Ideaya Reports Positive Interim Phase 2 Data for Darovasertib

Ideaya Reports Positive Interim Phase 2 Data for Darovasertib

By, Admin 25 September 2024

Ideaya reports positive interim phase 2 data for darovasertib and successful US FDA Type C meeting on registrational trial design for regulatory approval in neoadjuvant UM

Overview

Ideaya Biosciences, Inc., a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced positive interim phase 2 clinical trial data for darovasertib in neoadjuvant uveal melanoma (UM) and a successful FDA Type C meeting on registrational trial design for regulatory approval in neoadjuvant UM.

Statement from Thomas Jefferson University

  • Darovasertib has demonstrated compelling preliminary clinical efficacy and a favourable AE profile in the neoadjuvant UM setting, with approximately 49% of patients demonstrating greater than 30% tumor shrinkage and importantly approximately 61% eye preservation rate for enucleation patients.
  • The primary clinical endpoints supported by discussions with the FDA of eye preservation and time to vision loss are clinically meaningful for neoadjuvant UM patients, and darovasertib has the potential to provide a new standard of care in this setting,"" said Dr. Carol L. Shields, M.D., chief of the ocular oncology service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University.

Words from CMO: Ideaya Biosciences

  • The successful FDA Type C meeting provides darovasertib a potential registrational path in neoadjuvant UM, using primary clinical endpoints of eye preservation and time to vision loss, with no detriment to EFS in the treatment arms as a secondary endpoint.
  • Based on the highly promising preliminary clinical efficacy and manageable safety profile observed with darovasertib and the high unmet medical need of neoadjuvant UM, we are excited to advance darovasertib rapidly to a registrational trial in this indication,"" said Dr. Darrin Beaupre, M.D., Ph.D., chief medical officer, Ideaya Biosciences.

About Darovasertib

  • Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic UM. 
  • Darovasertib is currently being evaluated in four ongoing clinical trials, two of which are in collaboration with Pfizer. 
  • The darovasertib and crizotinib combination in metastatic uveal melanoma (MUM) has FDA Fast Track designation.

IDE196-009 Trials

  • IDE196-009 (NCT05907954) is a company-sponsored phase 2 trial evaluating darovasertib as neoadjuvant treatment for UM prior to primary interventional treatment of enucleation or radiation therapy, and as adjuvant therapy following the primary treatment. 
  • In addition, there is an investigator-sponsored trial (IST), NCT05187884, evaluating darovasertib as a neoadjuvant UM treatment.

Encouraged Evidences of Clinical Activity

  • The company observed further evidence of encouraging clinical activity from an ongoing company-sponsored phase 2 trial (NCT05907954) evaluating darovasertib in neoadjuvant uveal melanoma. 
  • The data cut-off date is August 15th, 2024, with an enrollment cut-off of May 13th, 2024, for the phase 2 company-sponsored trial.  
  • Collectively, these clinical efficacy data from the Phase 2 company-sponsored and IST further substantiate clinical proof of concept for the use of darovasertib in the neoadjuvant uveal melanoma setting.

Clinical data highlights

Clinical Data Update Highlights Include: 

  • 31 enucleation and 18 plaque brachytherapy evaluable UM patients treated with darovasertib neoadjuvant therapy in phase 2 company-sponsored and IST trials; ~59% (29 of 49) of patients with >20% ocular tumour shrinkage by product of diameters; ~49% (24 of 49) of patients with >30% ocular tumour shrinkage by product of diameters; ~61% (19 of 31) eye preservation rate observed; Evidence of visual preservation observed by reducing the amount of radiation associated with plaque brachytherapy; Manageable AE profile observed from phase 2 company-sponsored trial (n=38), including 11% grade 3 or higher AEs, and 5% serious AE rate. 
  • The discontinuation rate observed was 3%. The most common AEs observed included diarrhoea, nausea, vomiting and fatigue.

Ideaya's ocular oncology advisory board recommended product of diameters for tumour measurement to determine overall response rate (ORR) criteria in ocular melanoma. In Ideaya's ongoing phase 2 clinical study with darovasertib, a >20% ocular tumour shrinkage by product of diameters correlates to clinical benefit, including eye sparing for enucleation UM patients and visual preservation for plaque brachytherapy UM patients.

Ideaya on Phase 3 Randomized Clinical Trial

  • Ideaya is targeting to initiate a potential registration-enabling phase 3 randomized clinical trial in neoadjuvant UM patients following finalization of the clinical protocol with the FDA.  
  • The randomized phase 3 clinical trial design incorporates guidance and feedback from the US FDA following a recent Type C meeting.

About Phase 3 Trial

  • In the phase 3 clinical trial, we currently project approximately 400 patients will be randomized for treatment with darovasertib in the treatment arm or the control arm, with potential modifications pending further FDA feedback. 
  • Based on the currently targeted clinical trial design, there will be 2 cohorts enrolled: 1) enucleation eligible UM patients, 2) plaque brachytherapy eligible UM patients. 
  • For the enucleation cohort, the randomization will be with or without darovasertib as neoadjuvant therapy.  
  • For the plaque brachytherapy cohort, the randomization will be darovasertib followed by plaque brachytherapy versus plaque brachytherapy alone.

Neoadjuvant UM represents a significant expansion opportunity for darovasertib – with a potential annual incidence of approximately 12,000 patients aggregate in North America, Europe, and Australia.

Commercial Rights in Darovasertib

Ideaya owns or controls all commercial rights in darovasertib, including in MUM and in UM, subject to certain economic obligations pursuant to its exclusive, worldwide license with Novartis.

About Ideaya

Ideaya is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.

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