Topics: CAR T-cell therapy announcement; update on coronavirus in Australia, Bridget McKenzie
My name is Dr Shelley Dolan. I’m very proud to be the chief executive of the Sir Peter MacCallum Cancer Institute and I would like to give a very, very warm welcome to Federal Health Minister the Honourable Greg Hunt, to Australia’s Chief Medical Officer Professor Brendan Murphy, to representatives of Novartis including Didier Dargent, head of International Markets for Cell and Gene Therapy at Novartis Oncology.
I’d also like to welcome Associate Professor Leslie Reti, who is on the board of both Peter MacCallum and Cell Therapies and other representatives of Cell Therapies.
I’d also like to welcome Associate Professor Simon Harrison, director of the Centre of Excellence in Cellular Therapy and Dr Michael Dickinson, disease group lead for aggressive lymphoma.
I’d like to welcome everybody here, all of our media colleagues, and thank you for visiting Peter Mac early on a Monday (correction – should say Tuesday) morning to hear some very exciting news about CAR T-cell therapy.
To provide the context for everybody, Australia’s very first CAR T-cell therapy clinical trial was run here at Peter Mac a little over a decade ago.
Today, this therapy is seen as an absolute game changer, particularly for those people with very hard to treat blood cancers.
At Peter Mac, our newly established Centre of Excellence in Cellular Immunotherapy is expanding our research program and ability to deliver CAR-T to patients.
And I’d like to thank Minister Hunt for his government’s significant contribution of $80 million as announced in March last year.
Today’s further announcements will again build on Peter Mac’s capabilities and most importantly, improve access for Australian patients. Thank you.
And thanks very much to Dr Shelley Dolan, to Les, to Michael and Simon here at the extraordinary Peter MacCallum Centre and arguably the world’s leading- if not the world’s leading centre for cancer diagnosis, treatment, care, research and development.
To Didier Dargent, to the Chief Medical Officer and to everybody here.
Ultimately, today is about the patients though. Patients such as Paul, whom I had the privilege of meeting or Giovanni or others, who are on the journey of the battle against cancer.
It’s a condition which can be frightening, it can be debilitating and of course it can be tragic in outcomes.
We know that in any one year, 148,000 Australians are likely to be diagnosed with some form of cancer. We expect (inaudible) that perhaps 51,000 Australians will lose their battle over the course of this year.
And that’s why medical science and research and treatment are fundamental in giving people hope, in giving people a better quality of life, and in giving people better outcomes. As part of that, Shelley here is really privileged to help in the development and the growth of this great centre, the PMCC, with $460 million of federal money.
But it’s not the money. It’s the fact that this will allow- to develop and to become a world leading centre. And in particular, as we research into new treatments, new therapies to be able to bring the different forms of cell therapy to Australian patients is fundamental.
We’re able to contribute $80 million towards the development of Peter MacCallum as a not just Victorian, not just national but a global platform for manufacturing and delivery of new cellular immunotherapies and that supports Peter Mac and the National Centre for Cellular Immunotherapy.
As a consequence of that, I’m delighted to announce two things today. Firstly, that Peter Mac will, through the investment with Novartis, Didier, be a global manufacturing centre for CAR-T therapy.
That means that Australian patients will have access earlier, faster to the latest cutting edge treatment and technology.
That’s just a good outcome for patients. It gives them a better shot at life. It gives them real opportunities.
It also makes Australia the global hub that we set out to achieve.
It will help with employment and economic opportunities but above all else it will help drive forward medical research and therefore new treatments earlier for patients and that couldn’t be a more important outcome.
At the same time, I’m also delighted to announce that the Australian Government will make available CAR-T therapy for lymphoma.
It’s expected that this treatment, which would otherwise cost $500,000 a year, will help over 200 patients a year and up to 250. Each and every patient with the conditions that have been recommended by the Medical Services Advisory Committee will now have access to that treatment.
