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Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Shots: The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settings HERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…
August 28, 2025

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Regeneron New
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Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

Shots: The P-III NIMBLE trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to cemdisiran (600mg, SC, Q12W, n=64), cemdi-poze (SC, Q4W, n=67), or PBO (n=59), with completion rates of 100%, 96%, & 90%, respectively; FDA’s filing is expected in Q1’26, pending discussions Trial met its 1EP of improved MG-ADL total score, showing…
August 27, 2025

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Jazz Pharmaceuticals at ASCO 2025: Robert lannone in an Illuminating Conversation with PharmaShots
VIEWPOINTS

Jazz Pharmaceuticals at ASCO 2025: Robert lannone in an Illuminating Conversation with PharmaShots

Shots:  Jazz Pharmaceuticals and partners presented seven abstracts from their oncology development program at ASCO 2025   Robert Iannone, EVP, Global Head of Research and Development, and Chief Medical Officer at Jazz Pharmaceuticals, in an engaging discussion with PharmaShots, shared insights from the P-III IMforte trial assessing Zepzelca plus atezolizumab in first-line maintenance treatment for Extensive…
August 25, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo’s Datroway (Datopotamab Deruxtecan) Receives the NMPA’s Approval for Unresectable or Recurrent HR+/HER2- Breast Cancer

Shots: China’s NMPA has approved Datroway for treating adults with HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) inoperable or recurrent breast cancer after previous CT Approval was based on P-III (TROPION-Breast01) study assessing Datroway (6mg/kg, IV, Q21D) vs single-agent CT in adults (n=732) with HR+/HER2- metastatic breast cancer Study showed improved PFS by 37%…
August 25, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: Japan’s MHLW has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=152) pts Trial showed 38% PFS in CT-naïve HER2-low pts & mPFS of 13.2…
August 25, 2025

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Argenx
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argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis

Shots: argenx has reported topline P-III (ADAPT SERON) trial data on Vyvgart (efgartigimod alfa; IV) for AChR-Ab seronegative generalized myasthenia gravis (gMG) Trial (n=119) consist of 2 Parts: Part A assessed Vyvgart (QW × 4wks.) vs PBO, followed by 5wk. follow-up, while Part B was an OLE study, where pts received 2 fixed cycles of…
August 25, 2025

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