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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial01) Study Evaluating ENHERTU

Shots : Daiichi reported the first patient dosing in a P-III (DESTINY-Endometrial01) study evaluating ENHERTU (trastuzumab deruxtecan) + rilvegostomig or pembrolizumab vs Pt. chemotx. (carboplatin and paclitaxel) + pembrolizumab as 1L therapy, in HER2-expressing (IHC 3+/2+), pMMR advanced or recurrent endometrial cancer pts The study is assessing the efficacy and safety of ENHERTU (5.4 mg/kg)…
June 10, 2025

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Astrazeneca and Daiichi-Sankyo New
NEWS

Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca has reported topline P-III (DESTINY-Breast11) trial data assessing neoadj. Enhertu (5.4mg/kg) monotx. or Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) vs SoC + THP in high-risk, locally advanced HER2+ early-stage breast cancer pts (n=927) Trial showed that Enhertu regimen achieved significant improvement in pCR rate (1EP), while EFS (2EP) data was…
May 7, 2025

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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo & AstraZeneca Report Topline P-III (DESTINY-Breast09) Trial Data of Enhertu for HER2+ Metastatic Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca have reported topline P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± pertuzumab vs taxane, trastuzumab & pertuzumab (THP) as a 1L treatment of HER2+ metastatic breast cancer pts (n=1157) Enhertu + pertuzumab showed improved PFS (1EP), with PFS benefit observed across all pre-specified subgroups during interim analysis; OS (2EP) remain immature…
April 21, 2025

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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo and AstraZeneca Report the EC’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: The EC has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy, based on the P-III (DESTINY-Breast06) trial; regulatory review is ongoing in Japan & other regions Trial (N=866) assessed Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=153) pts, showing 38% PFS in CT-naïve…
April 4, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the First Patient Dosing in P-III (DESTINY-Gastric05) Trial of Enhertu Regimen to Treat G/GEJ Cancer

Shots: Daiichi has reported first pts dosing in its P-III (DESTINY-Gastric05) trial assessing Enhertu regimen in 1L, inoperable, locally advanced or metastatic HER2+ (IHC 3+ or IHC 2+/ISH+) G/GEJ cancer pts, with PD-L1 CPS ≥1 Trial will assess efficacy & safety of Enhertu (5.4mg/kg) + Keytruda + fluoropyrimidine-based CT vs trastuzumab + Keytruda + Pt-based…
April 2, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study Evaluating Enhertu in HER2+ Metastatic Gastric Cancer Patients

Shots: The data from P-III (DESTINY-Gastric04) study showed statistically significant and clinically meaningful improvement in OS vs ramucirumab & paclitaxel in 2L HER2+ (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma pts. The safety profile observed in DESTINY-Gastric04 aligns with Enhertu's established safety record. The company expects to present data…
March 4, 2025

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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Shots: The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…
January 28, 2025

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VIEWPOINTS_Nirja Patel_2023
VIEWPOINTS

Nirja Patel, Senior International Product Manager at Roche Shares her Views on the US FDA Approval of the PATHWAY anti-HER2 Test

Shots:  Nirja gave the details of the PATHWAY anti-HER2 (4B5) to identify metastatic breast cancer patients with low HER2 expression through its scoring algorithm that helps pathologists to identify “low expressors” of HER2  She told PharmaShots about how this test is able to identify patients who may benefit from Enhertu as a treatment option. She…
March 7, 2023

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