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Daiichi Sankyo

Daiichi Sankyo Initiates P-III (TROPIONLung17) Trial of Datroway in Nonsquamous NSCLC

Shots: Daiichi Sankyo has dosed the first patient in the P-III (TROPIONLung17) trial of Datroway for TROP2-NMR–positive LA/M nonsq. NSCLC without actionable genomic alterations previously treated with immunotherapy (IT) & Pt-based CT Trial will evaluate Datroway (6mg/kg) vs docetaxel in above-mentioned pts (n=~400) across Asia, EU & North America, assessing PFS & OS as dual…

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BMS

BMS Reports P-III (SCOUT-HCM) Trial Findings on Camzyos for Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: BMS reported topline P-III (SCOUT-HCM) trial data evaluating Camzyos (mavacamten) in 44 adolescents (12 to <18yrs.) with symptomatic oHCM, comprising a 28wk. PBO-controlled phase, an ongoing 28wk. active-treatment phase, & a 144wk. open-label LTE Trial met its 1EP, showing reduced Valsalva LVOT gradient at Wk. 28, & achieved statistical significance across multiple 2EPs, incl.…

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Pfizer New

Pfizer Reports P-III (BREAKWATER) Trial Results on Braftovi (Encorafenib) Regimen for Certain Metastatic Colorectal Cancer (mCRC)

Shots: Pfizer has reported data from Cohort 3 of P-III (BREAKWATER) trial, assessing Braftovi (300mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in pts with previously untreated BRAF V600E-mutated mCRC In Cohort 3, the combination improved ORR (64.4% vs 39.2%), with 57.4% vs 34.5% achieving ≥6mos. responses; mDoR was not…

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Merck new

Merck Initiates P-III (KANDLELIT-007) trial of Calderasib + Keytruda Qlex for KRAS G12C-Mutant Nonsquamous NSCLC

Shots: Merck has initiated P-III (KANDLELIT-007) trial of calderasib (MK-1084) + Keytruda Qlex for the 1L treatment of pts with KRAS G12C-mutant, advanced or metastatic nonsquamous NSCLC Trial will assess calderasib (PO, QD) + Keytruda Qlex (SC; Q6W) vs Keytruda Qlex + pemetrexed (IV) + CT in ~ 675 newly diagnosed pts with KRAS G12C-mutant nonsq. NSCLC, evaluating PFS as 1EP…

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Jazz Pharmaceuticals to Highlight P-III (HERIZON-GEA-01) Trial Data on Ziihera (Zanidatamab-hrii) for Gastroesophageal Adenocarcinoma (GEA) at ASCO 2026

Shots: The P-III (HERIZON-GEA-01) trial assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as the 1L treatment in 914 adults with HER2+ locally advanced or metastatic GEA Ziihera + CT & Ziihera + Tevimbra + CT showed prolonged PFS with 35% risk reduction delivering mPFS of 12.4mos., with mOS of 24.4 & 26.4mos., respectively,…

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J&J

Johnson & Johnson Reports Topline P-IIb (JASMINE) Trial Data on Imaavy (Nipocalimab) for Systemic Lupus Erythematosus (SLE)

Shots: J&J has reported the topline P-IIb (JASMINE) trial data assessing Imaavy (nipocalimab) vs PBO in 228 adults with SLE, along with the initiation of the P-III program Trial met its 1EP with higher SRI-4 composite response at Wk. 24, plus achieved secondary & exploratory endpoints, incl. those indicating the potential of nipocalimab for steroid sparing;…

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