ABOUT KEYTRUDA

KEYTRUDA and the
immune system

KEYTRUDA supports the immune system to help find and fight cancer cells

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Key trial facts

Ongoing clinical trials demonstrate positive results across numerous cancer types:

Lung Cancer

KEYNOTE-021G

KEYTRUDA + pemetrexed and carboplatin as first line therapy in lung cancer (n = 123)1

Study Design

KEYNOTE-021G Lung Cancer

An open-label, randomised, controlled, phase 2 study of KEYTRUDA plus pemetrexed and carboplatin vs pemetrexed and carboplatin alone in chemotherapy-naïve patients, stage IIIB or IV histologically or cytologically confirmed nonsquamous NSCLC without targetable EGFR mutations of ALK translocations. All patients were randomly assigned (1:1) in blocks of four stratified by PD-L1 tumour proportion score (<1% vs ≥ 1%) to 4 cycles of KEYTRUDA 200mg plus carboplatin AUC 5mg/ml/min and pemetrexed 500mg/m2 Q3W followed by KEYTRUDA for 24 months and pemetrexed maintenance. Or to 4 cycles of carboplatin and pemetrexed alone followed by pemetrexed maintenance. The primary endpoint was the proportion of patients who achieved an objective response, defined as the percentage of patients with radiologically confirmed complete or partial response according to RECIST v1.1.1

  • Significant improvement in ORR (KEYTRUDA + PC: 55%, PC alone: 29%; P = 0.0016 [95% CI, 9% - 42%) and PFS estimated at 6 months (KEYTRUDA + PC: 77% (95% CI, 64 - 86), PC alone: 63% (49 - 74))

KEYNOTE-189

KEYTRUDA + pemetrexed and carboplatin or cisplatin (PC) vs. PC alone as first line therapy in lung cancer (n=616)2

Study Design

KEYNOTE-189 Lung Cancer

A global, double-blind, placebo-controlled, phase 3 study of KEYTRUDA plus pemetrexed and carboplatin or cisplatin vs pemetrexed and carboplatin or cisplatin alone in patients with untreated, pathologically confirmed metastatic nonsquamous NSCLC without sensitising EGFR or ALK mutations. All patients were randomly assigned (2:1) to receive 4 cycles of KEYTRUDA 200mg plus pemetrexed 500mg/m2 and cisplatin 75mg/m2 or carboplatin AUC 5mg/ml/min Q3W IV, followed by KEYTRUDA plus pemetrexed maintenance Q3 IV for up to 31 cycles. Or to 4 cycles of saline placebo plus pemetrexed 500mg/m2 and cisplatin 75mg/m2 or carboplatin AUC 5mg/ml/min Q3W IV followed by saline plus pemetrexed maintenance Q3 IV for up to 31 cycles. Randomisation was stratified according to PD-L1 tumour proportion score (<1% vs. ≥1%). The two primary endpoints were overall survival (time from randomisation to death from any cause) and progression-free survival (time from randomisation to disease progression, as assessed by BICR review, or death from any cause, whichever occurred first).2

Keytruda KN-189

KEYNOTE-024

KEYTRUDA vs. chemotherapy as first line therapy in NSCLC (TPS≥50%) (n = 305)3

Study Design

KEYNOTE-024 Lung Cancer

An open-label, multicentre, randomised, phase 3 trial comparing single-agent KEYTRUDA vs the investigator’s choice of platinum- containing chemotherapy in 305 patients with previously untreated, squamous or non-squamous metastatic NSCLC. All randomised patients had tumours with high PD-L1 expression based on a TPS ≥ 50%, as determined by the PD-L1 immunohistochemistry 22C3 pharmDx assay and without EGFR or ALK genomic tumour aberrations. Patients received KEYTRUDA 200mg Q3W (n=154) or platinum- containing chemotherapy for 4-6 cycles (n=151) until the specified number of cycles, disease progression or unacceptable toxicity. Tumour status was assessed every 9 weeks. The primary endpoint was progression-free survival defined as disease progression or death from any cause.3

