EC Approves Imfinzi for Treatment of LS-SCLC

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In March 2025, the European Commission (EC) approved durvalumab (Imfinzi, AstraZeneca) as monotherapy to treat adults in the European Union (EU) with limited-stage small cell lung cancer (LS-SCLC). The indication is for those adult patients whose disease has not progressed following platinum-based chemoradiation therapy (CRT). This approval marks durvalumab as the first and only immunotherapy to treat LS-SCLC in the EU, according to AstraZeneca in a March 17, 2025 press release (1).

The EC’s approval follows a positive opinion granted by European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use. The committee’s positive opinion was based on results from a Phase III trial (ADRIATIC), which showed a 27% reduction in the risk of death versus placebo. In addition, durvalumab also reduced the risk of disease progression or death by 24% versus placebo (1).

“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,” said Suresh Senan, PhD, radiation oncologist at the Amsterdam University Medical Centers, The Netherlands, and principal investigator in the trial, in the company press release (1). “This significant advance establishes a new benchmark in a setting where the standard of care has remained unchanged for decades.”

A highly aggressive form of lung cancer, SCLC typically recurs and progresses rapidly, despite an initial response to standard-of-care chemotherapy and radiotherapy (2,3). Each year, an estimated 8000 people are treated for LS-SCLC across the five major European countries (4,5), and the prognosis is particularly poor. It is estimated that only 15–30% of patients survive for five years after being diagnosed (6).

“Imfinzi has the potential to transform how limited-stage small cell lung cancer is treated as the first immunotherapy approved in Europe in this setting. As the only immunotherapy approved for both early and late-stage disease, Imfinzi is poised to become the foundation for transforming outcomes for people with small cell lung cancer,” said Dave Fredrickson, executive vice president, Oncology Hematology Business Unit, AstraZeneca, in the press release.

Durvalumab (under the brand name Imfinzi) is approved in the United States and several other countries in the LS-SCLC setting based on the Phase III trial results. AstraZeneca also has regulatory applications under review in Japan and several other countries for the same indication. Durvalumab is also approved in combination with chemotherapy to treat extensive-stage SCLC based on another Phase III trial (CASPIAN).

In March 2025, a Phase III trial (MATTERHORN) evaluated the use of perioperative durvalumab added to standard-of-care chemotherapy. The trial met its primary endpoint: event-free survival in resectable gastric and gastroesophageal junction cancers (1).

Durvalumab is a human monoclonal antibody that binds to the programmed cell death ligand 1 (PD-L1) protein. It blocks the interaction of PD-L1 with the programmed cell death protein 1 and CD80 proteins. Blocking this interaction counters a tumor's ability to evade the immune system and releases the inhibition of immune responses.

References

1. AstraZeneca. Imfinzi Approved in the EU as First and Only Immunotherapy for Limited-Stage Small Cell Lung Cancer. Press Release. March 17, 2025.
2. Qin, A.; Kalemkerian, G. P. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? J. Oncol. Pract. 2018, 14 (6), 369–370. DOI: 10.1200/JOP.18.00278
3. Cheng, Y.; Spigel, D. R.; Cho, B. C.; et al. Durvalumab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N. Engl. J. Med. 2024, 391 (14), 1313–1327. DOI: 10.1056/NEJMoa2404873
4. National Cancer Institute. NCI Dictionary—Small Cell Lung Cancer. www.cancer.gov (accessed March 26, 2025).
5. AstraZeneca. Investor Relations Epidemiology Spreadsheet. astrazeneca.com/investor-relations (accessed March 26, 2025).
6. Bebb, D. G.; Murray, C.; Giannopoulou, A.; Felip, E. Symptoms and Experiences with Small Cell Lung Cancer: A Mixed Methods Study of Patients and Caregivers. Pulm. Ther. 2023, 9, 435–450. DOI: 10.1007/s41030-023-00229-9