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IMpassion130 was the first immunotherapy success in breast cancer, later undermined when a sister trial failed and the approval was withdrawn.
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metastatic triple-negative breast cancer, and it was later undermined when a sister trial failed and the approval was withdrawn.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formally tested under the hierarchical design, but IMpassion131 with paclitaxel was negative and the US approval was withdrawn in 2021.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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
902 enrolled.
Not formally tested under the hierarchical design
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival, PD-L1+ (SP142 IC ≥1%)primary | Atezolizumab + nab-paclitaxel | 185 | 7.5 months | 0.62 (0.49 to 0.78) | <0.001 | link |
| Placebo + nab-paclitaxel | 184 | 5 months | ||||
| Overall survival, PD-L1+ | Atezolizumab + nab-paclitaxel | - | 25.4 months | 0.67 (0.53 to 0.86) | - | link |
| Placebo + nab-paclitaxel | - | 17.9 months | ||||
| Overall survival, ITT | Atezolizumab + nab-paclitaxel | - | 21 months | 0.87 (0.75 to 1.02) | - | link |
| Placebo + nab-paclitaxel | - | 18.7 months |
The clearest demonstration that PD-L1 positive in triple-negative breast cancer means different things depending on the kit; with atezolizumab withdrawn, pembrolizumab's 22C3 combined positive score of 10 is the surviving standard, and roughly a quarter of patients get a different answer depending on which assay their laboratory runs.
A second publication from the IMpassion130 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT02425891 with the most citations, so it is the natural first reading for anyone following the IMpassion130 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer, VENTANA PD-L1 (SP142) Assay, PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel-Treated Advanced Triple-Negative Breast Cancer, Atezolizumab.
Shares PD-L1 assay discordance (SP142, SP263 and 22C3 in breast cancer), IMpassion131, PD-L1 combined positive score 10 in triple-negative breast cancer, Harmonise PD-L1 testing for triple-negative breast cancer around one scored assay, with external quality assurance.
Shares NeoTRIP (NeoTRIPaPDL1), Atezolizumab, Roche / Genentech, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares Harmonise PD-L1 testing for triple-negative breast cancer around one scored assay, with external quality assurance, KEYNOTE-355, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem, Metastatic triple-negative breast cancer.
Shares VENTANA PD-L1 (SP142) Assay, PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel-Treated Advanced Triple-Negative Breast Cancer, Atezolizumab, Roche / Genentech.
Shares NeoTRIP (NeoTRIPaPDL1), Atezolizumab, Roche / Genentech, Paclitaxel / nab-paclitaxel.
Shares Rebecca Dent, Roche / Genentech, Metastatic triple-negative breast cancer, Paclitaxel / nab-paclitaxel.
Shares NeoTRIP (NeoTRIPaPDL1), Atezolizumab, Roche / Genentech, Paclitaxel / nab-paclitaxel.