OrigAMI-3 Study Design^3,4

OrigAMI-3 (ClinicalTrials.gov Identifier: NCT06750094) enrollment period: December 2024 onwards; estimated study completion: April 13, 2029.
Abbreviations: 1L, first-line; BICR, blinded independent central review; C, cycle; CR, complete response; CRC, colorectal cancer; D, day; DCR, disease control rate; dMMR, mismatch repair deficiency; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; EORTC Q168, European Organisation for Research and Treatment of Cancer Item 168; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; EORTC QLQ-CR29, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29; EQ-5D-5L, European Quality of Life 5-Dimensions 5-Level questionnaire; FOLFIRI, combination of leucovorin calcium or levoleucovorin, 5-fluorouracil, and irinotecan hydrochloride; HER2, human epidermal growth factor receptor 2; IA, investigator-assessed; ILD, interstitial lung disease; IV, intravenous; MET, mesenchymal-epithelial transition; MSI-H, microsatellite instability-high; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PFS2, PFS after first subsequent therapy; PR, partial response; PRO, patient-reported outcome; Q2W, every 2 weeks; QW, once weekly; R, randomization; RECIST, Response Evaluation Criteria in Solid Tumors; rHuPH20, recombinant human hyaluronidase; SC, subcutaneous; SD, stable disease; TTF, time to treatment failure; VEGF, vascular endothelial growth factor; WT, wild-type.
^aPatients received prior 1L regimen that must be fluoropyrimidine- and oxaliplatin-based therapy ± anti-VEGF treatment.
^bBrain metastases that are definitively and locally treated, clinically stable, and asymptomatic for ≥2 weeks.
^cAmivantamab SC was co-formulated with 2000 U/mL rHuPH20.
^d2240 mg if body weight ≥80 kg.
^eLeft-sided CRC is defined as a primary tumor arising from the splenic flexure, descending colon, sigmoid colon, rectosigmoid, or rectum; right-sided CRC is defined as a primary tumor arising from the cecum, ascending colon, or transverse colon.
^fStart of therapy to disease progression.
^gFor patients who undergo curative-intent surgery/procedure during the treatment period, preintervention imaging will be used to determine the best response of CR, PR, or SD, and postintervention tumor assessments will be used to determine the time and location of PD (eg, recurrence at the site of resection or a distant new lesion).