In the dose optimization part of the ongoing Phase 2 IDeate-Lung01 study (NCT05280470), two doses of I-DXd (8 mg/kg and 12 mg/kg IV every 3 weeks) were evaluated in patients with ES-SCLC who had received at least one prior line of platinum-based chemotherapy and no more than three prior lines of systemic treatment in total. Patients with asymptomatic brain metastases could participate in the study. The primary endpoint was ORR by blinded independent central review, with secondary endpoints including DOR, progression-free survival, overall survival, disease control rate, time to response (TTR), and overall safety profile.
As of April 25, 2024, 88 patients had received at least one dose of I-DXd; 46 patients received I-DXd 8 mg/kg and 42 patients I-DXd 12 mg/kg, with a median follow-up of 14.6 and 15.3 months, respectively. I-DXd demonstrated promising efficacy, with a confirmed ORR of 54.8% in the 12-mg/kg cohort and of 26.1% in the 8-mg/kg cohort. A rapid response (TTR: 1.4 months) was observed at both doses, while median DOR was 7.9 months in the 8-mg/kg cohort and 4.2 months in the 12-mg/kg cohort. In a subgroup analysis of 16 patients with brain target lesions at baseline, the intracranial response was 66.7% among 6 patients who received I-DXd 8 mg/kg, and 50.0% among 10 patients treated with I DXd 12 mg/kg. During the study, a higher frequency of treatment-emergent adverse events was reported in the 12-mg/kg cohort than in the 8 mg/kg cohort; the most common TEAEs were gastrointestinal or hematologic in nature, or fatigue. The incidence of adjudicated interstitial lung disease was similar between cohorts, consistent with previous reports.
“I-DXd at both doses showed clinically meaningful efficacy in heavily pretreated patients with ES-SCLC, with the 12-mg/kg dose demonstrating approximately twice the confirmed ORR of the 8-mg/kg dose,” according to Dr. C.M. Rudin of Memorial Sloan Kettering Cancer Center in New York City. Dr. Rudin added that the safety profile was generally consistent across the two doses and while no new safety signals were observed, TEAEs were more frequent at the higher dose. Based on these findings, the 12-mg/kg dose has been selected as the optimal dose for monotherapy in SCLC and will be further studied in the extension part of IDeate-Lung01 and in the Phase 3 IDeate-Lung02 study.
About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association’s membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit http://www.iaslc.org for more information.
About the WCLC:
The World Conference on Lung Cancer (WCLC) is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit https://wclc2024.iaslc.org.
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