Months after Imfinzi combo flops, AstraZeneca wins NICE endorsement as lung cancer monotherapy
AstraZeneca’s big bet on a combination of its checkpoint inhibitor Imfinzi and in-house CTLA-4 drug has proved exceedingly costly, but the British drugmaker has something to cheer about as its PD-L1 inhibitor made the NICE cut for use in certain NHS patients with non-small-cell lung cancer, the largest, most lucrative field of oncology.
The drug will be made available by NHS England for patients with locally advanced unresectable non-small-cell lung cancer who have been treated with platinum-based chemoradiation. It was approved last September by the European Commission as the only immunotherapy to notch the nod in this patient population, giving it an edge over Merck’s trailblazing checkpoint inhibitor Keytruda.
Known chemically as durvalumab, Imfinzi was approved on the basis of data from the Phase III PACIFIC trial that showed the drug induced a statistically significant improvement in progression-free survival by 11.2 months versus placebo, and also helped patients live longer. Currently there are no other treatment options for these patients whose disease has not progressed post chemoradiation, NICE noted.
The drug is administered as an intravenous infusion every two weeks, until disease progression or for up to 12 months. A 500 mg vial has a list price of £2,466 but under NICE’s agreement AstraZeneca will provide it to the NHS at a confidential discounted price, NICE said.
Although the drug has the “potential to be curative”, there is a high level of uncertainty underlying its clinical evidence, so NICE has recommended its use within the Cancer Drugs Fund — a fund that aims to make promising cancer drugs available to patients before they are fully sanctioned for use in the NHS — while more data are collected.
Lung cancer is the leading cause of cancer death globally, according to the WHO. The two main types of lung cancer are non-small cell and small cell, and NSCLC accounts for about 85% of all cases. Lung cancer has a poor prognosis; statistics suggest over half of people diagnosed die within one year of diagnosis and the average 5-year overall survival rate is less than 18%. NICE said Imfinzi constituted a ‘big advance’ as it was plausible that between 27% and 40% of people taking durvalumab would have 5 years of progression-free survival.
In the final months of last year, AstraZeneca’s plan to expand the use of Imfinzi by combining it with its CTLA-4 tremelimumab — once touted as the cornerstone of the drugmaker’s checkpoint development strategy — failed to help certain patients with head and neck cancer, in addition to the big flop in the keenly-watched MYSTIC lung cancer trial.
Imfinzi generated 2018 sales of $633 million for AstraZeneca.