SAN FRANCISCO (Reuters) - An interim look at a pivotal trial of Oncothyreon’s experimental vaccine for lung cancer, expected this quarter, could signal whether its investment will ever pay off.
Robert Kirkman, chief executive officer of Oncothyreon, said the interim review is triggered when a certain number of patients have died.
“In some sense, the longer it takes the better it is,” he said in an interview on Wednesday during the JP Morgan Healthcare conference.
The worst case scenario would be if independent overseers stop the trial after determining that Stimuvax is not working, while the best case would be if they stop the study early because the data shows clear efficacy.
“We would be perfectly content if the decision is to continue the trial to its end,” Kirkman said. “We still expect to have top-line data in 2012. If the trial continues, we would have those results in the second half.”
Oncothyreon has licensed the vaccine, Stimuvax, to Germany’s Merck KGaA, which is conducting the expensive Phase III trial involving 1,514 patients.
The trial is designed to show that Stimuvax improves survival by at least 6 months in newly-diagnosed lung cancer patients who have tumors confined to the chest cavity, but are not eligible for surgery, the CEO said.
Patients are treated with standard therapy of chemo and radiation followed by maintenance with Stimuvax, which is designed to prime a patient’s immune system against certain cancer cells.
If Stimuvax is approved by regulators, Oncothyreon would receive $90 million in milestone payments as well as royalties in the mid-teens for North American sales and high single digits for the rest of the world.
“It will be transformative for us and it would be transformative in lung cancer,” Kirkman said.
Positive trial results would also be validation for Oncothyreon’s wholly owned follow-on cancer vaccine, ONT-10, for which it hopes to start human trials this quarter.
“We own all the rights. So to some extent we are doubling down on Stimuvax,” he said.
The biotech company also expects results late this year from four Phase II cancer trials of its experimental PX-866 — a drug from a class known as PI-3 kinase inhibitors. Several other companies are pursuing similar drugs and are likely to have mid-stage trial results this year as well.
“That’s going to shake the field up. We are hoping that somebody will fail and they will then come to us,” Kirkman said of potential partners.
Reporting by Deena Beasley; editing by Carol Bishopric