Trial to Investigate Novel Drug in KRAS-Mutant Lung Cancer

A new study just launched that will study a novel drug, VIC-1911, either alone or given in combination with Lumakras (sotorasib) for patients with KRAS G12C-mutant non-small cell lung cancer (NSCLC), according to VITRAC Therapeutics, the manufacturer of VIC-1911.

VIC-1911 works by inhibiting the amplification or overexpression of the AURKA gene, which, according to prior research, may play a role in regulating KRAS. Additionally, VITRAC explained in a press release that AURKA amplification may contribute to Lumakras resistance in patients with KRAS G12-mutant NSCLC. As such, researchers are hoping that the novel drug will boost responses to G12 inhibitors, such as Lumakras, in this patient population.

"Although response rates are considered good for patients naïve to KRAS G12C inhibitor therapy, more than 50% of patients have primary resistance and do not respond,” Dr. Sarah Goldberg, study chair, and associate professor of internal medicine at Tale School of Medicine, said in the press release. “In addition, many patients who do respond rapidly develop acquired resistance and relapse within months. With this new dual-targeted approach combining AURKA and KRAS G12C inhibitors, we hope to improve therapeutic outcomes for our patients with KRAS G12C-mutant NSCLC."

Researchers will soon start recruiting patients to participate in the clinical trial, which is occurring at cancer centers in California, Connecticut, Georgia, Maryland and New York. They plan on enrolling approximately 140 patients.

To be eligible, patients must have locally advanced or metastatic KRAS G12C-mutant NSCLC; have received one or more prior line of therapy with an anti-PD-1 or PD-L1 immunotherapy agent, with or without platinum-based chemotherapy; a life expectancy of three months or longer; are able to perform all or most of their daily tasks; and have adequate organ function.

The main goal of the phase 1 trial is to study the incidence and tolerability of treatment-related side effects. Secondary goals are: objective response rate (percentage of patients whose disease shrinks as a result of treatment); duration of response; time to response; disease control rate (percentage of patients whose cancer shrinks, disappears or stops growing); progression-free survival (time from treatment until disease worsens); and overall survival (time from treatment until death of any cause).

Once the ideal dose is determined in the earlier phases of the trial, the regimens will be given to more patients to determine how well it works.

"VIC-1911 is a potent, selective AURKA inhibitor. Preclinical studies strongly support the combination of AURKA inhibition with VIC-1911 and KRAS G12C inhibitors in KRAS G12C-mutant NSCLC", said Dr. Thomas Myers, chief medical officer at VITRAC. "By utilizing this multi-targeted approach, we hope to provide a more effective therapeutic outcome for patients with KRAS G12C-mutant NSCLC."

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