(Solid Tumors) FDA Grants Accelerated Approval for Jemperli in dMMR Advanced Solid Tumors

(Solid Tumors) FDA Grants Accelerated Approval for Jemperli in dMMR Advanced Solid Tumors

(Solid Tumors) FDA Grants Accelerated Approval for Jemperli in dMMR Advanced Solid Tumors

• August 24, 2021
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On August 17, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Jemperli for patients with recurrent or advanced solid tumors with mismatch repair deficiency (dMMR) who have progressed during or after treatment and have no satisfactory alternative therapeutic options. Additionally, the FDA approved Ventana MMR RxDx Panel as a companion diagnostic for dMMR solid tumor patients using Jemperli.

The efficacy of Jemperli was evaluated in the GARNET (NCT02715284) clinical trial, a non-randomized, multicenter, open-label, multi-cohort study. The trial included 209 patients with dMMR recurrent or advanced solid tumors who experienced disease progression after systemic therapy and had no satisfactory alternative treatment.

The primary endpoint objective response rate was 41.6%, with complete response in 9.1% and partial response in 32.5%. The median duration of response was 34.7 months, with 95.4% of patients achieving response duration of 6 months or longer.

The most common adverse events (≥20%) in dMMR solid tumor patients were fatigue, weakness, anemia, diarrhea, and nausea. The most common Grade 3 or 4 adverse events (≥2%) were anemia, fatigue, weakness, elevated transaminases, sepsis, and acute kidney injury. Additionally, immune-related adverse effects of Jemperli include pneumonitis, colitis, hepatitis, endocrine disorders, nephritis, and skin toxicity.

The recommended dose of Jemperli is 500mg every 3 weeks for cycles 1 through 4, then 1,000mg every 6 weeks starting 3 weeks after the fourth dose, administered intravenously over approximately 30 minutes.

Data Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dostarlimab-gxly-dmmr-advanced-solid-tumors?utm_medium=email&utm_source=govdelivery

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