Atezolizumab Granted FDA Approval for Specific Cases of NSCLC

Atezolizumab Granted FDA Approval for Specific Cases of NSCLC
Atezolizumab Granted FDA Approval for Specific Cases of NSCLC

Atezolizumab (Tecentriq®) was approved by the US Food and Drug Administration (FDA) for the treatment of certain cases of metastatic non-small cell lung cancer (NSCLC), according to a news statement from Genentech.1

Atezolizumab is a monoclonal antibody designed to bind with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It enables T cell activation by blocking the interactions of PD-L1 with both PD-1 and B7.1 receptors.

The immunotherapeutic agent is indicated for patients with NSCLC whose disease progressed during or following treatment with platinum-containing chemotherapy, and cases of tumors with EGFR or ALK gene abnormalities in which disease progressed despite treatment with an appropriate FDA-approved targeted therapy. FDA approval is based on the results of the phase 3 OAK and phase 2 POPLAR studies.

OAK is a global, multicenter, open-label, randomized, controlled phase 3 study that evaluated the efficacy and safety of atezolizumab compared with docetaxel in 1225 people with locally advanced or metastatic NSCLC whose disease progressed following treatment with platinum-containing chemotherapy, with a primary analysis consisting of data from the first 850 randomized patients.

Patients with both squamous and nonsquamous disease, regardless of their PD-L1 status, were randomized (1:1) to receive either atezolizumab 1200 mg intravenously every 3 weeks or docetaxel 75 mg/m2 intravenously every 3 weeks. Primary end points were overall survival in all randomized patients and in a PD-L1 selected subgroup of the primary analysis population. 

Findings showed that median overall survival [OS] with atezolizumab was 13.8 months vs. 9.6 months with docetaxel (HR = 0.74, 95% CI, 0.63-0.87).

The POPLAR study is a global, multicenter, open-label, randomized phase 2 trial comparing the efficacy and safety of atezolizumab with docetaxel in people with previously treated recurrent locally advanced or metastatic NSCLC. Primary end point was overall survival; secondary end points included progression-free survival, objective response rate, and safety. 

In terms of side effects, the most commonly reported effects (20% or more of participants) among patients with metastatic NSCLC were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation. Nine patients (6.3%) in the atezolizumab group experienced pulmonary embolism, pneumonia, pneumothorax, ulcer hemorrhage, cachexia secondary to dysphagia, myocardial infarction, or large intestinal perforation which led to death. Atezolizumab was discontinued due to adverse reactions in 6 of 142 patients (4%).

Atezolizumab may cause fertility problems in females. Women of child-bearing potential should use an effective contraception during treatment and for 5 months after receiving the last dose.

More than 15 clinical trials in lung cancer, including seven phase 3 studies in previously untreated (first-line) lung cancer, to evaluate the use of atezolizumab alone and in combination with other medicines, as part of the development program for atezolizumab.

Reference

1. FDA approves Genentech's cancer immunotherapy Tecentriq® (atezolizumab) for people with a specific type of metastatic lung cancer [news release]. South San Francisco, CA: Genentech; October 18, 2016.

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