Keytruda KN-024

KEYNOTE-010

KEYTRUDA vs. chemotherapy as second line therapy in NSCLC (TPS >= 1%) (n=1,033)4

Study Design

KEYNOTE-010 Lung Cancer

An open-label, multicentre, randomised, phase 3 trial of single-agent KEYTRUDA vs docetaxel in 1,033 patients with squamous or nonsquamous mNSCLC. The trial included patients whose tumours were PD-L1 positive based on a TPS ≥1%, as determined by the PD-L1 immunohistochemistry 22C3 pharmDx assay. Patients also had disease progression following platinum-containing chemotherapy and, if appropriate, targeted therapy for EGFR or ALK genomic tumour aberrations. Patients received KEYTRUDA 2mg/kg (n=344) or 10mg/kg* (n=346) or docetaxel 75mg/m2 (n=343) Q3W until unacceptable toxicity or disease progression. Tumour status was assessed every 9 weeks. Co-primary endpoints were OS and PFS, as assessed by BICR review using RECIST 1.1.4

Keytruda KN-010

Urothelial Cancer

KEYNOTE-045

KEYTRUDA as second line therapy in urothelial carcinoma (n = 542)5

Study Design

KEYNOTE-045 Urothelial Cancer

An open-label, multicentre, randomised, phase 3 trial in 542 patients, KEYTRUDA was associated with superior survival versus investigator’s choice of chemotherapy with paclitaxel, docetaxel or vinflunine with advanced urothelial carcinoma who had recurred or progressed after platinumbased chemotherapy. Clinically stable patients with initial evidence of PD were permitted to remain on treatment until PD was confirmed. Co-primary endpoints were OS and PFS, as assessed by blinded independent central review per RECIST v1.1 criteria at 9 weeks after randomisation, then every 6 weeks through the first year of treatment, followed by every 12 weeks thereafter. Secondary endpoints included ORR, DOR and safety.5

  • Demonstrates OS benefit in second line setting vs. chemotherapy (HR= 0.73 (95% CI, 0.59 - 0.91) [p = 0.002])

KEYNOTE-052

KEYTRUDA as first line therapy in urothelial carcinoma (n = 370)6

Study Design

KEYNOTE-052 Urothelial Cancer

A single-arm, multicentre, randomised, phase 2 trial in 370 patients, KEYTRUDA 200mg every 3 weeks elicited antitumour activity in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. Primary efficacy endpoint was ORR in patients with PD-L1 expressing tumours, as assessed by blinded independent central review per RECIST v1.1 criteria at 9 weeks after randomisation, then every 6 weeks through the first year of treatment, followed by every 12 weeks thereafter. Secondary endpoints included ORR, DOR and safety.6

  • 58% of patients experienced a decrease in target lesions
  • ORR of 24% in all patients

Hodgkin Lymphoma

KEYNOTE-087

KEYTRUDA in patients with refractory classic Hodgkin Lymphoma or those who have relapsed after ≥3 prior lines of therapy (n=210)7

Study Design

KEYNOTE-087 Hodgkin Lymphoma (cHL)

A multicentre, open-label, non randomised study of single agent KEYTRUDA, investigated in 210 patients, regardless of PD-L1 expression, with refractory cHL or who relapsed after 3 or more prior lines of therapy. Patients with active, noninfectious pneumonitis, an allogeneic hematopoietic SCT within the past 5 years (or greater than 5 years, but with graft-versus-host disease), active autoimmune disease, or a medical condition that required immunosuppression were ineligible. Patients received KEYTRUDA 200mg every 3 weeks until unacceptable toxicity or documented disease progression. Response was assessed using the revised lymphoma criteria by positron emission tomography/computed tomography scans, with the first planned post-baseline assessment at week 12. The major efficacy outcome measures were ORR, CRR, and DOR, assessed by blinded independent central review according to the 2007 revised International Working Group criteria.7

  • ORR was 69% (95% CI, 62.3 - 75.2) with 22% of patients achieving CR and 47% patients achieving PR
  • Across all cohorts, >90% of patients experienced a decrease in tumour burden
  • At 6 months, the OS rate was 99.5%, and the PFS rate was 72.4%. Median OS was not reached. 31 patients had a response ≥ 6 months

CI, confidence interval; HR, hazard ratio; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PC, platinum chemotherapy; PD-L1, programmed death-ligand 1; PFS, progression-free survival; TPS, tumour proportion score; PR, partial response; CR, complete response

References: 1. KEYNOTE 21G: Langer CJ, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non‑small‑cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016;17(11):1497–1508. 2. KEYNOTE 189: Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018; doi: 10.1056/NEJMoa1801005. [Epub ahead of print] 3. KEYNOTE 24: Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1–positive non–small-cell lung cancer. N Engl J Med. 2016;375(19):1823–1833. 4. KEYNOTE 10: Herbst RS, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non small-cell lung cancer; a randomised controlled trial. Lancet. 016;387(10027):1540–1550. 5. KEYNOTE 045: Bellmunt J, de Wit R, Vaughn DJ, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med.2017;376(11):1015–1026. 6. KEYNOTE 052: Balar AV et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer, a multicentre, single-arm, phase 2 study. Lancet Oncology September 2017; published online http://dx.doi.org/10.1016/S1470-2045(17)30616-2. Last accessed 1st October 2017. 7. KEYNOTE 087: Chen R, Zinzani PL, Fanale MA, et al. Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma. J Clin Oncol. 2017;35(19):2125-2132.











