{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:10:36Z","timestamp":1777421436235,"version":"3.51.4"},"reference-count":29,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2022,6,2]],"date-time":"2022-06-02T00:00:00Z","timestamp":1654128000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2023,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate clinical data regarding the use of amivantamab and mobocertinib for epidermal growth factor receptor (EGFR) exon 20 insertion mutation non\u2013small cell lung cancer (NSCLC) and assess their potential impact on the care of patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources<\/jats:title>\n                    <jats:p>A comprehensive literature search of PubMed and Clinicaltrials.gov was conducted using the terms amivantamab, Rybrevant, JNJ-61186372, mobocertinib, Exkivity, TAK-788.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Extraction<\/jats:title>\n                    <jats:p>Relevant English-language clinical trials were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis<\/jats:title>\n                    <jats:p>Amivantamab and mobocertinib were Food and Drug Administration (FDA) approved based on phases 1 and 2 studies. Amivantamab demonstrated an overall response rate (ORR) of 40% and median progression-free survival (PFS) of 8.3 months. Patients commonly experienced rash (86%), paronychia (45%), and stomatitis (21%). Mobocertinib demonstrated an ORR of 28% and median PFS of 7.3 months in phase 1\/2 study. Patients frequently experienced diarrhea (91%), rash (45%), and paronychia (38%). Cardiac monitoring is recommended with mobocertinib due to risk of QTc prolongation and cardiac failure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care<\/jats:title>\n                    <jats:p>For NSCLC patients who possess an EGFR exon 20 insertion mutation, amivantamab and mobocertinib are indicated as second-line therapy. Ongoing studies are evaluating these therapies as first-line monotherapy and as part of combination regimens in multiple cancer types. Dosage forms, drug interactions, and patient comorbidities should be considered when deciding which of the 2 agents may be most appropriate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Amivantamab and mobocertinib target an uncommon NSCLC mutation that has historically marked a poor prognosis because of innate resistance to previously approved EGFR tyrosine kinase inhibitors. Promising results from early phase trials supported accelerated FDA approval.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280221098398","type":"journal-article","created":{"date-parts":[[2022,6,2]],"date-time":"2022-06-02T09:34:22Z","timestamp":1654162462000},"page":"198-206","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["Targeting EGFR Exon 20 Insertion Mutation in Non\u2013small cell Lung Cancer: Amivantamab and Mobocertinib"],"prefix":"10.1177","volume":"57","author":[{"given":"Molly C.","family":"Russell","sequence":"first","affiliation":[{"name":"Franciscan Health Indianapolis, Indianapolis, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alyssa M.","family":"Garelli","sequence":"additional","affiliation":[{"name":"Butler University, Indianapolis, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1614-096X","authenticated-orcid":false,"given":"David J.","family":"Reeves","sequence":"additional","affiliation":[{"name":"Franciscan Health Indianapolis, Indianapolis, IN, USA"},{"name":"Butler University, Indianapolis, IN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2022,6,2]]},"reference":[{"key":"bibr1-10600280221098398","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21654."},{"key":"bibr2-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1016\/j.critrevonc.2020.102906."},{"key":"bibr3-10600280221098398","unstructured":"National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: non-small cell lung cancer. Version 1.2022. Accessed February 27, 2022. https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/nscl.pdf."},{"key":"bibr4-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1038\/nature25183."},{"key":"bibr5-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1016\/j.critrevonc.2020.103119."},{"key":"bibr6-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1038\/s41392-019-0038-9."},{"key":"bibr7-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctrv.2020.102105."},{"key":"bibr8-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1713137."},{"key":"bibr9-10600280221098398","unstructured":"Rybrevant (amivantamab-vmjw) [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2021. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761210s000lbl.pdf."},{"key":"bibr10-10600280221098398","unstructured":"Exkivity (mobocertinib) [package insert]. Lexington, MA: Takeda Pharmaceuticals, Inc.; 2021. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/215310s000lbl.pdf."},{"key":"bibr11-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.21.00662."},{"key":"bibr12-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2021.4761."},{"key":"bibr13-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-20-0071."},{"key":"bibr14-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-20-1683."},{"key":"bibr15-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2112431."},{"key":"bibr16-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-20-1598."},{"key":"bibr17-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2015.01.026."},{"key":"bibr18-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2021.04.009."},{"key":"bibr19-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1016\/j.cllc.2021.07.001."},{"key":"bibr20-10600280221098398","unstructured":"Janssen Pharmaceutical K.K. A Phase 2, Open-Label Study of Amivantamab in Subjects With Previously Treated Advanced or Metastatic Gastric or Esophageal Cancer. clinicaltrials.gov; 2022. Accessed February 24, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04945733."},{"key":"bibr21-10600280221098398","unstructured":"Wise-Draper T. Phase II Study to Evaluate Amivantamab in Recurrent and Metastatic Adenoid Cystic Carcinoma. clinicaltrials.gov; 2021. Accessed February 24, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05074940."},{"key":"bibr22-10600280221098398","unstructured":"Memorial Sloan Kettering Cancer Center. A Phase 2 Single-Arm Study of Amivantamab (JNJ-61186372) and Lazertinib in Metastatic EGFR-Mutant Lung Cancer With Progressive or New CNS Metastases on Previous Treatment. clinicaltrials.gov; 2022. Accessed February 24, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04965090."},{"key":"bibr23-10600280221098398","unstructured":"Janssen Research & Development, LLC. A Randomized, Open-Label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer. clinicaltrials.gov; 2021. Accessed February 24, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04538664."},{"key":"bibr24-10600280221098398","unstructured":"Janssen Research & Development, LLC. A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer. clinicaltrials.gov; 2022. Accessed February 24, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04487080."},{"key":"bibr25-10600280221098398","unstructured":"Takeda. A Phase 1\/2 Study of the Oral EGFR\/HER2 Inhibitor TAK-788 in Japanese Non-Small Cell Lung Cancer Patients. clinicaltrials.gov; 2021. Accessed February 24, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03807778."},{"key":"bibr26-10600280221098398","unstructured":"Millennium Pharmaceuticals, Inc. A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations. clinicaltrials.gov; 2022. Accessed February 24, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04129502."},{"key":"bibr27-10600280221098398","unstructured":"Millennium Pharmaceuticals, Inc. A Phase 1 Pharmacokinetic Study of Oral Mobocertinib in Subjects With Severe Renal Impairment and Normal Renal Function. clinicaltrials.gov; 2021. Accessed February 24, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04056455."},{"key":"bibr28-10600280221098398","unstructured":"Millennium Pharmaceuticals, Inc. Phase 1 Pharmacokinetics and Safety Study of Oral Mobocertinib in Subjects With Moderate or Severe Hepatic Impairment and Normal Hepatic Function. clinicaltrials.gov; 2021. Accessed February 24, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04056468."},{"key":"bibr29-10600280221098398","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2021.12.022."}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280221098398","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10600280221098398","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280221098398","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:16:53Z","timestamp":1777375013000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10600280221098398"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,6,2]]},"references-count":29,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,2]]}},"alternative-id":["10.1177\/10600280221098398"],"URL":"https:\/\/doi.org\/10.1177\/10600280221098398","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,6,2]]}}}