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The ALEXANDRA/IMpassion030 trial on Adjuvant Atezolizumab for Early TNBC by Michail Ignatiadis et al.

Michail Ignatiadis/X

Mar 2, 2025, 13:26

The ALEXANDRA/IMpassion030 trial on Adjuvant Atezolizumab for Early TNBC by Michail Ignatiadis et al.

A paper by Michail Ignatiadis et al. was published in JAMA, titled:

“Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA/IMpassion030 Randomized Clinical Trial”

Authors: Michail Ignatiadis, Andrew Bailey, Heather McArthur, Richard Gelber, Martine Piccart et al.

Michail Ignatiadis: The final analysis of the ALEXANDRA/IMpassion030 trial

This phase 3 international, open-label trial investigated whether adding one year of atezolizumab immunotherapy to standard postoperative chemotherapy reduces the recurrence risk in patients with stage II or III high-risk early-stage triple-negative breast cancer.

A total of 2,199 patients from 330 centers across 31 countries were randomized to receive either chemotherapy alone (n = 1,098) or chemotherapy with atezolizumab (n = 1,101). The primary endpoint, invasive disease-free survival (IDFS), measured the time to recurrence, metastasis, or death from any cause.

After a median follow-up of 32 months, IDFS events occurred in 12.8% of the atezolizumab group (141 patients) and 11.4% of the chemotherapy-alone group (125 patients), with a hazard ratio of 1.11 (95% CI, 0.87-1.42; P = .38). Due to lack of efficacy, an independent data monitoring committee halted enrollment early, and the trial proceeded to a premature final analysis.

The combination of atezolizumab and chemotherapy resulted in a higher incidence of grade 3 or 4 treatment-related adverse events (54% vs. 44%) compared to chemotherapy alone, but the rates of fatal adverse events (0.8% vs. 0.6%) and chemotherapy discontinuation were similar between groups.

Given these findings, the addition of atezolizumab to postoperative chemotherapy does not improve outcomes for patients with high-risk triple-negative breast cancer and is associated with increased toxicity.

Read the post “Immunotherapy for Breast Cancer: Types, Success Rate, Side Effects and More” on oncodaily.com.