ESMO 2025 | KANDLELIT-001: MK-1084 monotherapy in KRAS G12C- mutated advanced solid tumors

The KANDLELIT-001 trial is a Phase I, multi-center, multi-arm phase one trial evaluating safety, tolerability, and preliminary efficacy of MK-1084 alone or in combination with other agents in patients with KRAS G12C mutated advanced cancer, and I presented data results about the monotherapy arms, arm one and three, evaluating two different formulations of MK-1084 as monotherapy in pre-treated patients with KRAS G12C mutated advanced cancer, but I focused my attention on tumors other than non-small cell lung cancer and colorectal cancer. The main findings of the trial are that the drug was very well tolerated from a safety standpoint. There were just a few treatment-related adverse events, usually mild to moderate in severity and easily manageable. Just one patient discontinued treatment due to toxicity, and consistently with the safety profile of the KRAS inhibitor class, most common treatment-related adverse events were liver enzyme elevation and low-grade diarrhea, fatigue, and nausea. And from an anti-tumor activity standpoint, we saw great, encouraging, promising activity in tumors other than non-small cell lung cancer and colorectal cancer, with an overall response rate of 31%, disease control rate of 75%, and the median duration of response of 13.8 months. And particularly, responses were particularly amazing and encouraging in hepatobiliary cancer, with seven out of 11 patients responding, including one complete response and a remarkable 91% disease control rate. We saw responses also in pancreatic adenocarcinoma, with a good 60% disease control rate. And I think that these are the main findings of the trial.

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