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 Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC
Read More: Daiichi Sankyo
Genentech Reports P-III (ALLEGORY) Trial…
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The post hoc analysis of P-III (REDEFINE 1) trial assessed CagriSema (cagrilintide 2.4mg & semaglutide 2.4mg) vs PBO & individual components effects on CV risk factors in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without T2D
Trial showed CagriSema reduced systolic BP by -10.9 mmHg over 68wks. (vs -8.8 with semaglutide, & -2.1 with PBO),…
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UCB has reported 3yr. BE HEARD trials data where 2 P-III (BE HEARD I & II) trials assessed Bimzelx (320mg; Q2W till Wk. 16, then Q4W) vs PBO in 1,014 adults with mod. to sev. HS; 556 pts completing Wk. 48 entered the OLE (BE HEARD EXT) study
Among pts with ≥1 draining tunnel…
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Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300 adults with SLE on SoC for 52wks. followed by ~104wks. OLE period
Trial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…
Shots:
Daiichi Sankyo has dosed the first patient with Enhertu in combination with Keytruda in the P-III (DESTINYLung06) trial as a 1L treatment for unresectable, LA/M HER2 overexpressing & PD-L1 (TPS<50%) non-squamous NSCLC
Trial will assess Enhertu (5.4mg/kg) + Keytruda vs Keytruda + Pt-based CT + pemetrexed as the 1L treatment in the mentioned pts…
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:
Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome
Read More: Roche
Merck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear…
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AbbVie has reported topline P-III (M19-044) trial data on Rinvoq (15mg, QD, PO) in pts with non-segmental vitiligo (NSV) who were eligible for systemic therapy
Trial incl. 2 replicate studies in NSV pts (n=614; ≥12yrs.): Study 1 (206 Rinvoq, 102 PBO) & Study 2 (205 Rinvoq, 101 PBO), where in both studies' Period A, pts…
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J&J has reported 96wk. P-III trial data in mod. to sev. Crohn’s Disease incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara
In GRAVITI, 92% (100mg) & 93.4%…
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Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomy
Trial showed significantly improved disease-free survival (1EP), with OS as 2EP under evaluation; data to be presented in future & shared…
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Roche has reported the P-III (INShore) trial findings assessing Gazyva (Obinutuzumab; Wk. 0, 2, 24 & 26) vs mycophenolate mofetil (MMF; QD) in 85 pts (>2-25yrs.) with frequently relapsing or steroid-dependent nephrotic syndrome
Trial met its 1EP, with more pts achieving sustained complete remission at 1yr., & certain 2EPs. Gazyva showed significant benefits in…

