資料來源：https://www.businesswire.com/news/home/20161018006709/en/FDA-Approves-Genentech%E2%80%99s-Cancer-Immunotherapy-TECENTRIQ%C2%AE-Atezolizumab

– First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small cell lung cancer (NSCLC) –

– Approval based on survival benefit of TECENTRIQ compared to docetaxel chemotherapy, regardless of PD-L1 status –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved TECENTRIQ^® (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population 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 = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.

“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.”

“Over the past 15 years, survival rates for advanced lung cancer have been consistently improving,” said Bonnie J. Addario, a lung cancer survivor and founder of the Bonnie J. Addario Lung Cancer Foundation (ALCF). “The approval of TECENTRIQ is another important step for patients by increasing the number of medicines available to people living with lung cancer.”

The TECENTRIQ development program 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.

Possible serious side effects with TECENTRIQ include, but are not limited to, lung problems (pneumonitis), liver problems (hepatitis), intestinal problems (colitis), hormone gland problems (especially the pituitary, thyroid, adrenal glands and pancreas), nervous system problems (neuropathy, meningitis and encephalitis), eye problems (inflammation of the eyes), severe infections and severe infusion reactions. Additional information on these and other side effects can be found below.

About the OAK study

OAK is a global, multicenter, open-label, randomized, 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 randomized patients. Patients with both squamous and non-squamous disease were randomized (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 randomized patients (intention-to-treat [ITT] population) and in a PD-L1-selected subgroup in the primary analysis population.

About the POPLAR study

The POPLAR study is a global, multicenter, open-label, randomized Phase II trial that evaluated 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.

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 lung cancer

According to the American Cancer Society, it is estimated that more than 224,000 Americans will be diagnosed with lung cancer in 2016, and NSCLC accounts for up to 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the most advanced stages.

About TECENTRIQ^® (atezolizumab)

TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1. TECENTRIQ is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ may also affect normal cells.