Adjuvant immunotherapy with atezolizumab significantly extends disease-free survival after surgery and adjuvant chemotherapy in patients with PD-L1-expressing stage-II-IIIA non-small-cell lung cancer (NSCLC), according to interim results of the IMpower010 trial. IMpower010 is the "first global phase 3 trial using an immune checkpoint inhibitor to show a disease-free-survival outcome in early stage NSCLC," lead researcher Dr. Heather Wakelee of Stanford University Medical Center in California said during a press briefing ahead of presentation at the American Society of Clinical Oncology (ASCO) virtual annual meeting. For the vast majority of patients with resected NSCLC, the standard of care has not changed in over 15 years and remains adjuvant platinum-based chemotherapy. Adjuvant chemotherapy has been shown to reduce the risk of disease recurrence or death by 16% in patients with completely resected NSCLC, Dr. Wakelee said. IMpower010 is comparing atezolizumab with best supportive care (BSC) after surgery and adjuvant chemotherapy in patients with stage-IB to -IIIA NSCLC, with 248 in the atezolizumab group and 228 in the BSC group. After a median follow-up of 32.8 months, the addition of atezolizumab significantly reduced the risk of disease recurrence or death by 34% in patients with stage-II to -IIIA NSCLC and levels of the immune-checkpoint protein PD-L1 of 1% or greater, Dr. Wakelee reported. In this group, median disease-free survival (DFS) had not yet been reached at data cut-off, while the median DFS for BSC was 35.3 months. Among all patients with stage-II to -IIIA NSCLC, atezolizumab led to a 21% reduction in the risk of disease recurrence or death compared with BSC. DFS with atezolizumab was 42.3 months compared with 35.3 months for BSC. DFS for atezolizumab compared with BSC in the entire cohort of patients with stage-IB to -IIIA disease did not reach significance at this interim analysis. Overall survival data are not yet mature. Dr. Wakelee said planned analyses of DFS and overall survival will continue with longer patient follow-up to further assess endpoints. Adverse events of any grade occurred in 92.7% of the atezolizumab group and 70.7% of the BSC group, while grade-3 to -4 adverse events were reported in 21.8% and 11.5%, respectively. In 18.2% of patients treated with atezolizumab, adverse events led to treatment discontinuation. Speaking at the briefing, Dr. Julie Gralow, ASCO chief medical officer and executive vice president, noted that immune-checkpoint inhibitors have "changed the treatment landscape for many types of cancers" and the current study "is the first time we've seen an immunotherapy that's effective in treating early-stage NSCLC." "This is an important advance in understanding the role of immunotherapy in earlier-stage lung cancer and potentially a step forward for many patients," said Dr. Gralow. Dr. Fred R. Hirsch, director of the Center of Excellence for Thoracic Oncology at Mount Sinai's Tisch Cancer Institute in New York, said this "important study" clearly emphasizes the role of immunotherapy in early-stage NSCLC "and moves immunotherapy earlier and earlier in the treatment scenario" for these patients. "Of course, overall survival data are not yet matured, which is crucial for this stage of disease, but it is expected that these results will translate into better overall survival. We have not yet seen data from stage IB (> 4 cm) and/or patients with negative PD-L1," Dr. Hirsch, who was not involved in the study, told Reuters Health. Funding for the study was provided by Hoffmann-La Roche. Several authors have disclosed financial relationships with pharmaceutical industry. —Megan Brooks Source
