Cambridge-based pharmaceutical firm AstraZeneca (LON:AZN) has announced the EU approval of Imfinzi as a first-line treatment for adults suffering from extensive-stage small cell lung cancer (ES-SCLC).
The drug is to be used alongside standard chemotherapy after positive results from AstraZeneca’s Phase III CASPIAN trial showed that Imfinzi plus chemotherapy demonstrated a “statistically significant and clinically meaningful overall survival benefit” as a treatment for patients with ES-SCLC.
Imfinzi’s encouraging trial results have boosted hopes that the drug could be instrumental in treating ES-SCLC, which is a “highly aggressive, fast-growing form of lung cancer”, and poses a unique challenge as it “typically recurs and progresses rapidly despite initial response to chemotherapy”.
Lung cancer is the leading cause of cancer deaths worldwide, accounting for about one fifth of all fatalities. Prognosis for patients suffering from ES-SCLC is “particularly poor”, with an average survival rate of just 6% five years after diagnosis.
The CASPIAN trial showed that Imfinzi reduced the risk of death by 27% versus chemotherapy alone, helping patients sustain a median overall survival of 13.0 months versus 10.3 months for chemotherapy alone, and that Imfinzi administered alongside chemotherapy delayed the worsening of cancer symptoms.
Dave Fredrickson, AstraZeneca’s Executive Vice President of Oncology Business, welcomed the company’s pioneering new treatment:
“Imfinzi plus chemotherapy is becoming a new global standard of care for patients with extensive-stage small cell lung cancer, and we are pleased to bring this option to patients in Europe who urgently need it. This is the first immunotherapy regimen to offer both a sustained survival benefit and an improved response rate, as well as a choice of chemotherapies and convenient dosing every four weeks during maintenance”.
Imfinzi in combination with standard cancer treatments is already approved in the USA, Japan and several other countries for the first-line treatment of ES-SCLC, and is currently “under regulatory review” in others.