Download KEYTRUDA® approved for `chemo-free`

News Release
____________________________________________________________________________
FOR IMMEDIATE USE
KEYTRUDA® approved for ‘chemo-free’
treatment of Australia’s number one cancer killer1,2
SYDNEY, Australia, 8 March 2017 – Australians with a deadly form of lung cancer can now
bypass chemotherapy to receive medicine that activates the body’s immune system to fight
cancer cells.2
MSD today announced that its cancer fighting immunotherapy KEYTRUDA® (pembrolizumab)
has been approved for use prior to, as well as following, chemotherapy to treat advanced nonsmall cell lung cancer in patients with a protein known as programmed cell death ligand 1 (PDL1)*.2 For this immunotherapy, each patient needs to be tested to determine their suitability for
the treatment.*
Until now, this treatment had only been available for patients with advanced melanoma.2
“The great news is that KEYTRUDA can now be prescribed to previously untreated lung cancer
patients, as well those whose cancer has spread after chemotherapy,” said Associate Professor
Tom John, from the Olivia Newton-John Cancer Centre.
“This marks the first time that Australians with lung cancer can receive an immunotherapy without
having first failed chemotherapy,” he said.
The approval of KEYTRUDA for use in previously untreated lung cancer patients comes five
months after the publication of a landmark study that compared the immuno-oncology therapy to
traditional chemotherapy, involving Australian doctors – including Associate Professor John –
and patients.2,3
Nearly 9,000 Australians lose their lives to lung cancer each year – making it Australia’s biggest
cancer killer.1 Survival rates are low, with 85 per cent of lung cancer patients dying within five
years of diagnosis.1
KEYTRUDA is a cancer fighting immunotherapy that is matched with a specific biomarker, which
allows doctors to better target patients who are more likely to respond. In patients with advanced
non-small cell lung cancer, KEYTRUDA blocks the PD-L1 protein and harnesses the body’s
immune system to attack cancer cells.2
Associate Professor John explained that immunotherapy “turns the spotlight on tumour cells, so
the immune system can detect and destroy the cancer. Cancer cells are notoriously good at
evading destruction by the immune system, but by inhibiting the PD-L1 protein the immune
system is released to fight the cancer”.2,4
“With a simple test we can determine the amount of PD-L1 protein in cancer cells, which then
helps guide treatment decisions4,” she added.
1
Lung Foundation Australia CEO Heather Allan described the approval of KEYTRUDA as “great
news” for Australians with lung cancer, but noted that “without a government subsidy the
medicine will remain out of reach for many Australians with advanced lung cancer”.
A submission to add KEYTRUDA to the PBS will be reviewed by the Government’s expert
advisory committee on pharmaceutical reimbursement when it next meets.
Ms Allan stressed that Australians with advanced lung cancer do not have the luxury of time.
“Our fingers are crossed that this important medicine will receive a positive recommendation,
allowing it to be added to the PBS without delay,” she said.
MSD’s Managing Director Riad El-Dada acknowledged the Therapeutic Goods Administration for
recognising the role of KEYTRUDA in the treatment of advanced non-small cell lung cancer.
“MSD will continue to work with the Federal Government, lung cancer experts and health
consumer organisations to ensure KEYTRUDA is added to the PBS for Australians with nonsmall cell lung cancer,” he said.
*About KEYTRUDA2
Indications: KEYTRUDA® (pembrolizumab) is indicated: As monotherapy for the treatment of
unresectable or metastatic melanoma in adults. For first-line treatment of patients with metastatic
NSCLC whose tumours express PD-L1 ≥50% tumour proportion score (TPS) on a validated test,
with no EGFR or ALK genomic tumour aberrations. For the treatment of patients with advanced
NSCLC with a PD-L1 TPS level ≥1% and who have received platinum-containing chemotherapy.
Patients with EGFR or ALK genomic tumour aberrations should have received prior therapy for
these aberrations prior to receiving KEYTRUDA. See full PI.
Contraindications: Hypersensitivity to pembrolizumab or any of the inactive ingredients.