And that’s two forms of B-cell lymphoma, diffuse large B-cell lymphoma and PM B-cell lymphoma as well as follicular lymphoma. And so those three different forms of lymphoma have been recommended by the Medical Services Advisory Committee.
We’ve accepted those recommendations, we’ve reached agreement with Novartis to deliver the treatment called Kymriah, which is a form of CAR-T and that will help save lives and protect lives.
And right now, what really matters is we can get on with the job of treating those patients. We’ve worked to bring this forward at the fastest possible time and we’ve exceeded all of our expectations. And I want to thank everybody involved for that.
This is about saving lives and protecting lives. I’ll invite Didier and then Michael Dickinson. After that, Professor Murphy and myself will give a brief update on the coronavirus (inaudible).
So my name is Didier Dargent, I’m the head of International Markets for Cell and Gene Therapy, I’m based in New York.
So today we are very pleased to be here in the Peter Mac Cancer Centre, it’s one of the leading centre in the world for CAR-T.
It’s a pleasure to be here and it’s given me the opportunity to thank all the team who will make- who have make this project to become possible.
It’s also very important for me to acknowledge and to thank Minister Hunt, (inaudible) for his true commitment for innovation and ensuring that this kind of breakthrough treatment can arrive to the Australian patient.
It’s also for me an opportunity to thank again the Ministry of Health for extending the reimbursement of Kymriah, getting access to patients with lymphoma, with DLBCL patient.
So what is very important is giving (inaudible) opportunity to have a treatment to potentially cure their disease. I would like to thank also Shelley and all the team and (inaudible).
We’re going to release the tech transfer and ensure that the treatment will come as fast as possible in Australia.
So it’s a very important time for us (inaudible) for two reason.
So, first reason is today Peter Mac is becoming an innovation site (inaudible) and was already worldwide known, but also is going to provide a manufacturing something is unique.
It’s really process we sophisticated, we bring the patient and doing so, you need to understand that Australia, somewhere, is one of the seven country we manufacture Kymriah in the world after US, France, Germany, Switzerland, China and Japan.
It’s a unique opportunity for Australia to be able to provide the Australian patient, but also outside Australian (inaudible) manufacturing.
So Novartis have every time commit in a strong and intensive way at the early stage of CAR-T therapy and (inaudible) direction, because we are strongly believing that we are hear (inaudible) and to ensure that most of the patient can have access to a drug (inaudible).
Thank you, all of you, for these commitments, thank you (inaudible).
So perhaps, the best way is to (inaudible) Dr Michael Dickinson.
Thanks very much. I’m Michael Dickinson, I’m the disease group lead for aggressive lymphoma here at Peter Mac and Royal Melbourne Hospital.
And it’s a really exciting day to be a doctor who treats aggressive lymphoma. The sub-types of lymphomas that have been approved in this announcement today are our most common lymphomas and although most patients will be cured with standard therapies, when they relapse after standard therapies there are very few treatment options.
The availability of Kymriah for this- these new indications, is a really (inaudible) for patients with a diagnosis of diffuse large B-cell lymphoma and for doctors who treat these patients.
We’ve been using Kymriah at Peter Mac and Royal Melbourne for the last couple of month for the A-L-L indication and we have a lot of familiarity with this treatment, and to be able to expand access to our most common lymphomas is a really big deal for everyone across the country.
Okay. And we’ll also invite Sharon Millman, lymphoma, and if you’d like to speak from a patients’ and representatives’ perspective.
Thank you. On behalf of Lymphoma Australia, we would also like to say how grateful that we are also now able to offer this cutting edge therapy that potentially now can be curative for some lymphoma patients.
I’ve (inaudible) 250 of them that may have had a very dismal prognosis without this treatment.
We’re also excited that we’ve become a manufacturing site here in Australia, as this is a really important part of the process to ensure that patients have the best outcome.
So I’d really like to thank MSAC and the Federal Government for making this therapy come to Australia as quickly as it has done.
