**AstraZeneca’s (AZ) Imfinzi (durvalumab) has been approved by the US Food and Drug Administration (FDA) to treat adults with an aggressive form of lung cancer.**
The drug has been specifically authorised for use in patients with limited-stage small cell lung cancer (SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
SCLC accounts for approximately 15% of all lung cancer diagnoses and progresses rapidly. Around 30% of SCLC patients have limited-stage disease, classified as SCLC that is generally only in one lung or one side of the chest, and face a particularly poor prognosis despite curative-intent treatment with standard-of-care concurrent chemoradiotherapy.
AZ’s Imfinzi is designed to block the interaction of PD-L1 with the PD-1 and CD80 proteins, countering tumours’ immune-evading tactics and releasing the inhibition of immune responses. The drug is already approved in the US and other countries globally to treat extensive-stage SCLC, classed as SCLC that has spread to the other lung, the lymph nodes on the other side of the chest, or to distant organs.
The FDA’s latest decision was supported by positive results from the late-stage ADRIATIC trial, in which Imfinzi reduced the risk of death by 27% compared to placebo. Estimated median overall survival was 55.9 months for Imfinzi versus 33.4 months for placebo, and an estimated 57% of Imfinzi-treated patients were alive at three years compared to 48% of those in the placebo group.
Imfinzi was also shown to reduce the risk of disease progression or death by 24% compared to placebo. Median progression-free survival was 16.6 months for Imfinzi versus 9.2 months for placebo, and an estimated 46% of patients receiving Imfinzi had not experienced disease progression at two years compared to 34% for placebo.
Dave Fredrickson, executive vice president, oncology business unit, AZ, said: “This approval for Imfinzi marks a breakthrough for patients with limited-stage SCLC, allowing them to receive immunotherapy for the first time. The ADRIATIC trial showed an improvement in median overall survival of 22.5 months, setting a new benchmark.”
Fredrickson added that Imfinzi is now the only immunotherapy approved for both limited- and extensive-stage SCLC.
Imfinzi is also approved in Switzerland to treat limited-stage SCLC, and regulatory applications are currently under review in the EU and several other countries in this indication, AZ outlined.