Analysis of Antibody-Drug Conjugate Usage in Patients Undergoing Circulating Tumor DNA Testing
Author(s)
Avinash Ramu, PhD, Vasily N. Aushev, PhD, Yidan Qin, PhD, Caleb Frambach, PhD, Alyssa Antonopoulos, PhD, Angel Rodriguez, MD, Minetta C. Liu, MD;
Natera, Inc., Austin, TX, USA
Natera, Inc., Austin, TX, USA
OBJECTIVES: Antibody-drug conjugates (ADCs) are designed for targeted drug delivery to cancer cells. Several ADCs are FDA-approved for specific cancers, with many others under active investigation. Using Natera’s proprietary Real-World Database from commercial tumor-informed ctDNA testing (SignateraTM, Natera, Inc.), we evaluated patterns of ADC usage among patients with breast cancer.
METHODS: We utilized Komodo's Healthcare Map® to identify ADC usage among clinical cases in our database. We examined the use of 11 different FDA-approved ADCs across various cancer types and opted to focus on breast cancer patients first. Insurance claim codes were used to categorize patients and determine ADC usage.
RESULTS: In total, 3,181 patients across different cancer types were prescribed ADCs. For breast cancer, 1,217 patients had ctDNA data available. Patients received a median of 5 ADC doses (total n=10,700 doses), median total duration of treatment 91 days. In total, 6,763 ctDNA test results were analyzed (median 4 tests/patient), categorized as pre-ADC (n=1,419), during ADC treatment (within 30 days of dose, n=178), and post-ADC usage (1 year after last dose, n=1,669). Early-stage breast cancer patients were categorized as node-negative (N=183) or node-positive (N=276); metastatic patients were classified as de novo stage IV (N=260) or recurrent (N=498). Among patients with at least 3 ctDNA test results (N=892), 47% were persistently negative. Molecular progression (ctDNA- became ctDNA+) was observed in 8.1% of patients and this group displayed higher ADC usage (median 7 doses). Molecular clearance (ctDNA+ became ctDNA-) was observed in 11.8% of patients; of these, 36.4% returned to be ctDNA+ later.
CONCLUSIONS: Our study highlights the value of integrating real-world data with serial ctDNA testing to assess ADC usage and efficacy. Future studies will integrate these findings with whole exome sequencing data, ctDNA dynamics, and clinical outcomes to advance drug development and clinical trial design.
METHODS: We utilized Komodo's Healthcare Map® to identify ADC usage among clinical cases in our database. We examined the use of 11 different FDA-approved ADCs across various cancer types and opted to focus on breast cancer patients first. Insurance claim codes were used to categorize patients and determine ADC usage.
RESULTS: In total, 3,181 patients across different cancer types were prescribed ADCs. For breast cancer, 1,217 patients had ctDNA data available. Patients received a median of 5 ADC doses (total n=10,700 doses), median total duration of treatment 91 days. In total, 6,763 ctDNA test results were analyzed (median 4 tests/patient), categorized as pre-ADC (n=1,419), during ADC treatment (within 30 days of dose, n=178), and post-ADC usage (1 year after last dose, n=1,669). Early-stage breast cancer patients were categorized as node-negative (N=183) or node-positive (N=276); metastatic patients were classified as de novo stage IV (N=260) or recurrent (N=498). Among patients with at least 3 ctDNA test results (N=892), 47% were persistently negative. Molecular progression (ctDNA- became ctDNA+) was observed in 8.1% of patients and this group displayed higher ADC usage (median 7 doses). Molecular clearance (ctDNA+ became ctDNA-) was observed in 11.8% of patients; of these, 36.4% returned to be ctDNA+ later.
CONCLUSIONS: Our study highlights the value of integrating real-world data with serial ctDNA testing to assess ADC usage and efficacy. Future studies will integrate these findings with whole exome sequencing data, ctDNA dynamics, and clinical outcomes to advance drug development and clinical trial design.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
RWD107
Topic
Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
SDC: Oncology, STA: Multiple/Other Specialized Treatments