Roche and AbbVie Announce Phase 3 Venclexta Trial Fails to Meet Primary Endpoint in High-Risk MDS

On June 16, 2025, Roche (Genentech) and AbbVie announced that the Phase 3 VERONA trial evaluating Venclexta (venetoclax) in combination with azacitidine for newly diagnosed higher-risk myelodysplastic syndromes (MDS) did not meet its primary endpoint of overall survival at the final analysis235.

The VERONA study enrolled approximately 500 patients across 220 sites globally, randomly assigning them to Venclexta plus azacitidine or placebo plus azacitidine25.

The combination treatment's safety profile was consistent with known risks and no unexpected safety signals were seen25.

The trial’s failure does not impact any of Venclexta's currently approved indications4.

Full study data will be presented at an upcoming medical meeting in 202525.

Patients who participated in the trial will be informed of their treatment assignment by their physicians25.

Sources:

2. https://www.gene.com/media/press-releases/15068/2025-06-16/genentech-provides-update-on-phase-iii-v

3. https://www.morningstar.com/news/dow-jones/202506164170/abbvies-venetoclax-doesnt-meet-primary-endpoint-in-trial-for-higher-risk-myelodysplastic-syndrome-treatment

4. https://www.prnewswire.com/news-releases/abbvie-provides-update-on-verona-trial-for-newly-diagnosed-higher-risk-myelodysplastic-syndromes-302481869.html

5. https://www.businesswire.com/news/home/20250616013467/en/Genentech-Provides-Update-on-Phase-III-Verona-Study