AstraZeneca

Daiichi Sankyo initiated the Phase III QuANTUM-Wild trial of oral Vanflyta (quizartinib) for newly diagnosed FLT3-ITD negative AML. The placebo-controlled, double-blind trial aims to assess Vanflyta with standard intensive induction and consolidation therapy, HSCT, and post-maintenance monotherapy in subjects aged 18-70. The global trial plans to enroll nearly 700 subjects across continents, with overall survival as the primary endpoint.

The report covers idiopathic inflammatory myositis epidemiology, market trends, and emerging drugs in the US, EU4, UK, and Japan. Key highlights include 191,589 diagnosed cases in 2023, expected to rise by 2034, with the US having the highest cases (91,734). Marketed drugs like OCTAGAM 10% and VENOGLOBULIN-IH 5% IV, and emerging therapies such as Dazukibart and Efgartigimod are discussed. The market size was $447M in 2023, projected to grow due to emerging therapies.

The 'Idiopathic Inflammatory Myositis - Market Insights, Epidemiology, and Forecast to 2034' report by ResearchAndMarkets.com provides an in-depth analysis of the market, epidemiology, and emerging therapies for idiopathic inflammatory myositis. Key highlights include the projected growth of the market driven by innovative therapies like dazukibart and efgartigimod, the rising prevalence of cases, and the market size of approximately USD 447 million in 2023, expected to grow at a CAGR of 21.1% by 2034. The report also covers current treatment practices, unmet medical needs, and market share by therapies in the 7MM (US, EU4, UK, Japan).

DelveInsight's report on PD-1 Non-Small Cell Lung Cancer Market (2020-2034) highlights market growth, approvals, prevalence, therapies, and companies like Merck, Bristol-Myers Squibb, Genentech, and others. Key therapies include KEYTRUDA, OPDIVO, TECENTRIQ, and TIZVENI. Market drivers include premium-priced targeted agents and therapy expansion, while barriers include premium pricing of emerging therapies.

At the 2024 San Antonio Breast Cancer Symposium, experts discussed FDA approvals for ribociclib and inavolisib in HR+/HER2- BC, emphasizing treatment optimization, clinical trial design, and addressing ovarian/reproductive toxicities. Ribociclib's approval was based on NATALEE trial data showing improved invasive disease-free survival (iDFS) with safety concerns. Inavolisib, targeting PIK3CA mutations, showed improved progression-free survival (PFS) with post-marketing commitments for further evaluation. The session highlighted the need for comprehensive data analysis and monitoring of fertility impacts.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation in the US for treating EGFRm NSCLC progressing after EGFR-TKI and platinum-based chemotherapy. The FDA granted this based on TROPION-Lung05 Phase II and TROPION-Lung01 Phase III trial data, presented at ESMO Asia 2024. Datopotamab deruxtecan, a TROP2-directed ADC, is jointly developed by AstraZeneca and Daiichi Sankyo, with potential to address significant unmet needs in EGFRm NSCLC treatment.

AstraZeneca and Daiichi Sankyo's Dato-DXd received FDA Breakthrough Therapy designation for EGFRm NSCLC, based on phase II and III study data. They submitted a new BLA for accelerated approval in this indication and withdrew an earlier BLA for nonsquamous NSCLC. Dato-DXd is also under review for HR+ HER2- breast cancer, with regulatory applications ongoing globally.

Sirius Therapeutics' SRSD107, an anti-coagulant targeting Factor XI, showed safety and tolerability in a Phase I trial, with >90% reduction in FXI and >100% increase in aPTT at high doses, supporting Phase II studies.

AstraZeneca adopts Medera's CTScreen v1.5, an advanced automated cardiac screening platform using bioengineered human heart tissues, to advance cardiovascular therapy R&D. The platform features high-throughput 96-well technology, improved automation, and flexible testing protocols, aiming to streamline drug development and reduce costs.