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Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Background - In the phase III IMpassion130 trial, combining atezolizumab with first-line nanoparticle albumin-bound-paclitaxel for advanced triple-negative breast cancer (aTNBC) showed a statistically significant progression-free survival (PFS) benefit in the intention-to-treat (ITT) and programmed...

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Main Authors: Miles, David W. (Author) , Gligorov, J. (Author) , André, F. (Author) , Cameron, D. (Author) , Schneeweiss, Andreas (Author) , Barrios, C. (Author) , Xu, B. (Author) , Wardley, A. (Author) , Kaen, D. (Author) , Andrade, L. (Author) , Semiglazov, V. (Author) , Reinisch, M. (Author) , Patel, S. (Author) , Patre, M. (Author) , Morales, L. (Author) , Patel, S. L. (Author) , Kaul, M. (Author) , Barata, T. (Author) , O’Shaughnessy, J. (Author) , Zhang, Q. (Author) , Shao, Z. (Author) , Wang, X. (Author) , Geng, C. (Author) , Yan, X. (Author) , Tong, Z. (Author) , Shen, K. (Author) , Yin, Y. (Author) , Sun, T. (Author) , Yang, J. (Author) , Feng, J. (Author) , Yan, M. (Author) , Wang, Y. (Author) , Liu, Q. (Author) , Zhang, S. (Author) , De Laurentiis, M. (Author) , Santoro, A. (Author) , Guarneri, V. (Author) , Colleoni, M. (Author) , Natoli, C. (Author) , Cortesi, L. (Author) , Placido, S. (Author) , Gianni, L. (Author) , Ferrau, F. (Author) , Livi, L. (Author) , Zambelli, A. (Author) , Del Mastro, L. (Author) , Tonini, G. (Author) , Montemurro, F. (Author) , Bianchi, G. (Author) , Pedersini, R. (Author) , Prete, S. (Author) , Allegrini, G. (Author) , Naso, G. (Author) , Vici, P. (Author) , Loirat, D. (Author) , Mailliez, A. (Author) , Priou, F. (Author) , Tredan, O. (Author) , Dalenc, F. (Author) , Perrin, C. (Author) , Timar David, M. (Author) , Dohollou, N. (Author) , Teixeira, L. (Author) , Brocard, F. (Author) , Arnaud, A. (Author) , Delaloge, S. (Author) , Spano, J. -P. (Author) , Mansi, L. (Author) , Damian, F. (Author) , Pedrini, J. (Author) , Aleixo, S. (Author) , Hegg, R. (Author) , Junior, R. (Author) , Schmidt, M. (Author) , Wenzel, C. (Author) , Grischke, E. -M. (Author) , Schneeweiss, A. (Author) , Just, M. (Author) , Harbeck, N. (Author) , Schumacher, C. (Author) , Peters, U. (Author) , Fischer, D. (Author) , Forstbauer, H. (Author) , Liersch, R. (Author) , Warner, E. (Author) , Bouganim, N. (Author) , Doyle, C. (Author) , Price Hiller, J. (Author) , Vandenberg, T. (Author) , Pavic, M. (Author) , Robinson, A. (Author) , Roldan Urgoiti, G. (Author) , Califaretti, N. (Author) , Alacacioglu, A. (Author) , Gumus, M. (Author) , Yalcin, B. (Author) , Cicin, I. (Author) , Kose, F. (Author) , Uygun, K. (Author) , Kaplan, M. (Author) , Cubukcu, E. (Author) , Harries, M. (Author) , Miles, D. (Author) , Doval, D. (Author) , Gupta, S. (Author) , Mohapatra, P. (Author) , Chatterjee, S. (Author) , Ghadyalpatil, N. (Author) , Singhal, M. (Author) , Nag, S. (Author) , Agarwal, A. (Author) , Wolf, I. (Author) , Gal Yam, E. (Author) , Yerushalmi, R. (Author) , Peretz, T. (Author) , Fried, G. (Author) , Ben Baruch, N. (Author) , Katz, D. (Author) , Hamilton, E. (Author) , Kayali, F. (Author) , Brufsky, A. (Author) , Telli, M. (Author) , Wright, G. (Author) , Oyola, R. (Author) , Rakowski, T. (Author) , Graff, S. (Author) , Tjulandin, S. (Author) , Aparicio, A. (Author) , Ruiz Borrego, M. (Author) , Merino, L. (Author) , Guerra Martinez, J. (Author) , Lopez, E. (Author) , Yamashita, T. (Author) , Ohtani, S. (Author) , Inoue, K. (Author) , Ito, Y. (Author) , Niikura, N. (Author) , Nakayama, T. (Author) , Sagara, Y. (Author) , Yanagita, Y. (Author) , Kamada, Y. (Author) , Kaneko, K. (Author) , Nervo, A. (Author) , Eniu, A. (Author) , Schenker, M. (Author) , Priester, P. (Author) , Melichar, B. (Author) , Zimovjanova, M. (Author) , Sormova, P. (Author) , Sufliarsky, J. (Author) , Kakalejcik, M. (Author) , Belbaraka, R. (Author) , Errihani, H. (Author) , Le Than, D. (Author) , Pham, D. (Author) , Aravantinos, G. (Author) , Papadimitriou, C. (Author) , Koumakis, G. (Author) , Papandreou, C. (Author) , Podolski, P. (Author) , Tabane, K. (Author)
