HQ Team
August 4, 2024: The US drug regulator has granted permission for expanded use of British pharmaceutical company, GSK Plc’s endometrial cancer drug.
Branded as Jemperli, the dostarlimab combination drug has been allowed by the Food and Drug Administration for use in adult patients with primary advanced or recurrent endometrial cancer along with a type of tumour category.
Jemperli along with chemotherapy demonstrated a statistically significant and clinically meaningful 31% reduction in risk of death versus chemotherapy alone, according to the GSK statement.
At the 2.5-year landmark, 61% of patients in the Jemperli plus chemotherapy group were alive when compared to 49% in the chemotherapy group.
Overall survival benefit
“This is the only immuno-oncology treatment regimen that has shown a statistically significant overall survival benefit for the full patient population, which is a meaningful step forward in treating this challenging cancer,” said Matthew Powell, MD, principal investigator of the trial.
This approval broadens the previous indication for the therapy to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours representing 70-75% of patients diagnosed with endometrial cancer.
MSS is the most common type of colon cancer, occurring in 85% of all colorectal cancers. It’s more common in earlier stages of colon and rectal cancer (stage I and stage II).
MMR is the body’s system for recognising and repairing wrong letters in DNA synthesis. Microsatellites are short, repeated sequences in the DNA.
‘Fingerprint’
They can vary in length between people, but within one person’s DNA, they are a specific length. This can be used as a kind of “fingerprint” of someone’s DNA.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said Jemperli with chemotherapy was the “first and only immuno-oncology regimen” to show a significant improvement in overall survival for adult patients with primary advanced or recurrent endometrial cancer.
“The initial approval of Jemperli plus chemotherapy was practice-changing for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer and today’s expanded approval will offer even more patients the opportunity for improved outcomes.”
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. It is the most common gynecologic cancer in developed countries with an estimated 1.6 million people living with active disease at any stage.
About 417,000 new cases are reported each year worldwide. Incidence rates are expected to rise by approximately 40% between 2020 and 2040.
Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.
