Dr. Long on the Results of the Pooled Analysis of the COMBI-i Trial in Melanoma

Georgina V. Long, BSc, PhD, MBBS, FRACP, co-medical director of Melanoma Institute Australia (MIA), chair of Melanoma Medical Oncology and Translational Research at MIA and Royal North Shore Hospital, University of Sydney, discusses the results of the pooled analysis of parts 1 and 2 of the phase III COMBI-i study.

The COMBI-i trial is exploring the combination of targeted therapy and immunotherapy—specifically, dabrafenib (Tafinlar) and trametinib (Mekinist) plus an anti—PD-1 drug called spartalizumab. In parts 1 and 2, researchers evaluated 36 patients who were given a full dose of all 3 drugs together. The triplet therapy induced a response rate of 78%. Only one patient progressed on the treatment, says Long. Notably, the median progression-free survival was above 20 months with the triplet, which compares favorably to what has been observed with either a PD-1 inhibitor alone or the combination of dabrafenib and trametinib.

In terms of adverse events, pyrexia was more extensive with the triplet therapy than with the combination of dabrafenib and trametinib alone; however, this is being explored further in part 3 of the trial, says Long. In part 3, patients will be randomized to receive either the triplet therapy or dabrafenib and trametinib alone. To date, the toxicity appears to be very manageable with proper patient and physician education, concludes Long.