2019 ASCO Annual Meeting!
Session: Breast Cancer—Metastatic
Type: Oral Abstract Session
Time: Tuesday June 4, 9:45 AM to 12:45 PM
Location: Hall D1
IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab-paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC).
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 1003)
Author(s): Peter Schmid, Sylvia Adams, Hope S. Rugo, Andreas Schneeweiss, Carlos H. Barrios, Hiroji Iwata, Veronique Dieras, Volkmar Henschel, Luciana Molinero, Stephen Y. Chui, Amreen Husain, Eric P. Winer, Sherene Loi, Leisha A. Emens; Barts Cancer Institute, Queen Mary University of London, London, United Kingdom; New York University Cancer Institute, New York, NY; University of California San Francisco Comprehensive Cancer Center, San Francisco, CA; National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany; PUCRS School of Medicine, Porto Alegre, Brazil; Aichi Cancer Center Hospital, Nagoya, Japan; Centre Eugène Marquis, Rennes, France; F. Hoffmann-La Roche, Ltd., Basel, Switzerland; Genentech, Inc., South San Francisco, CA; F. Hoffmann-La Roche, Ltd., Basel, CA, Switzerland; Dana-Farber Cancer Institute, Boston, MA; Peter MacCallum Cancer Centre, Melbourne, Australia; University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA
Background: IMpassion130 evaluated atezo (anti–PD-L1) + nP vs placebo + nP in 1L mTNBC. The primary PFS analysis found that atezo + nP significantly improved PFS in intent-to-treat (ITT) and PD-L1+ pts vs placebo + nP, with efficacy driven by the PD-L1+ population. At that time, the 1st interim OS analysis was conducted (Schmid, NEJM 2018). Here we report the 2nd interim OS analysis. Methods: Eligible pts had histologically documented locally advanced or mTNBC, ECOG PS 0-1 and tumor tissue for PD-L1 testing. Pts were randomized 1:1 to IV atezo 840 mg or placebo on d1 and d15 + nP 100 mg/m2 on d1, d8 and d15 of each 28-d cycle until progression (stratification factors: prior taxanes, liver metastases, PD-L1 on tumor-infiltrating immune cells [IC]). RECIST 1.1 PFS (in ITT and PD-L1+ pts) and OS (tested in ITT and, if significant, PD-L1+ pts) were co-primary endpoints. Results: OS data are shown (Table). As of data cutoff (Jan 2, 2019), 9% of pts in the atezo + nP arm and 3% in the placebo + nP arm were still on treatment. Statistical significance was not demonstrated in ITT pts, but a 7.0-month improvement in median OS was observed in PD-L1+ pts with atezo + nP (25.0 mo) vs placebo + nP (18.0 mo; HR, 0.71 [95% CI: 0.54, 0.93]). A 4.5-mo safety update (Schneeweiss, ASCO 2019, submitted) showed that atezo + nP remained tolerable. Conclusions: The 2nd IMpassion130 interim OS analysis was consistent with the 1st analysis, confirming clinically meaningful OS benefit with atezo + nP in previously untreated PD-L1+ mTNBC. Clinical trial information: NCT02425891
|Atezo + nP||Placebo + nP|
|ITT population, events/pts, n/n (%)||255/451 (57%)||279/451 (62%)|
|HR (95% CI); log-rank P||0.86 (0.72, 1.02); 0.078a||―|
|Median OS (95% CI), mo||21.0 (19.0, 22.6)||18.7 (16.9, 20.3)|
|2-year OS (95% CI), %||42 (37, 47)||39 (34, 44)|
|Median follow-up duration, mo||18.5||17.5|
|PD-L1+ population,b events/pts, n/n (%)||94/185 (51%)||110/184 (60%)|
|HR (95% CI)||0.71 (0.54, 0.93)||―|
|Median OS (95% CI), mo||25.0 (19.6, 30.7)||18.0 (13.6, 20.1)|
|2-year OS (95% CI), %||51 (43, 59)||37 (29, 45)|
HRs estimated per stratified Cox model. a Not significant. b PD-L1 on IC ≥ 1% (VENTANA SP142 IHC assay).
1. Phase II COLET study: Atezolizumab (A) + cobimetinib (C) + paclitaxel (P)/nab-paclitaxel (nP) as first-line (1L) treatment (tx) for patients (pts) with locally advanced or metastatic triple-negative breast cancer (mTNBC).