Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)

First new initial treatment option approved by the U.S. Food and Drug Administration (FDA) for people with ES-SCLC in more than 20 years

Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved for the initial treatment of ES-SCLC. 

The approval also marks the first new initial treatment option approved by the FDA for ES-SCLC patients in more than 20 years.

“Tecentriq is the first cancer immunotherapy approved for the initial treatment of ES-SCLC, which is especially difficult to treat,” commented Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development.

The approval is based on data from the Phase III IMpower133, which study showed that Tecentriq in combination with chemotherapy helped individuals live significantly longer compared to chemotherapy alone (median overall survival = 12.3 versus 10.3 months) in the intention-to-treat population.

“Tecentriq is the first cancer immunotherapy approved for the initial treatment of ES-SCLC, which is especially difficult to treat,” commented Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development.

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq 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 Tecentriq-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 Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.

“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 Andrea Ferris, president and CEO of LUNGevity Foundation. “Today’s approval of Tecentriq is an important step forward in ensuring that people across the spectrum of lung cancer types have effective new therapies.”

Results from the Phase III IMpower133 study were simultaneously presented at the 2018 World Conference on Lung Cancer (WCLC) and published in The New England Journal of Medicine.

Tecentriq is also approved in combination with Avastin^® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Additionally, Tecentriq 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 Tecentriq.