The TGA has approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), and chemotherapy (paclitaxel and carboplatin), for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
The immunotherapy-chemotherapy combination is indicated for patients with EGFR mutant or ALK-positive NSCLC, after failure of appropriate targeted therapies.
The new approval was based on results from the phase 3 IMpower150 study, which showed improvements in progression-free survival (PFS) and overall survival (OS) with atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (ABCP) versus the standard-of-care bevacizumab plus carboplatin plus paclitaxel (BCP) in chemotherapy-naive patients.
In that study, the rate of progression-free survival at 12 months was twice as high with ABCP as with BCP (36.5% vs. 18.0%) and the rate of objective response higher (63.5% vs. 48.0%) with ABCP than with BCP.
Median overall survival among the patients who had a wild-type genotype was 19.2 months vs. 14.7 months for the ABCP vs standard of care group (hazard ratio for death, 0.78).
Professor Stephen Clarke, a medical oncologist at the University of Sydney said the new indication for of atezolizumab in combination with bevacizumab and chemotherapy as an initial treatment option was an “important milestone” for many people with NSCLC.
“There has been a significant unmet need within the EGF receptor mutation population of NSCLC, where patients have failed appropriate targeted therapies. Tecentriq in combination with Avastin and chemotherapy now offers an option for these patients and their oncologists,” he said.
The immunotherapy-chemotherapy combination is not listed on the PBS, and according to eviQ guidelines the cost of atezolizumab is about $7,560 per cycle.
Also this month, pemetrexed has had its PBS authority level reduced from streamlined to unrestricted for the treatment of metastatic NSCLC and mesothelioma.