Pembrolizumab

Control Arm

Docetaxel

Therapeutic Indication

EMA: Pembrolizumab is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received approved therapy for these mutations prior to receiving pembrolizumab. (2 mg/kg and 10mg/kg pooled data). FDA: Pembrolizumab for the treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.

Tumour Type

Thoracic Malignancies

Tumour Sub-type

Non-small-cell Lung Cancer

Tumour Stage

Locally advanced or metastatic

Tumour Sub-Group

PD-L1 ≥50%

Trial Name

KEYNOTE-010

NCT Number

NCT01905657

Trial Phase

Phase II/III

FDA Approval

FDA approval October 2016

EMA Approval

EMA (CHMP) June 2016. EC decision August 2016

Primary Outcome(s)

OS - PD-L1 ≥50% - 2 and 10 mg/kg

Evaluated Outcome

OS

Form(s)

Form 2a / Form 1

OS Control

8.2 months

OS Gain

8.7 months, 5-year OS gain 16.8 %

OS HR

0.55 (0.44--0.69)

QoL Comment

Not qualified for an ESMO-MCBS credit

Toxicity Comment

Reduced grade 3-5 AEs: 16.1% versus 36.6%

Preliminary non-curative score

4

Toxicity adjustment

1+

Non-curative score

5

Curative score

A

ESMO-MCBS version

ESMO-MCBS v1.1

Scorecard ID

53

Scorecard version

1

Issue date

11.12.2018

Last update

18.04.2025