Merck Eyes Third Endometrial Cancer Nod for Keytruda

Merck_Kena Betancur/Getty Images

Courtesy of Kena Betancur/Getty Images

Merck’s cornerstone, Keytruda, could be on its way to snagging another indication as a first-line therapy for endometrial cancer after the company announced positive Phase III results Friday.

Keytruda plus chemotherapy led to statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with stage III-IV or recurrent endometrial carcinoma compared to chemotherapy alone, Merck reported.

The results were consistent both in patients whose endometrial carcinoma was mismatch repair proficient and mismatch repair deficient.

No new safety signals were observed during the trial and the safety profile of Keytruda was in-line with that observed in other trials.

Merck will present these findings at an upcoming medical meeting and plans to discuss them with regulators.

Keytruda is already approved in two endometrial cancer indications in the U.S.

  • In combination with Lenvima in advanced cancer that is mismatch repair proficient
  • As a single agent for patients diagnosed with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient.

Merck is also evaluating Keytruda as a monotherapy for first-line treatment for advanced endometrial cancer and in the adjuvant setting.

As is often the case, Merck is on a roll with Keytruda.

On Jan. 27th, the FDA approved the drug for a fifth non-small cell lung cancer indication.

The same week, Keytruda won a Phase III win in advanced or unresectable biliary cancer while also suffering a rare defeat in Phase III for metastatic hormone-sensitive prostate cancer.

Keytruda Sales Continue to Climb

As the clock on Keytruda’s exclusivity winds down, Merck reported sales of the drug grew 22% in 2022 over the previous year, raking in $20.9 billion.

Merck’s key patents on Keytruda will expire in 2028, but the company is determined to keep the cash flowing with a new patent for subcutaneous injection.

The company is currently trialing two versions of the subcutaneous formulation. If approved, the formulation could see patent protection until at least 2040.

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