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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the EMA’s MAA Validation of Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The EMA has validated the Type II Variation MAA for Daiichi's Datroway (datopotamab deruxtecan) as monotx. For the 1L treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy; additional regulatory filings are underway MAA was supported by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644…
December 19, 2025

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Gilead
NEWS

Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

Shots: Gilead has reported topline P-III (ASCENT-03) trial data (n=~540) assessing Trodelvy vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who are previously treated with a PD-L1 inhibitor Trial met its 1EP of improved PFS in treatment-naïve mTNBC pts ineligible for PD-1/PD-L1 inhibitors; OS (2EP) data…
May 26, 2025

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Gilead
NEWS

Gilead Reports Topline P-III (ASCENT-04/KEYNOTE-D19) Trial Data of Trodelvy Regimen for Previously Untreated Triple-Negative Breast Cancer (TNBC)

Shots: The P-III (ASCENT-04/KEYNOTE-D19) trial assessed Trodelvy (10mg/kg, IV, Day 1 & 8 of 21-day cycle) + Keytruda (200mg, IV, Day 1 of 21-day cycle) vs Keytruda + CT in pts (n=443) with inoperable, locally advanced or metastatic TNBC expressing PD-L1 (CPS ≥ 10) Trial showed improved PFS (1EP); OS (2EP) was immature but showed…
April 22, 2025

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Akesobio
NEWS

Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China

Shots: Akeso enrolled the first patient in the P-III (HARMONi-BC1/AK112-308)  study of Ivonescimab + CT  for the treatment of unresectable locally advanced or metastatic TNBC (already approved for EGFR-TKI-resistant, non-squamous NSCLC in China) The preliminary efficacy data presented at ESMO’24 showed significant therapeutic efficacy of ivonescimab + CT and a favorable safety profile for…
February 21, 2025

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