Drugs / Darovasertib
Darovasertib
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02601378 | Feb 2016 → Jan 2022 | uveal melanoma | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03947385 | Jun 2019 → Jan 2027 expected | colorectal cancer, cutaneous melanoma, uveal melanoma | IDEAYA Biosciences | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05907954 | Jul 2023 → Apr 2027 expected | uveal melanoma | IDEAYA Biosciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05187884 | May 2022 → Jan 2025 | ocular melanoma | St Vincent's Hospital, Sydney | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT05987332 | Oct 2023 → Jan 2027 expected | uveal melanoma | IDEAYA Biosciences | Active not recruiting | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT07804186 | Sep 2026 → Mar 2034 expected | uveal melanoma | IDEAYA Biosciences | Recruiting | No outcome recorded |
| Phase 3 | NCT07015190 | Jan 2026 → Oct 2030 expected | uveal melanoma | IDEAYA Biosciences | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | IDEAYA Biosciences | Results IDEAYA Biosciences and Servier Provide Complete Data from Phase 2/3 Registrational OptimUM-02 Trial of the Darovasertib Combination in First Line HLA*A2:01 Negative Metastatic Uveal Melanoma in a Late-Breaking Oral Presentation at ASCO ideayabio.com ↗
Darovasertib combination resulted in a statistically significant and clinically meaningful improvement in median PFS vs. investigator's choice of therapy (ICT) – 6.9 months vs. 3.1 months, HR: 0.42, 58% reduction in risk of disease progression |
| 2026-04-30 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences to Initiate New Drug Application Submission from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence Real-time Oncology Review (RTOR) Program ideayabio.com ↗ |
| 2026-04-13 | IDEAYA Biosciences | Results IDEAYA Biosciences and Servier Announce Positive Topline Results from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA-A*02:01-Negative Metastatic Uveal Melanoma ideayabio.com ↗
The darovasertib combination met the trial's primary endpoint of a statistically significant improvement in median progression-free survival (PFS) relative to the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR). |
| 2025-10-20 | IDEAYA Biosciences | Results IDEAYA Biosciences Reports Positive Median Overall Survival Data from Phase 2 Trial of the Darovasertib and Crizotinib Combination in First-line Metastatic Uveal Melanoma at the 2025 Society for Melanoma Research Congress ideayabio.com ↗
Across all 44 patients treated with the darovasertib and crizotinib combination, a median OS of 21.1 months and a median PFS of 7.0 months was observed. |
| 2025-10-20 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces Positive Phase 2 Data for Darovasertib in the Neoadjuvant Setting of Primary Uveal Melanoma in a Proffered Paper Oral Presentation at ESMO 2025 ideayabio.com ↗
today presented positive clinical data from their ongoing Phase 2 OptimUM-09 trial of neoadjuvant darovasertib in patients with primary uveal melanoma (UM). |
| 2025-09-08 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces Positive Interim Phase 2 Data for Darovasertib in the Neoadjuvant Setting of Primary Uveal Melanoma ideayabio.com ↗
Treatment with darovasertib resulted in robust ocular tumor shrinkage, lower simulated radiation doses to the eye and meaningful visual gains and reduced long-term risk of blindness for patients in the neoadjuvant setting of primary uveal melanoma |
| 2025-03-31 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences Receives US FDA Breakthrough Therapy Designation for Darovasertib Monotherapy in Neoadjuvant Uveal Melanoma ideayabio.com ↗
We are pleased to receive FDA Breakthrough Therapy designation as we prepare to advance neoadjuvant darovasertib into a potential Phase 3 registrational trial in patients with primary UM. |
