# OrigAMI-1: HCP commentary report

> 180 verified statements (102 from clinicians verified by NPI or staff page) from 33 commentary sources · 11 findings · updated Oct 31, 2026

## Report

- Trial: A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
- NCT ID: NCT05379595
- Registry: https://clinicaltrials.gov/study/NCT05379595
- Sponsor: Janssen Research & Development, LLC
- Phase: Phase 1/Phase 2
- Status: Recruiting
- Drugs tested: amivantamab; amivantamab plus mFOLFOX6; amivantamab plus FOLFIRI
- Indication: RAS/BRAF wild-type metastatic colorectal cancer
- Version: v1.0.0, edition 1
- Accepted: 2026-10-31
- Last checked: 2026-10-31
- Release hash: e9c692bac11f927dc671a72d418081f57411561a0bc003fe259b9757a302a051

## Counts

- HCP commentary sources screened: 70
- Sources cited by verified statements: 34
- Verified statements: 180
- From speakers with a confirmed clinical role (verified by the NPI registry or their own institution's staff page): 102
- Findings: 11
- Named people in screened sources (unnamed speakers and accounts not counted): 23
- Voices cited: 23
- Cited voices identity-verified: 18
- Organisational or shared accounts (not counted as people): 7

Counts describe the retained sources. They do not estimate how many HCPs hold a view.

## Abstract

OrigAMI-1 asks whether amivantamab, alone or with chemotherapy, can produce tumor responses with acceptable safety in advanced or metastatic colorectal cancer. Commentary spans X and Bluesky posts, podcasts and YouTube discussions, with medical oncologists among the speakers. The discussion turns on how far enthusiasm for amivantamab in right-sided or previously anti-EGFR-treated disease should extend, when EGFR-directed rechallenge is appropriate, and whether earlier-line chemotherapy combinations will gain phase 3 validation.

## Open Medical Affairs question

What comparative benefit, molecular selection, treatment-free interval, tolerability and feasible access pathway would justify moving from trial interest to a routine-care role?

Raised by the leading finding. The report shows what clinicians said and the sources behind it; it does not settle the question.

## Findings (titles)

- F1. Right-sided activity supports a trial discussion, not an unconditional treatment recommendation
- F2. Activity after anti-EGFR exposure and in right-sided disease drives enthusiasm, with important evidence limits
- F3. Rechallenge interest depends on interval, prior response and molecular reversion—not elapsed time alone
- F4. ctDNA-guided selection is constrained by access to both testing and treatment
- F5. Molecular characterization may refine sidedness-based selection, but does not erase treatment-line distinctions
- F6. Mechanistic and correlative interest remains hypothesis-led
- F7. Manageable toxicity is not negligible toxicity, and the formulation question remains setting-specific
- F8. Earlier-line combination signals generate interest without establishing chemotherapy replacement
- F9. Phase 3 development is anticipated validation, not validation already achieved
- F10. Alternative bispecifics broaden the development question, with tolerability and small datasets limiting comparison
- F11. Strong public reactions and compassionate-use applications do not establish treatment delivery or consensus

## What sits behind each finding

Counts describe what the report retained, not how many clinicians hold a view. A statement can support more than one finding.

| Finding | Statements | Passages | Sources | Named voices | Counterview | Limitations |
| --- | ---: | ---: | ---: | ---: | --- | ---: |
| F1 | 7 | 6 | 1 | 3 | recorded | 2 |
| F2 | 18 | 16 | 7 | 6 | recorded | 3 |
| F3 | 14 | 9 | 6 | 4 | recorded | 3 |
| F4 | 8 | 2 | 1 | 1 | none recorded | 3 |
| F5 | 23 | 16 | 3 | 4 | recorded | 3 |
| F6 | 19 | 16 | 8 | 5 | recorded | 3 |
| F7 | 11 | 11 | 9 | 8 | recorded | 3 |
| F8 | 8 | 8 | 6 | 7 | recorded | 4 |
| F9 | 22 | 15 | 10 | 7 | recorded | 4 |
| F10 | 10 | 9 | 1 | 2 | recorded | 3 |
| F11 | 9 | 8 | 8 | 7 | none recorded | 3 |

