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Jemperli Another Therapy Approved for Patients with dMMR Recurrent or Advanced Solid Tumor

October 2021, Vol 11, No 10

On August 17, 2021, the FDA accelerated the approval of dostarlimab-gxly (Jemperli; GlaxoSmithKline) for adults with mismatch repair-deficient (dMMR), as determined by an FDA-approved test, recurrent or advanced solid tumor that progressed during or after treatment for whom there are no satisfactory alternative options.

On the same day, the FDA also approved the VENTANA MMR RxDx Panel as a companion diagnostic test to select appropriate candidates for dostarlimab therapy. Dostarlimab was initially approved in April 2021 for endometrial cancer.

The FDA approved dostarlimab for this indication based on the GARNET study, a nonrandomized, multicenter, open-label, multicohort clinical trial of 209 patients with dMMR recurrent or advanced solid tumors that progressed after systemic therapy.

The primary end points were ORR and DOR. The ORR was 41.6%, including 9.1% complete responses and 32.5% partial responses. The median DOR was 34.7 months; 95.4% of the patients had a response lasting ≥6 months.

The most common (≥2%) grade 3 or 4 adverse events were anemia, fatigue/asthenia, increased transaminases, sepsis, and acute kidney injury. Immune-mediated adverse reactions associated with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic toxicity.

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