CAR T-cell therapy for Australian patients with haematological malignancies will come without the international air miles as local manufacture ramps up.
As of last week, Cell Therapies Pty Ltd is the first TGA-approved commercial manufacturer of tisagenlecleucel (Kymriah) at its facility at Melbourne’s Peter MacCallum Cancer Centre.
Australia is one of seven manufacturing sites worldwide as part of the Novartis CAR-T manufacturing network.
“This is a significant day for Cell Therapies, and represents many years of investing in our facility, technology and our people to develop this capability,” Cell Therapies Acting Chief Executive Associate Professor Dominic Wall said of the announcement.
“We now look forward to making this CAR-T therapy onshore for patients in Australia and the broader Asia Pacific region.”
Local manufacture will mean faster access to Kymriah for patients with relapsed or refractory DLBCL, and eligible paediatric or young adult patients with relapsed or refractory ALL.
“Local manufacturing means patients’ cells can stay here in Australia without the need to ship them overseas, generating greater efficiencies and an expectation of quicker timelines for eligible patients to access Kymriah,” said Professor Simon Harrison, Director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre.
To date, over 100 Australians have been treated with Novartis CAR-T across clinical trials and commercially available therapy in seven treatment sites spanning Victoria, New South Wales, Queensland and Western Australia.
“The manufacturing process for Kymriah requires an extraordinary amount of testing and quality control to ensure the reprogrammed cells created are compliant with the Good Manufacturing Practice (GMP) standards.”
“Our manufacturing set-up has been highly collaborative and successfully executed despite the challenges of COVID-19,” Associate Professor Wall said.
“This important milestone is good news for patients, the clinical community and the economy,” he added.
“We anticipate this announcement will provide a significant economic boost through the creation of new highly-skilled jobs, now and into the future.”
Dr Michael Dickinson, from Peter Mac and the Royal Melbourne Hospital, told the limbic that local production of cellular therapies to this level of quality and at scale was very exciting.
“The fact that the main regional capacity for manufacturing for this sort of product is based in Melbourne is a huge boon in terms of Australia participating in the future of cellular therapies both in terms of invention, and commercialisation and translation.”
“As a doctor who treats lymphoma, I think there needs to be a choice of multiple CAR T-cell therapies and I don’t see this announcement as affecting that.”
He said other therapies on the horizon were Gilead’s Yescarta and Tekartis and Bristol Myers Squibb product Breyanzi.
“Those other therapies still need to go through the appropriate regulatory reviews in Australia but as a haematologist I think we have a need for choices and the different products do differentiate a little on their indications and their pros and cons.”
“I think all of those products have a future in Australia once reviewed and approved by the appropriate authorities.”
He said it had been estimated that 200-400 DLBCL patients and about 30 ALL patients would benefit each year.
“The number of patients whose CAR T products will be made in Australia will substantially ramp up over the coming months and years.”
Dr Dicksinson, disease group lead for aggressive lymphoma at Peter Mac, said early in the COVID-19 pandemic he had been concerned about transportation delays for CAR T therapies and an overseas manufacturing workforce potentially susceptible to coronavirus.
“I care about consistency of delivery very very much and anything that reduces risk is a good thing. In the simplest sense, I would see this reducing risk related to products being sent around the world and especially during a pandemic when circumstances can change at short notice.”