Early-stage NSCLC

KEYTRUDA® (pembrolizumab) for early-stage NSCLC

Prescribing Information [External link]

A key to more possibilities for treating your appropriate patients with early-stage NSCLC, regardless of PD-L1 expression^1–4

Learn more about how KEYTRUDA can benefit your patients with early-stage NSCLC from the KEYNOTE trial data:

KEYNOTE-671³

Neoadjuvant KEYTRUDA + chemotherapy, followed by adjuvant KEYTRUDA monotherapy

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KEYNOTE-091⁴

Adjuvant KEYTRUDA monotherapy following surgical resection and chemotherapy

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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

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.

Abbreviations

ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; IV, intravenous; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; Q3W, every 3 weeks; Q6W, every 6 weeks; TPS, tumour proportion score.

References

1. KEYTRUDA Summary of Product Characteristics. MSD.
   Available at: https://www.medicines.org.uk/emc/product/2498/smpc Accessed: September 2025.
2. Spicer J, et al. Lancet 2024;404:1240–1252 (including supplementary appendix).
3. Wakelee H, et al. N Engl J Med 2023;389:491–503.
4. O’Brien M, et al. Lancet Oncol 2022;23:1274–1286.

Supporting documentation

Prescribing Information(United Kingdom) [External link]
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