Incyte (NasdaqGS:INCY) FY 2025 Conference December 02, 2025 11:15 AM ET Company ParticipantsPablo Cagnoni - President of Research and DevelopmentHervé Hoppenot - CEOModeratorOkay, great. All right, let's get started with the next session of Citi's Global Healthcare Conference. It's my great pleasure to have with me the senior management of Incyte Corporation. We have the CEO, Hervé Hoppenot, and Pablo Cagnoni, the president of research and development. Gentlemen, thank you both so much for taking the time t ...

Core Insights - The combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) has been approved by the China National Medical Products Administration (NMPA) for treating patients with locally advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC) with MET amplification after progression on EGFR TKI therapy [1][2][3] - This combination treatment is the only all-oral option available for these patients, providing a chemotherapy-free approach [1][3] - The SACHI Phase III trial demonstrated a 66% reduction in the risk of disease progression or death compared to platinum-based chemotherapy, with a median progression-free survival (PFS) of 8.2 months for the combination versus 4.5 months for chemotherapy [1][3][12] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies for cancer and immunological diseases [15] - The approval of the ORPATHYS and TAGRISSO combination marks a significant milestone in HUTCHMED's mission to address MET-driven progression in NSCLC patients [3][15] - AstraZeneca collaborates with HUTCHMED to market both ORPATHYS and TAGRISSO in China, enhancing the reach of this new treatment option [3][15] Industry Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases [5] - Approximately 30-40% of NSCLC patients in Asia have EGFR mutations, highlighting the need for effective treatment options [5][6] - MET amplification is a common mechanism of acquired resistance to EGFR TKI therapy, affecting 15-50% of patients who experience disease progression [11][12]

Core Insights - The FRUSICA-2 Phase 2/3 clinical trial has successfully met its primary endpoint of progression-free survival (PFS) for the combination of sintilimab and fruquintinib in treating advanced renal cell carcinoma (RCC) in China [1][3] - The combination therapy has received conditional approval from China's National Medical Products Administration (NMPA) for advanced endometrial cancer, indicating its potential in multiple cancer types [2][11] - The study demonstrated improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR), with full results expected to be presented at a scientific conference [3] Company Overview - Innovent Biologics, Inc. is a biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune conditions [1][18] - HUTCHMED (China) Limited is committed to the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [21][22] - Both companies are collaborating to advance the registrational communication of the sintilimab and fruquintinib combination therapy [4][5] Clinical Trial Details - The FRUSICA-2 study is a randomized, open-label trial comparing sintilimab and fruquintinib against axitinib or everolimus monotherapy for second-line treatment of advanced RCC [3][16] - The trial's positive results are seen as a significant advancement in treatment options for patients who have not responded adequately to previous therapies [4][5] Market Context - In 2022, approximately 435,000 new kidney cancer cases were diagnosed globally, with 74,000 in China, highlighting the substantial market potential for effective treatments [5] - The combination of sintilimab and fruquintinib addresses an unmet medical need for advanced RCC patients who have previously failed single-agent targeted therapies [16][17]

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.