incyte employees and stockholders; in addition, several coauthors are employees of Cardinal Health, which conducted the chart review. Medical writing assistance was also funded by Incyte.

References

1. Epperla N, Nastoupil LJ, Feinberg B, et al. Real-world use of tafasitamab for relapsed or refractory diffuse large B-cell lymphoma among racial and ethnic minorities in the United States. Oncologist. Published online September 12, 2026. doi: 10.1093/oncolo/oyag357.
2. Hoy SM. Tafasitamab: First approval. Drugs. 2020;80(16):1731-1737. doi: 10.1007/s40265-020-01405-w.
3. Salles G, Duell J, González Barca E, et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020;21(7):978-988. doi:10.1016/S1470-2045(20)30225-4.
4. Incyte announces FDA approval of Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma. News release. Incyte. June 18, 2025. Accessed September 16, 2026. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-fda-approval-monjuvir-tafasitamab-cxix
5. Qualls DA, Lambert N, Caimi PF, et al. Tafasitamab and lenalidomide in large B-cell lymphoma: real-world outcomes in a multicenter retrospective study. Blood. 2023;142:2327-2331