AZ gets NICE nod for ‘big advance’ Imfinzi in lung cancer

AstraZeneca has won the backing of NICE for its cancer immunotherapy Imfinzi for non-small cell lung cancer (NSCLC), with the drug made available via the Cancer Drugs Fund for now.

The funding decision – released in draft final guidance today – means that PD-L1 inhibitor will be made available on the NHS in England immediately for people with locally-advanced NSCLC who can’t be treated with surgery and who have already had platinum-based chemotherapy plus concurrent radiation therapy.

NICE estimates there around 165 people will be eligible to receive Imfinzi (durvalumab) via the Cancer Drugs Fund (CDF) in the first year.

Imfinzi was approved by the European Commission for this patient group last September, opening up a niche for AZ’s drug in NSCLC where immunotherapy competitors – and particularly Merck & Co/MSD which dominates the NSCLC market – are not present. It was cleared by the FDA for the same indication the previous May.

The decision is based on a review of data from the PACIFIC trial, which NICE acknowledges showed that Imfinzi is a “big advance” in this patient group, with patients taking the drug going for an average of around two years without the disease progressing, versus six months for the placebo group.

The PACIFIC data was published in the New England Journal of Medicine (NEJM) in 2017, and showed that the median progression-free survival (PFS) with Imfinzi was 16.8 months, compared to 5.6 months with placebo, while an update last year showed that it reduced the risk of death by 32%.

The five-year survival rate for these patients has generally been around 15%, but NICE estimates that Imfinzi treatment could improve that to between 27% and 40%.

NICE’s independent technology appraisal committee concluded that durvalumab was “a potentially curative treatment,” but decided that the clinical trial data were too immature for this to be certain – hence the decision to offer it via the CDF rather than routinely on the NHS while more data is collected. Imfinzi was previously available in the UK at no charge through an early access programme.

The decision was welcomed by consultant clinical oncologist Dr Fiona McDonald, who advised the NICE committee on the review and described it as “the biggest advance we’ve seen for a number of years” in locally-advanced NSCLC.

“For our patients it’s fantastic news,” she added. “I expect to see an immediate impact on clinical practice, and for this treatment to become the standard of care for eligible patients.”

The PACIFIC target indication is viewed as a critical market for Imfinzi that could be a blockbuster market for the drug in its own right, perhaps worth $2 billion to $3 billion a year. Last year’s approvals for locally-advanced NSCLC came as sales of Imfinzi accelerated from just $19 million in 2017 to $633 million.

The backing also gives some comfort to AZ after its combination of Imfinzi and CTLA4 inhibitor tremelimumab bombed spectacularly in the MYSTIC trial in first-line NSCLC, a therapeutic category led by MSD’s PD-1 inhibitor Keytruda (pembrolizumab).