Immunotherapy 'Jemperli' enters drug price negotiations

The first-line treatment of endometrial cancer

Passed the Drug Reimbursement Evaluation Committee (DREC) review in June…a new treatment option is expected to emerge

The improvement in overall survival (OS) was confirmed through the RUBY study

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Jemperli, an immunotherapy for cancer, has entered the last stage for its expanded reimbursement for endometrial cancer.

 

According to industry sources, GSK Korea has initiated the drug price negotiations with the National Health Insurance Service (NHIS) for its PD-1 inhibitor, Jemperli (dostarlimab).

 

The detailed expanded reimbursement indication is to treat 'newly diagnosed recurrent or advanced deficient DNA mismatch repair (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer.' Accordingly, attention has been garnered to whether a new reimbursed medicine for the first-line treatment of endometrial cancer, which lacks treatment options.

 

The standard first-line treatment of endometrial cancer is a platinum-based combination chemotherapy of paclitaxel+carboplatin.

 

One out of four patients who use chemotherapy experience disease recurrence or progression.

 

Despite the increased number of patients at advanced·recurrence stages, the 5-year survival rate is below 20% because no effective treatment options are available.

 

Jemperli was first listed for reimbursement in December 2023 as a second-line treatment for recurrent·progressive (FIGO stage IIIB or higher) endometrial cancer that progressed during or after platinum-based chemotherapy.

 

Subsequently, the first-line therapy indication was added, and it is currently undergoing the relevant procedures.

 

The efficacy of this drug as a first-line treatment for endometrial cancer was confirmed through the Phase 3 RUBY study.

 

The RUBY study compared a combination therapy combining Jemperli with platinum-based chemotherapy (carboplatin + paclitaxel) against a control group of placebo plus platinum-based chemotherapy in 494 patients with advanced or recurrent endometrial cancer.

 

The study was designed to include a treatment period of over 3 years, considering that the average survival period for conventional platinum-based chemotherapy is less than 3 years.

 

The primary endpoints were progression-free survival (PFS) and overall survival (OS), as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).

 

The RUBY clinical study results showed that the Jemperli combination therapy reduced the risk of death by 31% compared to the control group in the overall advanced·recurrent endometrial cancer patient population.

 

During a median follow-up period of 37 months, the median OS for the patient group receiving Jemperli combination therapy was 44.6 months, which was 16.4 months longer than the control group (28.2 months), and it reduced the risk of death by 31%.

 

Dr.

 

Jae Kwan Lee of Korea University Guro Hospital, Professor of the Department of Obstetrics and Gynecology, said, "Endometrial cancer is a disease with a high risk of recurrence even after initial treatment.

 

Effective first-line treatment options are of utmost importance for patients.

 

Jemperli's RUBY study is considered a significant study that has demonstrated the efficacy of immunotherapy in endometrial cancer over a long period." Dr.

 

Lee also explained, "The combination therapy of Jemperli and platinum-based chemotherapy is the only immunotherapy available for endometrial cancer treatment in Korea with confirmed OS improvement.

 

The study demonstrated significant clinical value even though it included patients who experienced recurrence 6 months after chemotherapy and high-risk patients with carcinosarcoma."