New Medicines

MesoPherPleural malignant mesothelioma - maintenance therapy after chemotherapy


New molecular entity

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Aug 22Amphera plans to report top-line results of the DENIM trial early in Q4 2022. The results are expected to be the basis for an EMA Marketing Authorisation Application in H1 23 [9].
Jun 14Granted orphan drug status in EU & US [3].


Cancer vaccine comprising autologous dendritic cells pulsed with allogeneic tumour cell lysate. Dendritic cells taken from the patient are mixed in the laboratory with components of five different types of malignant mesothelioma cells. The immune system recognises similar components in the patient's own malignant mesothelioma cells as foreign and stimulates an immune response, when the cells are injected back into the patient. Given as three bi-weekly injections, plus 2 doses at weeks 18 and 30.
Malignant mesothelioma is a rare malignancy. It is three times more common in men than in women. Almost half (47%) of cases of mesothelioma are diagnosed in people aged 75 and over. The incidence of malignant pleural mesothelioma in males in the UK is 3.4 per 100,000. There are around 2,700 new cases in the UK each year [1].
Pleural malignant mesothelioma - maintenance therapy after chemotherapy

Trial or other data

Jun 22The last patient has completed the active follow-up in the PII/III DENIM study of MesoPher cell therapy to treat pleural mesothelioma [9].
Jun 21Pooled efficacy data from three phase I trials in mesothelioma presented at the 57th Annual Meeting of the American Society of Clinical Oncology (ASCO-2021) (n = 29), with a two year overall survival (OS) of over 50% and a five year OS of over 20%. Two patients were alive after 10 years of treatment. The median OS was 27 months (95% CI: 21, 47 months). The OS at two years was 55.2% (95% CI: 39.7%, 76.6%), and at five years was 20.7% (95% CI: 10.1%, 42.2%) [8].
Jan 21PII/III DENIM trial continues to recruit and is now due to complete collection of OS data in Feb 23 [7].
Nov 20No update has been posted by Amphera to the DENIM trial entry on the US clinical trials registry, but according to the company pipeline, development is continuing [5,6].
Dec 19NCT03610360 - UK sites: Leicester [4]
Jun 18PII/III DENIM trial to evaluate the efficacy and anti-tumour activity with allogeneic tumour cell lysate (PheraLys) loaded onto autologous dendritic cells (MesoPher) plus best supportive care (BSC) as a maintenance treatment, after chemotherapy, to be compared to BSC alone in patients with pleural malignant mesothelioma starts (MM04; NCT03610360). 230 patients will be recruited in the Netherlands, France, Belgium, Italy & UK. The patients in Arm A will receive three bi-weekly injections of MesoPher with best supportive care, plus two further injections of MesoPher at weeks 18 and 30. The patients in Arm B will receive best supportive care alone. The primary endpoint of the study is overall survival; collection of these data is expected to complete Jan 21 [2].