Clinical Trial Study to be Conducted at UPMC Hillman Cancer to Evaluate Novel Combination as Frontline Therapy CHICAGO and FORT WORTH, Texas, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced the initiation of the Phase 1b trial of elra ...

Incyte (INCY) Update Summary Company Overview - **Company**: Incyte Corporation - **Event**: Investor Event at ESMO 2024 - **Date**: September 14, 2024 Key Points Industry and Company Focus - Incyte is focusing on oncology, specifically targeting gynecological cancers and squamous cell anal cancer with their drug candidates, including retifanlimab and a new CDK2 inhibitor [2][3][4][5][6][9][31][41]. Core Programs and Data Updates - **Retifanlimab**: - Positive pivotal data presented for squamous cell anal cancer, showing a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for placebo, with a hazard ratio of 0.63 [24][30]. - The study design included a combination of retifanlimab with chemotherapy for patients with advanced disease [21][22]. - **CDK2 Inhibitor**: - Focused on ovarian and endometrial cancers, with plans to initiate pivotal trials in 2025 [10][43][60]. - The drug targets cyclin E overexpression, which is prevalent in HRD negative ovarian cancer patients [35][44][63]. - Early data shows a response rate of 31% in heavily pretreated ovarian cancer patients, with a disease control rate of 75% [56][60]. Pipeline and Milestones - Incyte has several near-term milestones, including: - Approval of axatilamab for chronic graft versus host disease [5][71]. - Submission for pediatric atopic dermatitis for OPSILURA [71]. - Potential approval of retifanlimab in new indications, including anal cancer and non-small cell lung cancer [71][72]. - Ongoing discussions for regulatory strategies for the CDK2 inhibitor in platinum-resistant ovarian cancer [66][69]. Market Dynamics and Competitive Landscape - The incidence of anal cancer is increasing by approximately 3% annually, largely due to HPV [14][15]. - Current treatment options for advanced anal cancer are limited, with chemotherapy being the standard of care [18][19]. - In ovarian cancer, there is a significant unmet need for effective treatments, especially in HRD negative patients, where current therapies have limited efficacy [32][34][63]. Safety and Efficacy - Safety data from the CDK2 inhibitor trials indicate manageable adverse events, primarily hematological toxicities, with few discontinuations due to treatment-related issues [50][51]. - The combination of retifanlimab with chemotherapy has shown promising results without compromising the delivery of chemotherapy [30][60]. Future Directions - Incyte aims to position the CDK2 inhibitor as a new standard of care in ovarian cancer, particularly in combination with existing therapies like bevacizumab [38][41][60]. - The company is also exploring the potential of retifanlimab in other cancer types and is preparing for commercial launches in 2025 [71][80]. Additional Insights - The company is leveraging its existing infrastructure from previous drug launches to facilitate the introduction of new therapies [78][80]. - There is a focus on developing companion diagnostics to identify patients who would benefit most from the CDK2 inhibitor [84][86]. This summary encapsulates the critical insights and developments from Incyte's recent investor event, highlighting the company's strategic focus on oncology and the promising data emerging from its clinical trials.