First-line treatment option available for eligible Australians with a type of aggressive breast cancer

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September 8, 2022 8:45 am Australia/Sydney

An estimated 1,500 eligible Australians with triple-negative breast cancer (TNBC) could receive access to immuno-oncology therapy KEYTRUDA (pembrolizumab) as a first-line treatment option. 1,2

KEYTRUDA is now listed on the Australian Register of Therapeutic Goods (ARTG) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery; and in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS ≥10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease.2

TNBC is a particularly aggressive form of breast cancer which means it can grow quickly.3,4,5 TNBC has a poor prognosis5,6 and is more like to recur within two to three years of diagnosis, as opposed to 10 to 15 years for those with estrogen receptor – positive breast cancer.4

While the average age of first being diagnosed with breast cancer in Australia is 61,4 TNBC occurs more often in patients who are under 50 years of age.7

Around 10-15% of all breast cancer cases are triple-negative breast cancers4,7,8 and there are around 2,500 new cases of TNBC in Australia each year.9

Professor Fran Boyle, Medical Oncologist at the Mater Hospital Sydney and Director of the Patricia Ritchie Centre for Cancer Care and Research says, “Many of these women will be below the usual age at which screening occurs. As TNBC has the potential to grow quickly, the cancer can reach a significant size before patients are diagnosed.”

Dr Sally Baron-Hay, Medical Oncologist, Royal North Shore Hospital, Sydney, says “There have been limited treatment options in the management of women with early stage TNBC. The addition of an immunotherapy option to neoadjuvant chemotherapy treatment gives medical oncologists and their patients an additional treatment option for those with this aggressive subtype of breast cancer.”

“As a medical oncologist it is rewarding to be able to offer this treatment option that could provide hope to women with early stage TNBC,” she added.

A survey of women with a TNBC diagnosis found that they experience increased levels of fear and anxiety at diagnosis compared to non-TNBC patients.10,11

Sarah Powell, CEO of Pink Hope says, “We encourage adult women of all ages to perform breast self-checks at least once a month as a preventative measure. We know that triple-negative breast cancer can occur in younger women. That’s why it’s crucial for women to become familiar with their breasts and learn how to spot any changes and speak to their GP if they notice anything unusual”.

Known risk factors for TNBC include having a BRCA1 or BRCA2 positive gene mutation, being pre-menopausal, being of African American and African descent, or having a family history of breast cancer.7,12

Treatments in both early and advanced TNBC remain a significant unmet need.8 Early-stage treatment means the treatment of cancer before it has spread or metastasised beyond the part of the body where the cancer originated.13

Early treatment includes neoadjuvant therapy – treatment given as a first step to shrink a tumour before surgery; or adjuvant therapy – additional cancer treatment given after surgery.14

Prashant Nikam, Managing Director, MSD Australia & New Zealand says, “This news is a meaningful step as it offers an additional treatment option for women with triple-negative breast cancer. We are committed to women’s cancers and MSD is rapidly expanding our extensive clinical development program in this area.”

“Patients can’t wait. We know that it can take 610 days on average for a cancer treatment to be listed on the Pharmaceutical Benefits Scheme in Australia after registration. Sadly, some cancer patients may not have this time,” he continued.

“We are committed to working collaboratively with the Pharmaceutical Benefits Advisory Committee to ensure eligible Australians with TNBC have funded access to this treatment option via the Pharmaceutical Benefits Scheme as soon as possible,” he added.