It isn’t an easy one, it is a complex treatment and we really appreciate that we can now offer this to Australia patients.
Thank you very much. Okay, with the Chief Medical Officer Professor Murphy, we’ll give a quick update on coronavirus.
As of this morning, there are five confirmed cases in Australia of coronavirus. Other cases will continue to be tested by state health authorities and as results are known they will be made available publicly.
All of those five patients, we are advised, are stable, in isolation and under very high quality care.
Globally, on the latest figures available, 2800 patients have been confirmed and 80 deaths, but we expect that the Chinese and World Health Organization authorities will provide an update on those figures during the course of today.
Yesterday, the Prime Minister chaired a meeting of the National Security Committee to reaffirm all of the elements of our national preparedness.
The World Health Organization reviewed Australia’s preparedness two years ago as part of a global survey, and we were identified as being at the absolute global forefront of preparedness.
But all of those elements are being put in place now, and I will let Professor Murphy speak to those a little bit more.
In particular, the Australian Government, through the embassy, has also been in contact with Chinese authorities about Australians who are in Wuhan and the broader Hubei Province.
Significant progress, significant progress has been made overnight, and we are exploring all options with the Chinese authorities, both to ensure that there is support and care for Australians on the ground, and that there is a pathway to returning them home.
And the advice from the Foreign Minister shortly before coming to this event is that there has been significant progress.
So I want to thank the embassy and the Chinese authorities, and we will continue to ensure that we have strong broader protection, the highest quality medical care in the world, and action to protect and secure those Australians who are in Hubei Province in China. Brendan?
Thank you, Minister. So as the Minister said, given the update on the numbers, the main message that we’re trying to give still to the Australian public is that there is no cause for concern in the Australian public.
There is no human to human transmission of this virus. And it’s important to note because we had some media about masks today.
There is no need for the Australian public to wear masks. There is- the only people who should wear masks in relation to this virus are those who are unwell and have a relevant travel history.
Our most important thing now is for those who have come back from China in the last two weeks, whom developed flu-like symptoms, particularly if they’ve come from the Hubei Province of China, they need to call ahead to their GP or their emergency department, tell them of their travel history and get tested.
As the Minister said, we’re testing a large number of people across the country every day.
The vast majority of them are negative, as we always expected it to be, but we all do expect that it is likely we might find some more positives over the next few days, but we are extremely well prepared.
All of our state and territory health services have stood up teams to be prepared, their public health units have activated. We’ve got very, very good isolation facilities.
We now have very good diagnostic facilities; same day diagnostics- turn around in diagnosis in most parts of the country.
And we have also put up additional border measures that I outlined yesterday – in addition to every single flight from China, because this disease is now present in significant numbers in other parts of China, mainly from people who have come from the Hubei Province.
There’s no clear evidence that there’s human to human transmission in those other parts of China, but because people are appearing with the disease in other parts of China, every flight from China is being met and entered by border security officers and making sure that everyone on the flight gets information in English and Mandarin about the need to report their travel history, if they develop symptoms after they arrive, and obviously if they have any symptoms, they should declare themselves to a border security officer at the airport.
And we’ve had a three-fold increase in people reporting ill symptoms to border security officers. Mostly just trivial symptoms, but the message is getting out there.
So we are well prepared. We are still concerned about what is happening in China.
This outbreak is not under control. The Chinese authorities are doing a lot of things.
As we know, they’ve locked down the Hubei Province, very hard to get out of there. That’s the main focus of this infection at the moment, but we are reviewing things daily.
Yesterday, I convened the expert public Health Committees of the Commonwealth and states and territories to review all of our advice and all of the situations that are happening at the moment.
So I’ll leave it at there, thanks Minister.
Yeah. Happy to take any questions.
When did you list coronavirus as a pandemic potential disease and (inaudible)?
