Immuno-oncology, Results

Merck racks up another win in wide-ranging PhIII Keytruda lung cancer study, this time as solo therapy

Merck $MRK has scored another big win in its broad range of pivotal Keytruda studies in lung cancer.

This morning investigators report that KEYNOTE-042 demonstrated that patients taking their PD-1 checkpoint drug as a monotherapy had a significant advantage over chemo alone in frontline non-small cell lung cancer. The study offers an opportunity to treat lung cancer without chemo, giving patients a route to forgoing some harsh side effects.

Roger Perlmutter

Significantly, the company tested overall survival in patients expressing PD-L1 at 1% or higher and swept the board. Evaluating patients with a tumor proportion score of ≥50 percent, with a TPS of ≥20 percent and then in the entire study population with a TPS of ≥1 percent, it hit on every measure — winning out over Bristol-Myers Squibb’s $BMY Opdivo, which failed in the overall population as a solo therapy.

The news gives Merck another leg up in the intense competition for lung cancer patients, where AstraZeneca $AZN has also been looking to carve out a major role for itself with durvalumab.

Investors liked the sound of it all, driving Merck shares up 2.6% Monday morning.

The pharma giant didn’t offer any data this morning, waiting for an upcoming conference. They’re also still evaluating the progression-free survival results.

Merck has fired up more than 700 clinical trials using Keytruda in various settings, looking to overtake Bristol-Myers as it evaluates a new wave of studies using different combination approaches to cancer.

“With KEYNOTE-042, Keytruda has now shown a significant survival benefit compared with chemotherapy for patients with locally advanced or metastatic nonsquamous or squamous NSCLC expressing PD-L1 at 1 percent or higher by tumor proportion score,” said Roger Perlmutter, the head of Merck Research Laboratories. “Keytruda is a foundational treatment for NSCLC and has consistently demonstrated a survival benefit as monotherapy, or in combination with chemotherapy, in the treatment of metastatic lung cancer.”


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 31,500+ biopharma pros who read Endpoints News by email every day.

Free Subscription


Chief Medical Officer
Skyhawk Therapeutics Waltham, MA
Chief of Staff, North America
Ipsen Biopharmaceuticals Cambridge, MA
Senior Director, NA Digital Customer Interaction
Ipsen Biopharmaceuticals Cambridge, MA
GMP Supervisor - Downstream
Molecular Templates Austin, TX
Quality Control (QC) Associate
Molecular Templates Austin, TX

Visit Endpoints Careers ->