IDEAYA Biosciences has dosed its first patient with cutaneous melanoma harboring a GNAQ or GNA11 (GNAQ/11) mutation, a key milestone for evaluating Protein Kinase C (PKC) inhibitor IDE196 in solid tumors outside of metastatic uveal melanoma (MUM) as part of IDEAYA's ongoing Phase 1/2 clinical trial entitled "Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions".
IDEAYA previously announced initiation of this Phase 1/2 clinical trial evaluating IDE196 in a tissue-type agnostic basket trial for treatment of metastatic uveal melanoma and other solid tumors harboring GNAQ/11 mutations. “The extension of IDEAYA’s clinical trial to treat patients having non-MUM tumors with GNAQ/11 hotspot mutations which activate the pathogenic PKC signaling pathway could be very meaningful. This may be particularly true in skin melanoma characterized by GNAQ/11 mutations. Such cases do not have actionable BRAF driver mutations and may also have a low tumor mutational burden and thus be less responsive to immuno-oncology agents,” said Dr. Richard Carvajal, M.D., Director of Experimental Therapeutics and Director of the Melanoma Service, at Columbia University Medical Center.
In addition, IDEAYA entered into a collaboration with Foundation Medicine in support of IDEAYA’s tissue-type agnostic strategy, which includes a genomic biomarker-driven approach to be enabled by FoundationOne CDx, Foundation Medicine’s FDA-approved broad companion diagnostic which includes comprehensive genomic profiling against 324 genes. This relationship allows for genomic profiling of patient tumor samples from IDEAYA’s ongoing Phase 1/2 clinical trial as well as advanced analyses of FoundationCORE, Foundation Medicine’s proprietary database of over 300,000 de-identified comprehensive genomic patient profiles.
“We are excited to evaluate IDE196 outside of metastatic uveal melanoma using a tissue-agnostic approach,” said Dr. Julie Hambleton, M.D., Senior Vice President and Chief Medical Officer of IDEAYA. “We anticipate continued enrollment of patients having solid tumors with GNAQ/11 hotspot mutations outside of MUM, including potentially in cutaneous melanoma, colorectal cancer, and other solid tumors,” continued Dr. Hambleton.
Source: Company Press Release