The immuno-oncology drug Jemperli (dostalimumab), which has emerged as a first-line treatment option for intractable endometrial cancer with a significant unmet medical need, is drawing attention to whether it will be designated as a breakthrough therapy in Korea following the U.S.

GSK Korea said Wednesday that it has applied for Jemperli’s designation as an innovative new drug. Jemperli has won Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the first- and second-line treatment of advanced or recurrent mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) endometrial cancer.

In December 2022, Jemperli won approval from the Ministry of Food and Drug Safety for treating adult patients with advanced or recurrent dMMR/MSI-H endometrial cancer who are on or have progressed after prior platinum-based systemic chemotherapy. Within a year, it obtained insurance benefits in the same patient population.

In March this year, the indication was expanded to include combination therapy with platinum-based chemotherapy in adult patients with newly diagnosed advanced or recurrent dMMR/MSI-H endometrial cancer based on the results of the first interim analysis of Part 1 of the RUBY study.

The U.S. National Comprehensive Cancer Network (NCCN) guidelines also recommend Jemperli in combination with platinum-based chemotherapy, the highest level of recommendation (category 1) for recurrent endometrial cancer.

The Korean Society of Gynecologic Oncology also recommended initial treatment with an immune checkpoint inhibitor, including Jemperli, in the first-line treatment of patients with advanced endometrial cancer and immune checkpoint inhibitor-based therapy, including Jemperli, in the second-line and beyond in its recently revised guidelines for cervical and gynecologic cancer.

“Jemperli has been recognized for its innovation at home and abroad as it has quickly become the standard of care in the first-line treatment of dMMR/MSI-H endometrial cancer, meeting a long-standing need,” said Yang Yoo-jin, head of GSK Korea's Anticancer Business Division. “Jemperli is an immuno-oncology drug designated as a breakthrough therapy by the U.S. FDA and is also expected to be evaluated as a breakthrough drug in Korea.”

At the Jemperli Webinar held by GSK Korea on Tuesday, Professor Park Jeong-yeol of the Department of Obstetrics and Gynecology at Asan Medical Center said, “The combination of Jemperli and platinum-based chemotherapy has been shown to improve progression-free survival (PFS) and overall survival (OS) compared to the existing standard of care in patients with advanced or recurrent dMMR/MSI-H endometrial cancer compared to the current standard of care,” helping to secure Jemperli’s innovative new drug designation.

“It is especially noteworthy that despite the inclusion of patients who relapsed six months after chemotherapy treatment and high-risk patients, such as carcinosarcoma, we could follow them for more than three years and showed a significant effect,” Professor Park said. “This has great clinical value in slowing down the recurrence of patients and, consequently, reducing the number of patients who need second-line treatment, providing hope for patients in the absence of an agent with the equivalent therapeutic position in Korea.”