Shots:
Ono Pharmaceutical has reported the P-II (ONO-4578-08) trial findings of ONO-4578 (EP4 antagonist) regimen for previously untreated, HER2-negative unresectable advanced or recurrent G/GEJ cancer
ONO-4578-08 assessed ONO-4578 (40mg, QD, PO) + Opdivo (360mg, Q3W) & CT (S-1 + Oxa or CapOx) vs PBO + Opdivo & CT in G/GEJ cancer pts across Japan, South Korea…
Shots:
J&J has reported P-III (ASTRO) trial data assessing Tremfya SC induction (400mg at Wks. 0, 4 & 8) followed by maintenance dose of either Tremfya 100mg (SC, Q8W) or 200mg (SC, Q4W) vs PBO in adults (n=418) with mod. to sev. active UC
At Wk. 48, trial showed improved clinical remission rates of 36.7%…
Shots:
Eli Lilly has reported long-term data from the P-III (LUCENT-3) OLE study of P-III (LUCENT-1 & LUCENT-2) trials, evaluating the efficacy & safety of Omvoh (mirikizumab-mrkz) in mod. to sev. active ulcerative colitis pts over an additional 3yrs., totaling ~4yrs. of treatment
In LUCENT-3, among pts who achieved clinical remission with Omvoh at 1yr.…
Shots:
Bavarian Nordic has reported topline P-II trial results evaluating two standard doses of the MVA-BN mpox/smallpox vaccine in 460 participants, incl. children (2–11 yrs) & adults (18–50 yrs) across 2 cohorts in the DRC & Uganda
In the trial, 227 children among 451 evaluable subjects showed a non-inferior immune response to adults (n=224) 2wks.…
Shots:
Sanofi has reported data from the ongoing P-II (ALPHAMEDIX-02) trial assessing AlphaMedix (67.6μCi/kg, Q8W, ~4 cycles) in pts, incl. PRRT-naïve (n=35) & exposed (n=26) pts with histologically confirmed unresectable or metastatic SSTR+ GEP-NETs & ≥1 site of measurable disease
Trial met all 1EPs with improved ORR & prolonged benefit, plus showed improvement across 2EPs…
Shots:
AbbVie has reported topline P-II (ELATE) trial data assessing Botox (onabotulinumtoxinA) vs PBO in pts with upper limb essential tremor
Trial met its 1EP with improved Tremor Disability Scale-Revised scores at 18wks. & showed a greater TREDS-R total unilateral score reduction (-2.61 vs -1.61), plus it also achieved all six 2EPs; data to be…
Shots:
AstraZeneca has reported P-III (Bax24) trial data assessing baxdrostat (2mg; QD) + SoC vs PBO + SoC in 218 pts with treatment-resistant hypertension for 12wks.
Trial achieved its 1EP, showing reduced 24hr. ambulatory systolic blood pressure at 12wks., with consistent efficacy across the day, incl. early morning; data to be presented at AHA’25 &…
Shots:
The global P-III (TROPION-Breast02) trial assessed Datroway vs CT in 644 pts with previously untreated locally recurrent inoperable or metastatic TNBC, regardless of PD-L1 expression, for whom immunotherapy was not an option
Trial showed Datroway significantly improved OS & PFS vs CT in TNBC pts; data to be presented in a future meeting &…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:
Daiichi Sankyo & AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer
Read More: Daiichi Sankyo & AstraZeneca
Merck Presents P-III (HYPERION) Trial Data…
Shots:
FDA has accepted an sBLA of neoadj. Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) for the treatment of adults with HER2+ (IHC 3+ or ISH+) stage 2/3 breast cancer (PDUFA: May 18, 2026)
sBLA was backed by the P-III (DESTINY-Breast11) trial assessing neoadj. Enhertu alone (5.4mg/kg) ± THP vs ddAC + THP in…

