Tafasitamab Combo Significantly Extends PFS in R/R Follicular Lymphoma

Results from the phase 3 inMIND trial (NCT04680052)demonstrated that adding tafasitamab (Monjuvi), a CD19-targeted monoclonal antibody, to the standard regimen of lenalidomide (Revlimid) and rituximab (Rituxan) yields a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients with relapsed or refractory follicular lymphoma (R/R FL).^1,2

Patients receiving the tafasitamab combination achieved a median PFS of 22.4 months, compared with 13.9 months for patients receiving placebo with lenalidomide and rituximab. This represents a 57% reduction in the risk of progression, relapse, or death (HR, 0.43; P <.0001).

The safety profile of the 3-drug combination was deemed acceptable, with a similar overall incidence of adverse events (AEs) between the 2 arms and no treatment-related deaths in the tafasitamab group. Safety was assessed in all randomized patients who received at least 1 dose of the study drug (n = 274 in the tafasitamab arm, n = 272 in the placebo arm).

The incidence of AEs was high and nearly identical in both arms.

• Tafasitamab arm: 99% (272 of 274 patients) reported AEs.
• Placebo arm: 99% (270 of 272 patients) reported AEs.

The most common AEs were neutropenia (49% in the tafasitamab arm vs 45% in the placebo arm) and diarrhea (38% vs 28%) in both arms. There were no deaths due to treatment-related AEs in the tafasitamab arm. In the placebo arm, 2 patients (1%) experienced fatal AEs related to treatment.

Study Design and Methodology

The inMIND study is a phase 3, double-blind, randomized, placebo-controlled trial designed to assess a new combination therapy for FL, a condition characterized by recurring episodes of remission and relapse.

The trial was conducted across 210 centers, including community clinics, hospitals, and academic institutions in North America, Europe, and the Asia–Pacific region.

Between April 16, 2021, and August 10, 2023, 817 patients were assessed for eligibility. A total of 548 patients were enrolled and randomly assigned on a 1:1 basis to 1 of 2 treatment arms:

• Tafasitamab arm: n = 273
• Placebo arm: n = 275

Of the 548 randomized patients, 299 (55%) were male and 249 (45%) were female.

Patients received up to 12 cycles of treatment, with each cycle lasting 28 days. Both arms received lenalidomide and rituximab, with the experimental arm also receiving tafasitamab and the control arm receiving a placebo. Patients in the experimental arm received 12 mg/kg of tafastimab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1 to 3, and on days 1 and 15 of cycles 4 to 12. All patients received 20 mg of lenalidomide orally on days 1 to 21, and 375 mg/m² of rituximab IV on days 1, 8, 15, and 22 in cycle 1, and on day 1 in cycles 2 to 5.

The primary end point was PFS, as assessed by the investigator, in the intention-to-treat population of all randomized patients.

Sehn et al, authors of the study, concluded that the inMIND trial results are both statistically significant and clinically meaningful for patients with R/R FL.

Based on the robust efficacy data and acceptable safety profile, the authors posit that this 3-drug regimen "represents a potential new standard-of-care treatment" for this patient population.

REFERENCES

1.Sehn L, Hubel K, Luminari S, et al. Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. The Lancet, Volume 407, Issue 10524, 133 – 146. Published January 10, 2026. Accessed January 23, 2026.

2.A phase 3 study to assess efficacy and safety of tafasitamab plus lenalidomide and rituximab compared to placebo plus lenalidomide and rituximab in patients with relapsed/refractory (R/R) follicular lymphoma or marginal zone lymphoma (InMIND). ClinicalTrials.gov. Updated December 22, 2025. Accessed January 23, 2026. https://clinicaltrials.gov/study/NCT04680052