On September 24, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported that the European Commission has granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT) (Press release, AstraZeneca, SEP 24, 2018, View Source [SID1234529611]). The approval is based on results from the Phase III PACIFIC trial.
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Dave Fredrickson, Executive Vice President, Head of the Oncology Business, said: "Patients in Europe diagnosed with locally-advanced, unresectable non-small cell lung cancer now have a new treatment option. Imfinzi is the only immunotherapy to be approved in this curative-intent setting, and we are proud to bring a new standard of care for this difficult disease."
Dr. Luis Paz-Ares, co-principal investigator of the PACIFIC trial, from the Hospital Universitario Doce de Octubre, Madrid, Spain, said: "Lung cancer is the leading cause of cancer-related death in Europe and approximately a third of European patients with NSCLC present with locally-advanced disease. For decades, the standard of care for these patients has been chemotherapy and radiation therapy followed by active surveillance, after which the majority of patients progress to advanced disease. Imfinzi has demonstrated a compelling survival benefit for these patients in this area of significant unmet need."
The approval follows the positive opinion on 27 July 2018 from the CHMP of the European Medicines Agency.
The most common adverse reactions (greater than or equal to 20% of patients) of Imfinzi versus placebo were cough (40.2% vs. 30.3%), upper respiratory tract infections (26.1% vs 11.5%) and rash (21.7% vs 12.0%). 12.8% of patients experienced a grade 3 or 4 AE with Imfinzi vs 9.8% with placebo.
Imfinzi is approved for the treatment of patients with unresectable, Stage III (locally-advanced) NSCLC in the US, Canada, Switzerland, India, Japan and Brazil. Other global health authority reviews and submissions are ongoing.
About Stage III NSCLC
Stage III (locally-advanced) NSCLC is divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery. Stage III disease is different from Stage IV disease, when the cancer has spread (metastasised) to distant organs, as Stage III is currently treated with curative intent.
Stage III NSCLC represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in the top-eight countries (China, France, Germany, Italy, Japan, Spain, UK, US) in 2017. The majority of Stage III NSCLC patients are diagnosed with unresectable tumours. No new treatments beyond chemoradiation therapy, followed by active surveillance to monitor for progression, have been available to patients for decades.
About PACIFIC
The PACIFIC trial is a Phase III, randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi as treatment in ‘all-comer’ patients (i.e. regardless of PD-L1 status) with unresectable, Stage III (locally-advanced) NSCLC whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT).
The trial is being conducted in 235 centres across 26 countries involving 713 patients. The primary endpoints of the trial are PFS and OS, and secondary endpoints include landmark PFS and OS, objective response rate, and duration of response.
About Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.
Imfinzi is approved for unresectable, Stage III NSCLC in the US, Canada, Switzerland, India, Japan, and Brazil based on the Phase III PACIFIC trial. Imfinzi is also approved for the treatment of patients with locally-advanced or metastatic urothelial carcinoma in the US, Canada, Brazil, Israel, Hong Kong, and India.
As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with chemotherapy, radiation therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal antibody, as a first or second-line treatment for patients with NSCLC, small-cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.