Expert: Atezolizumab Approval for Non-Small Lung Cancer Would Be First Major Improvement to Standard of Care in 15 Years
The safety of atezolizumab in the Impower010 trial was consistent with its known safety profile and no new safety signals were identified.
The FDA has granted Priority Review to atezolizumab (Tecentriq, Genentech) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small lung cancer (NSCLC) whose tumors express PD-L1≥1%, with the drug assigned a PDUFA date of December 1.
The standard adjuvant treatment for patients with resected early NSCLC is chemotherapy, however, this method only provides a 4% to 5% improvement in 5-year survival compared with observation. According to Charles Fuchs, MD, MPH, global head of hematology and oncology, product development at Genentech, the phase 3 Impower 010 trial showed that adding atezolizumab to standard surgery and chemotherapy reduced the risk of disease recurrence or death by more than one-third in programmed death-ligand 1 (PD-L1)-positive, early-stage lung cancer.
“Treatment with atezolizumab following surgery and chemotherapy reduced the risk of disease recurrence or death by more than one-third in PD-L1-positive early-stage lung cancer, compared with best supportive care,” Fuchs said in an interview with Pharmacy Times®. “These positive results point to a potential new era in lung cancer care where more patients diagnosed with early lung cancer have the opportunity to be treated with immunotherapy to increase their chances for cure.”
IMpower010 is a global, multicenter, open-label, randomized study evaluating the efficacy and safety of atezolizumab compared with best supportive care (BSC) in patients with stage IB-IIIA NSCLC following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1005 patients with a ratio of 1:1 to receive either atezolizumab for up to 16 cycles or BSC.
The study showed showed that treatment with atezolizumab following surgery and platinum-based chemotherapy decreased the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) among patients with stage II-IIIA NSCLC whose tumors express PD-L1≥1%, compared with BSC. The median DFS for the cohort treated with atezolizumab was not yet reached compared with 35.3 months for the BSC cohort.
The safety of atezolizumab in the Impower010 trial was consistent with its known safety profile and no new safety signals were identified, according to Fuchs.
If approved, atezolizumab will be the first and only cancer immunotherapy available to help people with early, resected NSCLC reduce their risk of recurrence. Fuchs emphasized how the approval would be the first major improvement to the standard of care in more than 15 years and would provide an important new option to help certain patients with resected lung cancer live longer without their cancer returning.
“This exciting potential treatment advance makes it more important than ever to screen for lung cancer and detect PD-L1-positive tumors through biomarker testing at diagnosis, so that we can help more people living with the disease,” Fuchs said in an interview with Pharmacy Times®. “Altogether, the new atezolizumab filing represents an exciting milestone in early lung cancer and advances Genentech’s mission to ensure a future where all people with cancer can receive the care that is precisely right for them.”
Genentech News: FDA grants Priority Review for adjuvant Tecentriq in early NSCLC [email]. https://www.gene.com/media/press-releases/14924/2021-08-02/fda-grants-priority-review-to-genentechs. August 3, 2021. Accessed August 10, 2021.