{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T05:44:53Z","timestamp":1786945493700,"version":"build-2736575974"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T00:00:00Z","timestamp":1772064000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T00:00:00Z","timestamp":1772064000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp;amp; Syst Pharma"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Telisotuzumab vedotin (Teliso\u2010V) is a c\u2010Met\u2010directed antibody\u2010drug conjugate that delivers a cytotoxic microtubule inhibitor monomethyl auristatin E (MMAE) payload to c\u2010Met\u2010expressing tumor cells. It received accelerated approval from the US FDA for the treatment of adults with locally advanced or metastatic non\u2010squamous non\u2010small cell lung cancer (NSCLC) with high c\u2010Met protein overexpression (\u2265\u200950% of tumor cells with strong [3+] staining) at a dose of 1.9\u2009mg\/kg every 2\u2009weeks (Q2W; maximum 190\u2009mg for patients\u2009\u2265\u2009100\u2009kg) as an intravenous infusion. Population pharmacokinetic (PK) modeling used pooled data from a phase 1 (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200935) and phase 2 study (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u2009269) to describe the Teliso\u2010V conjugate and unconjugated MMAE PK and evaluate the impact of intrinsic and extrinsic factors on exposures in patients with solid tumors. Body weight, race, albumin, and anti\u2010drug antibody status were identified as significant covariates on Teliso\u2010V conjugate clearance, but did not result in clinically meaningful changes in exposure. The exposure\u2010response evaluations for efficacy (based on the pivotal phase 2 study) showed significant correlations between conjugate exposure and overall response rates. Higher conjugate exposures were also correlated with improved progression\u2010free survival and overall survival, demonstrating meaningful clinical benefit with the 1.9\u2009mg\/kg Q2W dosing regimen. Exposure\u2010safety evaluations showed significant relationships between conjugate exposures and grade \u2265\u20092 and grade \u2265\u20093 peripheral neuropathy, and grade \u2265\u20092 corneal epitheliopathy. Unconjugated MMAE payload exposures were correlated with a greater probability of grade \u2265\u20093 treatment\u2010emergent adverse events. The 1.9\u2009mg\/kg Q2W dose maximized efficacy while balancing adverse events in patients with c\u2010Met overexpressing NSCLC.\n                  <\/jats:p>","DOI":"10.1002\/psp4.70219","type":"journal-article","created":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T00:18:40Z","timestamp":1773015520000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Population Pharmacokinetics and Exposure\u2010Response Analyses for Telisotuzumab Vedotin in Patients With c\u2010Met Protein Overexpressing Tumors"],"prefix":"10.1002","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8901-7882","authenticated-orcid":false,"given":"Heiko","family":"Babel","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie Deutschland GmbH Co. KG  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4375-4021","authenticated-orcid":false,"given":"Priya","family":"Brunsdon","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc.  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Engelhardt","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Deutschland GmbH Co. KG  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4268-6306","authenticated-orcid":false,"given":"Vanessa","family":"Schmitt","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Deutschland GmbH Co. KG  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2654-8110","authenticated-orcid":false,"given":"Christine","family":"Ratajczak","sequence":"additional","affiliation":[{"name":"Oncology Clinical Development AbbVie Inc.  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9434-647X","authenticated-orcid":false,"given":"Sven","family":"Mensing","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Deutschland GmbH Co. KG  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2945-0449","authenticated-orcid":false,"given":"Rajeev M.","family":"Menon","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc.  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3711-8718","authenticated-orcid":false,"given":"Apurvasena","family":"Parikh","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc.  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