On October 31, 2019 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, reported a regulatory and clinical update on IDE196 following receipt of meeting minutes from an End‑of‑Phase 1 (EOP1) meeting with the FDA (Press release, Ideaya Biosciences, OCT 31, 2019, View Source [SID1234550157]). IDE196 is being evaluated for the treatment of MUM and other solid tumors harboring activating GNAQ or GNA11 (GNAQ/11) mutations in its ongoing Phase 1/2 clinical trial entitled "Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385).
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"Following FDA feedback from the EOP1 meeting, we plan to initiate the Phase 2 single-arm, potentially registration-enabling clinical trial of IDE196 monotherapy. This arm of our clinical trial will target enrollment of 60 evaluable MUM patients with blinded independent central review (BICR)‑determined overall response rate (ORR) as the primary endpoint," said Bao Truong, Vice President, Head of Regulatory Affairs at IDEAYA Biosciences. "We look forward to the continued clinical advancement of IDE196 in MUM and in our broader tissue-type agnostic basket trial to treat other solid tumors that harbor activating GNAQ/11 mutations, including in cutaneous melanoma and colorectal cancer," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences.
Regulatory and Clinical Program Highlights for IDE196:
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
Phase 2 dose selection, and the single-arm, potentially registration‑enabling Phase 2 part of the Phase 1/2 clinical trial is anticipated to be initiated in Q4 2019
This Phase 2 clinical trial will target enrollment of 60 evaluable MUM patients with the primary endpoint of overall response rate (ORR) as determined by blinded independent central review (BICR), supported by BICR‑determined duration of response (DOR) as a secondary endpoint
The 13-week GLP-compliant toxicology studies in 2 species is scheduled to initiate in November 2019, in support of FDA requirement that results of these studies be submitted prior to enrollment of more than approximately 50 patients in the investigational arm of the clinical trial that will support a marketing application
An immediate release tablet formulation for IDE196 is on-track for introduction in the clinic in Q1 2020, as a potential registration and commercial formulation
Interim data for GNAQ/11 Phase 1/2 basket trial expected in Q2/Q3 2020
Confirmed Complete Response observed at month 31 in one patient previously reported with confirmed Partial Response in the ongoing IDE196 monotherapy clinical trial conducted by Novartis (ClinicalTrials.gov Identifier: NCT02601378)
"We are grateful for the regulatory feedback from the FDA on our single-arm trial design, providing an opportunity for a potential Accelerated Approval path for IDE196 monotherapy in MUM, a high unmet medical need and a solid tumor indication where there are no FDA approved therapies. We are also encouraged to see continued progress in our tissue-type agnostic GNAQ/11 Phase 1/2 basket trial to treat solid tumor patients beyond MUM," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.