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Unhappy times continue at OncoMed with more disappointing results

Lung cancer candidate tarextumab fails phase II trial

pharma

Bad news is supposed to come in threes but OncoMed is one ahead of that tally after a torrid few days that means it now has to completely rethink its R&D pipeline.

The US biotech has just revealed that its lung cancer candidate tarextumab has failed a phase II trial shortly after its lead drug demcizumab for pancreatic cancer did likewise, and after Bayer handed back rights to two partnered drugs. Adding to the pain OncoMed has also discontinued a phase 1b trial of a colorectal cancer drug because of toxicity.

Shares in the company were already in a steep decline but slumped by almost a third yesterday after OncoMed announced that its anti-Notch2/3 antibody tarextumab was unable to extend progression-free survival (PFS) or overall survival (OS) when added to chemotherapy in patients with small-cell lung cancer (SCLC) in the PINNACLE trial.

OncoMed delved into the biomarkers for Notch 2/3 activity to see if tarextumab was able to show some activity against a subset of patients, but was unable to find any evidence of a benefit or indeed signs that the drug was activating Notch pathway genes.

At the same time the company has confirmed it will halt a phase 1b trial of anti-Notch1 drug brontictuzumab as a third-line colorectal cancer treatment because the combination of the drug and chemotherapy was not tolerable for patients.

The brace of bad news comes just days after the company said Celgene-partnered anti-DLL4 antibody demicizumab flunked the YOSEMITE trial, which was looking at the combination of the drug with Celgene's Abraxane (albumin-bound paclitaxel) in previously-untreated patients with metastatic pancreatic cancer.

Adding demicizumab to Abraxane made no difference to PFS or OS, prompting OncoMed to halt enrolment in all trials of the antibody and casting a big doubt over a $70m opt-in to the programme.

Earlier this month OncoMed revealed that Bayer had decided not to license two Wnt inhibitors - vantictumab and ipafricept - for "strategic reasons". The company said it was pleased to regain ownership of the phase I assets saying that cash received from Bayer to date meant they were fully funded, but investors reacted negatively to the news and sent its shares into a tailspin.

OncoMed's remaining hope for some positive clinical trial newsflow in the first half of the year is the phase II DENALI trial of demicizumab in non-small cell lung cancer, which will likely determine the fate of the drug.

"Based on the events of today and last week, we will be undertaking a comprehensive portfolio prioritisation review immediately," said Paul Hastings, chief executive of OncoMed, which also saw the departure of chief medical officer Jakob Dupont earlier this year.

"The immediate task ahead is to thoroughly examine the available data, our resources and the opportunities to re-focus our efforts," he added.

Article by
Phil Taylor

18th April 2017

From: Regulatory

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