OnCo
trialsTrialMixed

IMpassion130

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was the first immunotherapy success in breast cancer, later undermined when a sister trial failed and the approval was withdrawn.

PFS benefit in PD-L1+ (SP142) patients; OS 25.4 vs 17.9 months in PD-L1+ but not statistically tested. IMpassion131 (with paclitaxel) was negative, leading to US withdrawal in 2021. A lesson in chemotherapy partner and biomarker assay choice.

Setting
First-line metastatic TNBC: atezolizumab + nab-paclitaxel
Phase
Phase 3
Sponsor
Roche
Registry
Headline result
PFS HR 0.62 in PD-L1+; approval withdrawn 2021 (US).
Reported
2018
Enrolled
902
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.

Outcomes

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In plain words
What these results mean for people, not percentages
902 people took part
Progression-free survival, PD-L1+ (SP142 IC ≥1%)primarysurrogate endpoint
  • Median 7.5 vs 5 months with Atezolizumab + nab-paclitaxel compared with Placebo + nab-paclitaxel; about 2.5 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.49 to 0.78).
  • 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.
Overall survival, PD-L1+survival endpoint
  • Median 25.4 vs 17.9 months with Atezolizumab + nab-paclitaxel compared with Placebo + nab-paclitaxel; about 7.5 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 33 percent lower chance of the event at any given time (hazard ratio 0.67, likely range 0.53 to 0.86).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Overall survival, ITTsurvival endpoint
  • Median 21 vs 18.7 months with Atezolizumab + nab-paclitaxel compared with Placebo + nab-paclitaxel; about 2.3 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 13 percent lower chance of the event at any given time (hazard ratio 0.87, likely range 0.75 to 1.02).
  • The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
  • Not significant.
Be careful
  • These results apply to the people the trial enrolled: First-line metastatic TNBC: atezolizumab + nab-paclitaxel. 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.

902 participants enrolled.

Progression-free survival, PD-L1+ (SP142 IC ≥1%)primary
HR 0.62 (0.49–0.78) · p <0.001
Atezolizumab + nab-paclitaxel
7.5 mo
Placebo + nab-paclitaxel
5 mo
Source
Overall survival, PD-L1+
HR 0.67 (0.53–0.86)
Atezolizumab + nab-paclitaxel
25.4 mo
Placebo + nab-paclitaxel
17.9 mo

Not formally tested under the hierarchical design

Source
Overall survival, ITT
HR 0.87 (0.75–1.02)
Atezolizumab + nab-paclitaxel
21 mo
Placebo + nab-paclitaxel
18.7 mo

Not significant

EndpointArmnValueHR (95% CI)pSource
Progression-free survival, PD-L1+ (SP142 IC ≥1%)primaryAtezolizumab + nab-paclitaxel1857.5 months0.62 (0.49–0.78)<0.001link
Placebo + nab-paclitaxel1845 months
Overall survival, PD-L1+Atezolizumab + nab-paclitaxel25.4 months0.67 (0.53–0.86)link
Placebo + nab-paclitaxel17.9 months
Overall survival, ITTAtezolizumab + nab-paclitaxel21 months0.87 (0.75–1.02)
Placebo + nab-paclitaxel18.7 months
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.

Connected

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