KEYTRUDA in NSCLC

Discover the potential of KEYTRUDA® (pembrolizumab) in both early-stage and metastatic NSCLC1

Prescribing Information [External link]

Explore how KEYTRUDA could benefit your eligible NSCLC patients by clicking on the treatment algorithm below. Click the KEYNOTE buttons on each treatment regimen to discover data from each trial.

*PD-L1 expression based on TPS.1

Early Stage NSCLC

Discover more about KEYTRUDA in early-stage NSCLC from the KEYNOTE-671 and KEYNOTE-091 trials

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Metastatic NSCLC

Discover more about KEYTRUDA in metastatic NSCLC from the KEYNOTE-024, KEYNOTE-189, KEYNOTE-407 and KEYNOTE-010 trials

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KEYTRUDA offers flexibility of dosing1

Administered as an IV infusion
Over 30 minutes
200 mg Q3W or 400 mg Q6W

Assessment of regimens

The 200 mg Q3W (once every 3 weeks) regimen has been assessed in phase 2 and 3 registration studies across a multitude of indications of KEYTRUDA. An exposure-response evaluation, using modelling and simulation, led to the approval of the 400 mg Q6W (once every 6 weeks) dosing for monotherapy and combination therapy.1

From a microbiological point of view, the product, once diluted, should be used immediately. The diluted solution must not be frozen. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 7 days at 2˚C to 8˚C, or 12 hours at room temperature, unless dilution has taken place in controlled and validated aseptic conditions. If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use.1

For stability related enquiries please contact medicalinformationuk@msd.com

NICE=National Institute For Health And Care Excellence.

Pembrolizumab is recommended, within its marketing authorisation, as an option for the adjuvant treatment of non-small-cell lung cancer (NSCLC) with a high risk of recurrence after complete resection and platinum-based chemotherapy in adults. Pembrolizumab is only recommended if the company provides it according to the commercial arrangement.2

Pembrolizumab is recommended, within its marketing authorisation, as an option for neoadjuvant treatment with platinum-based chemotherapy, then continued alone as adjuvant treatment, for resectable non-small-cell lung cancer (NSCLC) with a high risk of recurrence in adults. Pembrolizumab is only recommended if the company provides it according to the commercial arrangement.3

Pembrolizumab is recommended as an option for untreated PD-L1-positive metastatic non-small-cell lung cancer (NSCLC) in adults whose tumours express PD-L1 (with at least a 50% tumour proportion score) and have no epidermal growth factor receptor- or anaplastic lymphoma kinase-positive mutations, only if pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier in the event of disease progression and the company provides pembrolizumab according to the commercial access agreement.4

Pembrolizumab is recommended as an option for treating locally advanced or metastatic PD-L1-positive non-small-cell lung cancer in adults who have had at least one chemotherapy (and targeted treatment if they have an epidermal growth factor receptor [EGFR]- or anaplastic lymphoma kinase [ALK]-positive tumour), only if pembrolizumab is stopped at 2 years of uninterrupted treatment and no documented disease progression, and the company provides pembrolizumab in line with the commercial access agreement with NHS England.5

Pembrolizumab, with pemetrexed and platinum chemotherapy, is recommended 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, only if pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier if the disease progresses, and the company provides pembrolizumab according to the commercial arrangement.6

Pembrolizumab with carboplatin and paclitaxel is recommended as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, if their tumours express PD-L1 with a tumour proportion score less than 50%, their tumours express PD-L1 with a tumour proportion score of 50% or more and they need urgent clinical intervention, and it is stopped at 2 years of uninterrupted treatment or earlier if their disease progresses.7

SMC=Scottish Medicines Consortium.

