Shares of Oncothyreon Inc. (ONTY) fell hard Wednesday morning upon reports that pivotal Phase III trials for its L-BLP25 (formerly “Stimuvax”) missed on the primary endpoint of improving the overall survival rate in non-small cell lung cancer patients (NSCLC). The START trial, which was conducted by Merck KGaA under a license agreement with Oncothyreon included more than 1,500 patients with stage III NSCLC whose tumors were not resectable and whose cancer had been stabilized with chemoradiotherapy.
In a statement today, Oncothyreon noted that although the primary endpoint was not met, effects were seen in specific subgroups, opening the door to potential additional studies focused on those targets. It is planned that Merck Serono, a division of the German biotech giant that was responsible for the START trial, will speak with experts and regulatory authorities in coming months about possibilities within certain populations.
"These results from the START trial are disappointing, both for patients with NSCLC and for the many who have been involved in the L-BLP25 program," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon.
The disappointing results were foreshadowed in March when data only small amounts of efficacy were reported in data from three-quarters of the patient population. Many analysts had written-off the likelihood of success for the new drug candidate, limiting the impact on shares of Merck, which slipped about 3 percent in European trade. Shares of tiny Oncothyreon, which closed Tuesday at $4.50 are taking a beating; cratering as low as $1.44 in premarket trading.
"Given the history of the drug development with postponements, discontinuations and break-ups we are not surprised about today's outcome," said DZ Bank analyst Peter Spengler, according to a report from Reuters.
L-BLP25 has been in development for more than a decade as a vaccine therapy for cancer, a therapy that stimulates the body’s immune system to fight tumors. Immunologic therapies have been heralded for their great potential, but have yet to make much of a splash in oncology. Dendreon Corporation’s (DNDN) Provenge was the first cancer vaccine to win FDA approval two years ago, but has still not garnered the sales or industry acceptance to the magnitude that many analysts had predicted.
Just after the opening bell, shares of ONTY as still down 57% at $1.94.
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