Shots:
Takeda reported positive data from the global P-III (KEPLER) study evaluating IV ENTYVIO (vedolizumab) in children and adolescents (ages 2–17) with moderate to severe ulcerative colitis (UC) who had inadequate response to conventional therapies and/or TNF antagonists
Nearly half (47.3%) of pts achieved the 1EP of clinical remission at Wk. 54, while 34.7% achieved…
Shots:
The P-III (LATITUDE) trial assessed Cabenuva (cabotegravir + rilpivirine) in 453 adults facing adherence challenges, where 306 virally suppressed pts were randomized to Cabenuva (Q4W; n=152) or ART (QD, PO; n=154), with results published in The NEJM
At 48wks., Cabenuva reduced the cumulative risk of regimen failure (1EP) to 22.8% vs 41.2%, with fewer virologic failures…
Shots:
The EMA has validated the Type II Variation MAA for Enhertu as a monotx. for the treatment of adults with HER2+ (IHC 3+ or ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment
MAA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu (5.4mg/kg) vs trastuzumab emtansine in 1,635…
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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…
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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…
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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…
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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,…
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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,…
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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 &…

