China’s NMPA Approves Tafasitamab/Lenalidomide in ASCT-Ineligible DLBCL

Tafasitamab with lenalidomide was approved in China for patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for autologous stem cell transplant.

The Chinese National Medical Products Administration (NMPA) has approved tafasitamab (Minjuvi) combined with lenalidomide (Revlimid) and followed by tafasitamab monotherapy as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT), according to a press release from the developer, InnoCare Pharma.1

Previously, in August 2020, the FDA granted accelerated approval to tafasitamab with lenalidomide in the aforementioned indication.2 The combination has also received conditional marketing authorization from the European Medicines Agency in the same indication.

This approval marks tafasitamab as the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China. Additionally, tafasitamab has already been approved as a treatment for patients with DLBCL in Hong Kong, Macau, and Taiwan. Through the early access program in the Bo’ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, tafasitamab plus lenalidomide prescriptions have been given at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible patients.

Supporting results came from a Chinese, single-arm phase 2 trial (NCT05552937) that evaluated the safety and efficacy of tafasitamab combined with lenalidomide in patients with relapsed or refractory DLBCL.

“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],” as stated by Jie Jin, MD, PhD, senior physician, doctoral supervisor, and director Emeritus of the Department of Hematology at the First Affiliated Hospital at the Zhejiang University School of Medicine, in the press release.1 “The approval of [tafasitamab] is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients.”

The trial had an estimated enrollment of 50 patients; treatment consisted of intravenous tafasitamab administered weekly on days 1, 8, 15, and 22 for each 28-day cycle during cycles 1 through 3, and then on days 1 and 15 from cycle 4 on, and lenalidomide was administered orally on days 1 to 21 of each 28-day cycle for up to 12 cycles.3

In the Chinese trial, eligible patients were 18 years or older with a histologically confirmed diagnosis of DLBCL. Additional eligibility criteria included at least 1 and no more than 3 prior systemic regimens, with at least 1 containing a CD20-targeted therapy, for DLBCL treatment; an effective barrier method of contraception; and the ability to receive adequate prophylaxis and/or therapy for thromboembolic events.

Exclusion criteria included other histological types of lymphoma; major surgery or significant traumatic injury, receipt of live vaccines, and a requirement for parenteral antimicrobial therapy for active, intercurrent infections within 14 days of beginning treatment; receipt of prior ASCT; prior treatment with CD19-targeted therapy; history of deep venous thrombosis/embolism; and known seropositivity for or active history of viral infection with HIV.

The trial’s primary end point was objective response rate. Secondary end points included disease control rate, DOR, progression-free survival, time to progression, time to response, overall survival, and safety.

“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,” said Weili Zhao, MD, PhD, professor of hematology, first deputy director of Shanghai Institute of Hematology, and vice president of Shanghai Ruijin Hospital, in the press release.1 “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.”

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 22, 2025. https://tinyurl.com/37yj6c2y
2. FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma. News release. FDA. July 31, 2020. Accessed May 22, 2025. https://tinyurl.com/2zrmf56e
3. Evaluate the safety and efficacy of tafasitamab combined with lenalidomide in patients with relapsed or refractory DLBCL. ClincialTrials.gov. Updated September 23, 2022. Accessed May 22, 2025. https://tinyurl.com/4hsuz2bb