The P-II trial evaluating TAVO-EP + Keytruda in patients with unresectable or metastatic (Stage III/IV) melanoma showed ORR (10.2%) among 98 efficacy evaluable patients with 1 post-baseline tumor assessment which did not achieve the pre-specified clinical ORR of ≥17%
The ORR by investigator assessment of 18.8% for 101 patients prior reported as the 2EPs of the trial is lower than the BICR results for 98 patients4 had a CR, 6 with PR & 25 with SD, DCR (35.7%), and a durable response rate of ≥24wks. (8.2%), and the m-DoR (25.5mos.), was well tolerated with grade 3 TRAEs (4.8%), no patients experienced grade 4 or 5 TRAEs
The company plan to discuss with the US FDA for a P-II randomized trial design & future development plans in the melanoma neoadjuvant setting in May 2023
Ref: PRNewswire | Image: OncoSec
Related News:- OncoSec Reports P-II (KEYNOTE-695) Trial Results of TAVO-EP + Keytruda (pembrolizumab) for Advanced Melanoma
