IMpassion031
IMpassion031 showed that adding the immune drug atezolizumab to chemotherapy before surgery for early triple-negative breast cancer raised the share of women whose tumour had disappeared at surgery from 41 to 58 percent, whatever their PD-L1 status.
Overview
IMpassion031, trial NCT03197935 sponsored by Roche and Genentech and published in the Lancet in 2020, randomised 333 patients with previously untreated stage II or III triple-negative breast cancer to atezolizumab or placebo with nab-paclitaxel followed by doxorubicin and cyclophosphamide before surgery, with atezolizumab or observation after. Pathological complete response rose from 41 to 58 percent in all patients and from 49 to 69 percent in the PD-L1-positive subgroup, meeting the co-primary endpoint in the whole population but not the PD-L1-positive one at the prespecified boundary, with immune-related side effects as expected. It confirmed the KEYNOTE-522 finding that immunotherapy raises response rates in early disease regardless of PD-L1, but with no event-free survival benefit shown and the withdrawal of atezolizumab from metastatic breast cancer in 2021, pembrolizumab rather than atezolizumab became the standard. Whether the platinum-free backbone or the drug explains the smaller trial's limited uptake is a matter of debate.
- 58 vs 41 out of 100 had no cancer left at surgery with Atezolizumab + chemotherapy compared with Placebo + chemotherapy; 17 more per 100.
- Roughly one extra person helped for every 6 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.0044) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Early triple-negative breast cancer (tumours over 2 cm): neoadjuvant atezolizumab or placebo with nab-paclitaxel then doxorubicin and cyclophosphamide. People in a different situation may not see the same effect.
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.
333 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathological complete response (all patients)primary | Atezolizumab + chemotherapy | 165 | 58% | - | 0.0044 | link |
| Placebo + chemotherapy | 168 | 41% |
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