Asset profile

lifileucel · Amtagvi

Cell therapy

Approved / Phase 4Mechanism not established
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Approvedregulatory verdict

Evidence outlook

Approved: Melanoma

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

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Competitive landscape

4 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 4 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Lifileucel (Amtagvi): this drugApprovedCell therapy—
Intismeran AutogenePhase 3VaccinePatient-specific tumor neoantigens (personalized, up to 34 per patient)
NaporafenibPhase 3Small moleculePan-RAF
EIK1001Phase 2/3Small moleculeToll-like receptor 7 and 8 (TLR7/8)
RP1Phase 2Biologic (subtype unspecified)No discrete molecular target
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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(8 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (3)
May 2027 (1)
Phase 1MelanomaRecruiting
Est. primary completion 2027-05-01 · NCT05607095 · CT.gov ↗
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November 2027 (1)
Phase 1MelanomaActive not recruiting
Est. primary completion 2027-11 · NCT05640193 · CT.gov ↗
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December 2027 (1)
Phase 2MelanomaActive not recruiting
Est. primary completion 2027-12 · NCT07288203 · CT.gov ↗
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2028 (3)
March 2028 (1)
Phase 3MelanomaRecruiting
Est. primary completion 2028-03-01 · NCT05727904 · CT.gov ↗
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May 2028 (1)
Phase 2Endometrial CancerRecruiting
Est. primary completion 2028-05 · NCT06481592 · CT.gov ↗
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October 2028 (1)
Phase 1MelanomaNot yet recruiting
Est. primary completion 2028-10-01 · NCT07700121 · CT.gov ↗
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2032 (1)
June 2032 (1)
Phase 1/2MelanomaRecruiting
Est. primary completion 2032-06 · NCT06940739 · CT.gov ↗
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2033 (1)
September 2033 (1)
Phase 2Sarcoma, Soft Tissue Sarcoma (STS), Advanced Soft Tissue Sarcoma, Undifferentiated Pleomorphic Sarcoma (UPS) …Not yet recruiting
Est. primary completion 2033-09-01 · NCT07741877 · CT.gov ↗
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (1)
Phase 2 (6)
Phase 1/2 (1)
Phase 1 (4)
Used as active comparator (1)