Merck’s Endometrial Cancer Drug Cuts Risk Of Death By 32% – FDA Decision Due By June 2027

• The treatment reduced the risk of cancer progression or death by 41%.
• The U.S. FDA accepted Merck’s application for priority review
• The FDA set June 15, 2027 as the deadline to approve the drug.

Merck (MRK), on Monday, reported that Phase 3 of its experimental cancer drug Sacituzumab Tirumotecan (Sac-TMT) helped patients with advanced or recurrent endometrial cancer live longer than those receiving just chemotherapy.

The results were presented at the European Society for Medical Oncology (ESMO) Congress 2026, alongside new findings for Merck’s blockbuster cancer treatment Keytruda.

MRK shares traded 3% lower at the time of writing and were tracking their third straight session of losses.

What Did The Trial Show?

The Phase 3 TroFuse-005 trial enrolled 776 patients whose endometrial cancer, which affects the lining of the uterus, had progressed following chemotherapy and immunotherapy.

Sac-TMT reduced the risk of death by 32% compared with chemotherapy. Patients receiving the drug had a median overall survival of 19 months, compared with 12.1 months with chemotherapy.

The treatment also reduced the risk of cancer progression or death by 41%. Median progression-free survival reached 7.2 months, compared with 3.9 months for chemotherapy. Tumors shrank in 35.1% of patients receiving Sac-TMT, compared with 17.3% of patients receiving chemotherapy.

FDA Decision Expected In June 2027

Based on the findings, the U.S. Food and Drug Administration (FDA) accepted Merck’s application for priority review, setting June 15, 2027 as the PDUFA date. The PDUFA date is the regulatory body’s deadline to either approve the drug or issue a complete response letter.

Developed with Kelun-Biotech, the treatment is being evaluated in 18 global Phase 3 trials covering endometrial, breast, lung, bladder and other cancers.

Separately, Merck reported positive Phase 3 Keynote-C93 results for its blockbuster Keytruda drug as a monotherapy in certain patients with advanced or recurrent endometrial cancer. Keytruda reduced the risk of disease progression or death by 43% compared with chemotherapy.

Median progression-free survival was more than four times longer for patients treated with Keytruda as monotherapy compared to chemotherapy.

Retail Calls It ‘Sell The News Event’

Despite today’s fall, retail sentiment on MRK on Stocktwits turned ‘extremely bullish’ from ‘bullish’ over the past 24 hours, amid ‘high’ message volumes.

One user called it a “sell the news event.”

The stock has gained more than 32% so far in 2026.

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