Merck (MSD) has launched a Phase III clinical trial of its investigational oral selective Kirsten rat sarcoma glycine 12 to cysteine (KRAS G12C) inhibitor, MK-1084, plus KEYTRUDA to treat certain metastatic non-small cell lung cancer (NSCLC) patients.

This study will analyse the combination regimen as first-line treatment for metastatic NSCLC patients with tumours exhibiting KRAS G12C mutations and programmed death-1 ligand 1 (PD-L1) expression.

The double-blind, randomised, multicentre trial will assess the safety and effectiveness of MK-1084 plus KEYTRUDA against KEYTRUDA with a placebo.

Approximately 600 previously untreated patients with metastatic NSCLC with KRAS G12C mutations and a PD-L1 tumour proportion score (TPS) TPS of 50% or more from across the globe will be enrolled in the trial.

Progression-free survival and overall survival are the study’s primary endpoints.

Key secondary endpoints of the trial are objective response rate and duration of response.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Merck is developing MK-1084 in partnership with Taiho Pharmaceutical and Otsuka Pharmaceutical subsidiary Astex Pharmaceuticals under a deal signed in 2020.

The asset is currently being analysed in an open-label, multicentre Phase I trial to assess the safety, tolerability, pharmacokinetics, and efficacy as both a monotherapy and as a combination regimen in KRAS G12C mutant advanced solid tumour patients.

Merck Research Laboratories oncology global clinical development head and senior vice-president Dr Marjorie Green said: “KRAS is among the most prevalent mutations in cancer and KRAS G12C is the most common KRAS mutation in patients with non-small cell lung cancer.

“Based on early evidence showing MK-1084 in combination with KEYTRUDA had a manageable safety profile and promising anti-tumour activity, we are now proceeding to a larger Phase III trial to evaluate this combination in certain patients with metastatic non-small cell lung cancer.”

Last month, the company reported that the Phase III KEYNOTE-A18 trial of Keytruda plus chemoradiotherapy (CRT) in cervical cancer patients met the primary endpoint.