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Title: | Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein–Overexpressing Advanced Nonsquamous EGFR-Wildtype Non–Small Cell Lung Cancer in the Phase II LUMINOSITY Trial | Authors: | Camidge, D. Ross Bar, Jair Horinouchi, Hidehito Goldman, Jonathan Moiseenko, Fedor Filippova, Elena Cicin, Irfan Ciuleanu, Tudor Daaboul, Nathalie Liu, Chunling Bradbury, Penelope Moskovitz, Mor Katgi, Nuran Tomasini, Pascale Zer, Alona Girard, Nicolas CUPPENS, Kristof Han, Ji-Youn Wu, Shang-Yin Baijal, Shobhit Mansfield, Aaron S. Kuo, Chih-Hsi Nishino, Kazumi Lee, Se-Hoon Planchard, David Baik, Christina Li, Martha Ansell, Peter Xia, Summer Bolotin, Ellen Looman, Jim Ratajczak, Christine Lu, Shun |
Issue Date: | 2024 | Publisher: | LIPPINCOTT WILLIAMS & WILKINS | Source: | Journal of clinical oncology, 42 (25) , p. 3000 -3011 | Abstract: | PURPOSE Telisotuzumab vedotin (Teliso-V) is a c-Met-directed antibody-drug conjugate with a monomethyl auristatin E cytotoxic payload. The phase II LUMINOSITY trial (ClinicalTrials.gov identifier: NCT03539536) aimed to identify the optimal c-Met protein-overexpressing non-small cell lung cancer (NSCLC) population for treatment with Teliso-V (stage I) and expand the selected group for efficacy evaluation (stage II). Stage II enrolled patients with nonsquamous epidermal growth factor receptor (EGFR)-wildtype NSCLC. METHODS Eligible patients had locally advanced/metastatic c-Met protein-overexpressing NSCLC and <= 2 previous lines of therapy (including <= 1 line of systemic chemotherapy). c-Met protein overexpression in nonsquamous EGFR-wildtype NSCLC was defined as >= 25% tumor cells with 3+ staining (high [>= 50% 3+]; intermediate [>= 25%-<50%]). Teliso-V was administered at 1.9 mg/kg once every 2 weeks. The primary end point was overall response rate (ORR) by independent central review. RESULTS In total, 172 patients with nonsquamous EGFR-wildtype NSCLC received Teliso-V in stages I and II. ORR was 28.6% (95% CI, 21.7 to 36.2; c-Met high, 34.6% [95% CI, 24.2 to 46.2]; c-Met intermediate, 22.9% [95% CI, 14.4 to 33.4]). The median duration of response was 8.3 months (95% CI, 5.6 to 11.3; c-Met high, 9.0 [95% CI, 4.2 to 13.0]; c-Met intermediate: 7.2 [95% CI, 5.3 to 11.5]). The median overall survival was 14.5 months (95% CI, 9.9 to 16.6; c-Met high, 14.6 [95% CI, 9.2 to 25.6]; c-Met intermediate, 14.2 [95% CI, 9.6 to 16.6]). The median progression-free survival was 5.7 months (95% CI, 4.6 to 6.9; c-Met high, 5.5 [95% CI, 4.1 to 8.3]; c-Met intermediate: 6.0 [95% CI, 4.5 to 8.1]). Most common any-grade treatment-related adverse events (AEs) were peripheral sensory neuropathy (30%), peripheral edema (16%), and fatigue (14%); the most common grade >= 3 AE was peripheral sensory neuropathy (7%). CONCLUSION Teliso-V was associated with durable responses in c-Met protein-overexpressing nonsquamous EGFR-wildtype NSCLC, especially in those with high c-Met. AEs were generally manageable. | Notes: | Camidge, DR (corresponding author), Univ Colorado, Canc Ctr, Aurora, CO 80045 USA. ross.camidge@cuanschutz.edu |
Keywords: | Humans;Female;Male;Aged;Middle Aged;Adult;Aged, 80 and over;Antibodies, Monoclonal;Oligopeptides;Proto-Oncogene Proteins c-met;Carcinoma, Non-Small-Cell Lung;Lung Neoplasms;ErbB Receptors;Immunoconjugates | Document URI: | http://hdl.handle.net/1942/44429 | ISSN: | 0732-183X | e-ISSN: | 1527-7755 | DOI: | 10.1200/JCO.24.00720 | ISI #: | 001300322800012 | Rights: | 2024 by American Society of Clinical Oncology. Creative Commons Attribution Non-Commercial No Derivatives 4.0 License | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein–Overexpressing Advanced Nonsquamous EGFR-Wildtype .pdf | Published version | 1.28 MB | Adobe PDF | View/Open |
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