Servier eyes up Ideaya’s darovasertib
As pivotal data approach, the French group pays $210m for ex-US rights.
As pivotal data approach, the French group pays $210m for ex-US rights.
Ideaya Biosciences, approaching the first pivotal readout for its lead project darovasertib, has found a partner in the shape of Servier. The French company is paying $210m up front to license darovasertib outside the US, adding to Ideaya’s already sizeable cash pile.
Still, data with the PKC inhibitor in its first indication, first-line metastatic uveal melanoma, appear to have been delayed slightly. The companies said that median progression-free survival results from the phase 2/3 Dar-UM-2 study are now due in late 2025 or early 2026 – from a previous estimate of year-end 2025.
Dar-UM-2 is testing darovasertib plus Pfizer’s Xalkori, versus investigator’s choice of Keytruda, Opdivo plus Yervoy, or dacarbazine chemo.
Key darovasertib trials in uveal melanoma
| Trial | Setting | Population | Regimen | Note |
|---|---|---|---|---|
| Ph2/3 Dar-UM-2 | 1st-line metastatic | HLA-A2-negative | Darovasertib + Xalkori, vs investigator’s choice of Keytruda, Opdivo + Yervoy, or dacarbazine | mPFS data due YE 2025 to Q1 2026 (previously YE 2025) |
| Ph3 Optimum-10 | Neoadjuvant | Independent of HLA status | Darovasertib vs brachytherapy or placebo | To start Sep 2025 |
| Unnamed ph3 | Adjuvant | Independent of HLA status | TBC | To start 2026 |
Source: OncologyPipeline & clinicaltrials.gov.
In its second-quarter earnings presentation, the company highlighted mPFS of 7.1 months with the darovasertib/Xalkori combo in first-line disease in phase 2; meanwhile, Opdivo plus Yervoy has produced mPFS of 3 months, according to Ideaya.
Accelerated approval?
If Dar-UM-2 can produce similar figures, it could support accelerated approval in front-line HLA-A2 negative disease. Full approval would be supported by overall survival data from the same study, if positive.
Ideaya also plans to expand into HLA-A2-positive patients via real-world evidence and/or compendia listing.
The company estimates that metastatic uveal melanoma affects 4,000-5,000 patients per year in North America, Europe and Australia, but it’s hoping to go even bigger with darovasertib; the group is soon to begin a phase 3 trial testing neoadjuvant therapy, in patients scheduled for either enucleation (removal of the eyeball) or brachytherapy (localised radiotherapy). The company reckons this use could cover around 12,000 patients per year.
A similar number could be eligible for adjuvant therapy, and here Ideaya and Servier will be teaming up on another phase 3 trial, set to launch next year.
As well as the up-front fee, Servier could pay up to up to $100m in regulatory milestones, and up to $220m in commercial milestones, as well as double-digit royalties on sales outside the US.
Ideaya doesn’t seem to have a pressing need for cash: as of June it had $992m in the bank, enough to last until 2029. However, the company looks sensible for monetising darovasertib outside its home market. Ideaya will retain rights in the US.
Meanwhile, this is Servier’s second oncology deal this year; in March, the group licensed Black Diamond’s brain-penetrant RAF inhibitor BDTX-4933 for $70m up front. That project, which had previously been deprioritised by Black Diamond, is in phase 1.
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