Dual immunotherapy – nivolumab (Opdivo) plus ipilimumab (Yervoy) – will be PBS listed from July 1 for first-line treatment of unresectable malignant mesothelioma.
Evidence for the combination immunotherapy came from the CheckMate-743 trial which found nivolumab plus ipilimumab improved overall survival compared to standard of care chemotherapy (18·1 v 14·1 months: HR 0.74; p=0.002).
The international study, published in The Lancet earlier this year, found the 2-year overall survival rates were 41% with nivolumab plus ipilimumab compared to 27% with chemotherapy.
A third (32%) of patients who responded to immunotherapy were still responding at two years compared to only 8% of patients in the chemotherapy group.
The safety profile for nivolumab plus ipilimumab in first-line mesothelioma was manageable and consistent with previous studies of the combination in other tumour types.
Dr Benjamin Brady, a medical oncologist in the Skin and Melanoma Service at Peter MacCallum Cancer Centre and director of medical oncology and haematology at Cabrini Health in Melbourne, told the limbic that CheckMate-743 was a landmark study with convincing results.
“This is the first big advancement in mesothelioma in probably 15-20 years. I’m very pleased the government have acted quickly and put it on the PBS.”
Dr Brady said the 4-month overall survival benefit looked modest on paper.
“…but that translates into a significant percentage of patients living well beyond 12 months and having a very good quality of life. When I first looked after mesothelioma patients, not many survived beyond 12 months.”
Dr Brady said Australian patients have been able to access the drugs through the company’s compassionate access program.
“I’ve got now a few patients who’ve come off the 2-year cap and they are fine. It’s delivering the results with less toxicity which is equally important. I don’t think we have cured the patients but we have certainly bought them a bundle of time.”
A media release from the Health Minister Greg Hunt said more than 700 patients a year will benefit from the PBS listing.
“Without PBS subsidy, patients might pay more than $130,000 per course of treatment for this medicine,” it said.
Mark Brooke, CEO of Lung Foundation Australia, said in a statement that the availability of novel treatment options for Australians with mesothelioma was welcome news.
“The PBS listing of an additional treatment option for unresectable malignant mesothelioma will be warmly received by patients and their families.”
“Early diagnosis, support and equitable access to treatment and care is pivotal to improving outcomes for Australians living with this devastating disease,” Mr Brooke said.