Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer

Recommendation based on ADRIATIC Phase III trial results which showed a 27% reduction in the risk of death versus placebo

WEBWIRE – Monday, February 3, 2025

AstraZenecasImfinzi(durvalumab) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from theADRIATICPhase III trial, which were published inThe New England Journal of Medicine.

Results showedImfinzireduced the risk of death by 27% versus placebo (based on an overall survival [OS] hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.57-0.93; p=0.0104). Estimated median OS was 55.9 months forImfinziversus 33.4 months for placebo. An estimated 57% of patients treated withImfinziwere alive at three years compared to 48% for placebo.

Imfinzialso reduced the risk of disease progression or death by 24% (based on a progression-free survival [PFS] HR of 0.76; 95% CI 0.61-0.95; p=0.0161) versus placebo. Median PFS was 16.6 months forImfinziversus 9.2 months for placebo. An estimated 46% of patients treated withImfinzihad not experienced disease progression at two years compared to 34% for placebo.

SCLC is a highly aggressive form of lung cancer.¹LS-SCLC typically recurs and progresses rapidly, despite initial response to standard-of-care chemotherapy and radiotherapy.^2-3The prognosis for LS-SCLC is particularly poor, as only 15-30% of patients will be alive five years after diagnosis.⁴

Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, The Netherlands, and principal investigator in the trial, said: 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 per cent in patients treated with durvalumab versus placebo. Todays 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 per cent of patients still alive at three years in the ADRIATIC trial,Imfinzihas 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.

The safety profile forImfinziwas generally manageable and consistent with the known profile of this medicine. No new safety signals were observed.

Imfinziis 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 in this indication.

Notes

Small cell lung cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.^5-6Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% of cases classified as SCLC.⁷

LS-SCLC (Stage I-III) is classified as SCLC that is generally only in one lung or one side of the chest.⁸LS-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.^9-10The prognosis for patients with LS-SCLC remains poor despite curative-intent treatment with standard-of-care concurrent CRT (cCRT).⁹

ADRIATIC
The ADRIATIC trial is a randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluatingImfinzimonotherapy andImfinziplusImjudo(tremelimumab) versus placebo in the treatment of 730 patients with LS-SCLC who had not progressed following cCRT. In the experimental arms, patients were randomised to receive a 1500mg fixed dose ofImfinziwith or withoutImjudo75mg every four weeks for up to four doses/cycles each, followed byImfinzievery four weeks for up to 24 months.

The dual primary endpoints were PFS and OS forImfinzimonotherapy versus placebo. Key secondary endpoints included OS and PFS forImfinziplusImjudoversus placebo, safety and quality of life measures. The trial included 164 centres in 19 countries across North and South America, Europe and Asia.

Imfinzi
Imfinzi(durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumours immune-evading tactics and releasing the inhibition of immune responses.

In addition to its indication in LS-SCLC,Imfinziis the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after CRT. Additionally,Imfinziis approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC; in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC; and in combination with a short course ofImjudoand chemotherapy for the treatment of metastatic NSCLC.

Imfinziis also approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination withImjudoin unresectable hepatocellular carcinoma (HCC).Imfinziis also approved as a monotherapy in unresectable HCC in Japan and the EU.

Imfinziis also approved in combination with chemotherapy (carboplatin and paclitaxel) followed byImfinzimonotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) in the US. In the EU,Imfinziplus chemotherapy followed byLynparza(olaparib) andImfinziis approved for patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer, andImfinziplus chemotherapy followed byImfinzialone is approved for patients with dMMR disease. In Japan,Imfinziplus chemotherapy followed byImfinzimonotherapy has also been approved as 1st-line treatment in primary advanced or recurrent endometrial cancer, andImfinziplus chemotherapy followed byImfinziandLynparzahas been approved for patients with pMMR disease.

Since the first approval in May 2017, more than 374,000 patients have been treated withImfinzi. As part of a broad development programme,Imfinziis being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours.

AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Companys comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, includingTagrisso(osimertinib) andIressa(gefitinib);ImfinziandImjudo;Enhertu(trastuzumab deruxtecan) andDatroway(datopotamab deruxtecan) in collaboration with Daiichi Sankyo;Orpathys(savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the bodys immune system to attack tumours.

AstraZeneca strives to redefine cancer care and help transform outcomes for patients withImfinzias a monotherapy and in combination withImjudoas well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.

AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Companys focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZenecas innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visitastrazeneca.com

References

1. National Cancer Institute. NCI Dictionary – Small Cell Lung Cancer. Available at:https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer. Accessed February 2025.
2. Qin A, Kalemkerian GP. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made?J Oncol Pract. 2018;14(6):369-370.
3. Cheng Y, et al. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer.N Engl J Med.2024;391(14):1313-1327.
4. Bebb DG, et al. Symptoms and Experiences with Small Cell Lung Cancer: A Mixed Methods Study of Patients and Caregivers.Pulm Ther. 2023;9:435-450.
5. World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at:https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.Accessed February 2025.
6. World Health Organization. International Agency for Research on Cancer. World Fact Sheet. Available at:https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf. Accessed February 2025.
7. LUNGevity Foundation. Types of Lung Cancer. Available at:https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed February 2025.
8. American Cancer Society. Small Cell Lung Cancer Stages. Available at:https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/staging-sclc.html.Accessed February 2025.
9. Senan S, et al. ADRIATIC: A phase III trial of durvalumab tremelimumab after concurrent chemoradiation for patients with limited stage small cell lung cancer.Ann Oncol.2019;30(suppl. 2):ii25.
10. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Available at:https://www.astrazeneca.com/investor-relations.html. Accessed February 2025.

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