November 22, 2019

Immunotherapy Regimen Gets FDA Approval for Extensive Small Cell Lung Cancer

By SPT Staff
Published Online: Tuesday, Mar 26, 2019

Officials with the FDA have granted approval to Genentech’s atezolizumab (Tecentriq) in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), according to a press release.

ES-SCLC is a highly aggressive, difficult-to-treat form of lung cancer. SCLC accounts for approximately 13% of lung cancer cases, with the majority of patients with SCLC diagnosed with ES-SCLC.  

With this approval, the atezolizumab combination therapy is the first new initial treatment option for patients with the disease in more than 20 years and the first immunotherapy approved for ES-SCLC, according to Genentech.

The approval is based on data from the phase 3 IMpower133 clinical trial evaluating the safety and efficacy of atezolizumab in combination with carboplatin and etoposide versus chemotherapy alone in chemotherapy-naïve adults with ES-SCLC. For the trial, 403 patients were randomized to receive either atezolizumab in combination with carboplatin and etoposide or placebo in combination with carboplatin and etoposide.

According to the data, patients treated with the atezolizumab-based combination experienced significantly improved survival compared with chemotherapy alone (median overall survival [OS]=12.3 versus 10.3 months; hazard ratio [HR]=0.70, 95% CI: 0.54-0.91; p=0.0069) in the intention-to-treat population. Additionally, the study showed that atezolizumab plus chemotherapy also significantly improved progression-free survival (PFS) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95 percent CI: 0.62-0.96; p=0.017).

Safety for atezolizumab plus chemotherapy appeared consistent with the known safety profile of atezolizumab, according to the study. Serious adverse events (AEs) occurred in 37% of patients receiving the combination therapy compared with 35% of patients receiving chemotherapy alone.

The most common AEs reported in the trial for patients receiving atezolizumab with chemotherapy were fatigue, nausea, hair loss, decrease appetite, constipation, and vomiting.

“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,” Andrea Ferris, president and chief executive officer of LUNGevity Foundation, said in a prepared statement. “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.”

This is the second FDA approval this month for atezolizumab, which was recently approved in combination with chemotherapy for the treatment of adults with PD-L1 positive, metastatic triple-negative breast cancer. Atezolizumab is also approved in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the treatment of adults with non-small cell lung cancer.

Reference

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