Opdivo Study Offers Hope to Relapsed Mesothelioma Patients

A recent study out of the United Kingdom finds patients with relapsed malignant mesothelioma can be treated effectively with single-agent nivolumab, safely improving overall and progression-free survival.

Nivolumab, also known by the brand name Opdivo, is an immunotherapy drug already being used successfully with non-small cell lung cancer.

It is the first drug to show a significant survival advantage for relapsed mesothelioma in a phase III clinical trial, according to principal investigator Dr. Dean Fennell, medical oncologist at the University of Leicester in England.

“This is very encouraging news,” Fennell told The Mesothelioma Center at Asbestos.com. “Until now, we’ve never had a treatment for mesothelioma that demonstrated these kinds of study results. It should be made available now to patients with relapsed disease.”

Fennell presented results of the recent study, known as CONFIRM, at the World Conference on Lung Cancer last month.

The randomized trial involved 332 patients with unresectable disease across 24 study locations within the United Kingdom.

“Effective treatment for relapsed mesothelioma is an unmet need,” Fennell said. “This is first-ever evidence to support any treatment in a relapsed setting for mesothelioma.”

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Nivolumab Part of First-Line Mesothelioma Treatment

The U.S. Food and Drug Administration granted historic approval of the Opdivo and Yervoy immunotherapy combination for first-line treatment of mesothelioma in October 2020. Based on these latest results, FDA approval of nivolumab in a second-line setting is expected to follow soon.

Patients with mesothelioma in the U.S. have been using the drug with mixed results through clinical trials, compassionate care or off-label exceptions.

In this latest study as a second- or third-line treatment, median overall survival with nivolumab was 9.2 months, compared to 6.6 months for those receiving the placebo, an almost 40% improvement.

Progression-free survival with nivolumab was three months versus 1.8 months for the placebo.

One-Year Mesothelioma Survival Improves

Patients in the trial were randomized in a 2:1 ratio to receive treatment once every two weeks for a maximum of 12 months.

The 12-month survival rate from the start of the clinical trial was 39.5% for nivolumab and 26.9% for the placebo. The majority of patients already had received at least two prior lines of therapy before relapse and enrollment into the trial.

Twelve-month, progression-free survival rates were 14.5% and 4.9%, respectively.

According to study authors, the only previous phase III clinical trial involving single-agent immunotherapy and relapsed mesothelioma compared pembrolizumab, known as Keytruda, with chemotherapy. There was little or no difference in overall survival or median survival between the two.

The FDA approved limited use of Keytruda in 2020 for certain metastatic tumors, including relapsed mesothelioma with high mutational burden, and for patients with no alternative options.

A select group of mesothelioma survivors have shown that pembrolizumab can work exceptionally well at times, but only for a small percentage of patients.

Other Drugs for Mesothelioma Relapse Being Tested

Various other drugs have shown limited promise as a potential treatment for relapsed mesothelioma, but none have proven successful yet in a phase III trial.

Ramucirumab, already approved for use with other cancers, is part of a phase II trial. The UV1 and WT1 cancer vaccines also are being tested alongside an immunotherapy combination.

This latest study of nivolumab in the UK was stratified by histology, showing a 9.4-month median survival and a 12-month overall survival of 40% for those with epithelioid mesothelioma, the most common and more easily treatable type.

Adverse side effects were seen in 45% of the patients being treated with nivolumab, compared to 42% for those receiving the placebo. More serious side effects were found in 36% and 39%, respectively.

“Nivolumab is deemed a safe and effective treatment,” Fennell said. “It should be considered the new treatment option for patients with relapsed mesothelioma.”

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