Darovasertib, IDEAYA Biosciences and Servier’s PKC inhibitor for metastatic uveal melanoma, more than doubled median progression-free survival in its Phase 2/3 registrational trial, and it’s heading to the FDA in the second half of this year.
In the OptimUM-02 trial, darovasertib combined with crizotinib delivered 6.9 months of median PFS against 3.1 months for investigator’s choice of therapy across 313 patients. The control arm included Bristol Myers Squibb’s Yervoy plus Opdivo and Merck’s Keytruda. The overall response rate hit 37.1% vs. 5.8%, with five complete responses. Those results closely matched OptimUM-01, the Phase 1/2 precursor, which showed 7 months of median PFS.
Truist Securities projects $800 million peak revenue in the HLA-A*02:01-negative metastatic uveal melanoma indication, calling darovasertib’s profile “best-in-class.” IDEAYA’s stock jumped 21% in premarket trading Monday to just over $37.
The competitive picture won’t be simple. Darovasertib could also pursue HLA-A202:01-positive uveal melanoma, where Immunocore’s Kimmtrak cleared FDA in January 2022. If darovasertib captures a slice of those patients, Leerink Partners says it would be upside beyond their $415 million peak revenue estimate for the HLA-A02:01-negative population alone.
There are currently no FDA-approved systemic therapies for HLA-A*02:01-negative metastatic uveal melanoma. That’s darovasertib’s market.
Leerink called IDEAYA “a commercial ‘show-me’ story,” driven by price and how much of the HLA-A2*02:01-positive population the drug can capture. NDA filing: second half of this year.
Sarah Chen