FDA grants full approval to GSK for mismatch repair-deficient endometrial cancer treatment

pharmafile | February 10, 2023 | News story | Medical Communications  

GSK announced that its treatment for recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer has been granted full approval by the FDA.

 

Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)-blocking antibody which binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. The FDA’s approval was based on data collected from the A1 expansion cohort of the ongoing GARNET trial.

 

GARNET is a phase 1, multicentre, open-label, single-arm study of Jemperli. Cohort A1 evaluated the efficacy of Jemperli in 141 patients with dMMR advanced or recurrent endometrial cancer which has progressed on or following treatment with a platinum-containing regimen. Overall response rate (ORR) was 45.5%, with a complete response rate of 15.6% and a 29.8% partial response rate. The duration of response (DOR) saw 85.9% of patients have a 12 months or longer response, and 54.7% have 24 months or longer.

 

Hesham Abdullah, senior vice president and global head of oncology development at GSK, said: “This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer. We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programmes to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumours.” 

 

James Spargo


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