Tecentriq Approved as First Adjuvant Immunotherapy for NSCLC

The FDA cleared Genentech’s Tecentriq (atezolizumab) as the first immunotherapy adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage 2-3A nonsmall cell lung cancer (NSCLC) whose tumors express PD-L1.

"Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a press release. “Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.”

Bonnie Addario

Too many patients with early-stage lung cancer experience disease recurrence following surgery, added Bonnie Addario, cofounder and chair of GO2 Foundation for Lung Cancer. "Now, the availability of immunotherapy following surgery and chemotherapy offers many patients new hope and a powerful new tool to reduce their risk of cancer relapse. With this approval, it is more important than ever to screen for lung cancer early and test for PD-L1 at diagnosis to help bring this advance to the people who can benefit.”

Tecentriq has six approved indications for lung cancer in the United States. In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, Tecentriq was also the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer in combination with carboplatin and etoposide (chemotherapy).

Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies.

Tecentriq is available in three dosing options, with administration every 2, 3 or 4 weeks.

The new approval is based on results from an interim analysis of the phase 3 IMpower010 study that showed treatment with Tecentriq following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death by 34% in people with Stage 2-3A NSCLC whose tumors express PD-L1≥1%, compared with best supportive care.

Safety data for Tecentriq were consistent with its known safety profile, and no new safety signals were identified. Fatal and serious adverse reactions occurred in 1.8% and 18%, respectively, of patients receiving Tecentriq.

The review of Tecentriq’s application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. As a result, Genentech submitted simultaneous applications to regulators in the United States, Switzerland, the UK, Canada, Brazil and Australia.