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4

Indication details

Control Arm
Investigator Choice (either dacarbazine, ipilimumab or pembrolizumab)
Therapeutic Indication
Treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma
Tumour Type
Skin Cancers
Tumour Sub-type
Uveal melanoma
Tumour Stage
Unresectable or metastatic
Tumour Sub-Group
HLA-A*0201positive
Trial Name
IMCgp100-202
NCT Number
NCT03070392
Trial Phase
Phase II

Approval details

FDA Approval
FDA approval January 2022
EMA Approval
EMA (CHMP) February 2022 EC decision April 2022

Primary Outcome(s)

Primary Outcome(s)
OS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

PFS Control
2.9 months
PFS Gain
0.4 months
PFS HR
0.73 (0.58-0.94)
OS Control
16.0 months
OS Gain
5.7 months
OS HR
0.51 (0.37-0.71)

Adjustments

QoL Comment
QoL data pending

Score (after adjustments)

Preliminary non-curative score

4

Non-curative score

4

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
316
Scorecard version
1
Issue date
02.03.2022
Last update
26.09.2023
Tebentafusp IMCgp100-202

PRELIMINARY SCORE

OS

ADJUSTMENTS

?
QoL data pending
Tebentafusp IMCgp100-202

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
4
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Skin Cancers
Treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma
Tebentafusp
Investigator Choice (either dacarbazine, ipilimumab or pembrolizumab)

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