FDA Approves Tecentriq Immunotherapy For Certain Non-Small Cell Lung Cancers

Tecentriq is approved as an initial treatment for non-small cell lung cancer that has spread and expresses the protein PD-L1 but does not have alterations in the EGFR or ALK genes.

The Food and Drug Administration (FDA) has approved the immunotherapy Tecentriq (atezolizumab) as an initial treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high expression of the protein PD-L1 but no alterations to the EGFR or ALK genes.

The approval marks the fourth for Tecentriq in metastatic NSCLC and the fifth in lung cancer overall. It was based on findings from the phase 3 IMpower110 study, which showed that the immunotherapy lengthened life in the target population compared with chemotherapy.

“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” said Dr. Levi Garraway, chief medical officer and head of global product development for the drug’s maker, Genentech, in a press release.

Tecentriq is the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks, Genentech reported in the release.

It works by inhibiting the activity of PD-L1, which would otherwise keep the immune system in check. This frees up the immune system to recognize and fight cancer.

The results came from an interim analysis in Impower110, which showed that Tecentriq given by itself improved overall survival (OS) by 7.1 months compared with chemotherapy in patients whose cancers expressed a significant amount of PD-L1. Median OS was 20.2 in the Tecentriq group versus 13.1 months in the chemotherapy group.

Receiving medication during the study were 554 patients with stage 4 non-squamous or squamous NSCLC that expressed high levels of PD-L1 and had never been treated with chemotherapy. The patients were divided equally into two groups, one of which received Tecentriq monotherapy while the other took cisplatin or carboplatin plus pemetrexed or gemcitabine.

Genentech described the drug’s toxicity as being “consistent with its known safety profile,” with “no new safety signals … identified.”

Serious or severe treatment-related side effects were reported in 12.9% of those receiving Tecentriq compared with 44.1% of people receiving chemotherapy. The most common side effects of Tecentriq include fatigue, weakness, nausea, cough, shortness of breath and decreased appetite. Rarely, Tecentriq can cause the immune system to attack healthy organs and tissues. It can also cause fertility problems in women.

In the U.S., Tecentriq has already been approved as a single agent and in combination with targeted therapies and/or chemotherapies. It is also approved in combination with carboplatin and etoposide chemotherapies for the initial treatment of adults with extensive-stage small cell lung cancer.

Genentech plans to conduct additional phase 3 clinical trials of Tecentriq in patients with lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.

Check back later for what you need to know about this approval.