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…
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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…
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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 &…
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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…
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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…
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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…
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Adlai Nortye has dosed the first patient in the US with AN9025 in its ongoing P-I trial for the treatment of advanced or metastatic solid tumors harboring RAS mutations
Trial is being conducted by Adlai Nortye with ASK Pharm as a multi-regional study under a license agreement granting Adlai Nortye ex-China rights to AN9025,…
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The US FDA has approved Keytruda/Keytruda Qlex + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapy
Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W) with CT…

