Tafasitamab Plus Lenalidomide Wins Approval in Mexico for ASCT-Ineligible, R/R DLBCL

COFEPRIS, the health regulatory agency of Mexico, has approved the combination of tafasitamab (Minjuvi) and lenalidomide (Revlimid) followed by tafasitamab monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).¹

This regulatory decision was supported by findings from the open-label, multicenter, single-arm, phase 2 L-MIND trial (NCT02399085), which investigated tafasitamab plus lenalidomide in this population. Findings from the primary analysis of the trial demonstrated the combination elicited an overall response rate (ORR) of 60%, meeting the trial’s primary end point. The complete response (CR) rate was 43%, and the disease control rate was 74%.

“[Tafasitamab] has a unique and innovative mechanism of action targeting CD19 and represents a significant advancement in the treatment of DLBCL,” Dr Adrian Alejandro Ceballos, an internist and hematologist at CENIT Medical Center in Merida, Mexico, stated in a news release. “It is a chemotherapy-free targeted immunotherapy [that] offers sustained remission for non–transplant eligible adult patients who have relapsed or are refractory to at least 1 previous line of treatment. I am enthusiastic about the transformative potential of [tafasitamab] in improving patient outcomes.”

L-MIND enrolled 80 patients at least 18 years of age who had received 1 to 3 prior systemic therapies and had an ECOG performance status of 0 to 2.2 Patients received a maximum of 12 cycles of co-administered tafasitamab plus lenalidomide followed by tafasitamab monotherapy until progressive disease or unacceptable toxicity. Key secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.

At a median follow-up of 44.0 months, the median DOR was not reached (NR). At a median follow-up of 45.6 months (95% CI, 22.9-57.6), the median PFS was 11.6 months (95% CI, 5.7-45.7). At a median follow-up of 65.6 months (95% CI, 59.9-70.3), the median OS was 33.5 months (95% CI, 18.3-NR).

At the 5-year follow-up analysis, patients who had received 1 prior line of therapy (n = 40) had a higher ORR (67.5%) and CR rate (52.5%) compared with those who had received 2 or more prior lines of therapy (n = 40; ORR, 47.5%; CR, 30%). The median DOR was NR in both subgroups.

The frequency of treatment-emergent adverse effects (TEAEs) was less common with tafasitamab monotherapy than the combination. Most TEAEs of special interest during the combination period of the trial were hematologic in nature. The most common nonhematologic TEAEs during the combination period were peripheral edema and diarrhea. Most TEAEs were grade 1 or 2.

“This approval, with launch expected in the first half of 2025, marks an important step in our mission to bring life-changing therapies to the Mexican market and improve the lives of patients facing this challenging condition,” Samira Sakhia, president and chief executive officer of Knight Therapeutics, added in the news release.¹

In 2020, the FDA granted accelerated approval to tafasitamab-cxix (Monjuvi) plus lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, who are ineligible for ASCT.³

Furthermore, in 2021, the EMA granted conditional marketing authorization to tafasitamab plus lenalidomide followed by tafasitamab monotherapy for the treatment of adult patients with ASCT-ineligible, relapsed or refractory DLBCL.¹

The National Comprehensive Cancer Network guidelines also list tafasitamab in combination with lenalidomide as a preferred second-line therapy for patients with DLBCL who are ineligible for transplantation.⁴

References

1. Knight Therapeutics announces approval of Minjuvi (tafasitamab) in Mexico. News release. Knight Therapeutics, Inc. October 15, 2024. Accessed October 17, 2024. https://investors.knighttx.com/English/news/news-details/2024/Knight-Therapeutics-Announces-Approval-of-Minjuvi-tafasitamab-in-Mexico/default.aspx
2. 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
3. FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma. FDA. July 31, 2020. Accessed October 17, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma
4. NCCN. Clinical Practice Guidelines in Oncology. B-cell lymphomas, version 3.2024. Accessed October 17, 2024. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf