Boehringer's Vargatef comes up one endpoint short in colorectal cancer effort

COPENHAGEN, Denmark--Boehringer’s looking to break into new markets with lung cancer med Vargatef (nintedanib). But in a Phase III study of patients with metastatic colorectal cancer, it came up just one-for-two on primary endpoints.

The med, when paired with best supportive care, improved progression-free survival in previously treated patients by 42%, Boehringer announced at the ESMO 2016 Congress. But that benefit didn’t translate into an improvement in overall survival. 

Now, Boehringer is analyzing the data to better understand the outcome, lead study investigator Eric Van Cutsem said in a statement. “While the outcome of the ... trial is not what we had hoped for, we continue to learn and evolve our research strategy with every study result from our development program,” BI’s VP and global head of medicine for oncology, Medhi Shahidi, added in separate remarks.


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Right now, Vargatef is approved in the EU, in combination with docetaxel, as a treatment for some non-small cell lung cancer patients who've failed first-line chemo. But Boehringer is aiming to build on that indication, and to do so, it’s testing the product in other cancers, including malignant pleural mesothelioma.

Of course, nintedanib isn’t just a cancer drug. Back in October of 2014, the FDA approved it as Ofev, a therapy to treat deadly lung disease idiopathic pulmonary fibrosis.

But U.S. regulators didn’t approve Ofev alone. They also green-lighted Roche’s Esbriet on the very same day, setting up a head-to-head battle for U.S. market share. 

Related Articles:
Boehringer's Ofev, chasing a Roche rival, wins backing from NICE
Obstacles aside, Boehringer sees class-topping prospects for Ofev, Spiolto
Boehringer revs up Ofev sales force, support services to rival Roche's Esbriet in IPF
Same-day approvals send Roche, Boehringer to IPF market battle

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