SillaJen, Inc. has reached an agreement with the FDA on a Special Protocol Assessment for a phase 3 clinical trial of its drug Pexa-Vec for the treatment of advanced liver cancer and will begin enrolling patients later this year, according to a press release.
The primary objective of the trial is to determine the overall survival benefit for patients receiving Pexa-Vec followed by Nexavar (sorafenib, Bayer Healthcare), compared with sorafenib alone in patients with advanced liver cancer, according to the release.
“The [Special Protocol Assessment] now enables SillaJen and its global partners to have clarity on the full registration pathway for Pexa-Vec,” Eun Sang Moon, chief executive officer of SillaJen, said in the release. “We are pleased to be in the position to initiate this pivotal study, and to be one step closer to bringing this first-line treatment for advanced liver cancer patients worldwide. We look forward to launching this trial before the end of this year, and are excited to continue working toward the successful development of Pexa-Vec.”
The randomized trial will enroll 600 patients with advanced liver cancer who are eligible to receive sorafenib therapy, according to the release. The study will be conducted at 120 sites worldwide including North America, Asia and Europe.
“We are eagerly looking forward to the initiation of this trial of Pexa-Vec in patients with incurable liver cancer,” Ghassan Abou-Alfa, MD, medical oncologist at Memorial Sloan Kettering Cancer Center and investigator on the phase 3 trial, said in the release. “Cancer immunotherapy is making a significant impact across multiple cancer types and we hope this trial will help bring a novel immunotherapy to liver cancer patients, particularly given the limited viable treatment options available to this patient population.” – by Melinda Stevens