| 2024-09-23 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces Positive Interim Phase 2 Data for Darovasertib and Successful FDA Type C Meeting on Registrational Trial Design for Regulatory Approval in Neoadjuvant Uveal Melanoma ideayabio.com ↗
Phase 2 company-sponsored and IST neoadjuvant uveal melanoma (UM) clinical data update in 49 evaluable patients, demonstrates ~49% of patients with > 30% tumor shrinkage by product of diameters, and ~61% eye preservation rate for enucleation patients |
| 2024-06-03 | IDEAYA Biosciences | Results IDEAYA Announces Results for Darovasertib Phase 2 IST in Neoadjuvant Uveal Melanoma at ASCO and Clinical Update for Phase 2 Company-Sponsored Neoadjuvant Study ideayabio.com ↗
The clinical data presented at ASCO provides further validation for the potential of darovasertib in the neoadjuvant UM setting to preserve the eye and to shrink ocular tumors for UM patients, |
| 2024-05-23 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces Abstract Summary Results of ASCO 2024 Oral Presentation for Phase 2 Investigator Sponsored Study of Darovasertib in Neoadjuvant Uveal Melanoma ideayabio.com ↗
Darovasertib was generally well tolerated with no drug-related serious adverse events |
| 2023-10-23 | IDEAYA Biosciences | Results IDEAYA Announces Top-Line Phase 2 Results at ESMO 2023 of Darovasertib and Crizotinib Combo in MUM, and Clinical Efficacy Updates for Neoadjuvant UM, GNAQ/11 Cutaneous Melanoma, and Synthetic Lethality Pipeline ideayabio.com ↗
60% confirmed ORR% by RECIST 1.1 in HLA-A2(+) in 1L MUM, and 42% confirmed ORR% by RECIST 1.1 in HLA-A2(-) in 1L MUM |
| 2023-10-17 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces Proffered Paper Oral Presentation at ESMO 2023 for Phase 2 Clinical Data Update for Darovasertib and Crizotinib Combination in Metastatic Uveal Melanoma ideayabio.com ↗
Darovasertib and Crizotinib combination observed manageable safety profile and clinical efficacy that appears superior to current standard of care in MUM |
| 2023-06-22 | IDEAYA Biosciences | Results IDEAYA Announces First Reported Case of Uveal Melanoma Patient Spared Enucleation in Phase 1 Neoadjuvant IST with Darovasertib Monotherapy ideayabio.com ↗
This case suggests that treatment with darovasertib as monotherapy can preserve the eye and may have vision-sparing utility as well as quality of life benefits, |
| 2023-05-09 | IDEAYA Biosciences | Results IDEAYA Biosciences, Inc. Reports First Quarter 2023 Financial Results and Provides Business Update ideayabio.com ↗
IDEAYA reported data from its ongoing Phase 2 clinical trial, designated as IDE196-001, demonstrating compelling clinical efficacy of the darovasertib and crizotinib combination therapy in first-line and any-line MUM patients. |
| 2023-04-23 | IDEAYA Biosciences | Results IDEAYA Announces Positive Interim Phase 2 Data for Darovasertib and Crizotinib Combination and Successful FDA Type C Meeting on Registrational Trial Design for Accelerated Approval in First-Line Metastatic Uveal Melanoma ideayabio.com ↗
IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced further interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib combination in metastatic uveal melanoma (MUM) patients (ClinicalTrials.gov Identifier: NCT03947385). |
| 2022-12-05 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences Receives Fast Track Designation for Darovasertib Combination Therapy with Crizotinib for the Treatment of Metastatic Uveal Melanoma ideayabio.com ↗
Fast Track designation granted by U.S. FDA for evaluation of darovasertib in combination with crizotinib in adult patients being treated for metastatic uveal melanoma (MUM) |
| 2022-09-11 | IDEAYA Biosciences | Results IDEAYA Reports Positive Interim Phase 2 Clinical Results for Darovasertib and Crizotinib Synthetic Lethal Combination in Metastatic Uveal Melanoma ideayabio.com ↗
Confirmed partial responses by RECIST observed in 4 of 8 (50% ORR) evaluable First-Line MUM patients and in 11 of 35 (31% ORR) evaluable Any-Line MUM patients |
