19Sep

IMpassion031 Results at ESMO 2020

Abstract No : Abstract: #LBA11

Indication : Triple Negative Breast Cancer

Intervention : Atezolizumab

Company : Roche

Technology : Immune Checkpoint Inhibitor (ICI)


Results:

333 pts were assigned to A-chemo (n = 165) or P-chemo (n = 168). Median follow-up was 20.6 mos in the A-chemo arm and 19.8 mos in the P-chemo arm (data cutoff 3 Apr 2020). pCR was seen in 57.6% (95% CI: 49.7, 65.2) of pts in the A-chemo arm and 41.1% (33.6, 48.9) in the P-chemo arm (Δ16.5%; 5.9, 27.1; 1-sided P = 0.0044 [significance boundary, 0.0184], P = 0.0085 for the intersection hypothesis of ITT and PD-L1+ populations). In PD-L1+ pts (n=152), pCR was seen in 68.8% (57.3, 78.9) vs 49.3% (37.6, 61.1) of pts (Δ19.5%; 4.2, 34.8; 1-sided P = 0.021; not significant). Median EFS was not reached in either arm (HR, 0.76; 95% CI: 0.40, 1.44). In the neoadj phase, Grade 3/4 adverse events (AEs) were balanced, treatment-related serious AEs occurred in 22.6% (A-chemo) and 15.6% (P-chemo), and 1 pt per arm had an unrelated Grade 5 AE.


Conclusion:

In pts with eTNBC, A + neoadj chemo significantly improved pCR rates regardless of PD-L1 status with an acceptable safety profile.