Clinicians unveil Novartis and BMS practice-changing trial results

Pharma News: Australia, known for its alarming melanoma rates, witnesses one person diagnosed with the disease every 30 minutes, and one death every 6 hours. Australian clinicians welcomed the practice-changing trial results from Novartis and Bristol Myers Squibb (BMS) revealed at the recent American Society of Clinical Oncology (ASCO) Annual Meeting.

The COMBI-AD clinical trial’s final results were a focal point, demonstrating that 12 months of targeted therapy with Novartis’ BRAF inhibitor Tafinlar (dabrafenib) and MEK inhibitor Mekinist (trametinib) post-complete lymph node dissection significantly curbs disease progression in BRAF-positive stage III melanoma patients.

Professor Georgina Long AO, Co-Medical Director of Melanoma Institute Australia (MIA) and joint 2024 Australian of the Year, presented the final COMBI-AD results at ASCO.

“This long term follow up data shows significant benefit to be maintained at nearly 10-years, and is likely to be one of the only adjuvant trials in melanoma to show a difference in the overall survival with the use of adjuvant drug therapy,” Professor Long said. “This confirms the impact of dabrafenib and trametinib as a standard therapy in resected stage III melanoma, especially for patients with the BRAF V600E mutation.”

In her oral presentation, she revealed that in the combination arm, the 10-year rate for relapse-free survival was 48%, and for distant metastases-free survival was 63% (compared with 32% and 48% respectively in the placebo arms). The first and final analysis for overall survival was also presented, and Tafinlar plus Mekinist reduced the risk of death by 20%. This was reduced even more in those with the BRAF V600E mutation in their melanoma, by 25%.

In a parallel development, BMS’ NADINA trial results were also unveiled at ASCO, marking the first phase III trial to test a neoadjuvant checkpoint inhibitor without chemotherapy and could signal a new standard of care for the treatment of resectable macroscopic stage III melanoma.

Preoperative Opdivo (nivolumab) Plus Yervoy (ipilimumab) followed by lymph node dissection, with adjuvant therapy tailored based on treatment response depth, led to a significant 68% reduction in the risk of disease recurrence or death compared to standard-of-care dissection and adjuvant Opdivo.

Professor Long, who led the Australian arm of the NADINA trial across eight centres, emphasised the implications of these findings. “Combination neoadjuvant immunotherapy should now be considered the new standard for higher-risk Stage III melanoma and should be explored across oncology,” she said.

Professor Shahneen Sandhu led recruitment at Peter Mac and said the results were “transformative for advanced melanoma and will a lead to similar approaches being evaluated in multiple other tumour types.”

Event-free survival was 83.7% in the before-surgery group at 12 months after treatment, compared to 57.2% among patients who had immunotherapy after surgery. Of the 59% of patients achieving a major pathologic response, some were able to avoid adjuvant immunotherapy altogether, limiting their total treatment time to 6 weeks.

Associate Professor Alex van Akkooi from MIA echoed this sentiment, noting, “This trial has flipped the traditional ‘surgery then drugs’ rationale on its head, and melanoma patients across the world will now benefit.”

Professor Long concluded, “Both the COMBI-AD and NADINA trials have been critical in transforming melanoma clinical care, and we are proud that Melanoma Institute Australia and our patients have played a leading role in both trials.”

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