Patients in the European Union who have advanced or metastatic non-small cell lung cancer (NSCLC) now can be treated with Roche’s Tecentriq (atezolizumab).
According to the European Commission marketing authorization, Tecentriq can be prescribed to NSCLC patients who have not responded to prior chemotherapy regimens, or EGFR- and ALK-targeted therapies.
“We are delighted that the European Commission has approved Tecentriq, the first anti-PD-L1 cancer immunotherapy approved in the EU,” Sandra Horning, MD, chief medical officer and head of global product development of Roche, said in a press release.
Tecentriq is an engineered antibody that was designed to bind the surface protein PD-L1 that is found in cancer cells and tumor-infiltrating immune cells. By blocking the activity of PD-L1 protein, the antibody will trigger immune T-cells to recognize and attack cancer cells.
Tecentriq was approved by the U.S. Food and Drug Administration (FDA) in October 2016, and also is available in several other countries to treat patients with metastatic NSCLC.
The European Commission approval was based on the results of the Phase 2 POPLAR study (NCT01903993), and the Phase 3 OAK study (NCT02008227).
The POPLAR trial included a 87 patients with locally advanced or metastatic NSCLC who did not respond to platinum-containing regimen, independently of the PD-L1 expression status. Participants received intravenous infusions of 1,200 mg of Tecentriq every three weeks, or 75 mg/m2 of docetaxel (a chemotherapy drug).
Treatment with the PD-L1 inhibitor led to a median overall survival of 12.6 months compared to 9.7 months in patients treated with docetaxel. In addition, the median duration of response was 18.6 months in the Tecentriq group, versus 7.2 months in the docetaxel-treated group.
The OAK study enrolled 1,225 patients with squamous and non-squamous lung cancer, who received the same treatment regimen applied in the POPLAR trial. Following the same trend previously reported, the PD-L1 inhibitor improved the patients’ median overall survival by 4.2 months compared to the standard of care therapy (docetaxel chemotherapy).
These results showed that Tecentriq’s beneficial effects can be extended to patients with locally advanced or metastatic NSCLC, regardless of the levels of PD-L1 expressed by the cancer cells, Horning noted.
Pooled safety data from several Tecentriq clinical trials showed that the most common adverse effects related to treatment were fatigue, decreased appetite, nausea, difficulty breathing, diarrhea, fever, rash, vomiting, joint pain, low energy, and itching skin.
Tecentriq also has received approval by the European Commission as a treatment for advanced bladder cancer.