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Proffered Paper - Breast cancer, metastatic 1

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)

Date

19 Sep 2020

Session

Proffered Paper - Breast cancer, metastatic 1

Presenters

David Miles

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

D.W. Miles1, J. Gligorov2, F. André3, D. Cameron4, A. Schneeweiss5, C.H. Barrios6, B. Xu7, A.M. Wardley8, D. Kaen9, L. Andrade10, V. Semiglazov11, M. Reinisch12, M. Patre13, L. Morales13, K. Russell13, M. Donica14, J. O’Shaughnessy15

Author affiliations

  • 1 Medical Oncology, Mount Vernon Cancer Centre, HA6 2RN - Northwood/GB
  • 2 Medical Oncology Department, Institut Universitaire de Cancérologie APHP-Sorbonne Université, 75020 - Paris/FR
  • 3 Department Of Medical Oncology, Gustave Roussy, Université Paris Sud, 94805 - Villejuif/FR
  • 4 Oncology, University of Edinburgh and Cancer Services, NHS Lothian, EH4 2XU - Edinburgh/GB
  • 5 Division Of Gynecologic Oncology, National Center for Tumor Diseases, University of Heidelberg, 69115 - Heidelberg/DE
  • 6 Medical Oncology, Latin American Cooperative Oncology Group, 90610-000 - Porto Alegre/BR
  • 7 Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, 100021 - Beijing/CN
  • 8 Medical Oncology, NIHR Manchester Clinical Research Facility at The Christie & Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine & Health, University of Manchester, M20 4BX - Manchester/GB
  • 9 Medical Oncology, Centro Oncológico Riojano Integral and Universidad Nacional de La Rioja, La Rioja/AR
  • 10 Medical Oncology, Santa Casa de Misericordia de Salvador, Salvador/BR
  • 11 Medical Oncology, NN Petrov Research Institute of Oncology, 197758 - Saint-Petersburg/RU
  • 12 Breast Unit, Kliniken Essen-Mitte, 45136 - Essen/DE
  • 13 Global Product Development Medical Affairs Oncology, F. Hoffmann-La Roche Ltd, Basel/CH
  • 14 Pharma Development Biostatistics Oncology, F. Hoffmann-La Roche Ltd, Basel/CH
  • 15 Medical Oncology, Baylor University Medical Center, Texas Oncology, US Oncology, Dallas/US
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Resources

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Abstract LBA15

Background

In the phase 3 IMpassion130 trial, combining atezo with first-line nab-paclitaxel 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 first-line 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. Table: LBA15

PD-L1+ ITT
Placebo + PAC (n=101) Atezo + PAC (n=191) Placebo + PAC (n=220) Atezo + PAC (n=431)
Data cut-off: 15 Nov 2019
PFS events, n (%) 64 (63) 115 (60) 155 (70) 283 (66)
Median PFS, months (95% CI) 5.7 (5.4–7.2) 6.0 (5.6–7.4) 5.6 (5.4–6.5) 5.7 (5.4–7.2)
PFS HR (95% CI) 0.82 (0.60–1.12) 0.86 (0.70–1.05)
Stratified log-rank p-value 0.20 Not formally tested
Best ORR, % (95% CI)a 55 (45–65) 63 (56–70) 47 (41–54) 54 (49–58)
Data cut-off: 19 Aug 2020
Deaths, n (%) 38 (38) 82 (43) 97 (44) 207 (48)
Median OS, months (95% CI) 28.3 (19.1–NE) 22.1 (19.2–30.5) 22.8 (17.1–28.3) 19.2 (16.8–22.5)
OS HR (95% CI) 1.12 (0.76–1.65) 1.11 (0.87–1.42)
2-year OS rate, % (95% CI) 51 (38–65) 49 (40–58) 45 (36–54) 42 (36–48)

aUnconfirmed

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.

Clinical trial identification

NCT03125902.

