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Aduro Biotech Phase II Pancreatic Cancer Trial CRS-207 plus cancer vaccine GVAX Fails

Posted in Cancer - General, Cancer and Current Therapeutics, CANCER BIOLOGY & Innovations in Cancer Therapy, Immunology, Immunotherapy, tagged aduro biotech, Cancer - General, cancer immunotherapeutics, Cancer immunotherapy, cancer vaccine, Clinical trial, immunomodulators, listeria, Pancreatic cancer, PD1 on May 16, 2016| Leave a Comment »

Aduro Biotech Phase II Pancreatic Cancer Trial CRS-207 plus cancer vaccine GVAX Fails

Reporter: Stephen J. Williams, Ph.D

From Biospace News

May 16, 2016
By Alex Keown, BioSpace.com Breaking News Staff

BERKELEY, Calif. – Shares of Aduro Biotech (ADRO) have fallen more than 25 percent this morning following news that the company’s Phase II trial for its combination pancreatic cancer drug, CRS-207 did not meet its primary endpoint of survivability.

Aduro said its Eclipse trial of CRS-207 failed to show an improvement in overall survival for patients with pancreatic cancer who had failed at least two prior therapies in the metastatic setting. Median overall survival was 3.8 months for patients treated with the immunotherapy regimen of CRS-207 and the cancer vaccine GVAX pancreas, 5.4 months for patients treated with CRS-207 alone and 4.6 months for patients administered chemotherapy. Aduro said there were no reported safety concerns during the trial and full study findings will be presented at a later date.

Stephen T. Isaacs, chairman, president and chief executive officer of Aduro, called the findings a disappointing and “unexpected outcome.’

“While we are well aware of the very difficult-to-treat nature of late-stage metastatic pancreatic cancer, we are surprised by the divergence of these data from the results of our Phase IIa study. At the same time, we continue to look forward to the interim results later this year from our ongoing Stellar trial, which is evaluating CRS-207 and GVAX Pancreas with and without the anti-PD1 checkpoint inhibitor nivolumab as a second-line therapy for patients with metastatic pancreatic cancer,” Isaacs said in a statement.

For full story please see http://www.biospace.com/News/aduro-biotechs-stock-craters-after-pancreatic/419628/source=TopBreaking

Also from FierceBiotech

UPDATED: Aduro combo fails in a key pancreatic cancer study

see at http://www.fiercebiotech.com/aduro-combo-fails-a-key-pancreatic-cancer-study

by John Carroll |

May 16, 2016 8:38am

Breaking

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“Median overall survival (MOS) in this third-line and greater setting was 3.8 months for patients treated with the immunotherapy regimen of CRS-207 and GVAX Pancreas, 5.4 months for patients treated with CRS-207 alone and 4.6 months for patients administered chemotherapy,” the company reported.

Aduro’s stock ($ADRO) plunged 30% on the news in premarket trading.

“While we are well aware of the very difficult-to-treat nature of late-stage metastatic pancreatic cancer, we are surprised by the divergence of these data from the results of our Phase 2a study,” said CEO Stephen Isaacs. But the company hasn’t given up hope on its lead program.

“In the overall survival analysis, we were intrigued by activity seen with CRS-207 as a single-agent. While the median duration of 5.4 months appears greater for CRS-207, the overall survival curve of CRS-207 alone was comparable to overall survival seen with chemotherapy. Of note, due to a disproportionately high dropout rate in the single-agent chemotherapy arm, most of these patients instead received a variety of combination treatments, including chemotherapies, immunotherapies and targeted therapies,” said Dirk Brockstedt, executive vice president, research and development for Aduro.

In a conference call with analysts Aduro execs noted that they are now shelving plans for a pivotal Phase III study in pancreatic cancer, focusing on an ongoing study in the pipeline that includes a checkpoint inhibitor.

The history of cancer vaccines not customized to individual patients has been a litany of failure, with programs for Stimuvax and others experiencing a string of defeats in the clinic. Celldex joined that circle of failure recently with a Phase III miss for Rintega. Aduro, though, doubled down on the cancer vaccine strategy and was able to strike some big-money pacts along the way on the basis of some promising midstage data.

GVAX Pancreas is based on a pancreatic cell line modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine known to stimulate the immune system. CRS-207 is made up of attenuated (deactivated) Listeria monocytogenes that express mesothelin, sparking another immune response to a protein concentrated on pancreatic cancer cells. Together, they’re supposed to provide a one-two punch against cancer, with an option to add on additional drugs to continue to build an attack on cancer cells.

That was the only workable strategy with GVAX, which, like other cancer vaccines, wasn’t able to spur a strong enough response to make a significant difference in the fight against cancer as a solo therapy, allowing Aduro to buy it for a song in early 2013. Monday’s conference call included several skeptical remarks from analysts about GVAX’s future, if any.

Aduro was on hand at the 2013 ASCO confab to review the data from a midstage study involving 93 patients with advanced pancreatic cancer. A combination of chemo plus GVAX pancreas and CRS-207 significantly outperformed GVAX and chemo, bumping up overall survival from 3.9 months to 6.1 months. That’s not a big gain, but it was a sign of progress in a very tough field. And it was good enough for the FDA to grant a breakthrough drug designation.

Now the company is forced into a classic defensive crouch, citing its significant cash reserves as it looks to regroup.

– here’s the release