The FDA designation is intended for the usage of avutometinib along with Amgen’s LUMAKRAS to treat KRAS G12C-mutant metastatic NSCLC patients. Credit: Kateryna Kon / Shutterstock.com.

The US Food and Drug Administration (FDA) has granted fast track designation for Verastem Oncology’s investigational therapy, avutometinib, for treating non-small cell lung cancer (NSCLC).

The FDA designation is intended for the use of avutometinib along with Amgen’s LUMAKRAS (sotorasib) to treat KRAS G12C-mutant metastatic NSCLC patients previously treated with a systemic therapy.

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The process aids in the development of new therapies and speeds up their review for the treatment or prevention of serious ailments and for those with unmet medical needs.

A rapidly accelerated fibrosarcoma (Raf)/mitogen-activated protein kinase (MEK) RAF/MEK clamp drug, avutometinib acts on the rat sarcoma virus (RAS) pathway, a key source of acquired mutation in KRAS G12C-mutant NSCLC.

Preclinical studies have shown that an avutometinib and sotorasib combination regimen results in profound tumour regression and a reduction in tumour relapse frequency versus sotorasib alone.

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The RAMP 203 clinical development programme will indicate whether these preclinical results will translate into enhanced clinical outcomes in patients.

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The open-label, multicentre, RAMP 203 Phase I/II clinical trial evaluated the efficacy and safety of avutometinib in combination with sotorasib.

According to initial trial data, the combination regimen offered confirmed responses in both KRAS G12C inhibitor-resistant and naïve patients.

The pharmacokinetic profile of avutometinib plus sotorasib in the trial was consistent with the monotherapy trial with no drug-to-drug interactions reported.

Verastem Oncology president and CEO Dan Paterson stated: “Receiving fast track designation for the combination of avutometinib and sotorasib re-inforces the importance of improving the depth of MAPK pathway inhibition to enhance tumour regression relative to KRAS G12C inhibition alone and the potential of the combination of avutometinib and sotorasib in KRAS G12C mutant locally advanced or metastatic NSCLC.

“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.

“We look forward to continued interaction with the FDA as we advance the development of this promising treatment regimen.”