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Onco-Summaries: Daily Oncology Updates at a Glance

09/03/2026



















Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC (Ref)


The EC has approved an indication extension for Johnson & Johnson's AKEEGA® (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT), for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA1/2 mutations (germline and/or somatic).


  • The approval is supported by data from the Phase 3 AMPLITUDE study



























BMS announced positive Ph3 data of oral mezigdomide regimen in R/R Multiple Myeloma (Ref)


Bristol Myers Squibb's Phase 3 SUCCESSOR-2 trial of oral mezigdomide in combination with carfilzomib and dexamethasone demonstrated statistically significant and clinically meaningful improvement in PFS vs carfilzomib and dexamethasone alone (Kd) in patients with R/R multiple myeloma.


  • Safety findings were consistent with the known profile of mezigdomide and the combination regimen


  • Patients will continue to be followed for survival and safety


  • The results will be presented at a future medical meeting and be shared with health authorities


























AstraZeneca and Daiichi Sankyo’s Enhertu received priority review status for HER2-positive early breast cancer (Ref)


The US FDA accepted and granted Priority Review to AstraZeneca and Daiichi Sankyo’s sBLA for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.


  • The PDUFA date is anticipated during the third quarter of 2026


  • The sBLA is based on data from the Phase 3 DESTINY-Breast05 trial 


























Roche announced failure of the Phase 3 persevERA Breast Cancer trial (Ref)


Roche's Phase 3 persevERA Breast Cancer trial evaluating giredestrant + palbociclib in ER-positive, HER2-negative, locally advanced or metastatic breast cancer patients did not meet its primary objective of a statistically significant improvement in PFS vs letrozole + palbociclib.


  • Only a numerical improvement in PFS was observed


  • The adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of each individual treatment




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