KEYTRUDA ® (pembrolizumab) now registered as a potential treatment option for New Zealanders with an aggressive type of breast cancer- triple-negative breast cancer

28 October 2022. As part of Breast Cancer Awareness Month, Merck Sharp & Dohme (New Zealand) Limited (MSD) is pleased to share that immunotherapy drug, KEYTRUDA can now be used to treat certain patients with triple negative breast cancer (TNBC). 1

MSD New Zealand Director, Vanessa Gascoigne, says, “KEYTRUDA can now be used in combination with chemotherapy as treatment before surgery and then continued alone after surgery in patients with early-stage TNBC who are at high risk of their cancer coming back. 1

“KEYTRUDA can also be used in combination with chemotherapy in patients whose TNBC has returned and cannot be removed by surgery or has spread, and tests positive for a specific biomarker called PD-L1." 1

“TNBC occurs more often in pre-menopausal women and in those who have a BRCA1 gene mutation. It accounts for approximately 10-15% of all breast cancers.” 2

Chair of Breast Cancer Aotearoa Coalition, Libby Burgess, says “TNBC is more likely to recur within two to three years of diagnosis, compared to 10 to 15 years for those with other types of breast cancer. 3
“TNBC does not have receptors that can be targeted by current medications such as hormone and HER2-blocking drugs, meaning it has fewer treatment options available. 3 Therefore there is an urgent need to fund further treatment options for people with high-risk early stage TNBC, as well as those with advanced disease.”
Breast Cancer Foundation NZ Chief Executive, Ah-Leen Rayner, says, “Our research shows women under 45 have a higher proportion of TNBC compared with older women. 2 Since they are not eligible for free screening, which helps to detect breast cancer early, we encourage younger women to perform breast self-checks at least once a month. 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”.
Vanessa Gascoigne, adds, ‘Unfortunately, KEYTRUDA is only publicly funded in New Zealand for certain patients with unresectable or metastatic melanoma. 4 It is not publicly funded for the other 1200+ New Zealanders that could be treated each year. 5 This compares to Australia, where KEYTRUDA is funded for seven types of cancer. 6

“We welcome the Government’s recent increase to Pharmac’s budget and will continue to work with the agency, towards gaining access to funded KEYTRUDA across several different types of cancer, including TNBC.
“However, if New Zealand is going to keep pace with medicines development and be able to provide funded access to medicines in a timely way, further substantial budget uplifts over the coming years will be critical to help clear the medicines waitlist.”

KEYTRUDA® (pembrolizumab) is available as a 100 mg/4 mL concentrate for solution for infusion.
The KEYTRUDA Consumer Medicine Information is available at www.medsafe.govt.nz.

KEYTRUDA is a Prescription Medicine and may be used in adults:
• After surgery to remove melanoma or renal cell carcinoma to help prevent the cancer from coming back
• Before surgery to treat triple-negative breast cancer and then continued after surgery to help prevent the cancer from coming back
• To treat bladder cancer which has not spread to nearby tissues but is at high-risk of spreading and where bladder removal is not preferred
• To treat classical Hodgkin Lymphoma (cHL) that has returned or when other treatments have not worked
• To treat certain cancers when the cancer has spread (metastatic) or cannot be removed by surgery (unresectable), such as:
o melanoma
o non-small cell lung cancer
o urothelial carcinoma
o head and neck squamous cell carcinoma
o renal cell carcinoma
o oesophageal carcinoma
o endometrial carcinoma
o triple-negative breast cancer
o a kind of cancer that can occur in any part of the body and is shown by a laboratory test to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
o colon or rectal cancer that is shown by a laboratory test to be MSI-H or dMMR

KEYTRUDA may be used in children with cHL, MSI-H or dMMR cancer, or after surgery to remove melanoma. It is not known if KEYTRUDA is safe and effective in children with MSI-H or dMMR cancer of the brain or spinal cord (central nervous system cancers).

KEYTRUDA can cause harm or death to unborn babies. Talk to your doctor if you are a woman who could become pregnant and use effective contraception while you are being treated with KEYTRUDA and for at least 4 months after the last dose of KEYTRUDA. Do not breastfeed while taking KEYTRUDA.

Serious immune-mediated side effects have occurred affecting the lungs, intestines, liver, kidneys, hormone glands, blood sugar levels, skin, other organs and in transplant recipients. Some of these side effects can sometimes become life-threatening and can lead to death. These side effects may happen anytime during treatment or even after your treatment has ended and you may experience more than one side effect at the same time. Serious infusion reactions have also occurred.
Very common side effects with KEYTRUDA alone include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of discoloured skin, stomach pain, decreased levels of sodium in blood and low levels of thyroid hormone.
When KEYTRUDA was given in combination with chemotherapy, hair loss, vomiting, decrease in white-blood cell count, mouth sores, fever, decreased appetite, and swelling of the lining of the digestive system (for example mouth, intestines) were also commonly reported.
When KEYTRUDA was given in combination with axitinib, high blood pressure, fatigue, low levels of thyroid hormone, decreased appetite, blisters or rash on palms of your hands and soles of your feet, increase in liver enzyme levels, hoarseness, and constipation were also commonly reported.
When KEYTRUDA was given in combination with lenvatinib, high blood pressure, decreased appetite, low levels of thyroid hormone, vomiting, weight loss, headache, constipation, hoarseness, urinary tract infection, stomach-area (abdominal pain), blisters or rash on the palms of your hands and soles of your feet, protein in your urine, increased in liver enzyme levels and feeling weak were also commonly reported.
The most common side effects when KEYTRUDA is given alone to children include fever, vomiting, headache, stomach pain, decrease in number of red blood cells, cough, and constipation. (v41)

KEYTRUDA has risks and benefits. Talk to your doctor to see if KEYTRUDA is right for you. If symptoms continue or you have side effects, tell your doctor.

KEYTRUDA is only funded for the treatment of melanoma which has spread and cannot be removed by surgery. KEYTRUDA is unfunded for the treatment of all other cancers listed above. Ask your health professional about the cost of the medicine and any other medical fees that may apply.

Merck Sharp & Dohme (New Zealand) Limited. Level 3, 123 Carlton Gore Road, Newmarket, Auckland.