KENILWORTH (NJ) (dpa-AFX) - Merck & Co., Inc. (MRK) announced Monday the
discontinuation of the vibostolimab and pembrolizumab coformulation arm of the
Phase 3 KeyVibe-010 trial in patients with resected high-risk melanoma.

The trial is evaluating the investigational coformulation of vibostolimab, an
anti-TIGIT antibody, and pembrolizumab (KEYTRUDA), Merck's anti-PD-1 therapy,
compared to KEYTRUDA alone, as adjuvant treatment for patients with resected
high-risk melanoma or Stage IIB-IV.

Melanoma, the most serious form of skin cancer, is characterized by the
uncontrolled growth of pigment-producing cells.

The data, at a pre-planned analysis, showed that the primary endpoint of
recurrence-free survival or RFS met the pre-specified futility criteria.

Meanwhile, a higher rate of discontinuation of all adjuvant therapy by patients
in the coformulation arm versus the KEYTRUDA-only arm, primarily due to
immune-mediated adverse experiences, rendered it highly unlikely that the trial
could achieve a statistically
significant improvement in RFS.

Based on the recommendation of an independent Data Monitoring Committee or DMC,
Merck is unblinding the study and recommends that patients receiving the
vibostolimab and pembrolizumab coformulation be offered the option to be treated
with KEYTRUDA monotherapy.

Merck noted that data analysis from the study is ongoing, and that it plans to
share the results with the scientific community and
communicated to regulatory agencies,

In the U.S., KEYTRUDA has two approved indications in melanoma: for the
treatment of patients with unresectable or metastatic melanoma, and for the
adjuvant treatment of adult and pediatric (12 years and older) patients with
stage IIB, IIC, or III melanoma following complete resection.

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