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4

Indication details

Combined Agent(s)
Pembrolizumab
Control Arm
Sunitinib
Therapeutic Indication
Treatment of adults with advanced renal cell carcinoma in combination with pembrolizumab as first-line treatment
Tumour Type
Genitourinary Cancers
Tumour Sub-type
Renal cell cancer
Tumour Stage
Advanced
Trial Name
CLEAR
NCT Number
NCT02811861
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval August 2021
EMA Approval
EMA (CHMP) October 2021 EC decision November 2021

Primary Outcome(s)

Primary Outcome(s)
PFS/OS (hierarchically)
Evaluated Outcome
PFS
Form(s)
Form 2b

Outcome Data

PFS Control
9.2 months
PFS Gain
14.7 months
PFS HR
0.39 ( 0.32-0.49)
OS Control
2-years 70.4%
OS Gain
2-years 8.8%
OS HR
0.66 (0.49- 0.88); P = 0.005 <0.016 for early stopping

Adjustments

QoL Comment
Improved QoL

Final Score (after adjustments)

Preliminary non-curative score

3

Early stopping or crossover
1+
Final non-curative score

4

Comment
Score derived from form 2b criteria with an upgrade for early stopping based on OS advantage detected with both OS medians not reached.

Benefit may be exaggerated by low prevalence of subsequent immunotherapy in patients progressing in the control arm, indicating substandard post-progression therapy.

EMA (CHMP) October 2021 EC decision November 2021
FDA approval August 2021

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
284
Scorecard version
1
Issue date
27.08.2021
Last update
15.05.2023
Lenvatinib CLEAR

PRELIMINARY SCORE

PFS

ADJUSTMENTS

Early stopping or crossover
Lenvatinib CLEAR

FINAL SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
4
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Genitourinary Cancers
Treatment of adults with advanced renal cell carcinoma in combination with pembrolizumab as first-line treatment
Lenvatinib + Pembrolizumab
Sunitinib

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    Legend

    Information about symbols, abbrevations and color codes

    Red = negative
    Green = positive
    Grey = neutral
    ? Grey + ? = neutral with pending data
    DFS
    Disease-Free Survival
    DoR
    Duration of Response
    EFS
    Event-Free Survival
    HR
    Hazard Ratio
    NEB
    No evaluable benefit
    NI
    Non-inferiority Study
    ORR
    Overall Response Rate
    OS
    Overall Surival
    pCR
    Pathological Complete Response/Remission
    PFS
    Progression-Free Survival
    QoL
    Quality of Life
    RFS
    Relapse-Free Survival
    RR
    Response Rate

    QoL adjustments

    Other adjustments*

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    QoL adjustments

    Red = negative / deterioration

    Green = positive / improvement

    Other adjustments*

    Red = negative / deterioration

    Green = positive / improvement

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    * Other adjustments include:

    - Long-term plateau in the survival curve
    - Long-term plateau in the PFS curve
    - Early stopping or crossover
    - Only improved PFS mature data shows no OS advantage and no improved Qol.

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