2024 World Conference on Lung Cancer (WCLC) - Posters-P1.13A.12 Exposure-Response Analyses to Support Ph3 Dose Selection for I-Dxd (Ifinatamab Deruxtecan) in Extensive Stage SCLC Patients

P1.13A.12 Exposure-Response Analyses to Support Ph3 Dose Selection for I-Dxd (Ifinatamab Deruxtecan) in Extensive Stage SCLC Patients

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The document discusses exposure-response (ER) analyses for the investigational drug ifinatamab deruxtecan (I-DXd) aimed at treating patients with extensive-stage small cell lung cancer (ES-SCLC). Conducted by researchers from Daiichi Sankyo, Inc., and Certara, Inc., the study sought to understand the relationships between drug exposure and safety (ES), efficacy (EE), and support dose selection for Phase 3 trials.<br /><br />In ES analyses, significant relationships were found between I-DXd exposure and 9 out of 11 evaluated safety endpoints, including any-grade gastrointestinal disorders and Grade 3 anemia. EE analyses showed a significant correlation between I-DXd exposure and positive efficacy outcomes like objective response rates (ORR) and best percentage change from baseline in target lesion diameters (BTR). Higher efficacy was seen with increasing doses, with both 8 mg/kg and 12 mg/kg being effective and manageable. Ultimately, the 12 mg/kg dose every 3 weeks was suggested as the recommended dose for further study phases due to a favorable risk-benefit assessment.<br /><br />I-DXd is an antibody-drug conjugate comprising a monoclonal antibody linked to a topoisomerase I inhibitor, previously showing potential in early phases for heavily pretreated ES-SCLC patients. The ER study design included data stratification based on prior therapies and disease characteristics among others. These results are essential for optimizing dosing in later clinical trial phases.<br /><br />The study acknowledges ongoing trials and collaboration between Daiichi Sankyo and Merck & Co., underlining the comprehensive evaluation in determining I-DXd's efficacy and safety profile for eventual clinical use in targeting ES-SCLC. This work is crucial to developing targeted cancer therapies and improving outcomes for patients with limited treatment options.

Asset Subtitle

Narasimha Midde

Meta Tag

Speaker Narasimha Midde

Topic SCLC & Neuroendocrine Tumors

Keywords

ifinatamab deruxtecan

extensive-stage small cell lung cancer

exposure-response analyses

safety endpoints

efficacy outcomes

dose selection

antibody-drug conjugate

Daiichi Sankyo

Merck & Co.

targeted cancer therapies