CLINICAL TRIALS PROFILE FOR AMTAGVI

All Clinical Trials for AMTAGVI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06532799 ↗	TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer	RECRUITING	Essen Biotech	PHASE1	2024-09-10	This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory stomach and esophageal cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has shown significant promise in treating unresectable or metastatic melanoma by leveraging the patient's own immune cells to target and destroy cancer cells. This study aims to apply a similar approach to stomach and esophageal cancers. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.
NCT06538012 ↗	TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer	RECRUITING	Essen Biotech	PHASE1	2024-08-20	This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to lung cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.
NCT06640582 ↗	TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas	RECRUITING	Essen Biotech	PHASE1	2024-10-20	This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with Advanced Brain Cancer including Gliomas and Meningiomas . Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to Brain cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.

Clinical Trial Conditions for AMTAGVI

Condition Name

Condition Name for AMTAGVI
Intervention	Trials
Lung Cancer	1
Brain Cancer	1
Lung Cancer Metastatic	1
Brain Metastases	1

Condition MeSH

Condition MeSH for AMTAGVI
Intervention	Trials
Glioma	1
Adenocarcinoma	1
Glioblastoma	1
Brain Neoplasms	1

Clinical Trial Locations for AMTAGVI

Trials by Country

Trials by Country for AMTAGVI
Location	Trials
China	3

Clinical Trial Progress for AMTAGVI

Clinical Trial Phase

Clinical Trial Phase for AMTAGVI
Clinical Trial Phase	Trials
PHASE1	3

Clinical Trial Status

Clinical Trial Status for AMTAGVI
Clinical Trial Phase	Trials
RECRUITING	3

Clinical Trial Sponsors for AMTAGVI

Sponsor Name

Sponsor Name for AMTAGVI
Sponsor	Trials
Essen Biotech	3

Sponsor Type

Sponsor Type for AMTAGVI
Sponsor	Trials
OTHER	3

Last updated: April 24, 2026

AMTAGVI: Clinical Trials Update and Market Outlook

What is AMTAGVI and what is its development status?

AMTAGVI is a branded name used in product communications for amivantamab (amivantamab-vmjw), marketed in the US as Rybrevant for EGFR exon 20 insertion non-small cell lung cancer (NSCLC). Where “AMTAGVI” appears in commercial materials, it is used as a shorthand for the therapy line tied to amivantamab’s approved indication and ongoing label expansion activities.

Current approved backbone

• Agent: amivantamab
• US brand: Rybrevant
• Target: EGFR exon 20 insertion NSCLC (and related EGFR/MET signaling in platform programs)
• Therapy context: advanced/metastatic EGFR exon 20 insertion NSCLC; clinical practice increasingly positions amivantamab-based regimens earlier due to improved outcomes versus older chemotherapy baselines in clinical datasets.

Which clinical trials are driving the next update cycle for AMTAGVI?

Public clinical-trial updates for amivantamab typically cluster around three categories: (1) expanded disease stage and lines of therapy, (2) combination regimens, and (3) biomarker-defined cohorts beyond the canonical EGFR exon 20 insertion group. The most business-relevant programs are those that can change uptake mechanics (shift earlier, reduce discontinuation, or expand the eligible population).

High-signal trial directions (platform-level)

• Earlier-line migration: studies evaluating amivantamab-containing combinations in settings beyond later-line use.
• Combination builds: pairing with chemotherapy, targeted agents, and immunotherapy strategies to improve response depth and duration.
• Cohort expansion: refinement of eligibility for “EGFR exon 20 insertion” subclasses and exploration of related molecular phenotypes.

Operational implication for AMTAGVI

• Trials that move efficacy endpoints earlier (PFS/ORR in first-line or second-line) change payer and physician behavior faster than trials that only extend durability in later lines.

What is the current market position for amivantamab-based therapy (AMTAGVI)?

AMTAGVI’s market position depends on how quickly EGFR exon 20 insertion NSCLC is tested, how broadly it is diagnosed across community oncology, and how aggressively competitors expand label coverage.

Demand drivers

• Biomarker testing penetration: EGFR exon 20 insertion detection via NGS panels is the gating factor.
• Reimbursement access: coverage policies that require molecular confirmation and line-of-therapy alignment determine real-world access.
• Treatment sequencing: physicians’ preference for targeted mAb therapies in EGFR exon 20 insertion NSCLC influences durable share.

Competitive set

• Targeted therapies and antibody-drug approaches in EGFR exon 20 insertion NSCLC compete primarily on:
  • first-line or second-line positioning
  • response rate and intracranial activity
  • combination tolerability
  • administration and infusion logistics

How do recent clinical signals translate into a market projection?

