Breast and kidney cancer drugs approved on NHS Scotland

In collaboration with the Press Association

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Human breast cancer cells.

Human breast cancer cells. Credit: Jason Carroll at the CRI

Two new cancer treatment options have been accepted for use in Scotland for some patients living with breast and kidney cancer.

Lenvatinib (Kisplyx) and ribociclib (Kisqali) were given the green light by the Scottish Medical Consortium (SMC), although 3 further drugs have been rejected – including atezolizumab (Tecentriq) for a certain type of lung cancer.

Cancer Research UK’s public affairs manager in Scotland, Gordon Matheson, called the two approvals great news, as “both drugs extended the time before patients’ disease got worse in clinical trials".

Go-ahead for combination kidney cancer treatment

Lenvatinib has been accepted for use in combination with another targeted drug called everolimus (Afinitor), which stops cancer growing by starving it of blood. 

Lenvatinib is a type of drug called a tyrosine kinase inhibitor, which stops cancer cells receiving messages that tell them to grow and divide. It also stops the cancer growing new blood vessels that help it survive. 

Adults with advanced renal cell carcinoma who’ve already had a similar blood vessel-stunting treatment, vascular endothelial growth factor (VEGF)-targeted therapy, will be eligible for the combination. 

The decision is based on the results of a phase 2 trial that showed on average, patients remained stable without their disease getting worse for around 9 months longer when taking the combination than those who took everolimus alone. 

Almost 9 in 10 patients experienced diarrhoea when taking levatinib and everolimus, which was the most common side effect reported.

Matheson said: “Patients and clinicians told the SMC additional treatment options were needed for advanced kidney cancer, to offer patients improved quality of life and the chance of surviving their disease for longer – so it’s great that the SMC has been able to recommend this drug combination.”

Breast cancer combination gets approval for specific patients

Access to the targeted treatment ribociclib has also been approved for some women with breast cancer in Scotland whose cancer has spread near to where their tumour first appeared, or to another part of the body. 

Ribociclib works by blocking molecules that help cancer cells grow and divide.

Patients will now be able to receive ribociclib with fulvestrant – a drug that blocks the hormone oestrogen, which fuels this specific type of cancer called hormone receptor positive breast cancer. 

The decision is based on results from a phase 3 clinical trial, which showed the combination stopped the progression of cancer for almost 8 months longer than when fulvestrant was used with a dummy drug (placebo).

Only women whose cancer has returned within a year of completing hormone therapy before or following other treatments like surgery or radiotherapy, or those whose advanced cancer has not responded to other hormone therapies, will be eligible.

“The approval of ribociclib with fulvestrant offers an alternative to 2 other drug combinations recommended for the same group of breast cancer patients earlier this year – which is important because the drugs can cause different side effects in some patients,” Matheson said. 

“As with the other treatments, clinical trial evidence suggested this combination could delay the need for people affected by breast cancer to begin chemotherapy, potentially sparing patients some treatment side effects.”

Side effects were more likely in those taking the combination, with a reduce white blood cell count (neutropenia) being the most common. This can make a person prone to infection. Nausea was the second most commonly reported side effect.

Lung cancer drug case ‘not robust’ 

phase 3 trial of 1,202 lung cancer patientsshowed that adding the immunotherapy drug atezolizumab to the targeted treatment bevacizumab (Avastin), and chemotherapy drugs paclitaxel and carboplatin improved overall survival.

The SMC, however, has not recommended the combination as an initial treatment option for adults with non-squamous non-small cell lung cancer (NSCLC) that’s spread to other parts of the body.

Based on the clinical trial evidence presented by atezolizumab’s manufacturer, the SMC decided the treatment did not offer enough value to patients for the drug combination to be cost effective. 

Matheson pointed out that lung cancer is the most common cancer in Scotland and survival rates are amongst the lowest for any cancer type.

“If atezolizumab had been recommended, it would have made immunotherapy treatment available to some lung cancer patients in Scotland for the first time,” he added. “However, based on clinical trial evidence, the SMC were not confident that the drug offered significant clinical benefits or value for money.” 

Matheson says he hopes the SMC and the drug’s manufacturer will continue to work together so that the treatment can be made available for people in Scotland with this type of lung cancer in the future.

Blood and liver cancer drugs not recommended

Announcing 2 further decisions, the SMC confirmed it could not recommend either ibrutinib (Imbruvica) and ramucirumab (Cyramza) for use on the NHS in Scotland.

Ibrutinib was being considered as a treatment for adults with a rare type of slow-growing lymphoma called Waldenström’s macroglobulinaemias

Ramucirumab, meanwhile, is a treatment for adults with a type of advanced liver cancer that can’t be treated surgically, called hepatocellular carcinoma.

In both cases, the manufacturer did not submit clinical trial evidence to the SMC, so the drugs’ value for money couldn’t be assessed. The companies still have the option to submit the findings from the trials in future.

References

Motzer, RJ. (2015) Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncology. doi: 10.1016/S1470-2045(15)00290-9.

Reck, M. (2019) Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respiratory Medicine 

Slamon, DJ. (2018) Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: MONALEESA-3. Journal of Clincial Oncology DOI: 10.1200/JCO.2018.78.9909