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About KEYTRUDA® (pembrolizumab) in Melanoma

Updated on 27/06/2019

ONCOLOGY

KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection.

The recommended dose of KEYTRUDA is either 200 mg every 3 weeks or 400 mg every 6 weeks administered intravenously over 30 minutes.1

Advanced melanoma – Patients should be treated with KEYTRUDA until disease progression or unacceptable toxicity.

Adjuvant melanoma – KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration up to one year.

Adjuvant treatment

Front page of KEYNOTE-054 Slide Deck

Click to access and download your KEYNOTE-054 adjuvant melanoma slide deck

Prescribing Information
43% reduction in the risk of recurrence or death in patients with adjuvant melanoma treated with KEYTRUDA vs. standard of care (HR = 0.57 (0.43-0.74), P<0.001)^3

This benefit was consistent across all subgroups including stage of disease, BRAF mutation status and PD-L1 expression; and was achieved with a generally manageable safety profile, consistent with previous melanoma studies.3

Kaplan–Meier estimate of RFS in the overall intention-to-treat population3

Kaplan–Meier estimate of RFS in the overall intention-to-treat population Kaplan–Meier estimate of RFS in the overall intention-to-treat population

Adapted from Eggermont, et al. 2018

KEYNOTE-054: Randomised, controlled Phase 3 trial in Stage III melanoma

KEYNOTE-054: Randomised, controlled Phase 3 trial in Stage III melanoma KEYNOTE-054: Randomised, controlled Phase 3 trial in Stage III melanoma

Adapted from Eggermont, et al. 2018

Trial efficacy endpoints:3

  • Primary efficacy endpoints: Recurrence-free survival in overall intention-to-treat population and PD-L1+ subgroup*
  • Secondary efficacy endpoints: Distant-metastasis-free survival, overall survival, health-related QoL and safety

*A score of 2 or higher (i.e. staining on >1% of cells) was considered to indicate PD-L1 positivity.3

Subgroup analysis by PD-L1 status, BRAF status and stage
Safety and adverse events

Metastatic treatment

Keynote Banner Keynote Banner

41% of treatment-naïve advanced melanoma patients (n=151) and 34% of the entire cohort (n=655) survived for an estimated 5 years with KEYTRUDA in the KEYNOTE-001 trials, after a median follow-up duration of 55 months.5

Kaplan-Meier estimate of overall survival in KEYNOTE-001*5

Kaplan-Meier estimate of overall survival in KEYNOTE-001*5 Kaplan-Meier estimate of overall survival in KEYNOTE-001*5

Adapted from Hamid, et al. 20185
*Derived by the product limit (Kaplan-Meier) method of censored data. OS and PFS were secondary endpoints.5

Objective Response Rate was the Primary Endpoint in the KEYNOTE-001 trial.

Secondary Endpoints were: OS, PFS, Duration of Response, and Safety.

  • 41% of treatment-naïve and 34% of all patients survived for an estimated 5 years on KEYTRUDA
  • 25% (38) of treatment-naïve patients and 16% (104) of all patients achieved a complete response, per irRC by investigator review
  • 52% of treatment-naïve patients and 41% of all patients responded to treatment after 55 months of follow-up
  • 82% of treatment-naïve patients and 73% of all patients who responded maintained that response after 55 months of follow-up

KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. The recommended dose of KEYTRUDA is either 200 mg every 3 weeks or 400 mg every 6 weeks administered intravenously over 30 minutes. The SPC recommends treatment with KEYTRUDA in advanced melanoma until disease progression or unacceptable toxicity develops.1

KEYNOTE-001 study design6
KEYNOTE-001: Safety and adverse events
KEYNOTE-006 study design7,8
KEYNOTE-006: Safety and adverse events
KEYTRUDA: Efficacy and safety across different doses in adults with advanced melanoma11,12

References

  1. KEYTRUDA Summary of Product Characteristics.
  2. NICE. Pembrolizumab for adjuvant treatment of resected melanoma with high risk of recurrence [ID1266]. November 2018. Available from: https://www.nice.org.uk/guidance/gid-ta10247/documents/final-appraisal-determination-document.
  3. Eggermont, et al. NEJM 2018; DOI:10.1056/NEJMoa1802357.
  4. Eggermont A, et al. Presented at the American Association for Cancer Research Annual Meeting; April, 2018; Chicago, Illinois.
  5. Hamid O, et al. Presented at the American Society of Clinical Oncology Congress; June 2018, Chicago, IL.
  6. Ribas A, et al. JAMA 2016; 315 (15): 1600-1609.
  7. Long GV, et al. Presented at the American Society of Clinical Oncology Congress; June 2018, Chicago, IL.
  8. Robert C, et al. NEJM 2015;372(26):2521-2532.
  9. Robert C, et al. Presented at the American Society of Clinical Oncology Congress; June 2017,
    Chicago, Illinois.
  10. Schachter J, et al. Presented at the American Society of Clinical Oncology Congress; June 2016,
    Chicago, IL.
  11. Data on File: Job code Onco-1151601-0000 Date of preparation: May 2015.
  12. Data on File: Job code Onco-1151605-0000 Date of preparation: May 2015.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-OOC-00172 | Date of Preparation: June 2019