Merck Says Blockbuster Keytruda Outperforms Chemotherapy in Advanced Endometrial Cancer

Merck & Co Inc. (NYSE:MRK) on Wednesday released topline data from the Phase 3 KEYNOTE‑C93 trial of Keytruda (pembrolizumab).

Phase 3 Trial Meets Primary Progression-Free Survival Goal

The trial met its primary endpoint of progression-free survival (PFS) for mismatch repair-deficient (dMMR) advanced or recurrent endometrial cancer patients who had not previously received systemic chemotherapy or who experienced recurrence more than six months after completing prior adjuvant therapy.

Keytruda is the first and only PD-1 inhibitor to show a statistically significant and clinically meaningful improvement in PFS as monotherapy compared to platinum doublet chemotherapy for these patients in a Phase 3 trial.

At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, a trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed for Keytruda.

However, these OS data were not mature at the time of this analysis.

Overall Survival Data Continue To Mature

The trial is ongoing, and OS for the full study population will be evaluated at a future analysis. The analysis also showed a clinically meaningful overall response rate (ORR), as well as complete response rate (CRR) and duration of response (DOR) for Keytruda.

The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

In the U.S., Keytruda is the only anti-PD-1 therapy with three approved indications for patients with certain types of endometrial cancer.

Last week, the U.S. Food and Drug Administration (FDA) approved Merck’s Keytruda and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment. Then it continued after cystectomy as adjuvant treatment for muscle-invasive bladder cancer (MIBC).

These approvals represent the first and only PD-1 inhibitor plus antibody-drug conjugate regimens approved for adults with MIBC regardless of cisplatin eligibility.

MRK Price Action: Merck & Co shares were up 2.43% at $123.71 at the time of publication on Wednesday, according to Benzinga Pro data.

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