Format: Article (Journal)
Language:English
Published: 1 July 2021
In: Annals of oncology
Year: 2021, Volume: 32, Issue: 8, Pages: 994-1004
ISSN:1569-8041
DOI:10.1016/j.annonc.2021.05.801
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.annonc.2021.05.801
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753421020263
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Author Notes:D. Miles, J. Gligorov, F. André, D. Cameron, A. Schneeweiss, C. Barrios, B. Xu, A. Wardley, D. Kaen, L. Andrade, V. Semiglazov, M. Reinisch, S. Patel, M. Patre, L. Morales, S.L. Patel, M. Kaul, T. Barata & J.O’Shaughnessy, on behalf of the IMpassion131 investigators
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Summary:Background - In the phase III IMpassion130 trial, combining atezolizumab with first-line nanoparticle albumin-bound-paclitaxel for advanced triple-negative breast cancer (aTNBC) showed a statistically significant progression-free survival (PFS) benefit in the intention-to-treat (ITT) and programmed death-ligand 1 (PD-L1)-positive populations, and a clinically meaningful overall survival (OS) effect in PD-L1-positive aTNBC. The phase III KEYNOTE-355 trial adding pembrolizumab to chemotherapy for aTNBC showed similar PFS effects. IMpassion131 evaluated first-line atezolizumab-paclitaxel in aTNBC. - Patients and methods - Eligible patients [no prior systemic therapy or ≥12 months since (neo)adjuvant chemotherapy] were randomised 2:1 to atezolizumab 840 mg or placebo (days 1, 15), both with paclitaxel 90 mg/m2 (days 1, 8, 15), every 28 days until disease progression or unacceptable toxicity. Stratification factors were tumour PD-L1 status, prior taxane, liver metastases and geographical region. The primary endpoint was investigator-assessed PFS, tested hierarchically first in the PD-L1-positive [immune cell expression ≥1%, VENTANA PD-L1 (SP142) assay] population, and then in the ITT population. OS was a secondary endpoint. - Results - Of 651 randomised patients, 45% had PD-L1-positive aTNBC. At the primary PFS analysis, adding atezolizumab to paclitaxel did not improve investigator-assessed PFS in the PD-L1-positive population [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.60-1.12; P = 0.20; median PFS 6.0 months with atezolizumab-paclitaxel versus 5.7 months with placebo-paclitaxel]. In the PD-L1-positive population, atezolizumab-paclitaxel was associated with more favourable unconfirmed best overall response rate (63% versus 55% with placebo-paclitaxel) and median duration of response (7.2 versus 5.5 months, respectively). Final OS results showed no difference between arms (HR 1.11, 95% CI 0.76-1.64; median 22.1 months with atezolizumab-paclitaxel versus 28.3 months with placebo-paclitaxel in the PD-L1-positive population). Results in the ITT population were consistent with the PD-L1-positive population. The safety profile was consistent with known effects of each study drug. - Conclusion - Combining atezolizumab with paclitaxel did not improve PFS or OS versus paclitaxel alone. - ClinicalTrials.gov - NCT03125902.
Item Description:Gesehen am 03.11.2021
Physical Description:Online Resource
ISSN:1569-8041
DOI:10.1016/j.annonc.2021.05.801

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