Monday, October 19, 2015

Keytruda and Mesothelioma in Australia 19/10/2015

It has taken a few days to get my facts correct with Keytruda in Australia for Mesothelioma (asbestos cancer).  With good news to report the immunotherapy drug Keytruda is fast becoming a very talked about drug and is starting to show very promising results over time when used for Mesothelioma and 19 other rare cancers.  It already has shown great results with Melanoma and for this reason has been listed on the PBS (Pharmaceutical Benefits Scheme) in Australia for Melanoma only since early September 2015.
There have been phase I study trials in Australia for Lung Cancer, (with Mesothelioma patients taking part in these trials)  in particular at The Austin Hospital, Melbourne, Victoria with Professor Thomas John leading the way with this research.
There are several trials with immunotherapy drugs including Keytruda commenting early 2016 for Phase II and Phase III trials.  Specifically trials for Mesothelioma and Keytruda will commence early 2016.  More details to follow.

Keytruda and other immunotherapies will change how we treat diseases like Mesothelioma.  These drugs are here and available now, but at considerable costs.  There is data and the PBAC should allow a mechanism that enables access to it before the big trials are done.

Tanya Segelov from Turner Freeman Lawyers has written in the ADFA (Asbestos Diseases Foundation Australia) members Newsletter
Over the last few months there has been a development in relation to a second line treatment for mesothelioma.  Keytruda is an immunotherapy drug that has had some success in treating melanoma.  The drug is an immune check point inhibitor.  As cancers develop they paralyse the immune system so that the body is unable to destroy the cancer.  This involves a pathway known as PD-1, Keytruda inhibits PD-1 and enables the immune system to fight the cancer.  As the drug works on the immune system it is not cancer specific.
Merck recently trialled the drug in relation to mesothelioma.  In a study presented at the American Society of Clinical Oncology in April 2015, 25 patients with mesothelioma, all who had previously received standard chemotherapy and whose tumours had progressed, were treated with Keytruda.  Out of the 25 patients, 7 patients achieved a partial response (reduction of tumour) while 12 patients had stable disease (no growth of tumour), a disease control rate of 76%.
The author of the Abstract noted "76% disease control rate in this previously treated malignant pleural mesothelioma population is unprecendented and warrants further study."
These results suggest that the data for mesothelioma is likely to be consistent with those in non-small cell lung cancer and melanoma.

Following the success of the initial clinical trial, a Phase II clinical trial is now being undertaken in the US with results expected in 2016.
Keytruda is now being offered by many oncologists as a second line treatment for mesothelioma.  Prior to Keytruda, second line chemotherapy has been offered although the clinical data in relation to the success of second line chemotherapy shows that it has a less than 10% success rate.  Keytruda treatment is given once every three weeks intravenously. Side effects do not seem to be significant and less than those following chemotherapy.  Those who will benefit from the treatment (in melanoma about 50% of people have responded to this drug) appear to do so at an early stage, within the first 4 to 6 treatments.
There is anecdotal evidence that Keytruda is successful in treatting mesothelioma patients in Australia.  ADFA member, Lou (Louise) Williams, has been having Keytruda treatments for approximately 6 months and in this time has seen her mesothelioma tumours reduced significantly.  Lou's experiences are described in her blog.
Keytruda costs approximately $9,000 per treatment.  At present Merck is offering to pay for 3 of the first 6 treatments (the 2nd, 4th and 6th treatments).  This means that it will cost approx $30,000 for the first 6 treatments, by which stage an assessment should be able to be made as to whether the treatment is working.  If the treatment is successful then it will continue on a 3 weekly basis at a cost of $9,000 for at least 2 years, totalling approx $300,000.  At present Keytruda is on the PBS only in relation to melanoma.
Mesothelioma sufferers who have a current claim at common law can seek the cost of Keytruda treatment.  The test as to whether a defendant is required to pay treatment expenses is whether the expenses are reasonable in the circumstances of both the plaintiff and the defendant.  There are a number of cases on foot where the cost of Keytruda has been claimed.  Defendants have challenged their liability to pay for the treatment and we are waiting for a decision of the Court.  We are however hopeful that a Court will award the cost of Keytruda (at least the cost of the first six cycles with some allowance for the likelihood that the treatment may be successful and continue) where the treatment has been prescribed by the treating oncologist and in the context of promising early results from the Phase I clinical trial and the lack of any effective second line treatment for Mesothelioma.
Applications have also been made to the Dust Diseases Board for the payment of Keytruda.  To date the Dust Diseases Board has declined to make payments on the basis that the drug is not TGA approved. The test however in relation to the treatment expenses payable by the Board under the Workers Compensation Act 1987 is whether the treatment is 'reasonably necessary'.  For persons who have already settled a claim at common law and been refused the treatment cost for Keytruda by the Dust Diseases Board, there is an avenue to appeal the decision of the Dust Diseases Board.  Such an appeal is brought in the District Court of New South Wales.  In a no cost jurisdiction which means that if the case is not successful you will not be ordered to pay the Board's costs.

