DARMSTADT, Germany A division of German drug maker Merck KGaA has resumed its clinical trial of a vaccine for lung cancer, Merck KGaA said Thursday.
Merck Serono and U.S. affiliate EMD Serono, which operates under that name in the United States to avoid confusion with U.S.-based Merck, said they soon would start enrolling and treating patients with non-small cell lung cancer in the phase 3 “START” and “INSPIRE” studies of Stimuvax (BLP25 liposome vaccine), following approval by regulators. The Food and Drug Administration had placed a hold on the trial following reports of encephalitis in a patient during a phase 2 trial program, leading Merck Serono to suspend the trial worldwide. The hold remains in effect in a study of the vaccine in patients with advanced breast cancer.
“Merck Serono remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients,” Merck Serono EVP oncology Wolfgang Wein said. “We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients.”