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NICE lung cancer backing for Keytruda is biggest expansion yet

Access will be via the Cancer Drugs Fund until 2019 review


MSD's immunotherapy Keytruda will be made available to patients with untreated advanced lung cancer in combination with chemotherapy in England, the biggest expansion yet in its use.

England's cost effectiveness watchdog NICE has given the go-ahead for the drug to be used in this setting, opening up the drug to more than 3,000 non-small cell lung cancer (NSCLC) patients in combination with chemotherapy for up to two years.

NICE has, however, only given the green light to MSD's drug via the Cancer Drugs Fund (CDF), as there isn’t enough evidence yet for routine NHS use. This means the treatment will have to prove its value to patients for a period before it can be confirmed as a mainstream treatment.

The drug will be made available via the CDF to patients in England immediately, and meanwhile MSD will continue to collect data on the combination under a managed access agreement, which NICE will review in June 2019.

NICE says Keytruda (pembrolizumab) “has the potential to be cost-effective, and was likely to extend life.” Patients whose tumours have EGFR or ALK mutations should be treated first with targeted therapies, says NICE, matching the labelling for Keytruda in first-line NSCLC.

MSD welcomed the decision, saying that “for the first time, the treatment is available to all NSCLC patients, regardless of biomarker expression.”

The main KEYNOTE-189 study which backed the approval of Keytruda plus chemotherapy in first-line NSCLC therapy in Europe found that the combination regimen reduced the risk of death by 50% compared to chemotherapy alone.

“NICE recommends that this treatment is given for a maximum of two years, because it is thought that patients do not need to continue treatment beyond this point to achieve the benefits,” said Meindert Boysen, director of the NICE Centre for Health Technology Evaluation. That position will also be reviewed as new evidence comes in, he added.

Keytruda is given as an intravenous infusion every three weeks and has a list price of £5,260 for a 200mg dose, but has been offered at a discount to the NHS.

Prof Charles Swanton

Prof Charles Swanton

Medical charity Cancer Research UK (CRUK) also welcomed the news. “This drug combination has shown significant benefits for some patients in clinical trials, helping them to survive their cancer for longer,” said its chief clinician Prof Charles Swanton.

“This also shows the value of the Cancer Drugs Fund, which gives NICE the option to approve promising treatments while more data is collected on their long-term benefits,” he added. “Lung cancer is the biggest cancer killer in the UK so it’s vital that innovations like this reach patients as quickly as possible.”

Toby Talbot, Consultant Clinical Oncologist, Royal Cornwall Hospital, NHS, and KEYNOTE-189 investigator said: “This could be one of the biggest advances in the treatment of non-small cell lung cancer in recent years. The results are particularly impressive for patients with low PDL1 expression – these patients have not been able to access the benefits of immunotherapy without having conventional chemotherapy first. The availability of combination therapy is a huge leap forward in improving the prognosis of patients with non-squamous non-small cell lung cancer.”

The new guidance comes just a few months after Keytruda monotherapy as an alternative to chemotherapy for first-line advanced NSCLC moved in the other direction, exiting the CDF and transitioning to routine NHS use.

The decision came after a budget impact review which took into account additional data, including the results of the KEYNOTE-024 trial which showed a 37% reduction in the risk of death with the drug compared to chemotherapy alone after two years of follow-up.

The ruling confirms Keytruda's dominance among PD-1/PD-L1 immunotherapies in treating lung cancer in England, as in other markets. One of its closest rivals, Roche's Tecentriq, is in pursuit in patients with advanced lung cancer in combination with chemo, but NICE isn't due to rule on this until June 2019.

22nd November 2018


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