China’s NMPA Approves Tafasitamab Plus Lenalidomide in Transplant-Ineligible R/R DLBCL

R/R DLBCL | Image Credit:

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China’s National Medical Products Administration (NMPA) has approved tafasitamab (Minjuvi) in combination with lenalidomide (Revlimid), followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).1

This regulatory decision marks the first approval of a CD19 antibody for relapsed/refractory DLBCL in China, according to an announcement from InnoCare, tafasitamab’s developer.

“The data from the Chinese clinical study of [tafasitamab]—similar to the data from the global [phase 2] L-MIND study [NCT02399085]—reaffirms the significant clinical benefits for [patients with] DLBCL treated with the [tafasitamab] combination, particularly the notably prolonged duration of response [DOR],” Jie Jin, MD, PhD, director emeritus of the Department of Hematology at the First Affiliated Hospital, Zhejiang University School of Medicine, stated in a news release. “The approval of [tafasitamab] is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients.”

Zhao Wei-Li, MD, PhD, professor of hematology, first deputy director of Shanghai Institute of Hematology and vice president of Shanghai Ruijin Hospital, added that, “The durable responses and consistent safety profile observed in both the Chinese and global studies are encouraging and support the [tafasitamab] regimen as an effective option for patients with DLBCL. We are pleased that the first prescription of the [tafasitamab] regimen was filled in China at Ruijin Hainan Hospital for an eligible [patient with] DLBCL under the early access program in Bo’ao. Looking ahead, we hope that more eligible patients with DLBCL will benefit from this novel therapy.”

Tafasitamab-cxix (Monjuvi) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody that incorporates an engineered Fc domain to mediate B-cell lysis through direct apoptosis and immune effector mechanisms, including antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis.

The combination of tafasitamab plus lenalidomide is also approved for the treatment of eligible patients with DLBCL in the regions of Hong Kong, Macau, and Taiwan.

Previously, tafasitamab plus lenalidomide received accelerated approval from the FDA in July 2020 for adult patients with relapsed/refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not eligible for ASCT.2 Tafasitamab plus lenalidomide was granted conditional marketing authorization from the European Commission in August 2021 for the treatment of adult patients with relapsed/refractory DLBCL who are not eligible for ASCT.3

Both regulatory decisions were supported by data from the open-label, single-arm, phase 2 L-MIND trial, which enrolled patients at least 18 years of age with relapsed/refractory DLBCL who were ineligible for ASCT and had received 1 to 3 prior systemic regimens, including at least 1 CD20-directed therapy.4,5 Patients received tafasitamab intravenously at a dose of 12 mg/kg in combination with oral lenalidomide at 25 mg daily on days 1 to 21 of each 28-day cycle for up to 12 cycles. This was followed by tafasitamab monotherapy once every 2 weeks in patients with stable disease or better until disease progression.

The trial’s primary end point was overall response rate (ORR), with key secondary end points including DOR, progression-free survival (PFS), overall survival (OS), time to progression, time to next treatment, and safety.

Long-term findings from the trial, which were published in Haematologica, showed durable responses with the combination among evaluable patients (n = 80).4 The ORR with the combination was 57.5% (95% CI, 45.9%-68.5%), comprising a complete response (CR) rate of 41.3% and a partial response rate of 16.3%. The stable disease rate was 16.3%.

The median duration of CR and DOR were not reached, with an estimated 5-year CR rate of 80.7% (95% CI, 59.1%-91.6%). At a median follow-up of 45.6 months, median PFS was 11.6 months (95% CI, 5.7-45.7), and at 65.6 months, median OS was 33.5 months (95% CI, 18.3-not reached).

The safety profile of the tafasitamab regimen was consistent with earlier analyses. The rate of serious treatment-emergent adverse effects (AEs) was 58.0%, with the most common serious AEs including pneumonia (8.6%), febrile neutropenia (6.2%), neoplasms (4.9%), and thromboembolic or cardiac events. The incidence of AEs decreased during tafasitamab monotherapy, and no new safety signals were observed.

“Today's approval marks another important milestone for InnoCare as we will celebrate our 10th anniversary this year,” Jasmine Cui, PhD, cofounder, chairwoman and chief executive officer of InnoCare, concluded.1 “I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL is the most common form of non-Hodgkin lymphoma globally, and there are significant unmet needs among patients with DLBCL in China. We believe the [tafasitamab] regimen will provide a novel therapeutic option to patients with DLBCL in China.”

References

1. InnoCare announces the approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma in China. News release. InnoCare. May 21, 2025. Accessed May 21, 2025. https://www.innocarepharma.com/en/news/activity/en020250521-Approval-of-Minjuvi-in-Combination-with-Lenalidomide-for-R-R-DLBCL-in-China
2. FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma. FDA. Updated August 3, 2020. Accessed May 21, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma
3. Incyte and MorphoSys announce the European Commission approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory DLBCL. News release. Incyte. August 26, 2021. Accessed May 21, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-and-morphosys-announce-european-commission-approval
4. Duell J, Abrisqueta P, Andre M, et al. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica. 2024;109(2):553-566. doi:10.3324/haematol.2023.283480
5. 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, 2023. Accessed May 21, 2025. https://clinicaltrials.gov/study/NCT02399085