# IMpassion130

Source: https://onco.cc/trials/impassion130/  
OnCo record `impassion130` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

IMpassion130 was the first immunotherapy success in breast cancer, later undermined when a sister trial failed and the approval was withdrawn.

## Summary

IMpassion130, trial NCT02425891 sponsored by Roche and reported in 2018, was the first immunotherapy success in breast cancer, adding atezolizumab to nab-paclitaxel in first-line metastatic triple-negative breast cancer, and it was later undermined when a sister trial failed and the approval was withdrawn. It randomised 902 patients, met its primary progression-free survival endpoint in PD-L1-positive patients by the SP142 assay, and showed a survival difference in that group that was not formally tested under the hierarchical design, but IMpassion131 with paclitaxel was negative and the US approval was withdrawn in 2021. The record treats it as a lesson in chemotherapy partner and biomarker assay choice, and why the two trials diverged is the open question.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-04
- Registry id: NCT02425891
- Phase: 3
- Setting: First-line metastatic TNBC: atezolizumab + nab-paclitaxel
- Sponsor: Roche
- Enrolled: 902
- Result: PFS HR 0.62 in PD-L1+; approval withdrawn 2021 (US).
- Outcomes: Progression-free survival, PD-L1+ (SP142 IC ≥1%): Atezolizumab + nab-paclitaxel 7.5 months vs Placebo + nab-paclitaxel 5 months, HR 0.62; Overall survival, PD-L1+: Atezolizumab + nab-paclitaxel 25.4 months vs Placebo + nab-paclitaxel 17.9 months, HR 0.67; Overall survival, ITT: Atezolizumab + nab-paclitaxel 21 months vs Placebo + nab-paclitaxel 18.7 months, HR 0.87
- Replication: Not replicated: IMpassion131 with paclitaxel was negative, leading to US withdrawal in 2021. KEYNOTE-355 confirmed the broader concept of chemo-immunotherapy in PD-L1-high disease.

## Notes

- Design (NEJM 2018): 902 untreated metastatic patients randomised 1 to 1 to atezolizumab 840 mg or placebo with nab-paclitaxel 100 mg/m2, stratified by PD-L1 on immune cells (SP142). Final overall survival (Annals of Oncology 2021): intention-to-treat 21.0 versus 18.7 months (hazard ratio 0.87, p 0.077, not significant, so the PD-L1-positive group could not be formally tested); PD-L1-positive 25.4 versus 17.9 months (0.67) as an exploratory finding; immune-mediated adverse events of special interest 58.7 versus 41.6 percent. Regulatory result: US accelerated approval March 2019, withdrawn August 2021 after IMpassion131; EU licence and NICE TA639 (1 July 2020) remain.
- UK sites (registry, 10): Velindre Cardiff, Western General Edinburgh, St Bartholomew's, Guy's and St Thomas', Royal Marsden London and Sutton, the Christie, Derriford Plymouth, Royal Preston, Weston Park Sheffield.

## Sources

- ClinicalTrials.gov NCT02425891: https://clinicaltrials.gov/study/NCT02425891
- IMpassion130 primary analysis (NEJM 2018): https://doi.org/10.1056/NEJMoa1809615
- IMpassion130 final overall survival (Annals of Oncology 2021): https://doi.org/10.1016/j.annonc.2021.05.355
- NICE TA639 (1 July 2020): https://www.nice.org.uk/guidance/ta639

## Connected records

- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Atezolizumab](https://onco.cc/drugs/atezolizumab/), [Nab-paclitaxel](https://onco.cc/drugs/nab-paclitaxel/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [VENTANA PD-L1 (SP142) Assay](https://onco.cc/drugs/ventana-pd-l1-sp142/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- trials: [IMpassion131](https://onco.cc/trials/impassion131/), [KEYNOTE-355](https://onco.cc/trials/keynote-355/), [NeoTRIP (NeoTRIPaPDL1)](https://onco.cc/trials/neotrip/)
- people: [Peter Schmid](https://onco.cc/people/peter-schmid/), [Rebecca Dent](https://onco.cc/people/rebecca-dent/)
- key papers: [Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer](https://onco.cc/key-papers/paper-impassion130-n-engl-j-med-2018/), [Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial](https://onco.cc/key-papers/paper-impassion130-lancet-oncol-2020-update/), [PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel-Treated Advanced Triple-Negative Breast Cancer](https://onco.cc/key-papers/paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021/)
- terms: [PD-L1 assay discordance (SP142, SP263 and 22C3 in breast cancer)](https://onco.cc/terms/pd-l1-assay-discordance/), [PD-L1 combined positive score 10 in triple-negative breast cancer](https://onco.cc/terms/pd-l1-cps-10-tnbc/)
- roadmaps: [TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line](https://onco.cc/roadmaps/tnbc-history/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/)
- ideas: [Harmonise PD-L1 testing for triple-negative breast cancer around one scored assay, with external quality assurance](https://onco.cc/ideas/idea-tnbc-pd-l1-assay-harmonisation/)

---
JSON: https://onco.cc/api/v1/entities/impassion130.json