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…
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.…
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…
Shots:
Eli Lilly has reported P-IIIb (TOGETHER-PsA) trial assessing concomitant Taltz (ixekizumab) & Zepbound (tirzepatide) vs Taltz alone in 271 adults with active PsA & obesity or overweight with ≥1 weight-related condition
Trial met its 1EP, with 31.7% of pts achieving ACR50 & ≥10% weight loss at Wk. 36 vs 0.8%, & met a key…
Shots:
GSK has reported P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in over 1,800 pts from 29 countries for the treatment of chronic hepatitis B (CHB)
Both trials met the 1EP, with bepirovirsen delivering a statistically significant, clinically meaningful functional cure & showing superior cure rates vs SoC; Results were…
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…
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,…
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;…
Shots:
Acesion Pharma has enrolled the first patients in the P-II trial assessing AP31969 in pts with atrial fibrillation, with completion anticipated by Q1’27
Trial will enrol 200 pts across eight EU countries, with AF burden as the 1EP. Safety will be monitored using implantable loop recorders for continuous 24/7 cardiac rhythm tracking
In 2025,…
Shots:
The P-III (frontMIND) trial assessed Monjuvi (Minjuvi in EU) + lenalidomide & R-CHOP vs R-CHOP as the 1L treatment in ~900 adults with previously untreated DLBCL (IPI score of 3-5 for pts >60yrs or aaIPI of 2-3 for pts ≤60yrs.)
Trial met its 1EP of improved PFS by investigator assessment & achieved its key…