Keytruda details:
If you would like further details about any of the above, please contact me (Lou Williams) via my email
I will then help you with further information.

Lou's update on Keytruda No. 10:
Overnight in hospital last Wednesday I had my no. 10 infusion of Keytruda.  While waiting for my bed, I walked 3 kms to the local shopping centre (caught the tram back to the hospital area!), and upon discharge the next day walked 2 kms through the lovely gardens into the city of Melbourne.
By the time I arrived home - fatigue had set in, not sure if it was lack of hospital overnight sleep or a combination of that and Keytruda!  Fatigue lasted 5 days however NO PAIN!  This morning some fluid in the tummy area however nothing drastic. 

Discharged at 8.30am and walked through Fitzroy Gardens into city!

Nana enjoying the gardens with my lovely Melbourne grandkids Ruby, Henry and Oliver.

I have been enjoying our beautiful Spring weather and pottering in our garden.  Every day new flowers appear due to the recent rains.  The garden has been sadly neglected over the last couple of years due to illness, drought and lack of water so I am pleasantly surprised with my garden now!
Lilacs, daphne, violets, bearded iris, roses - not many flowers however little surprises every day!
Even Charlie has enjoyed the garden finding a shady spot to nap.

Our lavenders and gum trees blending in to the landscape.

Beautiful bearded iris

Keith's update:
Keith has now had 14 zaps of radiation - only 21 to go!  It is a 6 hour round trip to the hospital and home again (the radiation appointment takes a minimum of an hour or so).  He is getting fatigued however handling it well.

Lou's petition fast track Keytruda (in Australia) on the PBS (Pharmaceutical Benefits Scheme):
We now have over 4,000 signatures and valuable comments - a huge thank you to all who have signed, commented and shared the petition.  I am currently in discussion and further updates to follow.  Please keep sharing - we need more signatures.  In unity we are making this possible!
(This is the link below)

Sign Lou's petition and share.. ‪#‎Asbestos‬ does not discriminate

Nat's mum has Mesothelioma in NSW on life saving Keytruda costing $9,000 per dose. (Nat kindly shared her mum's story).

Lou (Louise) Williams
17 Oct 2015 — Natalie's mum was diagnosed in Oct 2014 with Mesothelioma. The diagnosis for mum and our close knit family was absolutely devastating. Mum contracted it when my dad and her built us a cubby house over 30 years ago. Mum was given no hope of treatment after her initial first round of chemo and was told by her oncologist that there was no point in her making any further appointments as there was nothing they could do, she was given 3 months at best and she should go home and spend time with her family. Mum before this disease was the life of our family and the most attentive of grandmothers. She went from fun loving, active and dependent to bed ridden and gravely ill, in daily pain within a very short space of time. Mum had all but given up until we heard about the wonder drug Keytruda. It gave mum the hope she needed to keep fighting. On discussing the treatment with her oncologist we discovered that the drug was not on the PBS for Mesothelioma and it would cost approx. $9000 every three weeks. Mum is a 69 year old pensioner!!! The family has rallied around and we are paying for her treatment privately. She has always been there for us and now we are trying to be there for her but the financial cost is crippling. Mum had her first dose of Keytruda last week, we are keeping our fingers crossed and supporting Lou's campaign to have this wonder drug put on the PBS for Mesothelioma as its the only chance mum has of regaining her life back.