Neoadjuvant Daromun Meets Primary End Point of RFS in Melanoma
Source: Targeted Oncology, October 2023
A trial of intratumoral daromun and surgical resection for the treatment of patients with locally advanced, fully resectable melanoma, showed a clinically meaningful improvement compared with surgery alone.
The phase 3 PIVOTAL trial (NCT02938299) of neoadjuvant intratumoral daromun (Nidlegy) met its primary end point of recurrence-free survival (RFS) in patients with locally advanced, fully resectable melanoma.
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he trial compared neoadjuvant intratumoral daromun followed by surgery vs surgery alone. At a median follow-up of 27.6 months, there was a significant reduction of the hazard ratio (HR) of 33% (HR = 0.67) and 37% (HR = 0.63), respectively, favoring the treatment arm. This improvement was clinically meaningful and statistically significant, according to investigator assessment.