Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced EGFR -mutated (MT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase 1 study.

作者：David Ross Camidge, Judith Raimbourg, Yun-Gyoo Lee, Maria J. de Miguel, Antoine Hollebecque, Tae Min Kim, Yutaka Fujiwara, François Ghiringhelli, Dae Ho Lee, Jonathan W. Goldman, Mor Moskovitz, Takako Eguchi Nakajima, D. Vincente Baz, Zoe Hunter, Michael Charles Burns, Martha Blaney, Rui Li, Tony Navas, Theodore S. Jennaro, David Sommerhalder · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.8512 · 被引用次数：14 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment、Gastric Cancer Management and Outcomes

8512 Background: c-Met protein (also known as MET protein) expression is increased in NSCLC and is a negative prognostic indicator. Temab-A is an ADC comprising the c-Met protein–targeting mAb telisotuzumab conjugated to a novel topoisomerase 1 inhibitor payload. A phase 1 study (NCT05029882) of Temab-A in advanced solid tumors is ongoing. In dose expansion, Temab-A had manageable safety and promising efficacy in pts with NSQ EGFR wildtype NSCLC ( Ann Oncol . 2024;35:1257MO). Herein, we present the results for pts with advanced EGFR MT NSQ NSCLC. Methods: Pts (≥18 yr) whose disease had progressed after platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKIs) were enrolled. Pts received Temab-A at 2.4 (n=36) or 3.0 (n=5) mg/kg Q3W. Primary objectives were evaluating safety, tolerability, PK, and preliminary efficacy of Temab-A. Tumor tissue c-Met protein expression was assessed centrally by IHC. Results: Forty-one pts were enrolled in the EGFR MT cohort. Median age was 64 yr (43–88), 63% were female, and 32% had baseline brain metastases. Median prior therapies was 3 (1–8); 93% had prior anti-EGFR treatment. Median treatment duration was 9.2 months; median follow-up was 9.7 months. TEAEs of any grade/grade ≥3 occurred in 100%/73% of pts. The most common any-grade TEAEs were hematologic (83%) and gastrointestinal (81%); any-grade TEAEs in ≥30% of pts were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%). Grade ≥3 TEA...