Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has granted approval to the cancer immunotherapy TECENTRIQ® (atezolizumab). TECENTRIQ is used to treat people with locally advanced or metastatic non-small cell lung cancer (NSCLC) following previous treatment with chemotherapy.1
The approval is based on results from the randomised Phase III OAK and Phase II POPLAR studies. The OAK study showed that TECENTRIQ helped people live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs 9.6 months; HR = 0.73, 95% CI: 0.62–0.87), regardless of their levels of programmed death-ligand 1 (PD-L1) expression.
Three Swiss centres were involved in the development of TECENTRIQ: Lucerne Cantonal Hospital (LUKS), Baden Cantonal Hospital (KSB) and Geneva University Hospitals (HUG).
Dr Nicolas Mach, head of the Clinical Research Unit of the Dr Henri Dubois-Ferrière Dinu Lipatti (DFDL) Foundation at the HUG Cancer Centre, commented: “We're pleased about the positive results of the clinical trial in which our patients participated. Thanks to the Swiss approval, we're delighted to be able to make this important new therapeutic option available to our patients.”
OAK is a global, multicentre, open-label, randomised, controlled Phase III study that evaluated the efficacy and safety of TECENTRIQ compared with docetaxel in 1,225 people with locally advanced or metastatic NSCLC whose disease had progressed following previous treatment with platinum‑containing chemotherapy, with the primary analysis consisting of the first 850 randomised patients. Approximately one-quarter of patients had squamous disease (26 percent). Patients were randomised (1:1) to receive either TECENTRIQ administered intravenously at 1200 mg every 3 weeks or docetaxel administered intravenously at 75 mg/m2 every 3 weeks until unacceptable toxicity or disease progression. The co-primary endpoints were overall survival (OS) in all randomised patients (ITT population) and in a PD-L1-selected subgroup in the primary analysis population. In the OAK study, median OS with TECENTRIQ was 13.8 months, compared with 9.6 months for docetaxel.2
POPLAR is a multicentre, open-label, randomised, Phase II study evaluating the efficacy and safety of TECENTRIQ compared with chemotherapy (docetaxel) in 142 people with previously treated recurrent locally advanced or metastatic NSCLC. The primary endpoint was OS; secondary endpoints included progression‑free survival (PFS), objective response rate (ORR) and safety. In the POPLAR study, median OS with TECENTRIQ was 12.6 months, compared with 9.7 months for docetaxel. The median response duration with TECENTRIQ was 18.6 months, compared with 7.2 months for docetaxel.3
The most common side effects (≥ 20%) were fatigue, decreased appetite, dyspnea (shortness of breath), cough, nausea, musculoskeletal pain and constipation. Nine patients (6.3 percent) who were treated with TECENTRIQ experienced either pulmonary embolism (2), pneumonia (2), pneumothorax, ulcer hemorrhage (bleeding ulcer), cachexia secondary to dysphagia, myocardial infarction (heart attack), or large intestinal perforation which led to death. TECENTRIQ was discontinued for adverse reactions in 6 (4 percent) of the 142 patients.3
Each year, approximately 4,000 people in Switzerland are diagnosed with lung cancer, which accounts for 10 percent of all new cases of cancer. Of those affected, 62% are men and 38% women. Lung cancer is the second most common type of cancer in men and the third most common in women. It is the leading cause of cancer death, responsible for 3,100 deaths per year. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.
TECENTRIQ is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1), which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this interaction, TECENTRIQ may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells. TECENTRIQ is already approved in the US.
For more than 50 years, Roche has been developing medicines with the goal of redefining treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.4
The aim of personalised cancer immunotherapy (PCI) is to provide patients and physicians with treatment options tailored to the specific immune biology associated with a person’s individual tumour. The purpose is to inform treatment strategies that provide the greatest number of people with a chance for transformative benefit. In the case of TECENTRIQ, the goal of PD-L1 as a biomarker is to explore PD-L1 expression on tumour cells and tumour-infiltrating immune cells and how that correlates with clinical benefit either as a monotherapy or in combination, and across a broad range of tumour types. The Roche PCI research and development programme comprises more than 20 investigational candidates, ten of which are in clinical trials.
PCI is an essential component of how Roche delivers on the broader commitment to personalised healthcare. To learn more about the Roche approach to cancer immunotherapy please follow this link: http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims for improving patient access to medical innovations by working with all relevant stakeholders. Twenty-eight medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
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