Follow-Up INVICTUS Trial Data Show Improved OS With Ripretinib for GIST
Overall survival (OS) improved for patients with advanced GIST treated with ripretinib from 15.1 months to not reached, according to an additional 9 months of data analysis presented at the 2020 Virtual ESMO Annual Meeting.
“In INVICTUS, a randomized, double-blind, placebo-controlled trial in ≥4th-line advanced GIST, ripretinib compared with placebo significantly improved progression-free survival (PFS, 6.3 vs. 1.0 months) reducing the risk of disease progression or death by 85% and showed a clinically meaningful improvement in [OS] (15.1 vs 6.6 months)” John Zalcberg, MD, Monash University, Melbourne, Australia and co-investigators wrote before presenting updated follow-up data at the virtual 2020 ESMO Annual Meeting.
A total of 128 with advanced GIST previously treated with imatinib, sunitinib, and regorafenib were included in the study and randomized to receive ripretinib (n = 85) or placebo (n = 43).
Updated PFS by blinded independent central review, OS, and safety data as of March 9, 2020, found that the median PFS for the ripretinib arm was 6.3 months versus 1 month for placebo arm. Median overall survival increased from the primary analysis and was not reached in the ripretinib arm versus 6.3 months in the placebo arm. No new safety concerns were reported in the follow-up data.
“Evaluation of mPFS and OS in the phase III randomized INVICTUS trial, with a cut-off date for analysis approximately 9 months after the primary results, has shown an improvement in the mOS in the ripretinib arm from 15.1 months to not reached (95% CI 13.1–NE) and a similar mPFS of 6.3 months in the ripretinib arm,” stated Dr Zalcberg.
The researchers concluded that the updated results confirm ripretinib, an FDA-approved TKI, yielded a clinically meaningful survival benefit for patients with advanced GIST, treated with at least 3 prior TKIs.—Kaitlyn Manasterski