Rodabe Amaria, M.D., Jennifer Litton, M.D., Funda Meric-Bernstam, M.D., Shannon Westin, M.D.
Several Phase II clinical trials conducted by researchers from The University of Texas MD Anderson Cancer Center show promising results for patients with melanoma, breast cancer, HER2-positive tumors and ovarian cancer. The results of these studies, which will be presented at the virtual 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, highlight new advances in drug therapy research to improve patient outcomes.
Combination therapy of nivolumab and relatlimab before and after surgery is effective against melanoma (Abstract #9502)
MD Anderson researchers showed that a regimen of neoadjuvant and adjuvant treatment with checkpoint inhibitors nivolumab, a PD-1 inhibitor, and relatlimab, a LAG-3 inhibitor, was safe and effective in patients with resectable clinical stage III melanoma.
Thirty patients were enrolled in the study and received two doses of nivolumab with relatlimab before surgery, followed by up to 10 additional doses of the combination therapy after surgery. The regimen achieved a pathologic complete response (pCR) rate of 59% and major pathologic response rate of 66%. The overall response rate (ORR) was 57%. With a median follow-up time of 16 months, the regimen resulted in an event-free survival of 90%, relapse-free survival of 93% and overall survival of 95%.
Previous studies combining ipilimumab and nivolumab in the neoadjuvant setting for stage III melanoma have shown high pCR rates, which indicates the absence of actively growing cancer cells in tissue removed during surgery but led to high-grade toxicity in 30-40% of patients in the neoadjuvant setting. The current study of nivolumab and relatlimab resulted in no Grade 3 or 4 adverse events prior to surgery and no delays to surgery. During adjuvant treatment, 26% of patients experienced a Grade 3 or 4 adverse event.
“The old standard of care was that stage III melanoma patients get surgery first, but we’ve shown they can really benefit from a neoadjuvant approach,” said Rodabe Amaria, M.D., associate professor of Melanoma Medical Oncology, who will present the findings. “Hopefully, our research will lead to a new treatment paradigm for metastatic melanoma patients.”