CHMP Recommends Imfinzi for Approval in EU for Limited-Stage Small Cell Lung Cancer

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On Feb. 3, 2025, AstraZeneca announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Imfinzi (durvalumab), a human monoclonal antibody, in the European Union (EU) as monotherapy treatment for adults with limited-stage small cell lung cancer (LS-SCLC). The indication is for LS-SCLC patients whose disease has not progressed following platinum-based chemoradiation therapy (CRT) (1).

CHMP’s positive opinion is based on the results of a Phase III trial (ADRIATIC) (2) showing a 27% reduction in the risk of death versus placebo. Approximately 57% of patients treated with durvalumab were alive at the three-year mark, compared to 48% of patients placed on the placebo. Durvalumab was also shown to reduce the risk of disease progression or death by 24% versus placebo. The average progression-free survival rate was 16.6 month for patients using durvalumab versus 9.2 months for patients treated with placebo. In addition, an estimated 46% of patients treated with durvalumab did not experience disease progression at two years compared to 34% of patients on the placebo (1).

“ADRIATIC 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. 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,” said Suresh Senan, PhD, professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, The Netherlands, and principal investigator in the trial, in a company press release (1).

SCLC is a highly aggressive form of lung cancer (3), and LS-SCLC is a typically recurring and rapidly progressing disease, despite a patient having an initial response to standard-of-care chemotherapy and radiotherapy (4–5). The prognosis for patients with LS-SCLC is particularly daunting, with approximately only 15–30% of patients able to remain alive five years after diagnosis (6).

“With 57% of patients still alive at three years in the ADRIATIC trial, [durvalumab] 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,” said Susan Galbraith, executive vice-president, Oncology Hematology, R&D, AstraZeneca, in the release.

Durvalumab (under the brand name Imfinzi) is approved in the United States and several other countries in the LS-SCLC indication based on the Phase III trial results. AstraZeneca also has regulatory applications under review in Japan and several other countries in this indication.

In addition to LS-SCLC, durvalumab is the only approved immunotherapy and the global standard-of-care “in the curative-intent setting” for unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after CRT. The therapy is also approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC; in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for treating extensive-stage SCLC; and in combination with a short course of tremelimumab (brand name Imjudo, AstraZeneca) and chemotherapy for treating metastatic NSCLC.

References

1. AstraZeneca. Imfinzi Recommended for Approval in the EU by CHMP as First and Only Immunotherapy for Limited-Stage Small Cell Lung Cancer. Press Release. Feb. 3, 2025.
2. AstraZeneca. Imfinzi is First and Only Immunotherapy to Show Survival Benefit in Limited-Stage Small Cell Lung Cancer in Global Phase III Trial, Reducing the Risk of Death by 27% vs. Placebo. Press Release. June 2, 2024.
3. National Cancer Institute. NCI Dictionary—Small Cell Lung Cancer. cancer.gov (accessed Feb. 5, 2025).
4. 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.
5. Cheng, Y.; Spigel, D. R.; Cho, B. C. Durvalumab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N. Engl. J. Med. 2024, 391 (14), 1313–1327.
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 (3), 435–450. DOI: 10.1007/s41030-023-00229-9