Shots:
Eli Lilly has reported P-IIIb (TOGETHER-PsO) trial data assessing Taltz (ixekizumab) + Zepbound (tirzepatide) vs Taltz alone in 274 adults with mod. to sev. plaque psoriasis & obesity/overweight with ≥1 additional weight-related comorbid condition
At 36wks., the trial met its 1EP with 27.1% pts reaching PASI 100 & ≥10% weight loss compared to 5.8% pts. Trial…
Shots:
Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines
Trial met its 1EP for the three prevalent subtypes of CIndU, incl. symptomatic dermographism, cold urticaria, & cholinergic urticaria, delivering significantly higher complete response rates at Wk. 12
Additionally, Novartis has submitted…
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 PFS as assessed by BICR, with OS showing meaningful prolonged improvement; ORR results were…
Shots:
Teva & Sanofi have reported RELIEVE UCCD LTE study data evaluating duvakitug (450 or 900mg, SC, Q4W) in 130 pts with ulcerative colitis (UC) or Crohn’s disease (CD) following P-IIb (RELIEVE UCCD) induction study
Trial showed that at Wk. 44 of maintenance, 58% (900mg) & 47% (450mg) of UC pts achieved clinical remission per mMS,…
Shots:
Eli Lilly has reported P-III (LIBRETTO-432) trial data assessing Retevmo vs PBO in 151 pts with RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy, if indicated
Trial met its 1EP, showing improvement in investigator-assessed EFS in early-stage (II-IIIA) pts, plus OS data was immature but demonstrated a…
Shots:
InnoCare has dosed the first patient with soficitinib (ICP-332) in the P-II/III trial for the treatment of chronic spontaneous urticaria
Additionally, the company has completed enrolment in soficitinib’s P-III trial for mod. to sev. atopic dermatitis & P-II trial for vitiligo
Soficitinib (ICP-332) is a selective TYK2 inhibitor in development for T-cell–mediated autoimmune diseases,…
Shots:
Genentech has reported the P-III (MAJESTY) trial results assessing Gazyva vs tacrolimus in 142 pts with primary membranous nephropathy
Trial met its 1EP, showing higher CR at Wk. 104 & achieved its key 2EPs, incl. improved overall remission & CR at Wks. 104 & 76, respectively; data to be presented in the future &…
Shots:
Lundbeck has reported P-IIb (PROCEED) trial results evaluating bocunebart (SC/IV; QM for 3mos.) vs PBO in migraine patients with prior failure of 1-4 preventive therapies, with the IV arm randomizing 431 pts across 14 countries
Trial met its 1EP in the multiple IV dosing arm, showing a statistically significant reduction in monthly migraine days…
Shots:
The global P-III (ALIGN) trial assessed Vanrafia (0.75mg, QD, PO) vs PBO for 132wks. in 340 IgAN pts at risk of progressive loss of kidney function. An additional 64 pts received an SGLT2 inhibitor alongside a RAS inhibitor for at least 12wks.
In the trial, Vanrafia showed a 2.39 mL/min/1.73m² difference in eGFR change…
Shots:
The P-III (LOGOS & KALOS) trials evaluated Breztri Aerosphere (BGF; 320/28.8/9.6μg or 320/14.4/9.6μg) vs PT009 (ICS/LABA via Aerosphere) & Symbicort pressurized metered-dose inhaler (pMDI) in pts with uncontrolled asthma; Regulatory filings in asthma are under review in all major regions
In pooled analysis, Breztri improved lung function by 76 mL in morning pre-dose trough…

