PARAMETER

DATA

Manufacturer

MERCK SHARP DOHME

Indication

KEYTRUDA is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor

Cell Substrate

IgG4//kappa isotype monoclonal antibody

Manufacturing platform

MK-3475 is a humanized monoclonal antibody that is expressed as a secreted product from a suspension Chinese Hamster Ovary (CHO) cell line. A fully characterized Master Cell Bank (MCB) as well as a Working Cell Bank (WCB) was established. Cells from the WCB are expanded in shake flasks, disposable rocker bags, and a seed bioreactor to generate the inoculum for a production bioreactor to produce the antibody product. The downstream processing includes three chromatography steps, two Page 12/160 orthogonal viral clearance steps, ultrafiltration/diafiltration, and a final 0.2 µm filtration step. All raw materials used in upstream/downstream manufacturing processes are animal component free. Upstream and downstream processing is considered as state of the art for production of monoclonal antibodies

Dose in vial/final container

50 mg, lyophilized powder in single-use vial for reconstitution

Dose to patient

2 mg/kg as an intravenous infusion over 30 minutes every 3 weeks.

NCT

TRIAL PHASE

NO OF PATIENTS ENROLLED

TITLE

COUNTRIES

Single arm/safety and response rate

NCT01295827

1

1260

Study of Pembrolizumab (MK-3475) in Participants with Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)

-

NCT01704287

2

540

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants with Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

-

NCT01866319

3

834

Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006)

-

NCT01905657

2, 3

1061

Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants with Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)

-

Safety and efficacy

NCT01848834

1

297

Study of Pembrolizumab (MK-3475) in Participants with Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)

-