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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.

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