Pembrolizumab is not recommended for use within NHS Scotland in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung carcinoma at high risk of recurrence in adults.8

Pembrolizumab is accepted for restricted use within NHS Scotland as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy. SMC restriction: adults whose tumours express programmed death-ligand 1 (PD-L1) with less than 50% (0 to 49%) tumour proportion score (TPS).9

Pembrolizumab is accepted for restricted use within NHS Scotland as monotherapy for the first‑line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) with a ≥50% tumour proportion score (TPS) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.10

Pembrolizumab is accepted for restricted use within NHS Scotland for the treatment of locally advanced or metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express programmed death ligand 1 (PD-L1) and who have received at least one prior chemotherapy regimen. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.11

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. SMC restriction: in patients 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. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.12

Pembrolizumab is accepted for restricted use within NHS Scotland in combination with carboplatin and paclitaxel, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults. SMC restriction: in combination with carboplatin and paclitaxel in patients 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. Treatment with pembrolizumab is subject to a two-year clinical stopping rule.13

KEYTRUDA early-stage and advanced NSCLC indications:1


KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with NSCLC who are at high risk of recurrence following complete resection and platinum-based chemotherapy

KEYTRUDA, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of resectable NSCLC at high risk of recurrence in adults

KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic NSCLC in adults whose tumours express PD-L1 with a ≥50% TPS with no EGFR– or ALK-positive tumour mutations

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

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

KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR– or ALK-positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA

Please consult the Summary of Product Characteristics for further information to minimise the risks associated with the use of KEYTRUDA before making prescribing decisions.

Explore our related resources to learn more about KEYTRUDA in NSCLC

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Abbreviations

ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; IV, intravenous; NICE, National Institute for Health and Care Excellence; NSCLC, non-small cell lung cancer PD-L1, programmed death-ligand 1; Q3W, every 3 weeks; Q6W, every 6 weeks; SMC, Scottish Medicines Consortium; SmPC, Summary of Product Characteristics.

References

  1. KEYTRUDA® (pembrolizumab) Summary of Product Characteristics. United Kingdom. Available at: https://www.medicines.org.uk/emc/product/2498/smpc Accessed: October 2025.
  2. National Institute for Health and Care Excellence. TA1037: Pembrolizumab for adjuvant treatment of resected non-small-cell lung cancer. Available at: https://www.nice.org.uk/guidance/ta1037. Accessed: October 2025. 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.
  3. National Institute for Health and Care Excellence. TA1017: Pembrolizumab with chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) for treating resectable non-small-cell lung cancer. Available at: https://www.nice.org.uk/guidance/ta1017. Accessed: October 2025. 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.
  4. National Institute for Health and Care Excellence. TA531: Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer. Available at: https://www.nice.org.uk/guidance/ta531. Accessed: October 2025. 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.
  5. National Institute for Health and Care Excellence. TA428: Pembrolizumab for treating PD-L1 positive non-small-cell lung cancer after chemotherapy. Available at: https://www.nice.org.uk/guidance/TA428. Accessed: October 2025. 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.
  6. National Institute for Health and Care Excellence. Final appraisal determination: Pembrolizumab with pemetrexed and platinum-based chemotherapy for untreated non-small-cell lung cancer (CDF Review of TA557) [ID1584]. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10529. Accessed: October 2025. 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 which it is taken.
  7. National Institute for Health and Care Excellence. Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer. Available at: https://www.nice.org.uk/guidance/ta770. Accessed: October 2025. 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.
  8. Scottish Medicines Consortium. Pembrolizumab in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung carcinoma at high risk of recurrence in adults. Available at: https://scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2688/. Accessed: October 2025.
  9. Scottish Medicines Consortium. Pembrolizumab as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy. Available at: https://scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2689/. Accessed: October 2025.
  10. Scottish Medicines Consortium. Pembrolizumab for untreated PD-L1 positive metastatic non-small-cell lung cancer. Available at: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-fullsubmission-123917/. Accessed: October 2025.
  11. Scottish Medicines Consortium. Appraisal determination: Pembrolizumab 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available at: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-fullsubmission-120417/. Accessed: October 2025.
  12. Scottish Medicines Consortium. Appraisal determination: Pembrolizumab 25mg/mL concentrate for solution for infusion and 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available at: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-resub-smc2207/. Accessed: October 2025.
  13. Scottish Medicines Consortium. Appraisal determination: Pembrolizumab 25mg/mL concentrate for solution for infusion and 50mg powder for concentrate for solution for infusion (KEYTRUDA®). Available at: https://www.scottishmedicines.org.uk/medicines-advice/pembrolizumab-keytruda-full-smc2187/. Accessed: October 2025.

Supporting documentation:

Prescribing Information (United Kingdom) [External link]
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GB-PDO-03612 | Date of Preparation: October 2025