Tafasitamab Combo Receives Japanese Approval for Relapsed/Refractory DLBCL

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of tafasitamab-cxix (Monjuvi) plus lenalidomide (Revlimid) for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), according to a news release from the developer, Incyte Biosciences Japan G.K.¹

Supporting the Japanese regulatory decision were findings from the phase 2 MOR208C203/L-MIND trial (NCT02399085) and the phase 1b/2 INCMOR 0208-102/J-MIND trial (NCT04661007), both of which evaluated tafasitamab/lenalidomide in patients with relapsed/refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). Regarding the L-MIND trial results, the overall response rate (ORR) per independent review committee (IRC) assessment was 58.8%, with a complete response (CR) rate of 41.3%. For responders, the median duration of response (DOR) had not been reached after more than 44 months of follow-up.

In the J-MIND trial, the ORR per IRC assessment was 71.4% with a CR rate of 45.2%. The safety analysis findings revealed that the most common adverse effects (AEs) were neutropenia and thrombocytopenia. The developers suggested that the tafasitamab-based combination demonstrated clinically meaningful responses and a manageable safety profile.

“This approval provides a new option for patients in Japan living with relapsed or refractory DLBCL, an aggressive disease with historically limited treatment options,” Yasuyuki Ishida, general manager of Incyte Biosciences Japan, stated in the news release.¹ “We are committed to helping address critical unmet needs for patients and their families affected by this challenging cancer.”

L-MIND Trial Design

In the single-arm L-MIND trial, patients with relapsed/refractory DLBCL received tafasitamab via intravenous infusion at 12 mg/kg weekly during the first three 28-day cycles, with a loading dose given on day 4 of cycle 1.² Tafasitamab was given on a biweekly basis for each 28-day cycle thereafter. Lenalidomide was self-administered orally on days 1 to 21 of each 21-day cycle for a maximum of 12 cycles, with the option to de-escalate or discontinue based on clinical and laboratory findings. Lenalidomide was given prior to tafasitamab on days when they were given together.

The primary end point of the trial was ORR per IRC assessment. Secondary end points included DOR, progression-free survival (PFS), overall survival (OS), and safety.

J-MIND Trial Design

In the DLBCL arm of the of the J-MIND trial, patients with relapsed/refractory disease received tafasitamab with lenalidomide, with a tafasitamab dose dependent on the weight-based recommended phase 2 dose in part 1 of the study.³ Those selected on the trial had biopsy-proven DLBCL, an ECOG performance status of 0 to 2, and received between 1 and 3 prior lines of systemic therapy, with at least 1 having been a CD20-targeted therapy.

The primary end point of the trial was ORR per IRC assessment. Secondary end points included CR rate, PFS, and OS.

In June 2025, the FDA had approved tafasitamab in combination with lenalidomide plus and rituximab (Rituxan)for the treatment of patients with relapsed/refractory follicular lymphoma.⁴ In December 2026, the Japanese MHLW also approved the tafasitamab-regimen for the treatment of relapsed/refractory follicular lymphoma.⁵

Additionally, findings from the phase 3 frontMIND trial (NCT04824092) presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting showed that the addition of tafasitamab and lenalidomide to a regimen consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) conferred a significant reduction in the risk of progression or death compared with R-CHOP alone as a treatment for patients with newly-diagnosed, high-risk DLBCL.⁶

References

1. Incyte Japan announces approval of Minjuvi® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). News release. Incyte Biosciences Japan G.K. June 19, 2026. Accessed June 25, 2026. https://tinyurl.com/25cw3xbj
2. Open label study to evaluate the safety and efficacy of lenalidomide with MOR00208 in patients with R-R DLBCL (L-MIND). ClinicalTrials.gov. Updated October 23, 2026. Accessed June 25, 2026. https://tinyurl.com/bdetu48y
3. To assess the safety and tolerability of tafasitamab alone or in combination with other drugs in Japanese participants with non-Hodgkins lymphoma (NHL) (J-MIND). ClinicalTrials.gov. Updated May 18, 2026. Accessed June 25, 2026. https://tinyurl.com/4u7cmtw9
4. FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. FDA. June 18, 2025. Accessed June 25, 2026. https://tinyurl.com/njjw9rpu
5. Incyte Japan announces approval of Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for the treatment of relapsed or refractory follicular lymphoma. News release. Incyte Biosciences Japan G.K. December 22, 2025. Accessed June 25, 2026. https://tinyurl.com/58cpy2he
6. Lenz, G, Trněný M, Burke JM, et al. frontMIND: phase 3 study of tafasitamab (Tafa) plus lenalidomide (Len) and R-CHOP for patients (pts) with newly diagnosed diffuse large B-cell lymphoma (DLBCL). J Clin Oncol. 2026;44(suppl 17):LBA7000. doi:10.1200/JCO.2026.44.17_suppl.LBA7000