Vaccination against mutated RAS in MM: the phase I/II TG01 study

Dr Hanne Norseth, a haematologist at the Oslo Myeloma Center in Norway, presented the results of the phase I/II TG01 study. This study evaluates the safety and efficacy of the TG01/QS-21 vaccine as a single agent in patients harbouring KRAS or NRAS codon 12/13 mutations. Eligible patients include those with measurable MM following at least one prior line of therapy or those with high-risk smoldering MM.

The primary endpoint of the study is safety and tolerability of TG01/QS-21. Secondary endpoints include evaluating response according to IMWG criteria, measuring the immunological response to the vaccine through TG01-specific cytokine production and assessing the size of the RAS-mutated clone before and after treatment or at disease progression.

Out of the 37 patients screened, nine have been enrolled since the initiation of the study. Of these, three patients have high-risk smoldering MM, while six patients have MM. No patients experienced adverse events of grade 3 or higher. However, there was no observed clinical response to the vaccine, with six out of nine patients showing disease progression, with a median time to progression of two months. Currently, three patients remain in the study with stable disease, having initiated a median of five treatment cycles (range 4-9).

These preliminary findings suggest that while the TG01/QS-21 vaccine is well-tolerated, its clinical efficacy in this cohort of patients remains to be further evaluated.