LONDON (dpa-AFX) - British drug major AstraZeneca Plc (AZN, AZN.L) announced Monday that its Imfinzi (durvalumab) has been approved in the European Union as first and only immunotherapy for limited-stage small cell lung cancer or LS-SCLC.
The approval is to treat adults with LS-SCLC whose disease has not progressed following platinum-based chemoradiation therapy or CRT.
The European Commission's approval follows the positive opinion of the Committee for Medicinal Products for Human Use, based on results from the ADRIATIC Phase III trial, which showed a 27% reduction in the risk of death versus placebo.
SCLC, a highly aggressive form of lung cancer, typically recurs and progresses rapidly, despite initial response to standard-of-care chemotherapy and radiotherapy. The prognosis for LS-SCLC is particularly poor, despite curative-intent treatment with standard-of-care concurrent CRT or cCRT.
The ADRIATIC trial is a randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi plus Imjudo (tremelimumab) versus placebo in the treatment of 730 patients with LS-SCLC who had not progressed following cCRT.
In the trial, results showed Imfinzi reduced the risk of death by 27% versus placebo. An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo.
Imfinzi also reduced the risk of disease progression or death by 24% versus placebo. An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% for placebo.
In the trial, the safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine. No new safety signals were observed.
The trial results were published in The New England Journal of Medicine.
Suresh Senan, radiation oncologist at the Amsterdam University Medical Centers, The Netherlands, and principal investigator in the trial, said, 'This approval marks a turning point for patients with limited-stage small cell lung cancer in Europe, bringing them an immunotherapy option for the first time. An unprecedented 57% of patients treated with durvalumab were still alive at three years in the ADRIATIC trial. This significant advance establishes a new benchmark in a setting where the standard of care has remained unchanged for decades.'
Imfinzi is approved in the US and several other countries in this setting based on the ADRIATIC results. Regulatory applications are currently under review in Japan and several other countries for this indication.
Imfinzi is also approved in combination with chemotherapy for the treatment of extensive-stage SCLC based on the CASPIAN Phase III trial.
Since the first approval in May 2017, more than 374,000 patients have been treated with Imfinzi, the company noted.
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