Knight Therapeutics Inc. announced that its Brazilian affiliate, United Medical Ltda., has submitted a supplemental application to ANVISA, Brazil's health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with rituximab and lenalidomide for treating adult patients with previously treated follicular lymphoma (FL). The supplemental application was selected for review under Project Orbis.
Clinical Evidence Supporting the Application
The regulatory submission is based on results from the pivotal Phase 3 inMIND trial, a double-blind, placebo-controlled study that randomized 548 patients with relapsed or refractory FL to receive either tafasitamab or placebo in combination with lenalidomide and rituximab. The trial demonstrated significant clinical benefits for the tafasitamab combination.
Key results showed that tafasitamab plus lenalidomide and rituximab significantly improved progression-free survival (PFS) compared to placebo. The median PFS reached 22.4 months in the treatment arm versus 13.9 months in the placebo arm, representing a 57% reduction in the risk of disease progression, relapse, or death. Secondary endpoints also showed improvements, with higher response rates and longer durations of response observed in the treatment arm.
Disease Burden and Treatment Landscape
Follicular lymphoma is the most common indolent, or slow-growing, form of non-Hodgkin lymphoma (NHL). In Brazil, according to 2023 data from the National Cancer Institute (INCA) Registries, the expected incidence per year of NHL (inclusive of all subtypes) was 5.57 per 100,000 in the general population, 6.42 per 100,000 in the male population, and 5.62 per 100,000 in the female population. Follicular lymphoma is expected to constitute 20% to 25% of adult NHL cases, with limited treatment options currently available for relapsed or refractory FL.
Mechanism of Action and Regulatory Status
MINJUVI® (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, MONJUVI® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma. The drug also received accelerated approval in the United States in combination with lenalidomide for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
Company Background and Market Strategy
Knight Therapeutics entered into an exclusive supply and distribution agreement with Incyte in September 2021 for the exclusive rights to distribute tafasitamab, as well as PEMAZYRE® (pemigatinib), in Latin America. In February 2024, Knight launched MINJUVI® in Brazil in combination with lenalidomide followed by MINJUVI® monotherapy for treating adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.
"This regulatory submission for a new indication for tafasitamab in relapsed or refractory FL highlights our steadfast commitment to bringing innovation and enhancing quality of life and care," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics. "If approved, the combination of tafasitamab, rituximab and lenalidomide will be an important new therapeutic option for eligible adult patients with previously treated FL in Brazil. We look forward to continuing to work towards regulatory submissions in additional countries in Latin America over the next months."
