Patients, clinicians, cancer support groups and industry have come together in a call for better access to immunotherapies in Australia.
An advocacy document sponsored by MSD, whose product list includes pembrolizumab (Keytruda), was launched in Canberra this week.
The New Wave of Immunotherapy Cancer Medicines –The Untapped Potential for Australians has called for a tumour-agnostic approach to new immunotherapies.
“Regulatory and reimbursement processes should change to ensure patients in need can access the biomarker tests and immunotherapies they are likely to benefit from, regardless of where their cancer originated,” it said.
The report also called for more investment in biomarker and screening tests and a faster PBAC approvals process.
It said ‘reimbursement delays and capacity constraints’ were preventing people with cancer accessing immunotherapies in a timely manner.
Medical oncologist Professor David Thomas, who contributed to the report, told the limbic the problem was bureaucratic structures evolve very slowly while cancer therapies were evolving rapidly.
“The challenge with immunotherapies in respect of regulatory approvals is that these are drugs which, similar to chemotherapies, seem to have activity across a very broad range of cancer types.”
“At this stage we don’t fully understand the full scope of opportunity but what is emerging is that in some cases, there are identifiable biomarkers shared by many different cancer types which could be used to predict response.”
Professor Thomas, from The Kinghorn Cancer Centre and the Garvan Institute of Medical Research, said the FDA decision to approve pembrolizumab across multiple cancer types on the basis of a shared biomarker was groundbreaking.
He said sequentially approving a drug for various cancer types took time that was ‘unaffordable for the patients dying of the disease right now’.
“It’s better to approve drugs for groups of cancers at one time – aggregating cancers according to some therapeutically meaningful biomarker.”
Professor Thomas said there was enormous value in the current regulatory process in Australia but also ways it could adapt and evolve.
While much more research was required, he said the durability of the response to immunotherapies was impressive.
“With immunotherapy, the added spice is that the immune system might be particularly effective at eradicating the micro-metastatic disease which causes people to relapse when receiving curative therapy. That’s very exciting.”
“What chemotherapy doesn’t have, which immunotherapy appears to, is the prospect of long-term disease control. We give chemotherapy and we need to keep giving it. In some patients with metastatic melanoma, a few months treatment controlled disease not for months, but for years afterwards.”
“That’s something we’ve never seen before and suggests once you harness the immune system it continues to do the job.”