Clinical Trial

A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD-(L)1 therapy based on PD-L1 negative disease (ROSETTA Breast-01)

MOA: BNT327 (pumitamig) is a bispecific antibody that targets PD-L1 and VEGF-A.

Key Eligibility:

• Confirmed metastatic TNBC (ER/PgR <1%), or ER-low (1
  10%), HER2-negative (IHC 0, 1+ or 2+/FISH-) BC
  • ER-low, HER2- must be ineligible for ET-based tx
• PD-L1 negative based on local PD-L1 IHC 22C3 pharmDx
  assay on tissue from metastatic biopsy
• No prior systemic tx (including immunotherapy/ET) in the LA
  unresectable/metastatic setting
  • Prior tx with PD-(L)1/VEGF bispecific antibody excluded
• Pts who had (neo)adjuvant tx for Stage I-III BC must be ≥6
  months from completion of treatment to recurrence
• At least 1 measurable lesion per RECIST v1.1
• Tumor tissue from a metastatic site required at screening
• Treated stable brain metastases are allowed