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NICE Recommends AstraZeneca's Imfinzi for PD-L1-Positive NSCLC

NEW YORK – The National Institute for Health and Care Excellence (NICE) on Friday recommended AstraZeneca's Imfinzi (durvalumab) for patients in England with PD-L1-positive locally advanced, unresectable, stage III non-small-cell lung cancer.

NICE recommended that the National Health Service (NHS) England provide Imfinzi specifically for advanced NSCLC patients who are responsive to platinum-based chemoradiation and have PD-L1 expression in at least 1 percent of tumor cells. The agency evaluated data from the Phase III PACIFIC trial and from patients who received Imfinzi in the UK when it was made available through the Cancer Drugs Fund in 2019.

Updated long-term results from the PACIFIC trial showed PD-L1-positive NSCLC patients treated with Imfinzi after platinum-based concurrent chemoradiotherapy had a five-year overall survival rate of 42.9 percent versus 33.4 percent in the placebo arm. The median overall survival on Imfinzi was 47.5 months compared to 29.1 for placebo.

Earlier data from the trial showed a response rate of 28.4 percent for patients treated with Imfinzi and 16 percent on placebo, and median progression-free survival was 16.8 months and 5.6 months, respectively.

"Sadly, not all people with stage III unresectable NSCLC are treated with the intention to cure and those that are, many will progress to develop advanced incurable disease," Patricia Fisher, a consultant clinical oncologist at Sheffield Teaching Hospitals NHS Foundation Trust, said in a statement. "Since durvalumab was made available within the Cancer Drugs Fund, we have seen a significant shift to more patients being treated with concurrent chemoradiation therapy because they then have the option to follow this with immunotherapy, giving them the chance of improved outcomes."

The list price for Imfinzi is £2,466 ($3,016) per 500 mg per 10 ml infusion vial, but the drug will be offered to the NHS at an undisclosed discount. AstraZeneca also offers qualifying patients a discount through an Imfinzi access program.

Imfinzi was approved in the US in 2018. However, the US Food and Drug Administration approved the immunotherapy for unresectable stage III NSCLC regardless of PD-L1 expression. The drug was also approved by the European Medicines Agency in 2018 for patients with locally advanced, unresectable NSCLC patients with PD-L1 expression greater than 1 percent.

Imfinzi is also approved in the US and Europe for the treatment of extensive-stage small cell lung cancer in combination with etoposide and either carboplatin or cisplatin chemotherapy. AstraZeneca is studying the drug in advanced biliary tract, liver, and prostate cancer.