IMpower010: pre-specified interim analysis of overall survival further support adjuvant atezolizumab in early-stage resected NSCLC

WCLC2022
  • The first pre-specified interim analysis of overall survival data from the phase III IMpower010 trial shows a trend in favor of adjuvant immunotherapy atezolizumab versus best supportive care in patients resected stage II-IIIA non-small-cell lung cancer (NSCLC) with tumor PD-L1 expression of at least 1%.
  • Presented on the ground by VHIO’s Enriqueta Felip at this week’s 2022 World Conference on Lung Cancer, results of this initial overall survival analysis did not however show the same potential promise of atezolizumab in the all randomized stage II-IIIA or intent-to-treat population.
  • The highest magnitude of overall survival improvement was observed in patietns with stage II-IIA disease with tumor PD-L1 expression of 50% or higher.

 

Presented on the ground at this week’s International Association for the Study of Lung Cancer’s (IASLC) 2022 World Conference on Lung Cancer, 06 – 09 August (Vienna, Austria), results of interim analysis of survival data(1) from the pivotal phase III IMpower010 study point to adjuvant atezolizumab immunotherapy over best supportive care  in some patients with early-stage PD-L1 positive non-small-cell lung cancer (NSCLC) following resection and platinum-based chemotherapy.

IMpower010 was designed to assess the efficacy and safety profile of immune checkpoint inhibitor (ICI) atezolizumab as adjuvant therapy in patients with resected, high-risk early-stage NSCLC. Co-led by VHIO’s Enriqueta Felip and Heather A. Wakelee, Stanford University School of Medicine/Stanford Cancer Institute (CA, USA), the investigators previously reported that treatment with atezolizumab compared with best supportive care showed a statistically significant disease-free survival benefit in stage II-IIIA NSCLC patients, with even greater benefit observed in the PD-L1-positive subgroup (2).

Based on these findings, atezolizumab was approved as adjuvant therapy after complete resection and platinum-based chemotherapy in patients with stage II-IIIA disease and tumor PD-L1 expression of at least 1% in the U.S., China, and other countries; and in patients with PD-L1 expression of 50% or higher in the European Union (excluding EGFR/ALK+) and other countries.

“These earlier data not only opened up a new therapeutic avenue for some of these patients but also shone important light on assessing the efficacy of immunotherapy in the early-stage setting before disease progression, as well as potentially preventing disease recurrence,” says Enriqueta Felip, first author of this present study and Principal Investigator of VHIO’s Thoracic Tumors & Head and Neck Cancer Group.

Building on subsequent subgroup analysis (3), suggesting little heterogeneity in the efficacy of atezolizumab across high PD-L1 expressers, results of this current interim analysis of overall survival and safety of this immunotherapy versus best supportive care, have now been presented by Enriqueta Felip during a Presidential Symposium at this week’s annual World Conference on Lung Cancer (1).

“The main secondary overall survival endpoint was not mature at disease-free survival interim analysis. We have now assessed overall survival and safety with 13 months of additional follow-up. While these data are not mature in the intention-to-treat population, they are of clinical interest in the curative setting,” explains co-author Alex Martinez, a Clinical Investigator and Medical Oncologist of Enriqueta Felip’s VHIO research group and team at Vall d’Hebron.

At the clinical cutoff date (18 April 2022), median follow-up was 45 months and an overall survival trend favoring atezolizumab over best supportive care was observed in those patients with stage II-IIIA NSCLC with tumor PD-L1 expression of at least 1%.

Results also show a clinically meaningful improvement in the population with PD-L1 expression of 50% or over, and better overall survival was observed across most subgroups. Reported data also support the previously reported benefit-risk profile and contribute to IMpower010’s mounting evidence that could help ring in immunotherapy for patients with non-metastatic disease in this setting.

“Longer-term follow-up and analyses of disease-free survival and overall survival are required, but even in this first analysis, we have observed an overall survival trend in favor of atezolizumab in the stage II to IIIA population with tumor cell PD-L1 expression of at 1% or higher, and the highest magnitude of overall survival improvement in patients with tumor PD-L1 expression of 50% or over,” concludes Enriqueta Felip, Head of the Thoracic Cancer Unit, Vall d’Hebron University Hospital – HUVH (Vall d’Hebron Barcelona Hospital Campus), and President of the Spanish Society of Medical Oncology (SEOM).

Also on the ground at this week’s 2022 World Conference on Lung Cancer, oncology channel ecancer caught up with VHIO’s Enriqueta Felip to discuss these present findings. To discover more, we invite you to watch this expert interview here:

 

 

 

 

 

 

 

 

 

 

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References:

1- PL03.09: IMpower010: Overall Survival Interim Analysis of a Phase III Study of Atezolizumab vs Best Supportive Care in Resected NSCLC. Enriqueta Felip, Nasser Altorki, Eric Vallieres, Ihor O. Vynnychenko, Andrey Akopov, Alex Martinez-Marti, Antonio Chella, Igor Bondarenko, Shunichi Sugawara, Yun Fan, Hirotsugu Kenmotsu, Yuh-Min Chen, Yu Deng, Meilin Huang, Virginia McNally, Elizabeth Bennett, Barbara J. Gitlitz, Caicun Zhou, Heather A. Wakelee.

Plenary 3: Presidential Symposium – Top Rated Abstracts, Monday 08 August. International Association for the Study of Lung Cancer’s (IASLC) 2022 World Conference on Lung Cancer, 06-09 August (Vienna, Austria).

2- Felip E, Altorki N, Zhou C, Csőszi T, Vynnychenko I, Goloborodko O, Luft A, Akopov A, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Voong D, Wu F, Yi J, Deng Y, McCleland M, Bennett E, Gitlitz B, Wakelee H; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021 Oct 9;398(10308):1344-1357.

3- 80O – Atezolizumab (atezo) vs best supportive care (BSC) in stage II-IIIA NSCLC with high PD-L1 expression: sub-analysis from the pivotal phase III IMpower010 study. E. Felip, N.K. Altorki, C. Zhou, E. Vallieres, I.O. Vynnychenko, A. Akopov, A. Martinez-Marti, A. Chella, I. Bondarenko, G. Ursol, E. Levchenko, N. Kislov, R. Liersch, R. Belleli, V.A. McNally, E. Bennett, B.J. Gitlitz, H. Wakelee. Annals of Oncology (2022) 33 (suppl_2): S71-S78. 10.1016/annonc/annonc857.

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