Next up for Aduro is the Stellar study, also of CRS-207, but with some differences: as well as GVAX Pancreas it also incorporates Bristol-Myers Squibb’s checkpoint inhibitor Opdivo, and is enrolling second-line pancreatic cancer patients. “The jury is out on what effect GVAX has – it appears not to add to the party but it’s not clear if it has a negative effect,” said Mr Isaacs.
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Nonetheless, Aduro does not plan on taking CRS-207 plus GVAX Pancreas into a phase III trial.
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This made the trial results “largely uninterpretable” according to Leerink analysts. One drawback of the trial was the inability to blind patients to what treatment they would be receiving, explained chief executive Steve Isaacs on a conference call to discuss the results – meaning that control patients, disappointed at not being in the immunotherapy arm, dropped out before receiving their first chemotherapy session and ended up getting more aggressive combination treatment including chemotherapies, immunotherapies and targeted therapies. Patients in the latter were scheduled to receive single-agent chemotherapy and this group saw a “disproportionately high dropout rate” that could have confounded results, Aduro believes. Overall survival was increased in the CRS-207 monotherapy arm versus the control arm. Two studies do not make a trend, but it is something that will be closely watched in future cancer vaccine trials – and could be another hurdle for an already troubled field ( Therapy focus – Testing times for cancer vaccines, May 12, 2016).Īduro had been hoping to show an overall survival benefit with CRS-207 plus GVAX Pancreas, another cancer vaccine, in the Eclipse phase IIb study in third-line pancreatic cancer – but actually found decreased survival in this arm.
This raises the question of whether cancer vaccines might be harmful rather than just ineffective. But perhaps most worrying is the fact that the control arm outperformed the main treatment arm – a phenomenon that was also seen last week with NewLink Genetics’ ( NLNK) vaccine algenpantucel-L. Aduro’s ( NASDAQ: ADRO) CRS-207 is the second pancreatic cancer vaccine to crash and burn this month, and the fourth drug candidate to fail in the disease this year.
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