"TECENTRIQ is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "TECENTRIQ is the first and only approved cancer immunotherapy designed to target the PD-L1 protein, which may play an important role in the way the medicine works."
The TECENTRIQ development programme includes more than 15 clinical trials in lung cancer, including seven phase III studies in previously untreated (first-line) lung cancer. These studies are evaluating the use of TECENTRIQ alone or in combination with other medicines.
About the OAK study
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. Patients with both squamous and non-squamous disease 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. 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.
About the POPLAR study
POPLAR is a multicentre, open-label, randomised, Phase II study evaluating the efficacy and safety of TECENTRIQ compared with chemotherapy (docetaxel) in 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.
The most common side effects (≥ 20%) in patients with metastatic non-small cell lung cancer were fatigue, decreased appetite, dyspnea (shortness of breath), cough, nausea, musculoskeletal pain, and constipation. Nine patients (6.3%) who were treated with TECENTRIQ experienced either pulmonary embolism (2), pneumonia (lung infection) (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 4 percent (6) of the 142 patients.
About non-small cell lung cancer
Lung cancer is the leading cause of cancer death globally. Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day. 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.
About TECENTRIQ (atezolizumab)
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 currently only approved in the US.
About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine 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.
About personalised cancer immunotherapy (PCI)
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 which 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.
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