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KEYTRUDA® is MSD’s immunotherapy that reshaped the treatment landscape for mNSCLC, broadening therapeutic options for more eligible patients.1-3 With robust clinical trial data that is supported by real-world evidence,1,4-7 KEYTRUDA® may offer you and your eligible patients more possibilities in NSCLC therapy.1

The evolution of KEYTRUDA® in treating NSCLC

With KEYTRUDA®, MSD has aimed to better the lives of eligible patients with mNSCLC by extending OS and PFS compared with chemotherapy.1,8-11

Reshaping NSCLC treatment

The KEYTRUDA® journey started in 2011 with the beginning of the first phase I trial.12 By 2016, the benefits of our trials spoke for themselves, receiving accelerated FDA approval for first-line KEYTRUDA® monotherapy in eligible patients with mNSCLC.3,13

Since then, additional indications have been approved for patients with squamous and non-squamous mNSCLC.1

Today, KEYTRUDA® is recognised by ESMO as one of the standard first-line treatment options in both squamous and non-squamous mNSCLC, as either monotherapy or in combination with chemotherapy.14

Expanding treatment options with KEYTRUDA®

The immunotherapy that has been approved for mNSCLC is also an option for certain patients with earlier stages of NSCLC.15,16

The recent expansion of indications means that KEYTRUDA® may offer you a treatment option for a broader range of eligible patients:1

  • across advanced or earlier stages of NSCLC
  • across histologies (NSq/Sq)
  • as monotherapy or in combination with chemotherapy
  • with Q3W or Q6W dosing options

Making our patients our compass

MSD cares about helping people live better lives.

With approval for use in the metastatic setting in more than 90 countries, and an expansion to [6] FDA and [6] EMA approved indications for NSCLC, every KEYTRUDA® milestone achieved is a testament to our commitment to offering treatment possibilities for more people living with NSCLC.17,18

The legacy of KEYTRUDA® does not end here. With indications approved for earlier stages of NSCLC, MSD is paving the way for more treatment possibilities for more patients.1

Discover more about KEYTRUDA®

Placeholder: Approved SSI to be added and approved by each regional market.

EMA: European Medicines Agency; ESMO: European Society for Medical Oncology; FDA: Food & Drug Administration; ICI: immune checkpoint inhibitor; mNSCLC: metastatic non-small cell lung cancer; NSCLC: non-small cell lung cancer; NSq: non-squamous; OS: overall survival; PFS: progression-free survival; Q3W: every three weeks; Q6W: every six weeks; Sq: squamous.

EN: For Healthcare professionals only.
EN: Please consult the full prescribing information before prescribing or delivering the product.

  1. KEYTRUDA®. Summary of product characteristics.
  2. Doroshow DB, Sanmamed MF, Hastings K, et al. Immunotherapy in non-small cell lung cancer: facts and hopes. Clin Cancer Res. 2019;25(15):4592-602.
  3. Pai-Scherf L, Blumenthal GM, Li H, et al. FDA approval summary: pembrolizumab for treatment of metastatic non-small cell lung cancer: first-line therapy and beyond. Oncologist. 2017;22(11):1392-9.
  4. Cortellini A, Friedlaender A, Banna GL, et al. Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50. Cancer Immunol Immunother. 2020;69(11):2209-21.
  5. Knetki-Wróblewska M, Dziadziuszko R, Jankowski T, et al. Pembrolizumab-combination therapy for NSCLC- effectiveness and predictive factors in real-world practice. Front Oncol. 2024;14.
  6. Velcheti V, Chandwani S, Chen X, et al. Outcomes of first-line pembrolizumab monotherapy for PD-L1-positive (TPS ≥50%) metastatic NSCLC at US oncology practices. Immunotherapy. 2019b;11(18):1541-54.
  7. Velcheti V, Hu X, Yang L, et al. