According to the limited clinical trial, company officials told a meeting of the European Society of Medical Oncology (ESMO) on Sunday that 11 out of 28 patients treated with adagrasib plus Erbitux had a contraction. tumor, notes Reuters.
Two patients had a tumor growth, but the cancer was stabilized in the others, Mirati said.
In this regard, the company’s chief executive Charles Baum told Reuters that Mirati plans to meet with the US Food and Drug Administration in October to discuss whether it can pursue accelerated approval based on combination therapy data.
Adagrasib targets a mutant form of a gene known as KRAS, which occurs in about 13% of non-small cell lung cancers, 3% -5% of colorectal cancers, and up to 2% of other solid tumor cancers.
Like other newer experimental drugs, it targets mutations in certain cancer-causing genes, regardless of the organ in which the disease occurred.
Erbitux is a drug from Eli Lilly designed to block one of the signals that indicate the growth of a tumor cell by attaching to a cell structure called the epidermal growth factor receptor (EGFR).
Mirati said that at the time of his analysis, with a median follow-up of seven months, 63% of enrolled patients remained in combination treatment.
In a segment of the study in which colorectal cancer patients received adagrasib alone, 22% of the patients evaluated responded to the drug, the company said. The researchers said that serious side effects occurred in 30% of patients treated with adagrasib alone and in 16% of patients treated with the combination.
Two patients receiving the combination discontinued treatment after infusion-related reactions.
“It seems that we have gained quite a lot in terms of effectiveness and we have not added too much significant toxicity. That’s why, you know, this combined approach can be the fastest approach for our accelerated approval, “said Charles Baum.
Mirati intends to present on Monday, at ESMO, the updated results of a study with adagrasib for lung cancer patients.