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FDA Approves Dostarlimab-gxly for dMMR Advanced Solid Tumors
On August 17, 2021, the FDA granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors (determined by FDA approved test) that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
In addition to dostarlimab-gxly, the FDA also approved VENTANA MMR RxDx Panel as a companion diagnostic device to select patients with dMMR solid tumors eligible for treatment with dostarlimab-gxly.
This approval was based on results from the GARNET Trial, a non-randomized, multi-center, multi-cohort, open-label trial; patients included those with dMMR recurrent or advanced solid tumors who progressed following systemic therapy and had no alternative satisfactory treatment options.
The primary efficacy endpoints were overall response rate (ORR) and duration of response (DoR) as determined by blinded independent central review according to RECIST 1.1.
Among the 209 patients enrolled, the ORR was 41.6% (95% CI: 34.9, 48.6), with a complete response rate of 9.1% and a partial response rate of 32.5%. The median DoR was 34.7 months (range 2.6, 35.8+); 95.4% of patients had a duration of ≥6 months.
The most common adverse reactions (AEs) included fatigue/asthenia, anemia, diarrhea, and nausea. AEs of grade 3 or higher occurred in ≥2% of patients, with the most common being anemia, fatigue/asthenia, increased transaminases, sepsis, and acute kidney injury. Additionally, immune-mediated AEs such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic toxicity are also associated with dostarlimab-gxly.—Alexandra Graziano
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
