IDEAYA Biosciences has reported positive interim results from Phase ll trial of darovasertib in combination with crizotinib to treat patients with metastatic uveal melanoma (MUM).
The results are based on 20 evaluable first-line and 63 evaluable any-line patients in the trial’s expansion dose.
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The patients received 300mg darovasertib and 200mg crizotinib twice-a-day until 22 September 2022.
As of the data analyses cut off date on 8 March 2023, 45% confirmed overall response rate (ORR) was observed in the 20 first-line MUM evaluable patients, with a confirmed partial response (PR) in nine patients.
The results also showed 90% disease control rate (DCR) in the first-line MUM evaluable patients, while 18 of those patients demonstrated disease control, including nine confirmed PRs, one unconfirmed PR and eight stable diseases.
Approximately seven months median progression free survival (PFS) was reported in these patients.
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By GlobalDataIn the 63 evaluable any-line MUM patients of the expansion dose, 30% confirmed ORR and 19 patients with a confirmed PR were observed.
Among these patients, 87% showed DCR as well as 55 evaluable patients demonstrated disease control, including 19 confirmed PRs, four unconfirmed PRs and 32 stable diseases.
Out of the trial’s 20 evaluable hepatic-only MUM patients, 35% and 100% showed ORR and DCR, respectively. The patients also demonstrated around 11 months of median PFS.
In addition, IDEAYA announced the success of a US Food and Drug Administration (FDA) Type C meeting that will help the firm begin a Phase ll/lll registrational trial in first-line HLA-A2 negative MUM in the second quarter of this year.
IDEAYA chief medical officer Dr Darrin Beaupre said: “These clinical data, considered with the FDA’s guidance from our recent Type C meeting, provides IDEAYA with a registrational trial design in first-line HLA-A2 negative MUM patients which includes a path to potential accelerated approval based on median PFS as the primary endpoint.”