| 2022-05-02 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences Receives Orphan Drug Designation for Darovasertib, a PKC Inhibitor, for the Treatment of Uveal Melanoma ideayabio.com ↗
IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the treatment of uveal melanoma. |
| 2021-12-07 | IDEAYA Biosciences | Results IDEAYA Reports Clinical Data from Phase 2 Expansion Dose of Darovasertib and Crizotinib Synthetic Lethal Combination in Heavily Pre-Treated Metastatic Uveal Melanoma ideayabio.com ↗
These data provide clinical proof-of-concept for the PKC and cMET synthetic lethal combination, and further validate IDEAYA's synthetic lethality platform. |
| 2021-05-10 | IDEAYA Biosciences | Results IDEAYA Announces Dose Expansion in Phase 1/2 Study of Darovasertib and Crizotinib Combination based on Early Clinical Efficacy in First Combination Cohort ideayabio.com ↗
We are encouraged to see the early deep partial response in the first cohort of the darovasertib and crizotinib combination. |
| 2021-04-16 | IDEAYA Biosciences | Results IDEAYA Reports Darovasertib (IDE196) Monotherapy Overall Survival Data and Observes Early Partial Responses in Binimetinib Combination in Metastatic Uveal Melanoma ideayabio.com ↗ |
| 2021-03-23 | IDEAYA Biosciences | Results IDEAYA Announces Dose Expansion in Phase 1/2 Study of IDE196 and Binimetinib Combination in Metastatic Uveal Melanoma Based on Early Clinical Activity ideayabio.com ↗
The IDE196 and binimetinib combination initiated dose expansion based on early clinical activity, including percentage of patients with tumor reduction. |
| 2020-07-16 | IDEAYA Biosciences | Results IDEAYA Announces IDE196 Program Update and Clinical Protocol Criteria Met for Cohort Expansion in Skin Melanoma for Phase 2 GNAQ/11 Basket Trial ideayabio.com ↗
The 1 confirmed partial response in a GNAQ/11 mutation skin melanoma patient was determined by RECIST guidelines (version 1.1). |
| 2020-03-18 | IDEAYA Biosciences | Results IDEAYA Biosciences Announces IDE196 Monotherapy Phase 2 Dose Selection and Clinical Program Update ideayabio.com ↗
The company selected a Phase 2 monotherapy dose of 400mg BID (with one-week 200mg BID run-in) and achieved first-patient-in (FPI) for the GNAQ/GNA11 non-MUM basket trial. |
| 2019-11-20 | IDEAYA Biosciences | Results Phase 1/2 Clinical Trial Data for IDE196 Presented at Society for Melanoma Research Congress ideayabio.com ↗
We are pleased to see the preliminary safety and tolerability of IDE196 in Phase 1 of the clinical trial, which may enable a duration of treatment that may be impactful, |
| 2019-10-31 | IDEAYA Biosciences | Regulatory IDEAYA Biosciences Reports End‑of‑Phase 1 Meeting with FDA for IDE196 Confirms Acceptability of Single-Arm Trial Design for Potential Phase 2 Registration-Enabling Study in Metastatic Uveal Melanoma ideayabio.com ↗
FDA EOP1 meeting minutes indicate that the proposed single-arm Phase 2 IDE196 clinical trial may be adequate to support a new drug application (NDA) seeking Accelerated Approval of IDE196 monotherapy for the treatment of MUM |
| 2019-05-08 | IDEAYA Biosciences | Regulatory IDEAYA Receives Authorization to Proceed with Phase 1/2 Tissue-Type Agnostic Basket Trial to Treat Patients with Tumors Harboring GNAQ/11 Mutations and PKC Fusions ideayabio.com ↗
the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application |
All press releases naming this drug 61 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Darovasertib | “IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma” NCT05987332 ↗ |
| Known as | IDE196 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05987332 ↗ |
| Known as | LXS196 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02601378 ↗ |
| Known as | NVP-LXS-196 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3982723 ↗ |
| Action | Inhibit | “Protein Kinase C Inhibitor” NCT02601378 ↗ |
| Modality | Small molecule | — CHEMBL3982723 ↗ |
| Route | Oral | “LXS196, an Oral Protein Kinase C Inhibitor” NCT02601378 ↗ |