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KEYTRUDA® (pembrolizumab) plus chemotherapy presents survival opportunity for more patients with metastatic non-small cell lung cancer1,3

Prescribing Information

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KEYTRUDA plus chemotherapy in non-squamous patients

KEYTRUDA plus chemotherapy (pemetrexed and platinum) provides superior survival vs. plat-pem* for the first-line treatment of metastatic non-squamous NSCLC in adults with no EGFR/ALK positive mutations:1

  • Superior OS with a 51% reduction in the risk of death (HR 0.49, p<0.001)
  • Superior PFS with a 48% reduction in the risk of progression or death (HR 0.52, p<0.001)
  • Survival benefit observed in each of the PD-L1 subgroups including the <1% and 1-49% expressers
  • Superior ORR (47.6% vs 18.9%, p<0.001) and improved DOR
  • A generally manageable tolerability profile. The frequency of adverse events for the combination was observed to be higher than for each agent alone, reflecting the contributions of each agent.1,2

Exploratory endpoints - no statistical conclusions can be drawn from them.

*KEYTRUDA + plat-pem n=410, plat-pem n=210
KEYNOTE-189 Clinical Trial
Randomised, controlled phase 3 trial (n=616); Primary endpoints: OS and PFS; Median follow-up 10.5 months

What the KEYNOTE-189 clinical trial showed

Prescribing Information

Prof. Gary Middleton summarises the KEYNOTE-189 trial design
Recorded on 4 June 2018
Length: 04:42

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KEYTRUDA plus chemotherapy in squamous patients

KEYTRUDA + carb-pac/nabpac provides superior survival vs. plat-pac/nabpac** for the first-line treatment of metastatic squamous NSCLC in adults:3

  • Superior OS with a 36% reduction in the risk of death (HR 0.64, p<0.001)< /li>
  • Superior PFS with a 44% reduction in the risk of progression or death (HR 0.56, p<0.001)< /li>
  • The overall survival benefit was consistent regardless of the level of PD-L1 expression
  • Superior ORR (57.9% vs 38.4%) and improved DOR
  • A generally manageable tolerability profile that is comparable to carb-pac/nabpac.3

Exploratory endpoints - no statistical conclusions can be drawn from them.

**KEYTRUDA + carb-pac/nabpac = 278, carb-pac/nabpac n=281
KEYNOTE-407 Clinical Trial
Randomised, controlled phase 3 trial (n=559); Primary endpoints: OS and PFS

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Managing your metastatic non-small cell lung cancer patients with KEYTRUDA plus chemotherapy

NICE guidance

Pembrolizumab, with pemetrexed and platinum chemotherapy is recommended for use within the Cancer Drugs Fund, as an option for untreated, metastatic, non-squamous non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)- positive mutations. Read more.4

Pembrolizumab, with carboplatin and paclitaxel, is recommended for use within the Cancer Drugs Fund as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults. Read more.5

SMC guidance

Pembrolizumab is accepted for restricted use within NHS Scotland in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of metastatic non-squamous non-small-cell lung carcinoma (NSCLC) in adults whose tumours have no EGFR or ALK positive mutations and whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Read more.6

Pembrolizumab is accepted for restricted use within NHS Scotland in combination with carboplatin and either paclitaxel or nabpaclitaxel, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) with a <50% tumour proportion score (TPS), or in those whom it has not been possible to evaluate PD-L1 TPS. Read more.7

Licensed indication

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.2

KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.2

The recommended dose of KEYTRUDA as part of combination therapy is 200 mg Q3W administered intravenously over 30 minutes. KEYTRUDA should be administered first when given in combination with chemotherapy.2

Q3W: Every three weeks.

References

  1. Gandhi L, et al. N Engl J Med 2018: 378: 2078-2092.
  2. KEYTRUDA Summary of Product Characteristics.
  3. Paz-Ares L et al. N Engl J Med 2018; 379: 2040-2051
  4. National Institute for Health and Care Excellence (2018). Final appraisal determination: Pembrolizumab in combination with pemetrexed and platinum based chemotherapy for untreated metastatic non-squamous NSCLC. Available from: https://www.nice.org.uk/guidance/ta557. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the user of its content in this document to confirm that it accurately reflects the NICE publication from with it is taken.
  5. National Institute for Health and Care Excellence (2019). Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer. Available from: https://www.nice.org.uk/guidance/ta600. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the user of its content in this document to confirm that it accurately reflects the NICE publication from with it is taken.
  6. Scottish Medicines Consortium (2019). Appraisal determination: Pembrolizumab 25mg/mL concentrate for solution for infusion and 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-resub-smc2207/.
  7. Scottish Medicines Consortium (2019). Appraisal determination: Pembrolizumab 25mg/mL concentrate for solution for infusion and 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2187/.
  8. National Institute for Health and Care Excellence (2018). TA531: Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer. Manchester: NICE. Available from: https://www.nice.org.uk/guidance/ta531. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the use of its content in this document to confirm that it accurately reflects the NICE publication from which it is taken.
  9. National Institute for Health and Care Excellence (2017). TA428: Pembrolizumab for treating PD-L1 positive non-small-cell lung cancer after chemotherapy. Manchester: NICE. Available from: https://www.nice.org.uk/guidance/TA428. NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the use of its content in this document to confirm that it accurately reflects the NICE publication from which it is taken.
  10. Scottish Medicines Consortium (2017). Pembrolizumab for untreated PD-L1 positive metastatic non-small-cell lung cancer. Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-fullsubmission-123917/.
  11. Scottish Medicines Consortium (2017). Appraisal determination: Pembrolizumab 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available from: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-fullsubmission-120417/.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-PDO-01111 | Date of Preparation: July 2020