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FDA Grants Fast Track Designation to Avutometinib-Lumakras Combo


The treatment combination of avutometinib and Lumakras has been granted a Fast Track designation from the FDA in some with metastatic NSCLC.

FDA on blue background

The FDA will speed up its review of avutometinib plus Lumakras.

The Food and Drug Administration (FDA) has granted a Fast Track designation to avutometinib, a type of novel inhibitor, plus Lumakras (sotorasib) as a treatment combination for patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC), according to Verastem Oncology, a biopharmaceutical company and the manufacturer of avutometinib.

More specifically, patients with KRAS G12C-mutant metastatic NSCLC who have previously been treated with at least one systemic therapy and have not received a KRAS G12C inhibitor may be eligible for the avutometinib-Lumakras combination, according to a news release.

A Fast Track designation, the FDA defines, is a process that is designed to expedite the development of a drug easier and to review the drug’s effectiveness promptly for the drug’s respective patient population.

Lumakras is a type of targeted therapy drug that blocks the KRAS G12C protein, which is produced by the mutated KRAS gene. The drug may help destroy cancer cells while preventing the growth of cancer cells.

In the news release, Verastem Oncology reported that the treatment combination has shown improvements in patients, which includes a deeper tumor regression (a reduction in tumor size) and a decrease in the frequency of cancer recurrence. The manufacturing company compared these results to Lumkras alone in previous pre-clinical (not involving humans) studies.

“Given that KRAS G12C is the most common KRAS mutation in NSCLC, the advancement of the combination is important in understanding potential new treatment approaches,” said Dan Paterson, president and chief executive officer of Verastem Oncology, in the news release.

An ongoing phase 1/2 trial, RAMP 203 is evaluating the treatment of avutometinib with Lumakras, particularly in patients with KRAS G12C-mutant locally advanced or metastatic NSCLC, according to the news release. However, the study’s patient population also included those who had previously received a KRAS G12C inhibitor and those who were untreated with a KRAS G12C inhibitor.

The trial will analyze the effectiveness of the drug, along with the overall response rate (percentage of patients who show a partial or complete response to treatment) and safety in approximately 53 patients, according to ClinicalTrials.gov.

READ MORE: Expert Panel to Review Lumakras for KRAS G12C-Mutant Lung Cancer

The second phase of the study, the news release noted, aims to analyze KRAS-activating mutations, in which the RAMP 203 trial is enrolling patients who are either KRAS G12C inhibitor-resistant or patients who are KRAS G12C-mutant naïve. Results from this portion of the study are expected to be reported in the first half of 2024, the news release stated.

Lumakras, manufactured by biotechnology company Amgen, was approved by the FDA in May 2021 for patients with NSCLC and had a KRAS G12C mutation, and had previously received at least one systemic therapy. According to the FDA, 25% of mutations in NSCLC are KRAS mutations, whereas 13% of mutations in NSCLC are KRAS G12C mutations.

“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said in a news release after Lumakras’ approval.

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