Australian cancer patients await decision on PBS access to KEYTRUDA® (pembrolizumab) – a treatment for certain eligible oesophageal cancer patients.
October 25, 2021 6:00 am Australia/Sydney
Immuno-oncology therapy KEYTRUDA® (pembrolizumab) has been listed on the Australian Register of Therapeutic Goods (ARTG) for the first-line treatment for certain eligible patients with locally advanced or metastatic carcinoma of the oesophagus or HER-2-negative gastroesophageal junction adenocarcinoma, when used in combination with certain chemotherapy agents.1
This treatment will be an option for approximately 700 eligible oesophageal patients per year2 and will be evaluated for the first time at the upcoming Pharmaceutical Benefits Advisory Committee (PBAC) meeting early November 2021.3 The PBAC and Medical Services Advisory Committee (MSAC)4 will also again be evaluating KEYTRUDA for eligible patients with squamous cell carcinoma of the head and neck at their November 2021 meetings.3,4
Treatment options are urgently needed for patients with this rare cancer.5,6,7 Early oesophageal cancer can present with non-specific or no symptoms. As a result, patients are often diagnosed at advanced stages when treatment options are limited.8
“Oesophageal cancer is a rare disease. Patients with non-curable locally advanced or metastatic oesophageal cancer have an extremely poor prognosis, and there remains a significant unmet medical need for Australians with this diagnosis,” said Associate Professor Mark Wong, Medical Oncologist and Honorary Clinical Associate Professor Macquarie University.
“Minimal progress in treatments for advanced oesophageal cancer over the past 30 years, has left patients with this aggressive cancer, limited treatment options. I believe people need and deserve to have all the treatment options available to them to manage an oesophageal cancer diagnosis,” he added.
Oesophageal cancer, defined as cancer which forms in the tissues lining the oesophageal tube which runs from the throat to the stomach5, can have a significant impact on quality of life6. Males are more than twice as likely as females to be diagnosed with the disease.5,9 In 2020, an estimated 1,587 Australians were diagnosed with oesophageal cancer, claiming 1,351 lives.10
“For patients and their families this news is incredibly hopeful. The treatment options available currently for oesophageal cancer are very limited, which is disheartening for patients at a time that is already difficult. We welcome any new therapy that provides patients greater choice regarding treatment,” said Doug Hawkins, CEO of Pancare Foundation – an Australian not-for-profit supporting patient with upper gastrointestinal cancers and their families.
“However, to provide the greatest impact, it must be made affordable as to not disadvantage already vulnerable patients. We want to see equitable access for therapies for all Australians living with oesophageal cancer. This would remove the disparity between those with the financial means to access therapies and those who cannot,” he added.
KEYTRUDA is a cancer immunotherapy that works to reactivate the immune system to attack tumour cells by blocking a cancer cell protein (known as programmed death receptor 1 or PD-1) which left unchecked allows cancer cells to pass undetected by the body’s natural defences.1
“This medicine is listed on the ARTG under ‘orphan status’, which recognises this treatment is for patients with a life-threatening or seriously debilitating condition, affecting a small patient population,” says Gary Jankelowitz, Medical Director, Australia and New Zealand.
Oesophageal cancer indication: KEYTRUDA® (pembrolizumab), in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the oesophagus or HER2 negative gastroesophageal junction adenocarcinoma (tumour centre 1 to 5 centimetres above the gastroesophageal junction) that is not amenable to surgical resection or definitive chemoradiation.1
KEYTRUDA SELECTED SAFETY INFORMATION1
Precautions: Immune-mediated adverse reactions, including severe and fatal cases, have occurred in patients receiving KEYTRUDA. These have included, but not limited to: pneumonitis, colitis, hepatitis, hepatoxicity (in combination with axitinib), nephritis, endocrinopathies (adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, hyperthyroidism, hypothyroidism, thyroiditis), uveitis, myositis, Guillain-Barre syndrome, myasthenic syndrome/myasthenia gravis (incl. exacerbation), myelitis, vasculitis, pancreatitis, sarcoidosis, encephalitis, myocarditis, pericarditis and pericardial effusion, peripheral neuropathy, sclerosing cholangitis, solid organ transplant rejection, severe skin reactions (SJS, TEN and bullous pemphigoid), severe infusion reactions (hypersensitivity, anaphylaxis) and complications of allogeneic HSCT. Monitor thyroid and liver function.
Immune-related adverse reactions have occurred after discontinuation of treatment with KEYTRUDA, can affect more than one body system and can occur simultaneously.
Adverse events: In patients with oesophageal cancer, adverse reactions occurring in at least 20% of patients and at a higher incidence (≥2%) of Grades 3-5 severity for KEYTRUDA in combination with chemotherapy (cisplatin and 5-FU) compared to placebo and chemotherapy (cisplatin and 5-FU) were: vomiting (7% vs. 5%), stomatitis (6% vs. 3.8%), neutrophil count decreased (24.1% vs 17.3%), and white blood cell count decreased (9.2% vs. 4.9%).
For further information, refer to the full Product Information: Approved September 2021.
Refer to the Consumer Medical Information leaflet, available at or your doctor or pharmacist for further information about KEYTRUDA.
PBS information: This product is not listed on the Pharmaceutical Benefits Scheme (PBS) for oesophageal cancer or head and neck cancer. For more information on other listings, go to www.pbs.gov.au
For more than 125 years, MSD has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. MSD is a trade name of Merck & Co., Inc., Kenilworth, N.J., U.S.A. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs, and partnerships. Today, MSD continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.msd-australia.com.au and connect with us on Twitter and LinkedIn.
Copyright © 2021 Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited. Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113. AU-PDO-00132. Issued October 2021.
1 KEYTRUDA Product Information. 23 September 2021. Accessed October 2021
2 MSD Data on file
3 PBAC Agenda November 2021 Accessed October 2021
4 MSAC Agenda. Accessed October 2021.
5 Australian Institute of Health and Welfare (AIHW). Accessed October 2021
6 Yang, YM., Hong, P., Xu, W.W. et al. Advances in targeted therapy for esophageal cancer. Sig Transduct Target Ther 5, 229 (2020).
7 Laursen et. al, (2019), ‘Table in the corner: a qualitative study of life situation and perspectives of the everyday lives of oesophageal cancer patients in palliative care’, BMC Palliative Care, (18:60)
8 QIMR Berghofer. Accessed October 2021
9 GI Cancer Australia. Accessed October 2021
10 Australian Government. Cancer Australia. Oesophageal Cancer. Accessed October 2021