Shots:
- The US FDA has granted BTD to zovegalisib + fulvestrant for the treatment of adults with PIK3CA mutant, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor
- Designation was supported by P-I/II (ReDiscover) trial data of zovegalisib + fulvestrant ± CDK inhibitors, showing activity across kinase & non-kinase PIK3CA mutations at 600mg BID fasted & 400mg BID fed, the latter selected for the ongoing P-III (ReDiscover-2) trial
- Safety & efficacy data from the 600 mg BID fasted cohort were presented at ASCO’25, with additional subgroup analyses at SABCS’25, while the results from the P-III trial for 400mg BID dose will be presented at the ESMO’26
Ref: Globenewswire | Image: Relay | Press Release
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