A multi-center British study suggests that the cancer drug Opdivo (nivolumab) may be a solid second-line treatment option for relapsed mesothelioma patients.
The Phase-3 trial involved mesothelioma patients from 24 UK hospitals. All had an ECOG score of 0 or 1, meaning they were in reasonably good health overall.
All of the patients had first-line treatment with platinum-based chemotherapy. Then their cancer came back. There is no approved treatment for relapsed mesothelioma patients. So these patients enrolled in the nivolumab trial.
Although Opdivo is not a cure for mesothelioma, the results of the news trial show it could extend survival for the right patients.
How Does Opdivo Work?
Nivolumab is sold under the brand name Opdivo. It is an immunotherapy drug that works by blocking a protein called PD-L1. This protein helps protect cancer cells and blocking it makes them more vulnerable to attack.
Scientists think Opdivo may be an option for relapsed mesothelioma patients because 3 out of 4 mesothelioma tumors overexpress PD-L1. It is the same protein blocked by the immunotherapy drug Keytruda.
The FDA approved nivolumab to treat non-small cell lung cancer and some other cancers. It is not yet approved for first-line mesothelioma treatment or for relapsed mesothelioma patients.
But the mesothelioma research community is hopeful. Nivolumab is the subject of several current mesothelioma studies. Some studies pair it with chemotherapy or with another immunotherapy drug. The current trial treated relapsed mesothelioma patients with Opdivo alone.
Nivolumab for Relapsed Mesothelioma Patients
The new Opdivo trial went by the acronym CONFIRM. The CONFIRM trial recruited mesothelioma patients between 2017 and 2020 who received first-line chemotherapy with pemetrexed (Alimta). This is the main first-line treatment for most people with mesothelioma.
Patients were randomly assigned to receive either Opdivo or a placebo. To participate, they had to have X-rays showing that their cancer had come back.
Two thirds of the patients received 240 mg of nivolumab for 30 minutes every two weeks. The other third received the placebo. There were two “endpoints” for the study: progression free survival and overall survival.
Relapsed mesothelioma patients in the Opdivo group had a median progression-free survival of 3 months. That compares to just 1.8 months for the placebo group. Patients on Opdivo had a median overall survival of 10.2 months compared to 6.9 months in the placebo group.
About 40 percent of both groups had serious side effects, but none of the patients died from the treatment.
Lead author Dean Fennell of the University of Leicester’s Mesothelioma Research Program concludes, “Nivolumab represents a treatment that might be beneficial to patients with malignant mesothelioma who have progressed on first-line therapy.”
The article appears in the latest issue of The Lancet Oncology.
Fennell, D, et al, “Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial”, October 14, 2021, The Lancet Oncology, Online ahead of print, https://linkinghub.elsevier.com/retrieve/pii/S147020452100471X