AstraZeneca PLC Sponsored ADR(AZN.US) oral small molecule therapy Phase 3 clinical trial results are positive.

On February 27th, Astrazeneca PLC Sponsored ADR (AZN.US) announced that the mid-term analysis of the phase 3 clinical trial SERENA-6 showed statistically significant and clinically meaningful improvement in progression-free survival (PFS) with the investigational oral selective estrogen receptor degrader (SERD) camizestrant when used in combination with a CDK4/6 inhibitor. The trial evaluated the effect of switching treatment from aromatase inhibitor (AI) combined with a CDK4/6 inhibitor to camizestrant combined with the same CDK4/6 inhibitor in patients with hormone receptor (HR)-positive and HER2-negative advanced breast cancer when a new ESR1 mutation is detected in the tumor. SERENA-6 is the first global phase 3 clinical trial to use circulating tumor DNA (ctDNA) testing to detect the emergence of endocrine resistance in tumors and signal the need for treatment switch before disease progression. The safety profile of camizestrant in combination with CDK4/6 inhibitors in the SERENA-6 trial was consistent with the known safety profiles of the individual drugs, with no new safety concerns identified and very low and similar discontinuation rates in both groups. Camizestrant is a potent new generation oral SERD and estrogen receptor antagonist currently being evaluated in phase 3 trials for the treatment of HR-positive breast cancer. Camizestrant has demonstrated anti-cancer activity in a range of preclinical models, including those with estrogen receptor activating mutations.