So, we listed it as a listed human disease early last week, as soon as we received the data from the weekend before last that there was a very significant increase in numbers.
As you recall only 10 days ago, the Chinese were reporting only 50 cases and there’d been no new cases for a week. But over that following weekend, the numbers increased significantly.
Our concern was such that we knew we needed to have the capacity to make additional border measures. So I signed the determination to make the listed human disease early last week.
You’ve spoken about those enhanced border measures and people going (inaudible) boarding these flights, but would this also involve turning away flights from China?
Look, what I’ll do is speak to that very briefly. We will follow the medical advice without fear or favour. And so if the medical advice is that stronger action is needed, the Prime Minister, the Cabinet, and the National Security Committee will adopt that immediately.
And so we continue to follow all of the advice.
I have to say, Professor Murphy listed this before the World Health Organization has declared it to be an epidemic of global significance, so he was ahead of the curve.
And again, to have people who are fearless in their advice and in their decision making is one of the great strengths of the Australian system, and I think that’s one of the reasons why the WHO recognised it.
(Inaudible) to that point of having to turn away flights?
There- the Chinese are actually already, as I’ve said they’ve locked down the Hubei Province, which is the main epicentre. It’s impossible to get out of there.
They have already stopped organised tour groups leaving China. The Chinese are putting significant restrictions in.
Even if you stop all of the flights from China, there are ways to come from China via other ports.
So we are also putting in additional border measures for every flight that comes into Australia, putting out announcements and providing those printed materials for people that have come from other ports.
It’s essentially not practical to really close off all traffic in an international transmission of a virus. All of the cases that we’ve detected so far were- came here when there wasn’t major concern about the disease internationally.
They all came before that escalation, the weekend before last. All of them were perfectly well when they arrived. So the medical advice and the World Health Organization advice is that complete travel bans are not an effective additional measure.
Okay, thank you. I think there was one, oh sorry there is one here.
There are five confirmed cases in Australia – without wanting to sound alarming, what are the chances there are going to be more?
My sense is there will be more, but I wouldn’t be alarmed about that. Given the traffic of people before this escalated from that region of China to Australia, I would be reasonably confident that we’ll find some more cases over the coming days.
But we’re incredibly well prepared to test and isolate them when they appear.
Minister, there has been some (inaudible) that Australian health authorities had been slow to act behind the (inaudible), Singapore in terms announcing extreme measures. Do you think that that’s a fair assessment?
Well I think what you’ll see is that we’ve been helping to lead at the global level in relation to this.
The World Health Organization, as I say, has yet to declare this to be a pandemic of global significance.
The measures that we’ve taken have been in conjunction with the international organisations, in conjunction with other countries, in conjunction with the state health and territory authorities, and have come from constant engagement between Professor Murphy as the Chief Medical Officer of Australia and the medical community, as well as the state and territory communities.
The doctors, sorry, the (inaudible) practitioners are saying that they would like more masks in their practices, because of the bushfires, everyone is running low on masks, and if they have cases, they want to be able to protect against the spread.
They were under the impression that there’s a government stockpile of masks that’s going to be released. Is that something.
So there is a national medical stockpile of 12 million, in addition to those that were provided for bushfires where there is still significant reserves with the states and territories.
And Professor Murphy will say a little bit more in a second, but he’s been in contact with the College of General Practitioners and we’ll work to make sure that anybody who needs them, has them. Brendan.
Yes thanks. I have spoken to the President of the RACGP this morning.
We’re investigating the supply situation to general practitioners. If it really is difficult and impossible for some of them to get them we’ll make sure they can get masks because we do want GP’s who sees someone with the relevant travel history is unwell to put a mask on the patient, and put a mask on the doctor and the staff when they’re assessing the patient – that is important advice.
So we need to be able to follow through with that, so we’re actively following that up with the college today.
You said that it might not be feasible to actually shut down flights but if need be would you also look at potentially quarantining people coming from China?
