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NEWS

SystImmune Doses First Patient in P-II/III (IZABRIGHT-Breast01) Trial of Iza-Bren to Treat Triple Negative Breast Cancer (TNBC)

Shots: SystImmune has dosed the first patient with izalontamab brengitecan (iza-bren) in the global P-II/III (IZABRIGHT-Breast01) study for previously untreated TNBC ineligible for anti-PD-(L)1 drugs First patient dosing triggered $250M milestone payment to SystImmune under its 2023 deal with BMS, where SystImmune is further eligible to receive additional ~$250M in contingent near-term payments & ~$7.1B…
October 14, 2025

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Pfizer & Astellas
NEWS

Pfizer and Astellas Report Follow-up Data from P-III (KEYNOTE-A39/EV-302) Trial of Padcev + Keytruda for Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

Shots: Pfizer & Astellas have reported follow-up data from P-III (KEYNOTE-A39/EV-302) trial assessing Padcev + Keytruda vs Pt-based CT in previously untreated la/mUCpts (n=886) The 12mos. follow up study (mFU: 29.1mos.) showed reduced risk of death by 49% & decrease in PFS by 52% (mPFS: 12.5 vs 6.3mos.) with improved mOS (33.8 vs 15.9mos.), where OS…
February 12, 2025

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Exclusive_Ahsan Arozullah_2024
EXCLUSIVE

Advancing Urothelial Carcinoma Care: Ahsan Arozullah from Astellas Pharma in an Exclusive Interview with PharmaShots

Shots:  Recently, the CHMP of the EMA adopted a positive opinion for Astellas’ Padcev + Keytruda combination therapy as the first-line treatment of patients with unresectable or metastatic urothelial cancer  Today, in an exclusive coverage, we bring an enlightening conversation with Ahsan Arozullah from Astellas Pharma, sharing insights from the P-III EV-302 study  Astellas looks…
September 4, 2024

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VIEWPOINTS

Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

Shots: Ahsan spoke about the US FDA acceptance for Priority Review of sBLAs for PADCEV and KEYTRUDA to treat patients with LA/mUC who are not eligible to receive cisplatin-containing CT He also talked about the study design and outcomes from the P-Ib/II (EV-103) clinical trial that supported the sBLA. The results from Dose Escalation/Cohort A…
August 17, 2023

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