logo
Plus   Neg
Share
Email

Merck: Phase III JAVELIN Lung 200 Trial With Avelumab Fails To Meet Endpoint

Merck KGaA (MKGAY.PK) and Pfizer Inc. (PFE) announced results from the Phase III JAVELIN Lung 200 trial comparing avelumab to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer whose disease progressed after treatment with a platinum-containing doublet therapy. The company said, while the trial did not meet its prespecified endpoint of improving overall survival in patients with programmed death ligand-1-positive tumors, the proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in post-platinum immunotherapy clinical trials, and this may have confounded the trial outcome.

The company said the safety profile for avelumab in the trial was consistent with that observed in the overall JAVELIN clinical development program; no new safety signals were identified.

"When the primary endpoint is not met, statistical significance cannot be formally claimed with the predefined statistical significance level. In this circumstance, the Type I error is not strictly controlled and the p-value should be interpreted cautiously," the company said.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
MillerCoors LLC has filed a lawsuit against Anheuser-Busch Companies LLC, part of Anheuser-Busch InBev, alleging that Anheuser-Busch's ad campaigns associating MillerCoors' products, Miller Lite and Coor Light, with corn syrup is "false and misleading." During the Super Bowl, ABInBev ran an advertising campaign that mocked Miller Lite and Coors Light use corn syrup in brewing. Shares of Biogen Inc. are falling almost 28 percent in Thursday's trading after the company and Japanese drugmaker Eisai Co. said they will discontinue two late-stage trials for their experimental Alzheimer's drug, Aducanumab. The two Phase 3 trials, ENGAGE and EMERGE, are multi-center, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate Aducanumab. The European Union on Wednesday ordered Alphabet Inc.'s Google to pay an antitrust fine of 1.49 billion euros for abusing its dominant position in the online search advertising intermediation market by preventing competition. This is the third antitrust fine by the EU against Google and it represents 1.29 percent of the tech giant's turnover in 2018.
Follow RTT