FDA Approves Atezolizumab Combination for Initial Treatment of Adults With ES-SCLC

This approval is based on results from the Phase III IMpower133 study, which showed that atezolizumab in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone in the intention-to-treat population.

Officials with the FDA have approved atezolizumab (Tecentriq, Genentech) in combination with carboplatin and etoposide (chemotherapy), for the firstline treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

“Tecentriq is the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer, which is especially difficult to treat,” said Sandra Horning, MD, chief medical officer and head of Global Product Development for Genentech, in a prepared statement. “Until now, there have been limited treatment advances for this disease, and we are excited to bring a potential new standard of care to patients that has been shown to improve survival compared to chemotherapy.”

According to Genentech, a member of the Roche Group, this approval is based on results from the Phase III IMpower133 study, which showed that atezolizumab in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS] = 12.3 versus 10.3 months; hazard ratio [HR] = 0.70, 95 percent CI: 0.54-0.91; p=0.0069) in the intention-to-treat (ITT) population. The atezolizumab-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared to chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95 percent CI: 0.62-0.96; p=0.017).

Safety for the atezolizumab and chemotherapy combination appeared consistent with the known safety profile of atezolizumab, according to Genentech.

The most common adverse effects of atezolizumab when used in lung cancer therapy with other anticancer medicines include feeling tired or weak, nausea, hair loss, constipation, diarrhea and decreased appetite.

The most common adverse effects of atezolizumab when used with paclitaxel protein-bound include hair loss, tingling or numbness in hands or feet, feeling tired, nausea, diarrhea, anemia, constipation, cough, headache, low white blood cells, vomiting, and decreased appetite.

Atezolizumab may also cause fertility problems in females, which may affect the ability to have children. Patients should talk to their health care provider if they have concerns about fertility, or about additional adverse effects.

In a prepared statement, Andrea Ferris, president and CEO of LUNGevity Foundation, said the FDA’s approval of atezolizumab with carboplatin and etoposide for initial treatment of ES-SCLC marks an important step forward in ensuring that individuals across the spectrum of lung cancer types have effective new therapies.

“Extensive-stage small cell lung cancer is a highly aggressive form of lung cancer, which until now, has seen limited treatment advances over the last 20 years,” said Ferris.

Atezolizumab is also approved in combination with bevacizumab (Avastin, Genentech), paclitaxel and carboplatin, for first-line treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Additionally, atezolizumab is approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving atezolizumab.

Pharmacists and other health care providers can provide patients with more information about atezolizumab.

Reference

FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer [news release]. South San Francisco, CA; March 18, 2019: Genentech website. https://www.gene.com/media/press-releases/14783/2019-03-18/fda-approves-genentechs-tecentriq-in-com. Accessed March 19, 2019.