Knight submits supplemental application for Minjuvi

Executive Summary

• Knight Therapeutics' Brazilian affiliate, United Medical Ltda., has submitted a supplemental application to ANVISA for Minjuvi (tafasitamab) to treat adult patients with previously treated follicular lymphoma (FL) in combination with rituximab and lenalidomide.
• The submission is being reviewed under Project Orbis, an international regulatory initiative.
• This follows the February 2024 launch of Minjuvi in Brazil for diffuse large B-cell lymphoma (DLBCL) and builds on the exclusive supply and distribution agreement with Incyte entered into in September 2021.

Key Details

• Regulatory Action: Supplemental application submitted to ANVISA (Brazilian health regulatory agency) for an additional indication for Minjuvi (tafasitamab).
• Indication: Treatment of adult patients with previously treated follicular lymphoma (FL) in combination with rituximab and lenalidomide.
• Review Process: Selected for review under Project Orbis.
• Clinical Basis: Submission based on pivotal phase 3 inMIND trial results.
  • Study Design: Double-blind, placebo-controlled trial randomizing 548 patients with relapsed or refractory FL.
  • Primary Endpoint: Tafasitamab plus lenalidomide and rituximab significantly improved progression-free survival (PFS) compared to placebo.
  • PFS Data: Median PFS was 22.4 months in the treatment arm versus 13.9 months in the placebo arm.
  • Risk Reduction: 57% reduction in the risk of disease progression, relapse, or death.
  • Secondary Endpoints: Higher response rates and longer durations of response observed in the treatment arm.
• Market Context:
  • Knight entered an exclusive supply and distribution agreement with Incyte in September 2021 for tafasitamab (Monjuvi/Minjuvi) and Pemazyre in Latin America.
  • Minjuvi was launched in Brazil in February 2024 for relapsed or refractory DLBCL.
  • Monjuvi is already approved in the U.S. for relapsed or refractory FL and DLBCL, and received conditional marketing authorization in Europe for DLBCL.
• Disease Statistics (Brazil):
  • Expected annual incidence of NHL (all subtypes) in 2023 was 5.57 per 100,000 general population.
  • Follicular lymphoma is expected to constitute 20% to 25% of adult NHL cases.

Notable Quotes

• "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."