Vibostolimab Trial for Melanoma Discontinued After Adverse Reactions

Clinical trials can be valuable tools in improving patient care directives and advancing drug development. Unfortunately, these trials can sometimes face challenges that impact their effectiveness. For example, the Phase 3 KeyVibe-010 trial evaluating a vibostolimab-Keytruda combination for melanoma was recently discontinued after too many participants left the trial, citing adverse reactions.

What is Vibostolimab?

The National Cancer Institute describes vibostolimab as:

an antagonistic agent targeting the co-inhibitory molecule and immune checkpoint inhibitor T-cell immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitor motif (ITIM) domains (TIGIT), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, vibostolimab targets and binds to TIGIT expressed on various immune cells…and activates the immune system to exert a T-cell-mediated immune response against cancer cells.

National Cancer Institute

James Waldron reports for FierceBiotech that the clinical study sought to understand whether vibostolimab in conjunction with pembrolizumab (Keytruda) could be an effective adjuvant therapy for those with resected high-risk melanoma. An adjuvant therapy is given after initial cancer treatment. 

However, the trial did not go the way that investigators expected. Many enrolled individuals experienced immune-mediated adverse experiences. This led to numerous discontinuations. Eventually, so many people discontinued treatment that it was unlikely that the trial would show a statistically significant improvement in recurrence-free survival. An independent data monitoring committee recommended that the trial be unblinded and all participants were given the option to receive Keytruda treatment.

Vibostolimab has also hit roadblocks in a study evaluating the combination treatment (with Keytruda) for non-small cell lung cancer (NSCLC). Despite these challenges, Merck remains committed to developing novel, effective, and beneficial therapeutics for people across the cancer spectrum.

Understanding Melanoma

Melanoma is a skin cancer that originates in melanin-producing cells called melanocytes. While melanoma is less common than other forms of skin cancer, it is considered more dangerous and aggressive. If not detected early, melanoma can spread to other parts of the body such as the eyes or internal organs. Melanoma usually forms on areas of the body with high sun exposure. In men, it is more common on the head, neck, or shoulders to the hips; in women, it is more common on the arms and legs. If you have fairer skin, a family history of melanoma, many moles, or high UV exposure, your risk of developing melanoma is heightened. 

You can use ABCDE to identify moles that could indicate melanoma. Moles indicating melanoma might have an asymmetrical shape, irregular border, color changes, a wider diameter, and evolution over time, such as growth or bleeding. If you notice changes in an existing mole or skin color changes, a new mole on your skin that changes size or shape, or new moles near an existing mole, please speak with your physician. 

Newly diagnosed? The Melanoma Research Foundation has helpful resources on what to do next.

clinical trial medical research melanoma oncology skin cancer vibostolimab

Last modified: June 18, 2024