In the phase II Reactive trial in patients with resected pancreatic cancer, MesoPher demonstrated a statistically significant 2-year Recurrence Free Survival of 60% and an excellent safety profile
The observed safety and statistically significant efficacy are the foundation for further randomized clinical research with MesoPher in pancreatic cancer
The randomized phase II/III DENIM trial in mesothelioma patients was completed but missed its primary endpoint despite MesoPher inducing a robust T-cell response
‘s-Hertogenbosch, the Netherlands; December 12, 2022. Amphera B.V., a late-stage biotechnology company developing MesoPher cell therapy to treat cancer, today reports topline results from both the phase II Reactive trial and the phase II/III DENIM trial.
In the phase II Reactive trial, patients with resected pancreatic cancer who had completed standard-of-care chemotherapy received 3 bi-weekly injections of Amphera’s MesoPher dendritic cell therapy and booster injections at 4 and 7 months.
The Reactive trial met the primary endpoint with topline safety and efficacy data from two cohorts of in total 38 patients demonstrating a statistically significant 2-year Recurrence Free Survival of 60%. The results from the first cohort of 10 patients have been published in the European Journal of Cancer1. Based on these results, a 2nd cohort of 28 patients was fully enrolled. As established in all MesoPher trials, the safety profile is excellent.
Prof Casper van Eijck, Principal Investigator of the Reactive trial: We are thrilled by the promising results of the Reactive trial. These 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 randomized 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.
In the DENIM trial, mesothelioma patients with stable disease or better after platin-pemetrexed chemotherapy received either MesoPher maintenance treatment or best supportive care (BSC). The dosing scheme was identical to the Reactive trial. The DENIM trial confirmed MesoPher’s excellent safety profile and MesoPher induced a robust T-cell response. The immune response did not translate into clinical benefit, and consequently the primary endpoint of an improvement of Overall Survival (OS) was not met.
The unexpected outcome of the DENIM trial can be attributed to two main factors. The majority of patients were already progressive before or during the first 3 bi-weekly injections, as evidenced by the CT scan performed after the third injection. As such, the first injections were administered too late, as MesoPher cannot exert its effects in progressive patients. Only a small proportion of patients received the full MesoPher treatment. In addition, both arms performed well with a median OS around 18 months after randomization, potentially due to the second-line therapy with checkpoint inhibitors.