Pembrolizumab

Control Arm

Standard of care (methotrexate, docetaxel or cetuximab)

FDA Therapeutic Indication

Recurrent or metastatic SCCHN in adults whose tumours express PD-L1 with a ≥50% TPS and progressing on or after platinum-containing ChT

Tumour Type

Head and neck cancer

Tumour Sub-type

Squamous cell

Tumour Stage

Recurrent or metastatic

Tumour Sub-Group

CPS PD-L1 expression ≥1

Trial Name

KEYNOTE-040

NCT Number

NCT02252042

Trial Phase

Phase III

FDA Approval

FDA approved

EMA Approval

EMA (CHMP) October 2019 EC decision December 2019

Comment

FDA approval is irrespective of PD-L1 status

Primary Outcome(s)

OS

Evaluated Outcome

OS

Form(s)

Form 2a

OS Control

7.1 months

OS Gain

1.6 months

OS HR

0.74 (0.58-0.93)

QoL Comment

QoL evaluated as exploratory end point (as distinct from primary or secondary end point) is not eligible for ESMO-MCBS grading.

Toxicity Comment

Reduced toxicity

Preliminary non-curative score

2

Toxicity adjustment

1+

Non-curative score

3

Comment

EMA approval is restricted to PD-L1 ≥50% TPS. PD-L1 ≥1 CPS was a secondary end point eligible for ESMO-MCBS scoring.

EMA indication is restricted to recurrent or metastatic head and neck cancer with PD-L1 ≥50% TPS. This approval is based on an exploratory analysis with no adjustment for multiplicity in which the median OS control arm was 6.6 months, with a gain of 5.0 months (HR 0.53 ; (95% CI 0.35–0.81). Although exploratory analyses can be the basis for hypothesis generation or conjecture or even licensing approvals by regulatory authorities, since they are exploratory (as distinct from primary or secondary end points), they are not eligible for grading using ESMO-MCBS.

ESMO-MCBS version

ESMO-MCBS v1.1

Scorecard ID

198

Scorecard version

1

Issue date

20.07.2020

Last update

07.08.2023