- IDEAYA Biosciences Inc IDYA announced further interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib combination in metastatic uveal melanoma (MUM) type of eye cancer.
- Confirmed overall response rate (ORR) of 45%, disease control rate (DCR) of 90%, and median progression-free survival (PFS) of ~7 months in 20 evaluable First-Line MUM patients.
- In the sixty-three (63) evaluable any-line MUM patients at the expansion dose, a confirmed overall response rate (ORR) of 30%, disease control rate (DCR) of 87%, and median PFS of ~7 months was observed.
- Twenty (20) evaluable hepatic-only MUM patients, including first-line and pre-treated patients with only hepatic metastases, confirmed ORR of 35%, DCR of 100%, and median PFS of ~11 months.
- IDEAYA plans to initiate a potential registration-enabling Phase 2/3 clinical trial in Q2 2023 in first-line HLA-A2 negative MUM patients.
- The company observed further evidence of clinical activity for darovasertib as neoadjuvant therapy in primary uveal melanoma (UM), including responses in primary ocular tumor lesions.
- Ocular tumor shrinkage in 9 of 9 (100%) UM / MUM patients, including a neoadjuvant UM patient with a partial response at 1 month and a second neoadjuvant UM patient who was spared enucleation with ~80% tumor shrinkage at four months.
- IDEAYA is initiating a company-sponsored clinical trial to evaluate darovasertib as monotherapy in (neo)adjuvant uveal melanoma and is evaluating potential near-term clinical neoadjuvant endpoints such as organ preservation (avoiding enucleation) for large ocular tumors and reduction in radiation dose and/or vision preservation for small or medium ocular tumors.
- Price Action: IDYA shares are up 27.30% at $19.01 on the last check Monday.
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