{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T09:54:48Z","timestamp":1781690088581,"version":"3.54.5"},"reference-count":13,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T00:00:00Z","timestamp":1779321600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T00:00:00Z","timestamp":1779321600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004331","name":"Johnson and Johnson","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004331","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp; Syst Pharma"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Amivantamab, a bispecific antibody targeting epidermal growth factor and mesenchymal\u2010epithelial transition receptors, was initially approved under accelerated approval as a monotherapy for second\u2010line treatment of non\u2010small cell lung cancer (NSCLC) with exon 20 insertion mutations. Subsequently, amivantamab in combination with carboplatin\u2010pemetrexed demonstrated prolonged progression\u2010free survival compared to chemotherapy alone in the first\u2010line treatment of NSCLC with exon 20 insertion mutations and the second\u2010line treatment of NSCLC with exon 19 deletion or exon 21 L858R substitution mutations. To enable the combination with chemotherapy, the amivantamab regimen was changed from every 2\u2009weeks (Q2W) to every 3\u2009weeks (Q3W); both are weight\u2010tiered with a cutoff at 80\u2009kg. Here we present the population pharmacokinetics (PK) and exposure\u2010response (E\u2010R) analysis supporting this dose regimen change. The population PK analysis demonstrated that the Q3W regimen achieved comparable trough concentrations as the approved Q2W regimen as well as between the two weight tiers. After accounting for confounding covariates, the E\u2010R relationship for PFS was flat in both indications. The safety profile of the Q3W regimen was generally manageable, despite trends of a positive E\u2010R relationship for adverse effects related to the mechanism of action. Besides weight, dose adjustment for other covariates was not warranted. These analyses supported the registration of the weight\u2010tiered Q3W regimen for amivantamab in combination with carboplatin\u2010pemetrexed in the new indications. This work demonstrates how the use of fit\u2010for\u2010purpose pharmacometrics analyses can support dose regimen changes without extensive dose selection clinical studies.<\/jats:p>","DOI":"10.1002\/psp4.70263","type":"journal-article","created":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T17:46:15Z","timestamp":1779385575000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development of the Weight\u2010Tiered\n                    <scp>Q3W<\/scp>\n                    Regimen of Amivantamab in Combination With Carboplatin\u2010Pemetrexed in\n                    <i>EGFR<\/i>\n                    \u2010Mutated Non\u2010Small Cell Lung Cancer"],"prefix":"10.1002","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5085-0682","authenticated-orcid":false,"given":"Dongfen","family":"Yuan","sequence":"first","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4299-451X","authenticated-orcid":false,"given":"Corey J.","family":"Bishop","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9634-5630","authenticated-orcid":false,"given":"Jaydeep","family":"Mehta","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5902-0709","authenticated-orcid":false,"given":"Wangda","family":"Zhou","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7217-4585","authenticated-orcid":false,"given":"Lu","family":"Zhang","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3626-4732","authenticated-orcid":false,"given":"Jie","family":"Zhou","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2764-0254","authenticated-orcid":false,"given":"Raja","family":"Venkatasubramanian","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1732-2631","authenticated-orcid":false,"given":"Alex","family":"Yu","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trishala","family":"Agrawal","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Horsham Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sujay","family":"Shah","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson  Horsham Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahadi","family":"Baig","sequence":"additional","affiliation":[{"name":"Johnson &amp; 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