Verastem Inc. (NASDAQ:VSTM) has announced the commencement of a second phase registration-directed clinical study of VS-6766 in patients with KRAS mutant non-small cell lung cancer (NSCLC). VS-6766 is an RAF/MEK inhibitor that the company will evaluate alone or in combination with its FAK inhibitor, defactinib.
Verastem to evaluate VS-6766 in KRAS mutant NSCLC
Brian Stuglik, the company’s CEO, said that the currently available alternative for KRAS mutant NSCLC patients are less effective and are often associated with toxicity and resistance issues. Stuglik said that the study will elucidate further VS-6766’s impact alone or in combination with FAK inhibitor to overcome these challenges and enhance outcome. He explained that the focus of the company’s VS-6766 and defactinib NSCLC development program on G12V mutation is unique and it represents a massive step forward in understanding how to deliver better treatment to mutant NSCLC patients.
The RAF/MEK program (RAMO 202) is a second phase adaptive two-part multicentre, open-label, parallel cohort, randomized trial. The study will evaluate VS-6766’s safety and efficacy alone or in combination with defactinib in KRAS mutant NSCLC patients, after a platinum-based regimen and immune checkpoint inhibitor treatment. The first part of the trial will be determining the optimal regimen of VS-6766 or in combination with defactinib in KRAS-G12V mutant NSCLC patients randomized 1:1 in each arm.
Verastem to determine regimen first before expanding the study
Notably, an exploratory arm in the first phase of the trial will evaluate KRAS mutations to determine the regimen to take forward for the expansion phase of the trial. In the second phase, the company will evaluate the safety and efficacy of the most effective regimen.
The study’s principal investigator D. Ross Camidge said that they are looking to advance understanding on a possible new alternative for KRAS mutant NSCLC patients by targeting RAF/MEK and FAK pathways. Camidge explained that there have been some critical advances from the evaluation of certain KRAS mutations and also focusing on G12V mutations. As a result, this will help the team to focus on areas that have demonstrated promise and determine the most ideal path forward.