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Merck has reported global P-III (TroFuse-005) trial data assessing sac-TMT (4 mg/kg, Q2W) vs doxorubicin/paclitaxel in 776 pts with endometrial carcinoma & carcinosarcoma who have received prior Pt-based CT & anti-PD-1/anti-PD-L1 immunotherapy either together or separately
Trial met its 1EP of improved OS & PFS in the above pts, plus it also reached its key…
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Trial assessed Lilly’s retatrutide (4, 9 & 12mg) with dose escalation vs PBO in adults with obesity/overweight & ≥1 weight-related comorbidity & without diabetes, meeting 1EP of 19% (4mg), 25.9% (9mg) & 28.3% (12mg) weight loss at 80wks.
In 2EPs, retatrutide reduced waist circumference by 16.3cm (4mg), 21.8cm (9mg), & 24.1cm (12mg) vs 3.6cm.…
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Pfizer has reported its P-II trial data assessing the safety, tolerability & immunogenicity of a 4 dose series of PF-07872412 (25vPnC) vs 4 doses of PREVNAR 20 at mos. 2, 4, 6 & 12-15 in infants
25vPnC vaccine generated higher immune responses against serotype 3 vs Prevnar 20, with geometric mean titers 8.8-fold higher…
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UCB has reported the (BE BOLD) trial data assessing Bimzelx(bimekizumab-bkzx) vs Skyrizi(risankizumab-rzaa) in 553 adults living with active psoriatic arthritis (PsA)
Trial met its 1EP, with 49.1% pts achieving ACR50 at Wk. 16 vs 38.4%. The first ranked 2EP, MDA was numerically higher at Wk. 16 (43% vs 39.9%), but did not reach statistical…
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Vincentage Pharma has reported topline P-III trial results evaluating VCT220 (120 0r 160mg, QD, PO) vs PBO for 52wks. in 840 Chinese adults with obesity or overweight with ≥1 weight-related comorbidity
The trial met its 1EP, showing mean body weight reduction of -12.2% and -12.4% in the 120 & 160mg groups, respectively, vs -1.3% for…
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The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy
sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…
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Sanofi has reported the P-II (ElevAATe) study data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (pdAAT; QW) in 97 pts with AATD-related emphysema
Efdoralprin alfa achieved a mean increase in fAAT trough levels of 24.1μM (Q3W) & 16.8μM (Q4W) vs 7.6μM at Wk. 32, with Q3W meeting the 1EP, while…
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Protara has reported 12mos. data from Cohort A of the ongoing P-II (ADVANCED-2) trial assessing TARA-002 in pts with carcinoma in situ or CIS (± Ta/T1) NMIBC who are BCG-Unresponsive or BCG-Naïve; P-III (ADVANCED-3)trialin BCG-Naïve pts to initiatein H2’26
The BCG-Naïve group (n=31), incl. 29 evaluable pts for efficacy, with 27 evaluable at 6mos.…
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MEDIPOST has reported the P-III trial data assessing Cartistem (n=59) vs hyaluronic acid (n=61) in 130 knee osteoarthritis pts over a 52wk. follow-up period across 13 Japanese sites
Trial met both co-1EPs of WOMAC knee pain & function scores, and ICRS cartilage repair grading. Improvements were also observed across all 2EPs, incl. VAS pain…
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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…

