Pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) has received final for the treatment of patients with advanced endometrial carcinoma.
In 2019 a fast track approval was sought for the combination based on collaboration with overseas regulators, the combination of anti-PD-1 immunotherapy and a multikinase inhibitor of VEGFR1, VEGFR2, and VEGFR3.
Merck has now announced that the combination has been listed on the Australian Register of Therapeutic Goods (ARTG for the treatment of people with endometrial cancer that is not is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
In collaboration with lenvatinib sponsor Eisai, the company said the approval represents first combination of immunotherapy and a tyrosine kinase inhibitor for Australian patients with advanced or recurrent endometrial carcinoma, and they would be seeking PBS listing.
Dr Sally Baron-Hay, Medical Oncologist, Royal North Shore Hospital said there was significant unmet need for treatment for women with advanced endometrial cancer who until now have had limited therapeutic options and have faced high mortality rates.
“This approval is a significant step forward in the management of this cancer,” she said.
The Study 309–KEYNOTE-775 recently published in NEJM showed that both progression-free survival and overall survival were significant longer with lenvatinib plus pembrolizumab than with chemotherapy, both in the pMMR population and among all patients with advanced endometrial cancer.
Meanwhile the TGA has also approved dostarlimab (Jemperli) as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
Dostarlimab is an anti-PD-1 therapy marketed by GSK.
The approval was based in part on results from the GARNET trial, which showed that dostarlimab treatment led to confirmed response in 42% of patients.