Editorial acknowledgement

Jennifer Kelly (Medi-Kelsey Ltd), funded by F. Hoffmann-La Roche Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

D.W. Miles: Honoraria (self), Advisory/Consultancy: Roche/Genentech; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy: Genomic Health. J. Gligorov: Advisory/Consultancy, Research grant/Funding (institution): Daichi; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Eisai; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genomic Health; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Macrogenics; Advisory/Consultancy: MSD; Advisory/Consultancy: Mylan; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Onxeo; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche/Genentech; Research grant/Funding (institution): Immunomedics. F. André: Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Research grant/Funding (institution): Lilly; Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: GlaxoSmithKline. D. Cameron: Honoraria (institution), Advisory/Consultancy: Roche; Honoraria (institution), Advisory/Consultancy: AstraZeneca. A. Schneeweiss: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Celgene; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Molecular Partner; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self): Novartis; Honoraria (self): MSD; Honoraria (self): Tesaro; Honoraria (self): Lilly. C.H. Barrios: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche/Genentech; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: GlaxoSmithKline; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Eisai; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution): Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Lilly; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Astellas Pharma; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Medivation; Research grant/Funding (institution): Covance; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Merck Serono; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD; Research grant/Funding (institution): PharmaMar; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer. B. Xu: Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Daiichi-Sankyo. A.M. Wardley: Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi-Sankyo; Honoraria (self), Travel/Accommodation/Expenses: MSD; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Athenex; Honoraria (self), Advisory/Consultancy: Gerson Lehrman Group; Honoraria (self), Advisory/Consultancy: Guidepoint Global; Honoraria (self): Coleman Expert Network; Honoraria (self): Helios; Honoraria (self): Health Care America; Advisory/Consultancy, Research grant/Funding (institution): MSD Oncology; Advisory/Consultancy: NAPP Pharma; Advisory/Consultancy, Research grant/Funding (institution): Accord Research; Advisory/Consultancy: Coleman Research; Leadership role, Full/Part-time employment, Medical Director: NIHR Manchester Clinical Research Facility at The Christie; Leadership role, Strategy Director: Association of Cancer Physicians; Leadership role, Committee Member: UK Breast Cancer Group; Leadership role, Committee Member: NHS England Chemotherapy Clinical Reference Group; Leadership role, Faculty: ESMO Breast cancer; Research grant/Funding (institution): Seattle Genetics; Research grant/Funding (institution): 1G1 Therapeutics; Shareholder/Stockholder/Stock options, Officer/Board of Directors, Spouse/Financial dependant: Andrew Wardley Limited; Shareholder/Stockholder/Stock options, Officer/Board of Directors: Manchester Cancer Academy; Shareholder/Stockholder/Stock options, Officer/Board of Directors: Outreach Research & Innovation Group Limited; Speaker Bureau/Expert testimony: Eisai; Research grant/Funding (self): NIHR. D. Kaen: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): MSD; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Raffo-Tecnofarma; Honoraria (self), Advisory/Consultancy: Varifarma; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Lilly Oncology; Research grant/Funding (institution): Clovis; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Array BioPharma Inc. L. Andrade: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Zodiac Pharma; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Janssen-Cilag; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche/Genentech; Speaker Bureau/Expert testimony: Merck Sharp Dohme; Speaker Bureau/Expert testimony: Novartis; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Regeneron. M. Reinisch: Honoraria (self), Advisory/Consultancy: Roche Pharma AG; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Hexal; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Celgene. M. Patre: Shareholder/Stockholder/Stock options, Full/Part-time employment: Roche. L. Morales: Shareholder/Stockholder/Stock options, Full/Part-time employment: Roche. K. Russell: Shareholder/Stockholder/Stock options, Full/Part-time employment: Roche. M. Donica: Shareholder/Stockholder/Stock options, Full/Part-time employment: Roche. J. O’Shaughnessy: Honoraria (self), Advisory/Consultancy: AbbVie Inc.; Honoraria (self), Advisory/Consultancy: Agendia; Honoraria (self), Advisory/Consultancy: Amgen Biotechnology; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Celgene Corporation; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy: Genentech; Honoraria (self), Advisory/Consultancy: Genomic Health; Honoraria (self), Advisory/Consultancy: GRAIL; Honoraria (self), Advisory/Consultancy: Immunomedics; Honoraria (self), Advisory/Consultancy: Heron Therapeutics; Honoraria (self), Advisory/Consultancy: Ipsen Biopharmaceuticals; Honoraria (self), Advisory/Consultancy: Jounce Therapeutics; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: Myriad; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Ondonate Therapeutics; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Puma Biotechnology; Honoraria (self), Advisory/Consultancy: Prime Oncology; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Seattle Genetics; Honoraria (self), Advisory/Consultancy: Syndax Pharmaceuticals; Honoraria (self), Advisory/Consultancy: Takeda. All other authors have declared no conflicts of interest.

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