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 and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Read More: Daiichi Sankyo and Merck
Gilead…
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Sanofi has reported the P-II (ElevAATe) trial data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (QW) in 97 adults with AATD emphysema for ~32wks.
Trial met its 1EP with a greater mean increase in functional AAT (fAAT) levels at Wk. 32 & achieved key 2EPs of higher fAAT levels &…
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Novartis has reported that Cosentyx met all 1 & 2 EPs in the P-III trial in adults with PMR
The global P-III (REPLENISH) trial showed that Cosentyx (secukinumab) significantly improved sustained remission at Wk 52 in PMR pts vs PBO, with a reduced steroid dose and a safety profile consistent with prior use. Conducted…
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The P-III (ASCENT-03) trial (n= 558) assessed Trodelvy (sacituzumab govitecan-hziy; 10mg/kg, IV, Day 1 & 8 of 21-day cycle) vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who were previously treated with a PD-L1 inhibitor
Trial met its 1EP of improved PFS by 38% (mPFS:…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below:
Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas
Read More: Arcus Biosciences
HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib…
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Merck has reported P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in Pt-resistant recurrent ovarian cancer pts (n=643)
Trial met its 2EP of improved OS in pts with PD-L1+ tumors, building on previously reported data, which will be presented at ESMO’25;…
Eli Lilly Reports Topline Data from P-III (ACHIEVE-2 & 5) Trials of Orforglipron for Type 2 Diabetes
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The 2 P-III (ACHIEVE-2 & 5) trials assessed orforglipron (3, 12 & 36mg; QD) vs dapagliflozin (10mg; QD) in 962 adults with T2D uncontrolled on metformin, & vs PBO in 546 adults with T2D uncontrolled on titrated insulin glargine ± metformin/SGLT2i for 40wks., respectively
ACHIEVE-2 showed reduced A1C (1EP) at Wk. 40 across both…
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Pfizer has reported P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC following induction therapy in the 1L setting
Trial met its 1EP with a significant improvement in the investigator-assessed PFS & showed favorable safety; data to…
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The P-III (CONVOKE) trial assessed CT-155 (BI 3972080) vs a digital control app as an adjunct to SoC antipsychotic therapy in pts (≥18yrs.) with experiential negative symptoms of schizophrenia
Trial met its 1EP with 6.8 vs 4.2-point improvement in negative symptom severity on the CAINS-MAP at 16wks., achieving a Cohen’s D of -0.36; most…
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SystImmune has dosed the first patient with izalontamab brengitecan (iza-bren) in the global P-II/III (IZABRIGHT-Breast01) study for previously untreated TNBC ineligible for anti-PD-(L)1 drugs
First patient dosing triggered $250M milestone payment to SystImmune under its 2023 deal with BMS, where SystImmune is further eligible to receive additional ~$250M in contingent near-term payments & ~$7.1B…

