3rd PD-1i Jemperli to soon receive approval in Korea

May be approved within the year at the earliest…demonstrates efficacy in endometrial cancer

A third PD-1 inhibitor is knocking to enter the Korean market.

 

According to industry sources, GSK Korea’s PD-1 inhibitor cancer immunotherapy ‘Jemperli (dostarlimab),’ which the company applied for approval earlier this year, may be approved within the year.

 

If approved, Jemperli will become the third PD-1 inhibitor introduced to the Korean market following Ono·BMS’s ‘Opdivo (nivolumab),’ and MSD’s ‘Keytruda (pembrolizumab).’ Unlike the other two drugs that were first indicated as melanoma treatments, Jemperli was first approved in the US in April last year as a treatment for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.’ In August of the same year, Jemperli was additionally approved for the treatment of adults with dMMR recurrent or advanced solid tumors who have progressed on or following previous treatment and have no satisfactory therapeutic options.

 

GSK plans to add other indications to endometrial cancer in Korea as well.

 

The efficacy of Jemperli was confirmed through the multicohort GARNET trial that included a cohort of patients with dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen.

 

Trial results showed an objective response rate (ORR) of 43.5% and the disease control rate of 55.6% in the Jemperli-treated group.

 

The median duration of response was not reached yet, and the rate of patients whose duration lasted 6 months and 12 months were 97.9% and 90.9%, respectively.

 

Meanwhile, the other companies are also actively working to expand their indication and reimbursement for Keytruda and Opdivo in Korea as well.

 

MSD succeeded in expanding the reimbursement standards for Keytruda to first-line NSCLC in 1H this year, and Opdivo's indication as a first-line treatment in gastric cancer has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee.