JEMPERLI(dostarlimab-gxly)

JEMPERLI (dostarlimab-gxly) received conditional marketing authorization on 21 April 2021. Its initial approved monotherapy indication is for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen. A proposed combination therapy indication is for use with carboplatin and paclitaxel for adult patients with dMMR/MSI-H primary advanced or recurrent EC who are candidates for systemic therapy.

Efficacy findings in some studies showed an Objective Response Rate (ORR) of 9% with a Duration of Response of 37.29 months, while in other studies, ORR was not achieved or reported as 0%. Median Progression-Free Survival (PFS) ranged from 1.2 months to 2.9 months. No efficacy response was observed in osteosarcoma or neuroblastoma. Safety data indicates that 23.7% of patients in the dostarlimab + carboplatin-paclitaxel arm experienced any treatment-emergent adverse event (TEAE) leading to treatment discontinuation, compared to 16.7% in the control arm. Serious TEAEs occurred in 27.6% of the control arm. Liver enzyme elevations included AST ≥5×ULN in 3.3% of patients and ALT ≥20×ULN in 0.4% of patients.