Precautions: Immune-mediated adverse reactions, including pneumonitis, colitis (including
gastrointestinal perforation), hepatitis, nephritis, hypophysitis, type 1 diabetes mellitus,
hyperthyroidism, hypothyroidism, uveitis, myositis, Guillain-Barre syndrome, myasthenic
syndrome, pancreatitis, myocarditis, solid organ transplant rejection and severe skin reactions
(including Stevens-Johnson syndrome and toxic epidermal necrolysis). Immune-mediated
adverse reactions affecting more than one body system can occur simultaneously. For
management of immune-mediated adverse events, see full PI. Limited information in patients
with active infection and patients with on-going adverse reaction to ipilimumab – use caution. See
full PI for further information.
Pregnancy: Category D.
Interactions: None expected. Avoid corticosteroids or immunosuppressants prior to treatment.
Adverse events: Clinical trials (treatment-related only): hypothyroidism, nausea, fatigue,
hyperthyroidism, pneumonitis, colitis, hepatitis, hypophysitis, nephritis, type 1 diabetes mellitus,
arthralgia, cough, back pain, vitiligo, abdominal pain, pruritus, rash, hyponatremia, anaemia,
diarrhoea, pyrexia, adrenal insufficiency, autoimmune hepatitis.
Dosage: The recommended dose of KEYTRUDA is 200 mg for previously untreated NSCLC and
2 mg/kg for melanoma or previously treated NSCLC (administered as an intravenous infusion
over 30 minutes every 3 weeks).
Treat with KEYTRUDA until disease progression or unacceptable toxicity, or up to two years for
NSCLC if no disease progression. Atypical responses (i.e. an initial transient increase in tumour
size or small new lesions followed by shrinkage) have been observed. Clinically stable patients
2
(i.e. asymptomatic and not requiring urgent intervention) with initial evidence of progression can
remain on treatment until confirmed. See full PI for further information.
Refer to the CMI or your doctor or pharmacist for further information about KEYTRUDA, what it is
prescribed for and possible side-effect.
About Lung Cancer
• More than 12,000 Australians will be diagnosed with lung cancer and almost 9,000 Australians
will lose their lives to the disease this year alone.1 Non-small cell lung cancer represents more
than 80 per cent of all cases of lung cancer.5
• Lung cancer is Australia’s biggest cancer killer, causing almost 20 per cent of all cancerrelated deaths, and more deaths than breast, prostate, and ovarian cancer combined. 1
• The outlook for patients with lung cancer is poor, with only a 15 per cent chance of surviving
for five years after diagnosis. For patients diagnosed with advanced disease, the five year
survival rate drops to just one per cent. 1
-ENDSMedia Contacts: Jay Pleass
Ethical Strategies
0412 623 578
John Morton
Ethical Strategies
0416 184 044
About MSD
For more than a century, MSD has been a global health care leader working to help the world be
well. MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A.
Through our prescription medicines, vaccines, biologic therapies and animal health products, we
work with customers and operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to health care through farreaching policies, programs and partnerships. Visit www.msd-australia.com.au
Issued by Ethical Strategies on behalf of MSD in Australia.
References
1. Lung Foundation Australia Improving outcomes for Australians with lung cancer A Call to Action available at
http://lungfoundation.com.au/wp-content/uploads/2016/08/LFA-improving-outcomes-report-0816-proof10.pdf
2. MSD Australia. Approved Keytruda Product Information. March 2017.
3. Reck M, et al. Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer. N Engl J
Med 2016; 375:1823-1833
4. Ma et al. Current status and perspectives in translational biomarker research for PD-1/PD-L1 immune checkpoint
blockade therapy, Journal of Hematology & Oncology 2016. 9:47
5. Lung cancer: what you need to know http://www.mydr.com.au/cancer-care/lung-cancer-what-you-need-to-know
Copyright © 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All rights reserved. Merck
Sharp & Dohme (Australia) Pty Limited. Level 1, 26 Talavera Road, Macquarie Park, NSW 2113. ONCO-1209192-0000. First Issued
March 2017.
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