Prodotti competitors / Area Oncology
Atezolizumab in early-relapsing mTNBC did not show a statistically significant improvement in PFS or OS
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IMpassion132 double-blind randomized phase 3 trial of chemotherapy (CT) ± atezolizumab (atezo) for early-relapsing unresectable locally advanced or metastatic triple-negative breast cancer (aTNBC) - (Abstract #180O; Dent et al.)
Data from the P3 IMpassion132 trial of atezolizumab (anti-PD-L1) in early-relapsing mTNBC did not show a statistically significant improvement in PFS or OS for atezolizumab + chemotherapy versus chemotherapy alone;
- Assessment
- The P3 IMPassion132 trial failed to show a statistically significant improvement in PFS or OS for atezolizumab + chemotherapy vs chemotherapy alone in both PD-L1+ and all-comer early relapsing TNBC populations
- mOS (12.1mo vs 11.2mo, HR: 0.93 for PL-L1+; 10.4mo vs 9.8mo, HR: 0.94 for mITT) is consistent with RWE data in this population
- No new safety signals were identified
- It was highlighted that there is a high unmet need in early relapsing TNBC, despite fewer patients at this stage
- Despite regulatory submission guided for 2024, filing is unlikely given the negative data
- atezolizumab is currently approved in the EU for 1L PD-L1+ TNBC only in combination with nab-paclitaxel based on Phase 3 IMpassion130; in the US, Roche withdrew its AA in 1L TNBC after Phase 3 IMpassion131 (+ pac) failed to meet its primary endpoint
- Negative data from IMpassion132 as well its history of other failures in this space may further reinforce HCPs’ existing concerns about atezolizumab, potentially creating a negative halo effect
- Study Information
- IMpassion132 (NCT03371017): P3, atezolizumab + chemo (capecitabine or carboplatin/gemcitabine) vs placebo + chemo, 1L early-relapsing TNBC
- N=177 vs 177 (PD-L1+), 192 vs 188 (modified ITT)
- 1EP: OS in PD-L1+ and mITT
- Key 2EP: PFS, ORR, safety
- mFU: 9.8mo
- Efficacy (atezolizumab + chemo vs placebo + chemo)
- PD-L1+ TNBC:
- mOS: 12.1mo vs 11.2mo (HR: 0.93; p=0.59)
- mPFS: 4.2mo vs 3.6mo (HR: 0.84)
- Unconfirmed ORR: 40% vs 28%
- mITT:
- mOS: 10.4mo vs 9.8mo (HR: 0.94)
- mPFS: 3.7mo vs 3.6mo (HR: 0.96)
- Unconfirmed ORR: 31% vs 32%
- Safety (atezolizumab + chemo vs placebo + chemo)
- AEs: 96% vs 96%
- Gr3/4: 67% vs 71%
- Gr5: 1% vs 1%
- TRAEs: 90% vs 91%
- Gr3/4: 62% vs 65%
- Gr5: <1% vs 1%
- AEs: 96% vs 96%
- PD-L1+ TNBC:
- IMpassion132 (NCT03371017): P3, atezolizumab + chemo (capecitabine or carboplatin/gemcitabine) vs placebo + chemo, 1L early-relapsing TNBC
- The P3 IMPassion132 trial failed to show a statistically significant improvement in PFS or OS for atezolizumab + chemotherapy vs chemotherapy alone in both PD-L1+ and all-comer early relapsing TNBC populations
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