TGA indication: Triple-negative breast cancer: KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. KEYTRUDA (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS ≥10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease.2

About KEYTRUDA. KEYTRUDA contains the active ingredient pembrolizumab.15 KEYTRUDA is a medicine that may treat certain cancers by working with the immune system.15 KEYTRUDA may be given in combination with other anticancer medicines. Not everybody is suitable to have KEYTRUDA as a treatment for their cancer.15 Before using KEYTRUDA, a doctor will check if a person with cancer has a disease of the immune system like Crohn’s, ulcerative colitis, or lupus; had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of the lungs (called pneumonitis); have liver damage.15 If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby.15 Effective birth control must be used during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your health care provider if you are breastfeeding or plan to breastfeed.15 Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them.15 KEYTRUDA can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work.15 Sometimes these problems can become severe or life-threatening. More than one side effect can occur at the same time and side effects can arise at any time during treatment and even after the treatment has ended.15  These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening.15  Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur.15  Very common side effects include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain, decreased sodium levels in the blood, fever, infections of the upper respiratory tract, a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma.15  These are not the only side effects that occur with KEYTRUDA.15  

For further information read the KEYTRUDA Consumer Medicine Information available at and speak to your doctor.

PBS information: KEYTRUDA (pembrolizumab) not listed on the Pharmaceutical Benefits Scheme for triple-negative breast cancer.

  1. MSD Data on file.
  2. KEYTRUDA (pembrolizumab) Product Information. Accessed September 2022
  3. American Cancer Society. Accessed August 2022
  4. Breast Cancer Trials. Australia. Accessed August 2022
  5. Dent, R., Trudeau, M., Pritchard, K. I., Hanna, W. M., Kahn, H. K., Sawka, C. A., et al. (2007). Triple-negative Breast Cancer: Clinical Features and Patterns of Recurrence. Clin. Cancer Res. 13, 4429–4434. doi:10.1158/1078-0432.ccr-06-3045
  6. Scott LC, et al. Update on triple-negative breast cancer disparities for the United States: A population-based study from the United States Cancer Statistics database, 2010 through 2014. Cancer. 2019 Oct 1;125(19):3412-3417. doi: 10.1002/cncr.32207. Epub 2019 Jul 8. PMID: 31282032; PMCID: PMC6744285.
  7. Dolle JM, et al. Risk factors for triple-negative breast cancer in women under the age of 45 years. Cancer Epidemiol Biomarkers Prev. 2009 Apr;18(4):1157-66. doi: 10.1158/1055-9965.EPI-08-1005. Epub 2009 Mar 31. PMID: 19336554; PMCID: PMC2754710.
  8. Won KA, Spruck C. Triple‑negative breast cancer therapy: Current and future perspectives (Review). Int J Oncol. 2020 Dec;57(6):1245-1261. doi: 10.3892/ijo.2020.5135. Epub 2020 Oct 16. PMID: 33174058; PMCID: PMC7646583.
  9. Cancer Council Australia. A targeted approach to triple-negative breast cancer. cancer/#:~:text=Triple%2Dnegative%20breast%20cancer%20(TNBC,TNBC%20in%20Australia%20each%20year. Accessed August 2022
  10. Susman, Ed. Study Shows Extra Emotional Effects of Diagnosis of Triple-Negative Breast Cancer. Oncology Times: February 25, 2015 – Volume 37 – Issue 4 – p 48-49 doi: 10.1097/01.COT.0000461875.30493.48
  11. Swiger, K et al. (2015). Abstract P5-17-06: Emotional/psychological characteristics of women with triple-negative breast cancer: Do socioeconomic, demographic, and provider variables impact emotional change from diagnosis to post-treatment? Cancer Research. 75. P5-17. 10.1158/1538-7445.SABCS14-P5-17-06.
  12. Almansour NM. Triple-Negative Breast Cancer: A Brief Review About Epidemiology, Risk Factors, Signaling Pathways, Treatment and Role of Artificial Intelligence. Front Mol Biosci. 2022 Jan 25;9:836417. doi: 10.3389/fmolb.2022.836417. PMID: 35145999; PMCID: PMC8824427.
  13. NIH. National Cancer Institute. Accessed August 2022
  14. Mayo Clinic. Treatment to keep cancer from returning.,abnormalities%20present%20within%20cancer%20cells Accessed August 2022
  15. KEYTRUDA (pembrolizumab) Consumer Medicine Information. Accessed September 2022