ESMO: Merck's Keytruda pushes for 2nd esophageal cancer nod with first-line survival win

Keytruda
Merck's Keytruda already boasts a second-line esophageal cancer approval. (Merck)

Merck’s Keytruda already boasts an OK in some esophageal cancer patients, but it’s looking to widen its reach in the tough-to-treat disease.

Adding Keytruda to platinum-based chemo reduced the risk of death by 27% and the risk of disease worsening or death by 35% for previously untreated patients with advanced or metastatic forms of the disease, the company said Monday at the European Society for Medical Oncology’s (ESMO's) virtual annual congress.

Patients on Keytruda lived a median 12.4 months versus 9.8 months for chemo, Merck said.

Free Webinar

Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. In this webinar, learn the benefits of utilizing demand-led supply and direct-to-patient distribution models in the clinical supply chain, as well as how they can be used to both improve flexibility and better align with patient needs. Register today!

RELATED: Merck's Keytruda slashes death risk by 31% in esophageal cancer victory

Chemotherapy has long been the standard of care in this setting, “so being able to actually show that something improves on what’s been kind of the gold standard for many years is really going to be very well received by the physicians and the patients that they serve,” Scot Ebbinghaus, Merck's vice president of clinical research, said.

What’s more, Keytruda boosted survival across various subgroups. Patients saw benefit whether their cancer was in the esophagus or the gastroesophageal junction, whether their cancer was classified as adenocarcinoma or squamous cell carcinoma and whether their tumors expressed biomarker PD-L1.

“Overall, the take-home message is that irrespective of histology, irrespective of the expression of PD-L1, there was an improvement in overall survival,” Ebbinghaus said.

That across-the-board benefit is not something Merck saw for Keytruda in previously treated patients. In the second-line setting, the drug is approved only for those with squamous cell carcinoma whose tumors test positive for PD-L1.

But Merck, looking to expand Keytruda’s role in treating the disease, is taking the new data—which come from the Keynote-590 trial—to regulators around the world, it said.

RELATED: ESMO: Bristol Myers' Opdivo racks up GI cancer data for two potentially practice-changing FDA nods

Keytruda, though, was not the only immuno-oncology drug to make waves at ESMO with new data in the metastatic gastroesophageal arena. Also Monday, Bristol Myers Squibb showed that adding its rival drug Opdivo to chemo could cut the risk of death by 20% among first-line patients—and that figure went up to 23% among PD-L1-positive patients.

The results from the two studies can’t be directly compared, considering differences in trial population; Opdivo’s trial included gastric cancer patients in addition to those with esophageal cancer. But the companies are likely to be touting at least partially overlapping approvals in the not-too-distant future.

Suggested Articles

Former Indivior CEO Shaun Thaxter will face six months in federal prison for his role in misleading government officials on the dangers of Suboxone.

As of Friday after local time, 36 people have died in Korea after getting flu shots provided by at least seven companies, including Sanofi.

Two prominent pneumococcal vaccines from Merck and Pfizer are running low in Europe in a possible ill omen for the coming winter: report.