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PharmaShots Weekly Snapshots (Oct 21, 2025 – Oct 24, 2025)    

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:    Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer  Read More: Daiichi Sankyo and Merck  Gilead…

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Gilead

Gilead Highlights P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) at ESMO 2025

Shots: The P-III (ASCENT-03) trial (n= 558) assessed Trodelvy (sacituzumab govitecan-hziy; 10mg/kg, IV, Day 1 & 8 of 21-day cycle) vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who were previously treated with a PD-L1 inhibitor Trial met its 1EP of improved PFS by 38% (mPFS:…

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PharmaShots Weekly Snapshots (Oct 13, 2025 – Oct 17, 2025)    

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below:  Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas  Read More: Arcus Biosciences  HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib…

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Merck new

Merck Highlights P-III (KEYNOTE-B96/ENGOT-ov65) Trial Findings on Keytruda for Platinum-Resistant Ovarian Cancer

Shots: Merck has reported P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in Pt-resistant recurrent ovarian cancer pts (n=643) Trial met its 2EP of improved OS in pts with PD-L1+ tumors, building on previously reported data, which will be presented at ESMO’25;…

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Pfizer New

Pfizer Reports Topline P-III (HER2CLIMB-05) Trial Data of Tukysa (Tucatinib) in Metastatic Breast Cancer (MBC)

Shots: Pfizer has reported P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC following induction therapy in the 1L setting Trial met its 1EP with a significant improvement in the investigator-assessed PFS & showed favorable safety; data to…

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Boehringer Ingelheim and Click Therapeutics Report P-III (CONVOKE) Trial Data on CT-155 for Schizophrenia

Shots: The P-III (CONVOKE) trial assessed CT-155 (BI 3972080) vs a digital control app as an adjunct to SoC antipsychotic therapy in pts (≥18yrs.) with experiential negative symptoms of schizophrenia Trial met its 1EP with 6.8 vs 4.2-point improvement in negative symptom severity on the CAINS-MAP at 16wks., achieving a Cohen’s D of -0.36; most…

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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…

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