Mexico's health regulatory agency, COFEPRIS, has approved tafasitamab (Minjuvi) in combination with lenalidomide (Revlimid) for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who cannot undergo autologous stem cell transplant (ASCT). This decision brings a new treatment option to patients facing this aggressive form of lymphoma.
The approval is based on data from the phase 2 L-MIND trial (NCT02399085), an open-label, multicenter, single-arm study evaluating the combination of tafasitamab and lenalidomide in this specific patient population. The trial's primary analysis demonstrated a 60% overall response rate (ORR), meeting the primary endpoint. The complete response (CR) rate was 43%, and the disease control rate reached 74%.
Dr. Adrian Alejandro Ceballos, a hematologist at CENIT Medical Center in Merida, Mexico, highlighted the significance of this approval: "[Tafasitamab] has a unique and innovative mechanism of action targeting CD19 and represents a significant advancement in the treatment of DLBCL. 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."
The L-MIND trial enrolled 80 patients aged 18 years or older who had received one to three prior systemic therapies and had an ECOG performance status of 0 to 2. Patients received up to 12 cycles of tafasitamab plus lenalidomide, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity. Key secondary endpoints 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. The median PFS was 11.6 months (95% CI, 5.7-45.7) at a median follow-up of 45.6 months (95% CI, 22.9-57.6). The median OS was 33.5 months (95% CI, 18.3-NR) at a median follow-up of 65.6 months (95% CI, 59.9-70.3).
Further analysis at the 5-year follow-up showed that patients who had received only one prior line of therapy (n = 40) experienced a higher ORR (67.5%) and CR rate (52.5%) compared to those who had received two or more prior lines of therapy (n = 40; ORR, 47.5%; CR, 30%). The median DOR was not reached in either subgroup.
The frequency of treatment-emergent adverse effects (TEAEs) was lower with tafasitamab monotherapy compared to the combination. The most common nonhematologic TEAEs during the combination period were peripheral edema and diarrhea. Most TEAEs were grade 1 or 2.
Samira Sakhia, president and CEO of Knight Therapeutics, stated, "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."
Tafasitamab previously received accelerated approval from the FDA in 2020 and conditional marketing authorization from the EMA in 2021 for similar indications. The National Comprehensive Cancer Network guidelines also recommend tafasitamab in combination with lenalidomide as a preferred second-line therapy for DLBCL patients ineligible for transplantation.
