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Primary results from IMpassion131, a double-blind placebo-controlled randomised phase III trial of first- line paclitaxel (PAC) +/- atezolizumab (atezo) for unresectable locally advanced/metastatic triple-negative breast cancer (mTNBC)
Miles, D. W. Gligorov, J. Andre, F. Cameron, D. Schneeweiss, A. Barrios, C. H. Xu, B. Wardley, Andrew M Kaen, D. Andrade, L.
Miles, D. W.
Gligorov, J.
Andre, F.
Cameron, D.
Schneeweiss, A.
Barrios, C. H.
Xu, B.
Wardley, Andrew M
Kaen, D.
Andrade, L.
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Abstract
Background: In the phase 3 IMpassion130 trial, combining atezo with first-line nabpaclitaxel
for mTNBC showed significantly improved progression-free survival (PFS)
and clinically meaningful overall survival (OS) benefit in patients with PD-L1+ mTNBC
[Schmid NEJM 2018]. IMpassion131 (NCT03125902) evaluated atezo + PAC as firstline
treatment for mTNBC.
Methods: Eligible patients (no prior systemic therapy or ≥12 months since [neo]
adjuvant chemotherapy) were randomised 2:1 to atezo 840 mg or placebo (d 1 & 15
q28d), both with PAC 90 mg/m2 (d 1, 8 & 15 q28d) until disease progression or
unacceptable toxicity. Stratification factors were tumour PD-L1 status (immune cell
[IC] expression <1% vs 1% by VENTANA SP142 assay), prior taxane, liver metastases
and geographic region. The primary endpoint was investigator-assessed PFS, tested
hierarchically first in the PD-L1+ (IC 1%) population, then in the intent-to-treat (ITT)
population. OS and overall response rate (ORR) were secondary endpoints.
Results: Of 651 randomised patients, 45% had PD-L1+ mTNBC, 48% were taxane
pretreated, 31% had de novo mTNBC and 27% liver metastases. Adding atezo to PAC
did not improve PFS or OS in either the PD-L1+ or ITT populations (Table). PFS results
in subgroups were consistent with primary results. PAC exposure was not compromised
by the addition of atezo. Grade 5 (2% placebo vs 2% atezo) and grade 3/4 AEs
(43% vs 49%) were balanced between arms and the safety profile was consistent with
known risks of each study drug.
Conclusions: Atezo + PAC did not improve PFS or OS vs placebo + PAC. No new safety
signals were seen. Potential reasons for the contrast with the benefit seen in
IMpassion130 (atezo + nab-paclitaxel) need further exploration.
Description
Date
2020
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Article
Citation
Miles DW, Gligorov J, André F, Cameron D, Schneeweiss A, Barrios CH, et al. LBA15 Primary results from IMpassion131, a double-blind placebo-controlled randomised phase III trial of first-line paclitaxel (PAC) ± atezolizumab (atezo) for unresectable locally advanced/metastatic triple-negative breast cancer (mTNBC). Annals of Oncology. 2020;31:S1147-S8.