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IND
Key Highlights:
- Knight Therapeutics' Minjuvi® receives approval for relapsed or refractory DLBCL patients not eligible for stem cell transplantation.
- The L-MIND trial shows promising results with a 60% objective response rate for Minjuvi® combined with lenalidomide.
- Launch of Minjuvi® in Mexico is expected in the first half of 2025, expanding treatment options for patients.
Knight Therapeutics Inc., a pan-American specialty pharmaceutical company, has announced that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., has received regulatory approval from COFEPRIS, Mexico's health regulatory agency, for Minjuvi® (tafasitamab) in combination with lenalidomide. This treatment is specifically indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplantation (ASCT).
DLBCL is the most prevalent subtype of non-Hodgkin lymphoma, characterized by an aggressive clinical profile. While standard front-line therapies can effectively cure many patients, a significant number either develop refractory disease or experience relapse after an initial response. For these patients, who are often ineligible for ASCT, treatment options have traditionally been limited, underscoring the critical need for new therapies that can enhance patient outcomes.
The approval for Minjuvi® is grounded in the results from the L-MIND trial, an open-label, multicenter, single-arm Phase 2 study. This trial assessed the efficacy of Minjuvi® in combination with lenalidomide for adult patients facing relapsed or refractory DLBCL. The primary analysis yielded an impressive objective response rate (ORR) of 60%, with a complete response rate (CR) of 43% and a disease control rate (DCR) of 74%. According to the 2024 National Comprehensive Cancer Network (NCCN) Guidelines, Minjuvi® is recognized as one of the preferred second-line treatment options for DLBCL patients who cannot undergo transplantation.
Dr. Adrian Alejandro Ceballos, an internist and hematologist at CENIT Medical Center in Merida, Mexico, expressed enthusiasm about the treatment’s potential. “Minjuvi® has a unique and innovative mechanism of action targeting CD19 and represents a significant advancement in the treatment of DLBCL. It is a chemo-free targeted immunotherapy which offers sustained remission for non-transplant eligible adult patients who have relapsed or are refractory to at least one previous line of treatment,” he stated.
Samira Sakhia, President and CEO of Knight, emphasized the importance of this approval, stating, “We are thrilled to announce the approval of Minjuvi® in Mexico. This innovative treatment offers a new alternative for adult patients with limited options. The launch, expected in the first half of 2025, marks an important step in our mission to provide life-changing therapies to the Mexican market and improve the lives of patients facing this challenging condition.”
In September 2021, Knight entered into a supply and distribution agreement with Incyte (NASDAQ:INCY), securing exclusive rights to distribute tafasitamab in Latin America. This collaboration positions Knight favorably within the competitive landscape of oncology treatments.
Minjuvi® is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, licensed by MorphoSys in 2010. Its unique mechanism, incorporating an XmAb® engineered Fc domain, enables B-cell lysis through multiple immune effector mechanisms, offering hope for patients battling DLBCL.
As Knight Therapeutics prepares for the launch of Minjuvi® in Mexico, the company reinforces its commitment to addressing the unmet needs of patients in the region. This approval not only enhances the treatment landscape for DLBCL but also symbolizes a significant advancement in cancer care, promising improved outcomes for patients facing this aggressive disease.
