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Until about three to four years ago for decades there had been little progress in treatment for mesothelioma. For the majority of patients who do not undergo surgery, only chemotherapy has been available. Patients can be offered one phase of chemotherapy and, if their condition remains stable, a second phase, often with a different chemotherapy drug. Once mesothelioma starts to progress, however, the only option has been palliative care.
Immunotherapy is a form of treatment which over recent years has produced impressive results with different types of cancer, including lung cancer. There have been some small scale (phase 1 and phase 2) trials which have indicated positive results with immunotherapy treatment for patients with mesothelioma.
The CONFIRM trial was the first large scale (phase 3) trial which considered the effectiveness of immunotherapy treatment for patients whose mesothelioma had progressed after having one or more phases of chemotherapy treatment.
It was funded by Cancer Research UK, carried out at 35 centres in the UK and co-ordinated from the Clinical Trials Unit at the University of Southampton. The Lead Investigators were Professors Gareth Griffiths (based at Southampton) and Dean Fennell (of the University of Leicester). The trial recruited a total of 332 patients between May 2017 and March 2020. Of these, 221 received immunotherapy treatment with Nivolumab. The remaining 111 were given a saline placebo. Patients received treatment once every two weeks for up to 12 months. The trial included patients with pleural and peritoneal mesothelioma and with epithelioid and non-epithelioid mesothelioma.
The first results from the trial were announced on 30 January 2021. These showed that the period of survival for patients treated with Nivolumab increased by 50% compared with the patients who received the placebo and that they had a longer period over which their symptoms from mesothelioma remained stable. Also, Nivolumab was not reported to show unduly damaging side-effects.
Professor Fennell has said that, in the light of the results, he is confident that Nivolumab represents a safe and effective treatment for mesothelioma. Professor Griffiths called the trial a major breakthrough in the treatment of mesothelioma.
CONFIRM has shown Nivolumab to be the first form of treatment which improves the survival prospects for patients with mesothelioma whose disease has shown signs of progression. Previously, at this stage only palliative treatment would have been available.
Nivolumab has not yet been licensed by NICE. It was until last year not available to patients with mesothelioma being treated by the NHS and could only be provided on a private basis. As a result of the Covid pandemic NHS England has allowed some patients with mesothelioma to receive Nivolumab (because it poses a smaller risk of serious illness to patients than treatment with chemotherapy does). Nivolumab will continue to be available to mesothelioma patients in this way until at least the end of March.
We are now all keen to find out whether the results of the CONFIRM trial will lead to immunotherapy treatment becoming available through the NHS on a permanent basis.