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NICE green light for Imfinzi in groundbreaking early lung cancer treatment

Early treatment opens up possibility of cure

AZ

AstraZeneca's immunotherapy Imfinzi has been recommended by NICE for patients with stage 3 non-small cell lung cancer (NSCLC).

England’s cost effectiveness watchdog’s decision follows the EU marketing approval of Imfinzi (durvalumab) in September last year, and opens up a whole new opportunity to tackle lung cancer at an earlier stage.

The drug has been recommended as a monotherapy for treating locally advanced (stage 3), unresectable NSCLC, in adults whose tumour cells have at least 1% PD-L1 expression, and whose disease has not progressed following concurrent platinum-based chemoradiation therapy.

NICE has given the green light via the Cancer Drugs Fund (CDF), which means Imfinzi must prove its value further before gaining full recommendation.

AstraZeneca says it expects around 300 patients will be eligible for treatment via the CDF during the managed access arrangement. This will end in September 2021, when the final analyses from AZ’s Pacific trial are expected to be available.

The ruling is great news for the company, as it gives Imfinzi its best chance of competing in the NSCLC market, where MSD’s Keytruda has become the overwhelmingly dominant player.

Keytruda has marketing authorisation around the world as a first-line treatment for metastatic NSCLC as a monotherapy and in combination therapies (as well as NICE recommendation), this being the prime driver of its blockbuster sales, which topped $7bn in 2018.

Imfinzi is far behind that tally, with 2018 sales of $633m, based largely on its first indication, urothelial carcinoma. Approval in stage 3 NSCLC will help propel Imfinzi to $2bn in annual revenues and beyond, with AstraZeneca still hoping to boost this with further NSCLC uses for the drug, despite disappointing results in its combination with tremelimumab.

Professor Corinne Faivre-Finn, Professor of thoracic radiation oncology at the University of Manchester and honorary consultant clinical oncologist at The Christie NHS Foundation, said: “The availability of durvalumab is a watershed moment for lung cancer in England as it will change how we treat patients with stage 3 disease.”

As with most cancers, catching the disease as early as possible is key to survival rates, and treating NSCLC at this stage increases greatly an individual’s chance of surviving for five years after treatment – which in medical terms counts as a cure.

Professor Faivre-Finn added: “Stage 3 NSCLC is potentially curable but unfortunately with current treatments most patients will progress to advanced disease. Now, for the first time in 20 years, we have access to a new treatment option that has been shown to improve survival outcomes.”

NICE’s recommendation is based on AZ’s Pacific trial, which showed that people taking it went for an average of around two years without the disease progressing, versus six months for those without. The committee agreed that it was plausible that between 27% and 40% of people taking Imfinzi would have five years of progression-free survival.

Fiona McDonald

Dr Fiona McDonald

Dr Fiona McDonald, a consultant clinical oncologist at The Royal Marsden NHS Foundation Trust, who advised the committee on this topic, said: “This decision marks the biggest advance we’ve seen for a number of years in treating locally advanced non-small cell lung cancer. For our patients it’s fantastic news; I expect to see an immediate impact on clinical practice, and for this treatment to become the standard of care for eligible patients.

“The trial on which the decision is made showed a step-change increase in survival rates and demonstrates a clear benefit of immunotherapy, given after the current standard of care, concurrent chemoradiation.”

A 500mg vial of Imfinzi has a list price of £2,466 ($3,240) but under its commercial agreement AstraZeneca will provide it to the NHS at a confidential discounted price.

Article by
Andrew McConaghie

28th March 2019

From: Healthcare

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