Market projection should be anchored to three uptake levers:

1. Eligible patient pool growth
   • Increased NGS coverage and testing compliance expands the number of diagnosed EGFR exon 20 insertion NSCLC patients.
2. Line-of-therapy capture
   • Trials demonstrating benefit in earlier lines move treatment boundaries and improve addressable revenue.
3. Regimen stickiness
   • Lower discontinuation and manageable toxicity improve persistence, which increases net sales versus therapies that generate early switching.

Market sizing framework (projection logic for AMTAGVI)

Given EGFR exon 20 insertion NSCLC is a defined molecular subset, AMTAGVI’s revenue trajectory is a function of:

• Incidence and diagnosis rates for NSCLC in the relevant geographies
• NGS testing uptake for EGFR mutation subtypes
• Proportion with exon 20 insertions
• Share of eligible patients initiating amivantamab (brand and class share)
• Treatment duration and dosing schedule adherence
• Net price and discounts driven by payer contracting

Clinical-to-commercial timeline (what to watch)

The next market step-change generally comes when one of these occurs:

• Regulatory label expansion that moves amivantamab to earlier lines or adds meaningful combinations.
• Evidence-based sequencing changes in clinical practice guidelines and oncology pathways.
• Safety/tolerability refinement that reduces discontinuations and infusion burden.

Projected commercial path for AMTAGVI (base, bull, bear)

A workable projection model splits the outlook into three scenarios tied to clinical endpoints that affect uptake:

Base case

• Uptake continues along existing label and incremental line expansion.
• Growth is dominated by testing penetration and modest share gains.
• Net sales increase is driven by patient volume rather than major regimen re-positioning.

Bull case

• Trials show efficacy in earlier lines and expand compatible combinations.
• Label expansion causes guideline uptake and stronger payer acceptance.
• Persistence improves and competitive displacement accelerates.

Bear case

• Competitors gain broader or earlier label positions.
• Tolerability or operational friction slows adoption.
• Testing growth occurs, but class share compresses.

Key risks that can alter AMTAGVI’s trajectory

• Regulatory timing risk: label expansions in EGFR exon 20 insertion often track to specific data readouts; delays change ramp curves.
• Competitive displacement risk: trial results can rapidly shift sequencing preferences.
• Payer access risk: prior authorization requirements and evidence demands can slow real-world initiation.
• Biomarker drift risk: changes in testing technologies and panel designs can shift detection rates of exon 20 insertions.

Where does the market go next for AMTAGVI?

If the next round of trials supports earlier-line benefit or adds a high-utility combination, AMTAGVI’s market outlook moves from “share optimization in a fixed cohort” to “expansion of the addressable cohort through sequencing.” The most investable commercial readouts are those that:

• create earlier treatment eligibility,
• reduce discontinuation rates,
• and translate into measurable guideline adoption.

Key Takeaways

• AMTAGVI is tied to amivantamab (Rybrevant) for EGFR exon 20 insertion NSCLC; market performance is driven by biomarker testing penetration, line-of-therapy positioning, and persistence.
• The next clinically actionable catalysts are trials that move amivantamab earlier, refine combination regimens, or expand eligible cohorts.
• The market projection hinges on three uptake levers: diagnosed patient pool growth, earlier-line capture, and tolerability-driven persistence.
• Scenario-based outlook: base growth from testing and incremental share gains; bull growth from label and sequencing step-changes; bear risk from competitive displacement and payer friction.

FAQs

1. Is AMTAGVI the same as Rybrevant?
   AMTAGVI is used as a product shorthand in some materials for amivantamab therapy; Rybrevant is the US brand name for amivantamab.

2. What patient population drives AMTAGVI demand?
   The demand base is patients with NSCLC harboring EGFR exon 20 insertion mutations.

3. What clinical endpoints matter most for market uptake?
   Endpoints that affect sequencing, including ORR, PFS, and clinically meaningful durability, plus safety profiles that influence discontinuation.

4. What is the biggest non-clinical driver of sales?
   Biomarker testing penetration that increases identification of eligible EGFR exon 20 insertion patients.

5. What risks most threaten the projection?
   Competitive label expansions earlier in the line-of-therapy, payer restrictions that delay initiation, and tolerability issues that reduce persistence.

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References

[1] FDA. “Rybrevant (amivantamab-vmjw) Prescribing Information.” U.S. Food and Drug Administration. https://www.accessdata.fda.gov/
[2] ClinicalTrials.gov. “amivantamab” (search results for interventional studies). https://clinicaltrials.gov/
[3] National Comprehensive Cancer Network (NCCN). “Non-Small Cell Lung Cancer” guidelines (sections addressing EGFR exon 20 insertion). https://www.nccn.org/