Topline results are expected to be announced by the fourth quarter of 2022.
The last patient has completed the follow-up period for Amphera’s phase 2/3 clinical trial (DENIM; NCT03610360) of MesoPher, an autologous cell therapy being evaluated for the treatment of mesothelioma.1
MesoPher is made up of dendritic cells generated from monocytes obtained via leukapheresis from patients’ own blood. The dendritic cells are loaded in vitro with an allogeneic lysate of tumor cell lines called PheraLys, within which there are tumor-associated antigens. MesoPher previously received Orphan Drug Designation from both the FDA and the EMA.
“Despite the challenges experienced during the pandemic, we were able to maintain strong enrollment to the study,” Ilona Enninga, PhD, chief operating officer, Amphera, said in a statement.1 “The first patient was included in 2018, the last patient was included in June 2021 and completed the 12 month follow-up in June 2022. In total 176 patients were included. I would like to thank our investigators and the clinical study team for their exceptional efforts in keeping the study on track. We are now focused on database lock and subsequent statistical analysis.”
The open-label, two-arm, multicenter study enrolled patients over the age of 18 years who had a histologically confirmed diagnosis of pleural malignant mesothelioma. To be included, patients were required to be non-progressive following 4 to 6 cycles of first line chemotherapy with antifolate/platinum. In addition to best supportive care (BSC), patients in the experimental arm received MesoPher in the form of 3 bi-weekly injections, followed by 2 further injections at 4 months and 7 months, for a maximum of 5 injections. Patients in the non-intervention arm received BSC alone, as deemed appropriate by the local investigator. The primary end point is the overall survival (OS) rate of participants who received MesoPher and BSC compared to participants who received BSC alone, measured from random assignment to the last visit and last data collection point. Additional analysis will examine safety, tolerability, quality of life, and the immunogenicity of MesoPher.
In addition to Amphera’s lead trial DENIM, MesoPher is also being evaluated in 4 other ongoing clinical studies, including REACtiVe, a phase 2 study of MesoPher for the treatment of resected pancreatic cancer; REACtiVe-2, a study testing a combination of MesoPher and a CD40 agonist for patients with metastatic pancreatic cancer; and ENSURE (NCT05304208), a phase 1 study focused on treating abdominal mesothelioma and pleural mesothelioma with a combination of MesoPher and surgical resection.
“This is another significant milestone in the development of MesoPher after the promising efficacy results in pancreatic cancer reported earlier this year,” Rob Meijer, chief executive officer, Amphera, added.1 “The DENIM study is designed to be pivotal following discussions with the regulators. We plan to report topline results early in Q4 2022. The results are expected to be the basis for an EMA Marketing Authorization Application in H1 2023, starting the process of bringing this new therapy to mesothelioma patients.”