Endometrial carcinoma is the first approved indication for the Keytruda-Lenvima combination. Credit: Ed Uthman via Flickr.

The US Food and Drug Administration (FDA) has approved Merck’s anti-programmed cell death protein 1 (PD-1) Keytruda and Eisai’s kinase inhibitor Lenvima for certain advanced endometrial carcinoma patients.

This approval was based upon results from the Phase II Keynote-146/Study 111 trial; the overall response rate (ORR) and durability of response was good in patients with tumours that were not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The participants had also undergone at least one prior systemic therapy and were not able to undergo curative surgery or radiation.

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In the study, ORR in the non-MSI-H and dMMR group was 38.3%, complete response rate was 10.6% and partial response was 27.7%. Although duration of response was not met at the trial cut-off, 68% of patients experienced responses lasting at least six months.

Keytruda was discontinued due to adverse reactions in 19% of patients and 3% of participants’ experienced fatal adverse reactions from the combination therapy. Continual approval for this endometrial carcinoma patient group may be contingent upon verification of clinical benefit in a confirmatory study.

Merck vice-president of oncology clinical research Dr. Jonathan Cheng said: “Today’s approval of the KEYTRUDA plus LENVIMA combination for advanced endometrial carcinoma that has progressed following prior systemic therapy brings the first approved combination treatment to women with this type of cancer whose tumors are not MSI-H or dMMR and who are not candidates for curative surgery or radiation, and demonstrates the potential of our collaboration with Eisai.

Eisai’s oncology business vice-president, chief medicine creation and chief discovery officer Dr Takashi Owa added: “At least 75% of endometrial cancer cases are not microsatellite instability-high or mismatch repair deficient, and these women have been in need of new treatment options.

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“We are excited for the advancement that today’s approval of the KEYTRUDA plus LENVIMA combination treatment represents for these women whose advanced endometrial carcinoma is not microsatellite instability-high or mismatch repair deficient, has progressed following prior systemic therapy and who are not candidates for curative surgery or radiation, and we look forward to the possibilities that our collaboration holds.”

This is the first approved indication for the Keytruda-Lenvima combination; Keytruda has been approved for 14 cancer types to date. It is also the first time an anti-PD-1 therapy and kinase inhibitor have been approved together for endometrial carcinoma in the US.