Melanoma cells ImageJ=1.47v unit=um
Two cancer drugs have been approved for patients on the NHS in Scotland. An immunotherapy for some people with advanced skin cancer and a targeted drug for some patients with breast cancer got the green light this week.
The fresh batch of decisions from the Scottish Medicines Consortium (SMC) this week were hailed as “great news” by Gordon Matheson, Cancer Research UK’s public affairs manager in Scotland.
“The decisions mean that a treatment called pembrolizumab is now available for some patients whose skin cancer has spread to the lymph nodes.”
Pembrolizumab (Keytruda) will now be an option for patients whose melanoma has spread to the lymph nodes and who have already had surgery.
Matheson said the treatment provides another treatment option for patients who’ve had surgery to remove their cancer but who are at high risk of it returning.
New option for patients with melanoma after surgery
Pembrolizumab works by boosting the immune system’s ability to kill cancer cells and can help target any cancer cells left behind after surgery.
In a clinical trial involving over 1000 patients, pembrolizumab increased the length of time patients lived without their cancer coming back.
15 in 20 of those taking pembrolizumab were cancer free 12 months after treatment, compared to just over 12 in 20 of those taking a dummy drug. And in data provided to the SMC, 7 in 10 patients taking pembrolizumab were alive without their cancer coming back 18 months after treatment, compared to 5 in 10 patients taking the dummy drug.
But severe side effects, including type 1 diabetes and bowel inflammation, were more common in patients taking pembrolizumab. And one person died as a result of taking pembrolizumab, which caused muscle inflammation.
Clinical experts told the SMC they considered pembrolizumab to be an advancement in treatment as it significantly reduced the risk of cancer coming back after surgery.
Pembrolizumab was approved for NHS use in England in November 2018 by the National Institute of Health and Care Excellence (NICE). NICE decisions are also adopted by Wales and Northern Ireland, so the drug should be available for eligible patients there too.
Targeted drug gets green light for advanced breast cancer
The SMC also approved two combinations, including the drug abemaciclib for breast cancer, in their latest batch of decisions.
The targeted cancer drug works by blocking growth molecules inside cancer cells, which stops them from dividing. It’s been developed for patients whose cancer cells test positive for certain hormone receptors, but not the HER2 receptor.
Abemaciclib will now be available as part of two different treatment combinations to patients whose breast cancer has spread. It can either be used with the hormone treatment fulvestrant or in combination with a group of hormone therapies called aromatase inhibitors.
Both combos will be available to patients who’ve already had hormone therapy. But the combination of abemaciclib and aromatase inhibitors will also be available to women who haven’t had any treatment for their breast cancer.
Matheson said the double abemaciclib decision would “provide new treatment options for patients with HER2-negative breast cancer.”
“This will be very welcome for patients and their families,” he said.
The data behind the decisions
Combining abemaciclib with fulvestrant was shown to slow disease progression and delay the need for chemotherapy in a trial involving 669 patients with advanced breast cancer.
Taking a combination of abemaciclib and fulvestrant increased the time before patients’ cancers got worse, compared to taking fulvestrant alone. Patients taking the drug combo were alive for an average of 16.5 months without their cancer getting worse, compared to 9.3 months for those just taking fulvestrant.
But serious side effects were more common in the group taking the drug combination, with 1 in 5 people experiencing side effects including severe diarrhoea and blood clots.
The trial has not been running for long enough to know how much the drug combination will improve long-term survival for these patients.
Abemaciclib has also been tested in combination with an aromatase inhibitor in a separate trial involving 493 women with advanced, untreated breast cancer. Adding abemaciclib to aromatase inhibitors significantly increased the time patients lived without their disease getting worse compared to those taking aromatase inhibitors alone.
The most frequent severe side effects for those taking the combo in the trial were low levels of one type of white blood cell (neutropenia) and diarrhoea.
SMC (2019) Pembrolizaumb [SMC2144]
SMC (2019) Abemaciclib in combination with fulvestrant [SMC2179]
SMC (2019) Abemaciclib in combination with an aromatase inhibitor [SMC2135]