OncoMed racks up three straight clinical disasters as lead drug implodes

OncoMed CEO Paul J. Hastings

OncoMed $OMED just added a fresh page to its nightmare story on cancer drug development.

Following up recent back-to-back clinical failures, the biotech says that its lead drug — demcizumab, partnered with Celgene — just failed a Phase II study for non-small cell lung cancer. The drug already failed a Phase II study for pancreatic cancer recently. And then three weeks ago tarextumab plus chemo also failed a Phase II study. And that all followed a key mid-stage flop a year ago.

This time, the drug not only failed to beat a placebo, it did significantly worse than the sugar pill.

Specifically, the ORR was 28% versus 52% (p=0.04) and CBR was 79% versus 92% (p=0.17) in the pooled demcizumab arms and the placebo arm, respectively. Median PFS was 5.5 months versus 8.7 months (p=0.02) and mOS was 15.5 months versus not reached (p=.06) in the pooled demcizumab arms and the placebo arm, respectively.  No statistically significant differences in efficacy were observed between patients receiving one course or two courses of demcizumab.

It’s all over for demcizumab now. OncoMed says it will halt all work on the drug, including a combination trial with Keytruda.

A little over three years ago Celgene bought into that drug and a package of six therapies with a $177.5 million upfront, including money for an equity stake.

The litany of disasters in recent weeks also includes Bayer Pharma’s decision to notify OncoMed that it decided not to exercise its option on the biotech’s Wnt pathway inhibitors vantictumab (anti-Fzd, OMP-18R5) and ipafricept (Fzd8-Fc, OMP-54F28) for “strategic reasons.”

OncoMed now has $156 million in cash to work with. Its shares, already beaten down with a market cap at $135 million, dropped another 17% on the news.

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