### What the statements are

| Finding | Views | Questions and uncertainty | Clinical experience | Comparisons | Restated results and context | Passages supporting | Passages giving context | Sources by kind | Feeds the Medical Affairs question |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | --- | --- |
| F1 | 4 | 1 | 1 | 0 | 1 | 8 | 4 | 1 podcast or video | yes |
| F2 | 10 | 1 | 0 | 2 | 5 | 21 | 3 | 3 posts and articles, 3 podcasts and video, 1 publication | yes |
| F3 | 9 | 2 | 0 | 0 | 3 | 16 | 0 | 4 posts and articles, 1 podcast or video, 1 publication | yes |
| F4 | 5 | 2 | 1 | 0 | 0 | 9 | 0 | 1 podcast or video | yes |
| F5 | 12 | 1 | 4 | 1 | 5 | 27 | 4 | 3 podcasts and video | yes |
| F6 | 11 | 3 | 0 | 2 | 3 | 22 | 3 | 7 podcasts and video, 1 publication | yes |
| F7 | 7 | 1 | 0 | 1 | 2 | 12 | 0 | 7 posts and articles, 1 podcast or video, 1 publication | yes |
| F8 | 5 | 2 | 0 | 0 | 1 | 8 | 1 | 6 posts and articles | yes |
| F9 | 7 | 0 | 0 | 1 | 14 | 29 | 4 | 3 posts and articles, 7 podcasts and video | yes |
| F10 | 5 | 0 | 0 | 2 | 3 | 11 | 1 | 1 podcast or video | yes |
| F11 | 6 | 0 | 2 | 0 | 1 | 9 | 0 | 8 posts and articles | yes |

### Trial dimensions

- Primary endpoint: Cohorts A, B, and C: Objective Response Rate (ORR): F2 (5 shared claims), F7 (4 shared claims), F11 (1 shared claims)
- Primary endpoint: Cohorts Ph1b-D and Ph1b-E: Number of Participants with Dose-limiting Toxicity (DLT): no finding draws on it directly
- Primary endpoint: Cohorts Ph1b-D and Ph1b-E: Number of Participants with DLT by Severity: no finding draws on it directly
- Primary endpoint: Cohorts D and E: Number of Participants with Adverse Events (AE): F2 (1 shared claims), F7 (1 shared claims), F8 (2 shared claims)
- Primary endpoint: Cohorts D and E: Number of Participants with Laboratory Values Abnormalities: no finding draws on it directly
- Primary endpoint: Cohorts D and E: Number of Participants with Vital Signs Abnormalities: no finding draws on it directly
- Primary endpoint: Cohorts F: Number of Participants with Adverse Events (AE): no finding draws on it directly
- Primary endpoint: Cohorts F: Number of Participants with Laboratory Values Abnormalities: no finding draws on it directly
- Primary endpoint: Cohorts F: Number of Participants with Vital Signs Abnormalities: no finding draws on it directly
- Secondary endpoints: F2 (4 shared claims), F7 (6 shared claims), F8 (3 shared claims)
- Population and setting: F1 (1 shared claims), F2 (2 shared claims), F7 (1 shared claims), F9 (1 shared claims)
- The comparison: F2 (1 shared claims), F8 (2 shared claims), F9 (1 shared claims)
- Safety and tolerability: F1 (1 shared claims), F2 (3 shared claims), F7 (8 shared claims), F8 (2 shared claims), F10 (1 shared claims)
- Design and conduct: F2 (4 shared claims), F5 (1 shared claims), F6 (2 shared claims), F9 (6 shared claims), F10 (1 shared claims)

## Sample findings

Paraphrased; the full report links each statement to its source.

### F8. Earlier-line combination signals generate interest without establishing chemotherapy replacement

An X reply asked whether chemotherapy with bevacizumab should be the comparator in a larger study of amivantamab plus chemotherapy.

Source: X thread, 2024-09-14.

### F9. Phase 3 development is anticipated validation, not validation already achieved

A medical oncologist in a YouTube discussion asked which patients were eligible for OrigAMI-1.

Source: YouTube video, 2026-05-29.

