Treatment demonstrated significant survival data in addition to a sustained safety profile
Amphera – a company developing MesoPher cell therapy to treat cancer – has delivered positive results from its phase 2 Reactive trial and phase 2/3 DENIM trial.
During the phase 2 Reactive study, patients with resected pancreatic cancer who had completed standard-of-care chemotherapy received three bi-weekly injections of Amphera’s MesoPher dendritic cell therapy along with booster injections at four- and seven-month intervals.
The research met the primary endpoint with efficacy and safety data from two cohorts across a study of 38 patients. This demonstrated a statistically significant two-year recurrence free survival of 60% as well as an excellent safety.
Meanwhile, in the DENIM trial, mesothelioma patients with stable disease received either MesoPher maintenance treatment or the best supportive care available. The study also involved identical dosing to the Reactive trial.
The study reinforced MesoPher’s sound safety profile, while also demonstrating the therapy’s ability to induce a robust T-cell response. The immune response, however, did not translate into clinical benefit and therefore the primary endpoint of improved of overall survival was not met.
This could be attributed to two main factors – the majority of patients were already progressive before or during the first 3 bi-weekly injections, while only a small proportion of patients actually received the full MesoPher treatment.
Professor Casper van Eijck, principal investigator of the Reactive trial, commented: “We are thrilled by the promising results of the Reactive trial. The results exceed expectations for this group of patients compared to the best current treatments. A 60% 2-year recurrence free survival after surgical resection truly is an exceptional outcome.”
“Further randomised clinical research with MesoPher in pancreatic cancer is a likely next step. In addition, we have seen that MesoPher induces a T-cell response against the tumour of patients, which could explain the efficacy, although pancreatic cancer is known as a cold tumour,” he added.
