WCLC 2022 | IMpower010: OS results of atezolizumab vs best supportive care in resected NSCLC
Enriqueta Felip, MD, PhD, Vall d’Hebron Institute of Oncology, Barcelona, Spain, shares overall-survival (OS) interim analysis results of the Phase III IMpower010 (NCT02486718) trial, a study of atezolizumab versus best supportive care in patients with resected non-small cell lung cancer (NSCLC). An OS trend in favor of atezolizumab was seen in the PD-L1 TC greater than or equal to 1% stage II-IIIA population which support the previously reported positive benefit-risk profile of adjuvant atezolizumab in PD-L1 positive resected NSCLC. This interview took place at the IASLC 2022 World Conference on Lung Cancer congress in Vienna, Austria.
Transcript (edited for clarity)
IMpower010 is a trial in patients with early stage disease, patients with stage IB, with tumor size of at least four centimeters, II and IIIA, according to the TNM classification. These patients receive adjuvant cisplatin-based chemotherapy, and then 1000 patients were randomized to receive atezolizumab for one year or best supportive care. In this trial, primary endpoint was disease-free survival assessed by the principal investigator, and we previously published the results of disease-free survival in a hierarchy situation, because this is the design of the trial...
IMpower010 is a trial in patients with early stage disease, patients with stage IB, with tumor size of at least four centimeters, II and IIIA, according to the TNM classification. These patients receive adjuvant cisplatin-based chemotherapy, and then 1000 patients were randomized to receive atezolizumab for one year or best supportive care. In this trial, primary endpoint was disease-free survival assessed by the principal investigator, and we previously published the results of disease-free survival in a hierarchy situation, because this is the design of the trial. And first we analyze disease-free survival in patients with a stage II and IIIA, and PD-L1 positive tumors. In this group, disease-free survival was longer with atezolizumab, with a hazard ratio of 0.66. Then in patients with a stage II and IIIA, in this group also disease-free survival is longer with atezolizumab, with a hazard ratio of 0.79. And finally, in patients with a stage IB, II and IIIA, and in this group, the hazard ratio was 0.81, but the statistical significance boundary was not crossed. So we need further follow up.
During this conference, we have updated, we have presented the first overall-survival interim analysis. It’s an interim analysis, but is the first design in the trial. And with 13 month additional follow-up, total of 49 million follow-up of the patients, we have reported results in overall-survival. For those patients with a stage II and IIIA, and PD-L1 positive tumors, there is a trend towards an improve in overall-survival for those patients treated with atezolizumab, with a hazard ratio of 0.71. For those patients with a stage II and IIIA, including all patients, even PD-L1 negative tumors, there is no difference in overall survival between the two treatment arms and in patients with the stage IB, II and IIIA, also no differences in the two treatment arms.
So it’s important that this trial show that atezolizumab is working in those patients with PD-L1 positive, and at that stage in patients with a stage II and IIIA disease. We need to wait because patients with stage IB probably have later recurrence. So these studies are still ongoing, but it’s also important that we have analyzed those patients with stage II and IIIA, and PD-L1 50% or higher. And in this group, the hazard ratio for overall-survival following atezolizumab is 0.43. This is what we have presented. Also, we have updated safety, with 13 month of additional follow-up and again, the agent is very well tolerated and no other signs of toxicity have been seen after a longer follow up.
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