Incyte Biosciences Japan G.K. (INCY) today announced that Japan's Ministry of Health, Labor and Welfare has approved two of its oncology therapies: Zynyz and Minjuvi.
Zynyz (retifanlimab), a PD-1 inhibitor, was approved in combination with chemotherapy as a first-line treatment for advanced or recurrent squamous cell carcinoma of the anal canal (SCAC), a rare but aggressive cancer with limited treatment options.
The approval was based on the Phase 3 POD1UM-303/InterAACT2 trial, which enrolled adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.
Results published in The Lancet showed a 37% reduction in the risk of progression or death. Patients receiving Zynyz plus chemotherapy achieved improved progression-free and overall survival compared to the chemotherapy-only group. Safety findings were consistent with the known profile of PD-1 inhibitors.
In the U.S., Zynyz is indicated for the treatment of squamous cell carcinoma of the anal canal and Merkel cell carcinoma.
Minjuvi, a CD19-targeting monoclonal antibody, received approval in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (FL).
The approval was based on the Phase 3 inMIND trial, which enrolled 654 patients globally.
Results demonstrated a median progression-free survival of 22.4 months versus 13.9 months in the control arm, with a hazard ratio of 0.43.
Assessments by an Independent Review Committee confirmed these findings, with median PFS not reached in the Minjuvi group compared to 16.0 months in the placebo group.
The regimen was generally well tolerated, with respiratory infections, diarrhea, and fatigue among the most common adverse events.
In the U.S., the drug is sold under the brand name Monjuvi, where it is used to treat diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide that is relapsed or refractory (r/r), or r/r follicular lymphoma (FL) in combination with lenalidomide and rituximab.
INCY has traded between $53.56 and $109.28 over the past year. The stock is currently trading at $99.43, down 3.17%.
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