The expert advice is quarantining is not of practical public health value at the moment.
The advice of all of the public health experts that convened yesterday remains the same – that people who have come from China should be treated like any normal member of the community unless they develop symptoms of fever, flu-like symptoms that could suggest this virus – and it probably won’t be.
But if they’re unwell they must immediately wear a mask, ring forward to their GP or their emergency department.
But there is- most of the international advice – I know there’s been a bit of story in the media about potentially some people being slightly infectious before their symptoms – but all of the previous experience with these coronaviruses is that people are only infectious when they’re symptomatic.
So, our focus at the moment is identifying symptomatic people with that travel history and managing and isolating them.
And after those initial symptoms, what will somebody with coronavirus experience (inaudible)?
We know that there are a very large number of mild cases. We suspect that in Hubei Province there are probably a large number of people who have never even been diagnosed.
In Thailand, of the eight cases that have been exported to there, five have now gone home well.
The five people in Australia are all in a very stable condition – in fact one of them is so well they’re only in hospital because of the quarantine requirements.
So, but we know that 25 per cent of people reported from China do have a more severe illness with a pneumonia and we know there have been 80 deaths.
Now, the median age of those deaths is 71.5 years and the Chinese are reporting that many of them have elderly and have other comorbidities.
But the concerning development in that 25 per cent is the development of a viral pneumonia and, obviously, there is no specific treatment for that other than respiratory support. But a lot of people do have mild disease.
Minister, we know there was a family in New South Wales who were tested yesterday for a coronavirus. Just confirming you’re (inaudible) with news about that this morning?
Yes. So, just before arriving here at Peter Mac we’ve had advice from both the New South Wales Minister for Health – Brad Hazzard – and the Department of Health that that family of four, they have all been tested and they’ve all received a clearance or a negative test.
So these are the preliminary results, but it’s good news so far.
Two questions, one quickly. Is there any other cases that are being likely to be confirmed at this stage?
Look, every day there are a number of cases who what we call meet the case definition. They have come from that part of China, they have relevant symptoms and they’re being tested.
But- so, there are potential positive cases every day. As I said, over the weekend we only had one additional confirmed one after the reports on Saturday.
So as I said, I expect to see some more positives but there is nothing that we know of that’s a very strong likelihood at the moment.
Any- one more?
Sorry, I just want to ask when you said earlier that there’d been significant progress overnight about these Chinese in Wuhan. What’s that mean? Is that in terms of negotiating with the Chinese authorities? And will we be able to get them out?
Well, our work has been to provide support on the ground and then to provide a pathway home.
The Foreign Minister and the Embassy are working with the Chinese authorities and the advice I have from Foreign Minister Payne this morning, again just before coming here, is significant progress.
So, the Foreign Minister is working to ensure we have a pathway home for each and every one of those Australians. The timing is something that will be worked on with the Chinese authorities.
And this is part of a global challenge, but Australia has been working with countries such as the United States, the United Kingdom, and many others directly with the Chinese authorities.
And we are confident that given time we will get all of our Australians back and we are also working in the meantime to make sure that they have the best care, the best support on the ground.
Are we talking days or weeks?
I will leave that for the Foreign Minister.
The DFAT is compiling a list of people are currently in Wuhan.
How many people have (inaudible) registered as being in that region?
So again, the advice from the Foreign Minister just before coming here was approximately 400 calls have been received in terms of registration.
They are being crosscheck to ensure there is no double counting – because sometimes you will have, understandably, multiple family members report the same person.
So they are going through that process, but at this stage approximately 400 registrations have been placed with Foreign Affairs.
Are you expecting an influx of Australians and nationals coming back from the Chinese New Year celebrations (inaudible) in terms of that?
Well we have the border protection measures in place. One of the things which the Prime Minister has ordered and instructed is to ensure that all planes coming from China are boarded by biosecurity officials and that’s, I think, an extremely important measure.
