Shots:
Ipsen has reported topline P-III (E-BEOND & C-BEOND) trial results assessing Dysport (abobotulinumtoxinA) vs PBO in a total of 1,510 adults with episodic & chronic migraine, respectively
Both trials met their 1EP, with a reduction in monthly migraine days vs PBO & demonstrated a favorable safety profile; detailed results will be presented at a future…
Shots:
The topline P-III (EPCORE DLBCL-4) trial results assessed epcoritamab + lenalidomide vs rituximab + gemcitabine + oxaliplatin (R-GemOx) in adults with R/R DLBCL who received ≥1L prior of therapy
Trial met its 1EP, significantly improving PFS & reducing the risk of disease progression or death by 60% (US censoring) & 56% (ex-US censoring). AbbVie…
Shots:
F2G & Shionogi have reported the topline P-III (OASIS) trial data assessing olorofim (PO) vs AmBisome followed by SoC in 225 pts with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy
Trial met its 1EP of non-inferiority, with a rate of all-cause mortality of 23.8% vs 24.3% at Day 42,…
Shots:
Takeda has reported topline P-III (LATITUDE Atlas) trial data assessing zasocitinib (TAK-279; 30mg, PO, QD) vs deucravacitinib (6mg, QD) in 606 adults with mod. to sev. PsO
Trial showed that zasocitinib was superior to deucravacitinib in the 1EP, with improved PASI 100 response rates at Wk. 16, plus in all key 2EPs, incl. PASI 90…
Shots:
Biogen has reported the global P-II (CELIA) trial data assessing diranersen [60mg (Q24W), 115mg (Q24W), or 115mg (Q12W); intrathecal) vs PBO over 76wks. in 416 pts with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia
Although CELIA did not meet its 1EP of dose response on CDR-SB change from baseline…
Shots:
Bayer has reported topline P-III (REVEAL) trial data assessing PET/CT radiotracerI 124 evuzamitide (IV) vs clinical SoC diagnosis in 170 adults with suspected cardiac amyloidosis
Trial met its 1EPs of sensitivity & specificity for the diagnosis of cardiac amyloidosis based on visual scan; data will be discussed with regulators, presented in future & submitted…
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SynOx has reported the global P-III (TANGENT) trial data assessing emactuzumab (1000 mg Q2W × 5 doses over 8wks.) vs PBO in TGCT for 6mos., followed by 18mos. follow-up with option for open-label emactuzumab upon disease progression
Trial met 1 & 2EPs with high significance, improving ORR (RECIST v1.1) & Tumor Volume Score, along…
Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease
Shots:
Amgen has reported topline P-III results assessing Tepezza (SC, Q2W × 12) vs PBO dosed via an on-body injector in pts with mod. to sev. active Thyroid Eye Disease (TED)
The trial met its 1EP, showing a 76.7% vs 19.6% proptosis response rate, with 3.17 vs 0.80 mm mean proptosis reduction (key 2EP) at 24wks.…
Shots:
The P-III (EMERALD-3) trial assessed single priming dose of Imjudo (300mg) + Imfinzi (1500mg) followed by Imfinzi (Q4W) + transarterial chemoembolisation (TACE) ± lenvatinib vs TACE alone in 760 pts unresectable HCC eligible for embolization
Imjudo + Imfinzi + Lenvatinib & TACE showed improved PFS (1EP) vs TACE alone, with OS (2EP) demonstrating a favorable trend in the…
Shots:
Novocure reported P-II (PANOVA-4) trial data evaluating Tumor Treating Fields (TTFields) with Tecentriq & gemcitabine/nab-paclitaxel as a 1L treatment for mPDAC, with a median TTFields duration of 25.6wks. & median systemic therapy duration of 6 cycles
Trial met its 1EP, showing a DCR of 74.4% in TTFields group (N=78) vs 48% with gem/nab-pac alone…

