A new study has just been launched that will study a new drug, VIC-1911, alone or given in combination with Lumakras (sotorasib) for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC), according to VITRAC Therapeutics, the maker of VIC-1911.
VIC-1911 works by inhibiting the amplification or overexpression of the AURKA gene, which previous research suggests may play a role in regulating KRAS. In addition, VITRAC explained in a press release that AURKA amplification may contribute to resistance to Lumakras in patients with KRAS G12-mutated NSCLC. As such, the researchers hope that the new drug will promote responses to G12 inhibitors, such as Lumakras, in this patient population.
“Although response rates are considered good for patients who have not yet received KRAS G12C inhibitor therapy, more than 50% of patients have primary resistance and do not respond,” said Sarah Goldberg, Ph.D., study leader and associate professor of internal medicine at the Tale School of Medicine. is in a press release.”Furthermore, many patients who respond quickly 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 begin recruiting patients to participate in the clinical trial, which is taking place at cancer centers in California, Connecticut, Georgia, Maryland and New York. They plan to include about 140 patients.
To be eligible, patients must have locally advanced or metastatic KRAS G12C-mutant NSCLC; have received one or more prior lines of therapy with an anti-PD-1 or PD-L1 immunotherapy agent, with or without platinum-based chemotherapy; life expectancy of three months or longer; are able to perform all or most of their daily tasks; and have the appropriate organ function.
The main objective of the phase 1 trial is to study the incidence and tolerability of treatment-related adverse events. Secondary objectives are: objective response rate (percentage of patients whose disease is reduced as a result of treatment); response duration; response time; disease control rate (percentage of patients whose cancer shrinks, disappears or stops growing); progression-free survival (time from treatment to disease worsening); and overall survival (time from treatment to death from any cause).
Once the ideal dose is determined in the earlier stages of the trial, the regimens will be given to a larger number of patients to see 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. “Using this multi-targeted approach, we hope to provide a more effective therapeutic outcome for patients with KRAS G12C-mutant NSCLC.”
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