ONCO-1230760-0048


Online enrolment and ordering for the Patient Programme
is under development.
To register a patient or request resupply please contact dpoc.nz@merck.com

KEYTRUDA (pembrolizumab) 50mg powder for infusion

Before prescribing KEYTRUDA, read the data sheet for information on dosage, contraindications, precautions, interactions and adverse effects available at www.medsafe.govt.nz or on request from Merck Sharp & Dohme (New Zealand) Limited. Prescription Only Medicine Indication: As monotherapy for the treatment of unresectable or metastatic melanoma in adults. In combination with pemetrexed and platinum chemotherapy for first-line treatment of metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations. As monotherapy for first-line treatment of patients with metastatic NSCLC whose tumours express PD-L1 ≥50% tumour proportion score (TPS) on a validated test, with no EGFR or ALK genomic tumour aberrations. As monotherapy for the treatment of patients with advanced NSCLC with a PD-L1 TPS level ≥1% and who have received platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving KEYTRUDA. As monotherapy for refractory/ relapsed classical Hodgkin Lymphoma (cHL). As monotherapy for patients with locally advanced/ metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, or who have received platinum-containing chemotherapy. See full data sheet. Contraindications: None. Precautions: Immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, nephritis, hypophysitis, type 1 diabetes mellitus, hyperthyroidism, hypothyroidism, thyroiditis, uveitis, myositis, Guillain-Barre syndrome, pancreatitis, encephalitis, sarcoidosis, myasthenic syndrome, severe skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis), and severe infusion reactions including hypersensitivity and anaphylaxis. Severe and fatal cases of immune-mediated adverse reactions have occurred. Increased mortality when in combination with dexamethasone and a thalidomide analogue in multiple myeloma (not indicated). Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. For management of immune-mediated adverse events, see full data sheet. Limited information in patients with active infection and patients with on-going adverse reaction to ipilimumab – use caution. Acute graft-versus-host-disease (potentially fatal) in patients with history of allogeneic HSCT. Post-marketing: solid organ transplant rejection and myocarditis. See full data sheet for further information. Interactions: None expected. Avoid corticosteroids or immunosuppressants prior to treatment. Side effects: Clinical trials (treatment-related only): nasopharyngitis, anaemia, neutropenia, hypothyroidism, decreased appetite, dizziness, headache, cough, dyspnea, abdominal pain, constipation, diarrhea, nausea, vomiting, erythema, pruritus, rash, vitiligo, arthralgia, back pain, myalgia, pain in extremity, asthenia, chills, fatigue, oedema peripheral, pyrexia, colitis, hepatitis, hyperthyroidism, hypophysitis, nephritis, pneumonitis, type 1 diabetes mellitus, adrenal insufficiency, autoimmune hepatitis, alopecia, upper respiratory tract infection. Dosage and administration: The recommended dose of KEYTRUDA is 200 mg for previously untreated NSCLC, cHL, and urothelial carcinoma, and 2 mg/kg or 200 mg for melanoma or previously treated NSCLC (administered as an intravenous infusion over 30 minutes every 3 weeks). KEYTRUDA should be administered first when given in combination with pemetrexed and platinum chemotherapy. Treat with KEYTRUDA until disease progression or unacceptable toxicity. Atypical responses (i.e. an initial transient increase in tumour size or small new lesions followed by shrinkage) have been observed. Clinically stable patients (i.e. asymptomatic and not requiring urgent intervention) with initial evidence of progression can remain on treatment until confirmed. See full data sheet for further information, including details on PD-L1 testing. KEYTRUDA is a funded medicine for melanoma patients– restrictions apply. KEYTRUDA is a private purchase medicine for NSCLC, cHL and urothelial carcinoma patients. Based on data sheet prepared 08 June 2018.

Copyright © 2018 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All rights reserved. Copyright © 2018 Merck Sharp & Dohme (New Zealand) Limited. Level 3, 123 Carlton Gore Road, Newmarket, Auckland. All rights reserved.
ONCO-1230760-0024 DA1827MW First Issued October 2015 Updated: August 2018
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