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.

Amazing how KEYNOTE-042 succeeded in the entire > 1% cohort that Bristol failed in years ago. Keytruda is king.

— Brad Loncar (@bradloncar) April 9, 2018

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.”