cohort of the Phase 1 dose escalation arm, an earlier-reported unconfirmed partial response was subsequently confirmed with a 56.5% tumor reduction, which represents the deepest response observed to date in the Phase 1/2 clinical trial evaluating darovasertib as monotherapy or in combinations. Drug-related adverse events observed in the darovasertib/crizotinib combination arm in MUM as of June 22, 2021, based on preliminary data from an unlocked database, primarily include: serious adverse events of syncope and hypotension, each of which resolved with patients continuing dosing; and adverse events that occurred in at least two of the treated patients include nausea, diarrhea, vomiting, edema, decreased appetite, rash, hypotension and syncope. The observed syncope and hypotension were transient, often occurring in the first week of dosing, and are being managed and mitigated through a one week run-in dosing regimen and by limiting use of certain concurrent medications, such as diuretics.
As of April 13, 2021, 24 MUM patients have enrolled in the darovasertib/binimetinib combination arm and 14 of these patients were evaluable, including eight patients dosed in the Phase 1/2 dose expansion cohort of the combination study. As of April 13, 2021, based on preliminary data from an unlocked database, we observed two partial responses, or PRs, one confirmed PR and one unconfirmed PR with a 40.5% tumor reduction, which was confirmed with a 51.7% tumor reduction after the next scan following the data cut-off date, reflecting two confirmed PR out of nine evaluable MUM patients with at least two post-baseline scans (22%) per RECIST 1.1 guidelines. We also observed tumor reduction in seventy-nine percent (79%) out of the 14 evaluable MUM patients with at least one post-baseline scan as of April 13, 2021. Drug-related adverse events observed in the darovasertib/binimetinib combination arm in MUM as related to darovasertib as of June 22, 2021 primarily include: serious adverse events of liver toxicity, nausea and vomiting, syncope and fall; and adverse events, that occurred in greater than 10% of patients, of nausea, vomiting, diarrhea, rash, edema, aminotransminase, or AST, increase, alanine aminotransferase, or ALT, increase, fatigue, hypotension and creatine phosphokinase, or CK, increase.
Our ongoing monotherapy arm of the Phase 1/2 clinical trial was initiated in June 2019 to evaluate darovasertib in solid tumors harboring GNAQ or GNA11 hotspot mutations in a basket trial design. We have completed enrollment in the monotherapy arm of the Phase 1/2 clinical trial in patients with MUM. We are continuing to evaluate darovasertib as monotherapy in non-MUM solid tumors harboring GNAQ or GNA11 hotspot mutations, including in skin melanoma.
There were 81 darovasertib monotherapy BID MUM and seven skin melanoma patients enrolled across the IDEAYA and Novartis Phase 1/2 clinical trials at the time of data and analyses cutoff on April 13, 2021, with an aggregate of 88 patients evaluable for safety and an aggregate of 80 patients evaluable for efficacy per RECIST 1.1 guidelines. As of April 13, 2021, based on preliminary data from an unlocked database, we observed (i) a fifty-seven percent (57%) one-year overall survival rate, or OS, in predominantly second line, third line and heavily pre-treated (out to 7 and 8 lines of prior treatment) MUM patients with ninety-five percent (95%) confidence interval (44%, 69%), (ii) a median OS of 13.2 months in predominantly second line, third line and heavily pre-treated (out to 7 and 8 lines of prior treatment) MUM patients with ninety-five percent (95%) confidence interval (10.7 months, not reached), and (iii) sixty-one percent (61%) (n=46) of MUM patients out of 75 evaluable had tumor reduction per RECIST 1.1 guidelines, including 15 patients (20%) with greater than thirty percent (30%) target lesion reduction, including one confirmed complete response. As of April 13, 2021, based on preliminary data from an unlocked database, in the skin melanoma cohort, of the monotherapy arm of our darovasertib clinical trial, four of five evaluable patients (80%) had tumor reduction per RECIST 1.1 guidelines, including one confirmed PR.
The overall safety profile of darovasertib monotherapy is consistent with prior experience and includes primarily common low grade but manageable GI and skin toxicities. Drug-related adverse events observed with darovasertib monotherapy include: serious adverse events of hypotension, nausea, vomiting, rash and