HQ Team
February 3, 2025: AstraZeneca’s drug for treating limited-stage small cell lung cancer got a recommendation for approval from an EU regulator panel, according to the British-Swedish drugmaker.
Imfinzi (durvalumab) was given the nod by the Committee for Medicinal Products for Human Use of the European Medicines Agency for those whose disease has not progressed following chemoradiation therapy, according to a statement.
The nod was based on results from an end-stage trial which showed a 27% reduction in the risk of death when compared with the placebo or dummy drug.
“An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo.”
Aggressive form of cancer
Median disease progression free survival was 16.6 months compared to 9.2 months for the placebo.
Limited-stage small-cell lung cancer (LS-SCLC) is a highly aggressive form of lung cancer. It typically recurs and progresses rapidly despite initial response to standard-of-care chemotherapy and radiotherapy.
The prognosis for LS-SCLC is particularly poor, as only 15-30% of patients will be alive five years after diagnosis.
The end-stage trial “was the first Phase III trial in decades to demonstrate a survival benefit in limited-stage small cell lung cancer, reducing the risk of death by 27% in patients treated with durvalumab versus placebo,” said Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, The Netherlands, and principal investigator in the trial.
US approval
“Today’s positive recommendation from the CHMP means that our patients in Europe are one step closer to gaining access to this practice-changing treatment regimen.”
Susan Galbraith, Executive Vice President, Oncology Haematology, R&D, AstraZeneca, said: “With 57% of patients still alive at three years,” in the trial, Imfinzi has the potential to transform treatment for people with limited-stage small cell lung cancer.
“If approved, these patients will have access to immunotherapy for the first time, redefining expectations of survival outcomes in this setting,” she said.
The drug has been approved in the US and regulatory applications are currently under review in Japan and several other countries, according to the company.
30% of SCLC diagnosis
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.
Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC (small cell lung cancer), with about 15% of cases classified as SCLC.
Limited-stage-SCLC (Stage I-III) is classified as SCLC which is generally only in one lung or one side of the chest.
LS-SCLC accounts for approximately 30% of SCLC diagnoses, with an estimated 8,000 people treated for LS-SCLC across the five major European countries each year.
