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NewLink pancreatic cancer vaccine flunks phase III test

Survival rate slightly lower for patients on vaccine than those in control group

NewLinkNewLink Genetics is under pressure after its pancreatic cancer vaccine fared poorly in a phase III trial, raising doubts about its R&D platform.

The IMPRESS trial of algenpantucel-L in patients with post-surgical (resected) pancreatic cancer showed that patients on the vaccine actually survived for a slightly shorter time than a control group (27 months versus 30 months) - although there was no statistically significant difference between the two arms.

Three years after enrolment the survival rate in the algenpantucel-L-treated group was 41%, compared to 42% for the control group, dropping to around 33% apiece after four years.

The resounding failure of the trial dashes NewLink's hopes that algenpantucel-L would become the first FDA-approved therapy for post-surgical pancreatic cancer, and looks likely to reflect very poorly on its HyperAcute cellular immunotherapy programme. 

Along with algenpantucel-L, the HyperAcute pipeline also includes candidates for non-small cell lung cancer (NSCLC) and melanoma in phase II and two therapies for solid tumours in phase I. The firm's chief medical officer Nicholas Vahanian said it was "evaluating the future of the HyperAcute platform" in light of the new data.

NewLink is also carrying out a phase III trial (PILLAR) of algenpantucel-L in patients with locally-advanced pancreatic cancer, which completed enrolment in December 2015, but for now has not commented on the status of that study.

The company said in a statement that it was "deeply disappointed for patients", extending its thanks to all those who contributed to the trial, and indicating it would now focus its efforts on its IDO checkpoint inhibitor programme.

The IDO inhibitor pipeline is currently led by indoximod, which is in phase II for breast cancer (in combination with taxane drugs docetaxel and paclitaxel) and prostate cancer (in combination with Valeant's Provenge vaccine), with Genentech-partnered taxane drug GDC-0919 following on behind.

Shares in NewLink lost more than a third of their value in after-hours trading. The company said it ended the first quarter with cash reserves of $178m, and should end the year with around two years' operating money.

Article by
Phil Taylor

11th May 2016

From: Research, Regulatory

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