So each and every passenger is met with and by biosecurity officials and that not only are they provided with information, but there is a review of their symptoms and situation.
Minister, I have been sent a text from one of the producers back in the office that they heard further ten students have been quarantined at a Queensland private school. Do you know about that?
No, I’m sorry. I don’t have any information on that.
Is Australia playing any broad role in patient diagnosis (inaudible)?
So we are very actively involved in the World Health Organization emergency response. We also have researchers at the University of Queensland who are actively involved in vaccine development, and we have staff in the WHO.
We have also offered to the WHO any assistance. We have assistance, medical assistance teams and experts – obviously that’s a matter for the Chinese whether they take that up.
So, we have epidemiology experts who are participating nightly in modelling teleconferences with the WHO. So we are very actively involved. Okay.
Thank you very much.
And if I can just ask you another couple of quick questions, Minister. Just given the scathing Auditor-General’s report into Bridget McKenzie and the fact that there’s now an investigation into her by the Secretary of the PM&C, how can she remain in the Minister?
Look, obviously the Prime Minister’s referred that to the Secretary of PM&C so I won’t (inaudible).
And did you have any knowledge of Senator McKenzie supplementing Sport Australia’s list of recommended clubs for funding within her- by herself given that it was being run from your department.
No, that was a process conducted by the Minister.
Can I please ask a few more questions (inaudible) cancer? Is that all right?
How does the drug work?
So this is a CAR T-cell therapy so chimeric antigen receptor T-cells. Basically what we do is take lymphocytes from patients using a blood donation procedure and they get modified to express a protein which targets the cancer.
And we give them back as a single infusion which acts like a live drug in the patient. It sees the target which is the cancer and expands, and keeps working until the cancer is gone.
What’s its success rate?
So in diffuse large B-cell lymphoma which is the indication just being announced today, about 50 per cent of patients will respond and between a third and 40 per cent of patients will have a durable (inaudible) response of being in complete remission at the one-year mark.
And these are people who previously were- they’d been clear-
These are people who previously had no treatment options available to them. So our standard approach to diffuse large B-cell lymphoma is to use chemotherapy. And when patients relapse, is to try chemotherapy again and in many cases that will be curative.
In fact, in most cases in the front line setting we’re able to cure diffuse large B-cell lymphoma.
But for the patients who are unlucky with the standard therapies or unlucky with our standard approach to relapse disease, Kymriah offers a new opportunity for a durable remission which is the big news today for patients with this disease.
As the Minister mentioned previously, our blood had to be sent to America and now it can be here. What kind of difference does that make to the outcome?
Well we hope that will shorten manufacturing time, broaden the number of patients that, where manufacturing can occur around the world, which will mean hopefully that we’re able to deliver this product faster to Australian patients.
People may- sorry, just one more question (inaudible). People may go to America or Switzerland for treatment, is it the case that people from all around the world are coming to Australia for cutting edge treatment, or is that something that you’re aiming to?
Well no, I mean, our current plan at the moment is to deal with Australian patients and that’s the approval that’s being announced at the moment.
It’s medi- patients are eligible through public health care in Australia.
Our goal of course is to become a centre for research and to do more trials using this kind of technology and that is part of the centre of excellence announcement that was earlier this year and some of the federal funding support that we’ve received.
But at the moment, the announcement is largely about public health funding.
And if you’re a patient who’s not in Victoria, do you need to come here for treatment or did they send your blood to Melbourne and then send it back? Is that how it works?
So two different things, there’s the availability under the public health portal of Kymriah and CAR-T; we’re hopeful that other states and territories will also be able to provide this.
But for the manufacturing, that will ultimately be here as a- not just a Victorian, not just an Australian headquarters, but as (inaudible) said, one of only seven global manufacturing facilities.
And so that will be good for all of the Australian patients, but this will not be the only place in Australia where patients can be treated, it will be the only place where it is manufactured at this point in time.
Great. Thank you very much.