## What's inside

| Section | Items | Access |
| --- | ---: | --- |
| Findings with interpretation, counterviews and limits | 11 | Titles free |
| Detailed analysis | 13 sections | Paid |
| Verified statements with short source quotes and links | 180 | Paid |
| Trial aspects mapped | 23 | Free |
| Sources with links | 34 | Counts free |
| Speaker attribution for cited voices | 23 | Paid |

## Trial aspects

16 discussed · 7 no commentary found · 0 assessment incomplete.

| Aspect | Coverage | Statements | Sources |
| --- | --- | ---: | ---: |
| Primary endpoint: Cohorts A, B, and C: Objective Response Rate (ORR) | discussed | 16 | 11 |
| Primary endpoint: Cohorts Ph1b-D and Ph1b-E: Number of Participants with Dose-limiting Toxicity (DLT) | no commentary found | 0 | 0 |
| Primary endpoint: Cohorts Ph1b-D and Ph1b-E: Number of Participants with DLT by Severity | no commentary found | 0 | 0 |
| Primary endpoint: Cohorts D and E: Number of Participants with Adverse Events (AE) | discussed | 3 | 3 |
| Primary endpoint: Cohorts D and E: Number of Participants with Laboratory Values Abnormalities | no commentary found | 0 | 0 |
| Primary endpoint: Cohorts D and E: Number of Participants with Vital Signs Abnormalities | no commentary found | 0 | 0 |
| Primary endpoint: Cohorts F: Number of Participants with Adverse Events (AE) | no commentary found | 0 | 0 |
| Primary endpoint: Cohorts F: Number of Participants with Laboratory Values Abnormalities | no commentary found | 0 | 0 |
| Primary endpoint: Cohorts F: Number of Participants with Vital Signs Abnormalities | no commentary found | 0 | 0 |
| Secondary endpoints | discussed | 14 | 11 |
| Population and setting | discussed | 13 | 9 |
| The comparison | discussed | 7 | 7 |
| Safety and tolerability | discussed | 12 | 11 |
| Design and conduct | discussed | 12 | 7 |
| Right-sided second-line trial consideration and reasons for caution | discussed | 8 | 1 |
| EGFR rechallenge biology, interval and intervening treatment | discussed | 12 | 5 |
| ctDNA implementation, funding and unequal access | discussed | 8 | 1 |
| Conventional anti-EGFR alternatives, sidedness and molecular work-up | discussed | 22 | 3 |
| Resistance mechanisms and exploratory correlative markers | discussed | 18 | 7 |
| Earlier-line combination development and randomized comparator questions | discussed | 29 | 16 |
| Alternative bispecific strategies and preserving useful chemotherapy | discussed | 9 | 1 |
| Subcutaneous formulation in the CRC setting | discussed | 2 | 1 |
| Access seeking, public amplification and patient-facing participation descriptions | discussed | 13 | 9 |

An aspect marked incomplete is a question the public commentary did not let us answer. We show it rather than hide it.

## Sources

| Channel | Screened | Cited |
| --- | ---: | ---: |
| X threads | 55 | 22 |
| YouTube | 8 | 8 |
| Podcasts | 3 | 3 |
| Bluesky threads | 4 | 0 |
| Publications (primary source, cited for context) | not screened | 1 |

- Screened window: 2023-07-05 to 2026-09-18
- Cited window: 2023-09-15 to 2026-08-13
- Retrieved: 2026-10-31

Screened sources were retrieved for this trial. Cited sources back at least one verified statement and include primary sources used for context.

## The trial

From ClinicalTrials.gov.

