Additional Advances in Melanoma Research and Clinical Trials With Michael Davies, MD, PhD
Expert Perspectives · Keira Smith · 2026-01-28
The treatment landscape for melanoma continues to evolve at a rapid pace, with new clinical trial data and therapeutic modalities refining how clinicians approach both early-stage and advanced disease. Michael Davies, MD, PhD, Professor and Chairman of the Department of Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center, recently chaired i3 Health’s CME/NCPD/AAPA activity, "Melanoma in Minutes: Evidence-Driven Care for Improved Patient Outcomes." With numerous new developments in the melanoma treatment landscape over recent months, Dr. Davies sat down again to share these critical updates that are impacting practice.
Refining Adjuvant and Neoadjuvant Strategies
One of the most significant updates involves the management of stage III melanoma. While the field has seen a surge in combination therapies, recent data have helped clarify which treatments provide the most benefit in the adjuvant setting. Dr. Davies noted that results from a clinical trial comparing adjuvant nivolumab/relatlimab to nivolumab monotherapy showed that the combination did not improve outcomes over the standard of care. "For patients with stage III melanoma, the standard of care immunotherapy options remain single-agent anti–PD-1 antibodies with either nivolumab or pembrolizumab," he explained.
Conversely, the neoadjuvant setting continues to show remarkable promise. Updated four-year results from trials investigating neoadjuvant nivolumab/relatlimab demonstrate significant durability. "At four years, 80% of patients remain free of any disease recurrence," Dr. Davies shared. "For patients who had achieved a major pathologic response with neoadjuvant therapy, 95% of those patients remained free of disease four years later." These findings underscore the power of early intervention and the potential for long-term remission.
Breakthroughs in Stage IV and Cellular Therapy
In the metastatic setting, the focus has shifted toward cellular immunotherapies and novel combinations for patients who have progressed on standard anti-PD-1 therapies. The FDA approval of lifileucel has marked a new era in tumor-infiltrating lymphocyte (TIL) therapy, and further advancements are on the horizon. Dr. Davies highlighted the phase 3 SUPRAME trial, which is evaluating a novel cellular therapy, IMA-203, against the standard of care in PD-1 refractory patients.
Additionally, the field is awaiting an FDA decision this spring regarding the intratumoral therapy RP1 in combination with nivolumab. "Hopefully, we'll have a decision from the FDA early this spring about whether that will become a treatment available to our patients as well," said Dr. Davies.
The Role of Supportive Care and Collaboration
Beyond direct anti-tumor therapy, Dr. Davies pointed to intriguing research regarding the synergy between COVID-19 vaccinations and immunotherapy. A study published in Nature suggested that vaccines were not only safe but might correlate with improved outcomes in melanoma and lung cancer patients. "This has caused a lot of new thinking about what our recommendations should be around COVID vaccines for patients receiving immunotherapy," he noted.
As these therapies become more complex, the necessity of interdisciplinary collaboration has never been greater. Whether coordinating neoadjuvant schedules between surgeons and medical oncologists or managing the intensive requirements of TIL therapy, a team-based approach is essential.
"It's a really good problem to have that our treatment landscape continues to evolve," Dr. Davies concluded, encouraging clinicians to utilize online educational opportunities to stay current with these life-saving advancements.
Key Takeaways
Adjuvant Standards: Single-agent anti-PD-1 antibodies (nivolumab or pembrolizumab) remain the standard of care for adjuvant treatment in stage III melanoma, as combination nivolumab/relatlimab did not show superior outcomes in this setting.
Neoadjuvant Durability: Neoadjuvant nivolumab/relatlimab shows high durability at four years, particularly for patients achieving a major pathologic response, 95% of whom remain disease-free.
Emerging Refractory Options: The phase 3 SUPRAME trial (IMA-203) and the pending FDA decision on RP1 plus nivolumab represent potential new standards for patients who have progressed on initial immunotherapy.
Vaccination Synergy: Recent evidence suggests that COVID-19 vaccinations are safe for patients on immunotherapy and may even be associated with improved clinical outcomes.
Multidisciplinary Necessity: The rise of neoadjuvant protocols and complex cellular therapies like TIL therapy (lifileucel) requires seamless coordination between medical oncology and surgical oncology.
About Dr. Davies
Michael A. Davies, MD, PhD, is a Professor and the Chairman of the Department of Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center. He also has joint appointments in the Department of Systems Biology and the Department of Translational Molecular Pathology. Dr. Davies specializes in the management of patients with advanced melanoma, with expertise in multidisciplinary care plans and treatment with immunotherapy, targeted therapy, and chemotherapy. He has led numerous clinical trials investigating novel therapies for advanced melanoma.