Merck reports positive results for Keytruda plus chemotherapy in endometrial cancer

Merck – known as MSD outside the US and Canada – has announced positive results from its phase 3 trial of Keytruda (pembrolizumab) plus chemotherapy for patients with advanced or recurrent endometrial carcinoma, the most common type of uterine cancer.

The NRG-GY018 trial met its primary endpoint, demonstrating that the combination therapy significantly improved progression-free survival as a first-line treatment versus standard of care chemotherapy (carboplatin and paclitaxel) alone.

This result was seen across patients whose cancer was either mismatch repair proficient or mismatch repair deficient, the company said.

Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and remains the only gynaecological malignancy with rising incidence and mortality rates.

Globally, endometrial cancer is the sixth most common cancer in women and the 15th most common cancer overall. In the US alone, it is estimated there will be approximately 66,000 new cases of uterine cancer and approximately 13,000 deaths from the disease this year.

Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells.

The therapy already has two approved indications for certain patients with endometrial cancer in the US as a combination treatment with Eisai’s Lenvima (lenvatinib) and as a single agent.

“In certain patients with advanced endometrial cancer who have progressed following prior systemic therapy and are not candidates for surgery or radiation, Keytruda has become an important treatment option, both as monotherapy and in combination,” said Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

“These latest results in the first-line setting are very encouraging and show the potential of Keytruda plus chemotherapy for patients with stage three to four or recurrent disease, regardless of mismatch repair status,” Barr added.

The results come just days after the therapy was approved by the US Food and Drug Administration as an adjuvant treatment following surgical resection and platinum-based chemotherapy for certain patients with non-small cell lung cancer.

The approval was based on results from the phase 3 KEYNOTE-091 trial in which Keytruda was shown to reduce the risk of disease recurrence or death by 27% versus placebo regardless of PD-L1 expression.