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Aduro pancreatic cancer vaccine trial disappoints

Immunotherapy combination fails to improve overall survival over existing treatments

Aduro logoAduro's combination immunotherapy regimen has failed a phase III trial in pancreatic cancer, the second cancer vaccine to do so in less than a week.

The immunotherapy combines CRS-207 - a drug that promotes the expression of the tumour-associated antigen mesothelin - with an immune-boosting GVAX cell line, and is Aduro's lead product candidate.

The regimen was unable to improve overall survival compared to chemotherapy or CRS-207 given alone, despite achieving that objective in an earlier phase IIa study, and shares in the company fell 17% yesterday.

Overall, patients on the combination lived for a median time of 3.8 months, less than the 5.4 months for the CRS-207 group and 4.6 months for those on chemotherapy, a finding chief executive Stephen Isaacs described as "unexpected".

"We are disappointed particularly for the pancreatic cancer patients who are in need of additional treatment options," continued Isaacs.

News that Aduro's combination product failed to meet its objectives in the phase IIb ECLIPSE trial comes just a few days after NewLink Genetics announced it was abandoning development of algenpantucel-L for post-surgical pancreatic cancer.

The failures are the latest in a string of setbacks for cancer vaccines, including clinical failures for GlaxoSmithKline's MAGE-A3 lung cancer vaccine, Vical's Allovectin and Merck KGaA/Oncothyreon's Stimuvax, and indeed GVAX itself as a monotherapy.

Add in the lacklustre commercial performance for Dendreon's (now Valeant's) Provenge - the only approved cancer vaccine - and the track record of the category makes for grim reading.

Aduro is not giving up on the CRS-207/GVAX vaccine just yet, although for the time being it has decided not to press ahead with plans to start a phase III trial of the vaccine.

The company said it was also "intrigued by activity seen with CRS-207 as a single-agent" and pointed to a high dropout rate in the chemo group which meant most patients "received a variety of combination treatments, including chemotherapies, immunotherapies and targeted therapies".

Isaacs said it continues to look forward to interim results later this year from its ongoing STELLAR trial, which is evaluating CRS-207 and GVAX pancreas given with and without Bristol-Myers Squibb's anti-PD1 checkpoint inhibitor Opdivo (nivolumab) as a second-line therapy for pancreatic cancer.

"Immunotherapy is ushering in a new era in our fundamental understanding of human biology," said clinical investigator Andrew Ko of the University of California, San Francisco.

"Although the results are not what we had hoped for from this well-executed trial, they will provide important information for changing the treatment paradigm in the future."

Article by
Phil Taylor

17th May 2016

From: Research

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