Uveal melanoma gives Ideaya a clear line of sight to market
The first look at data on darovasertib in uveal melanoma helped Ideaya investors get over the disappointment of GSK’s rejection of a separate project, and a fresh update today lifted spirits further. Impressive response rates have held up in a later cut of the ongoing phase 2 study, which tests darovasertib plus Pfizer’s Xalkori in first-line and pretreated patients with metastatic disease; these easily beat other treatment options, according to a cross-trial comparison compiled by Ideaya. The FDA has signed off on the design of a phase 2/3 registrational trial that could win accelerated approval in the first-line HLA-negative metastatic population – Immunocore’s Kimmtrack is approved in HLA-positive patients – that should start in the coming months. Ideaya also has accelerated approval in its sights in the neoadjuvant setting, where a phase 2 study will start later year; this would not be restricted to HLA-negatives, which presumably introduces a risk on the horizon for Kimmtrack. That drug generated $141m for Immunocore in 2022, its first year on the market. Stifel analysts reckon darovasertib's first-line opportunity could be worth almost $400m in the US, but the 27% jump in Ideaya stock this morning suggests that some are already thinking bigger.