- Title: A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
- Registry: NCT05379595 (https://clinicaltrials.gov/study/NCT05379595)
- Study IDs: CR109215 · 61186372GIC2002 (Janssen Research & Development, LLC) · 2021-006629-23 · 2023-506517-22-00 (EUCT number)
- Sponsor: Janssen Research & Development, LLC
- Design: Phase 1/Phase 2 · interventional, non randomized, parallel, phase1, phase2
- Status: Recruiting
- Enrollment: 225 (estimated)
- Start: 2022-07-29 (actual)
- Primary completion: 2027-04-27 (estimated)
- Primary endpoint: Cohorts A, B, and C: Objective Response Rate (ORR) (Up to 4 years 3 months)
- Primary endpoint: Cohorts Ph1b-D and Ph1b-E: Number of Participants with Dose-limiting Toxicity (DLT) (Up to 4 years 3 months)
- Primary endpoint: Cohorts Ph1b-D and Ph1b-E: Number of Participants with DLT by Severity (Up to 4 years 3 months)
- Primary endpoint: Cohorts D and E: Number of Participants with Adverse Events (AE) (Up to 4 years 3 months)
- Primary endpoint: Cohorts D and E: Number of Participants with Laboratory Values Abnormalities (Up to 4 years 3 months)
- Primary endpoint: Cohorts D and E: Number of Participants with Vital Signs Abnormalities (Up to 4 years 3 months)
- Primary endpoint: Cohorts F: Number of Participants with Adverse Events (AE) (Up to 4 years 3 months)
- Primary endpoint: Cohorts F: Number of Participants with Laboratory Values Abnormalities (Up to 4 years 3 months)
- Primary endpoint: Cohorts F: Number of Participants with Vital Signs Abnormalities (Up to 4 years 3 months)
- Intervention: Amivantamab IV (biological)
- Intervention: Fluorouracil (biological)
- Intervention: Leucovorin (biological)
- Intervention: Oxaliplatin (biological)
- Intervention: Irinotecan (biological)
- Intervention: Amivantamab (biological)

## Scope and limits

This report does not judge efficacy, estimate HCP prevalence or consensus or give treatment advice.

- Discussion that does not name the trial may be missing from this edition.
- Not yet captured in this edition: a view on pembrolizumab versus chemotherapy and crossover-related interpretation in MSI-high advanced or metastatic colorectal cancer.
- Not yet captured in this edition: a view on orthogonal confirmation of mismatch-repair testing to avoid misclassification before metastatic colorectal cancer treatment.
- Not yet captured in this edition: a view on alternative later-line treatment sequences guided by patient goals and discussion of risks and benefits.
- Not yet captured in this edition: a view on dual-method mismatch-repair testing to avoid misclassification when selecting treatment for metastatic colorectal cancer.
- Not yet captured in this edition: a view on confirming mismatch-repair immunohistochemistry with an orthogonal method to avoid misclassification before systemic-treatment selection.
- Some passages in the sources used in this report were not fully assessed for clinician views, so a view there may be missing from this edition.
- 178 statements in the sources reviewed for this edition are about other patients or topics, or only mention the trial, and are not counted.
- Further source limits: discussion that describes the trial without naming it may be incomplete; some discussion that describes the trial without naming it may be missing; sources about other trials are not included.
- Discussion coverage is incomplete. References that do not use the trial's recognized names or identifier, including different spellings, may be missing.
- Some portions of longer discussions were not fully assessed for clinician views; potentially relevant testing and treatment-sequencing positions may therefore be absent. The referral discussion is not exhaustive: not every alternative trial and its prior-treatment conditions is described here.
- Multiple podcast/video versions and reposts repeat material. Source counts cannot be interpreted as independent-HCP counts or consensus.
- Some remarks cannot be assigned to a named speaker. A participant list, title, profile or publication authorship does not resolve who spoke those passages.
- Some named public authors do not have an established clinical role in the sources reviewed. Organizational summaries and source-described roles or trial involvement are not independent confirmation of clinical credentials or independence.
- The early-phase monotherapy population was highly selected, with small cohorts, early enrollment closure in two cohorts and possible survivor bias in the interval analysis. These constraints limit generalization and comparative interpretation.
- Different reports concern monotherapy, chemotherapy combinations, different cohorts and different follow-up. Their response, durability and safety descriptions should not be pooled.
- A speaker's right-sided CRC post and another speaker's future-studies interview do not name OrigAMI-1 and are treated as setting or development context, not as this trial's results.
- Some source descriptions of treatment allocation, comparators and eligibility are not corroborated by the cited primary statements. They are preserved as what was said, not as validated study methods.
- A full protocol and complete colorectal-cancer regulatory assessment were not available. This report does not establish exact current eligibility, entitlement to access or approved CRC use.

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## Editions and corrections

- v1.0.0, accepted 2026-10-31: current edition

Last checked for new commentary 2026-10-31. No corrections. Versions follow semver: a new or changed finding is a minor version, more evidence without a material change is a patch.

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## Cite

Erudio Health. OrigAMI-1 (NCT05379595): HCP commentary report. Edition 1, v1.0.0. Accepted Oct 31, 2026. https://www.erudio.com/reports/origami-1-nct05379595

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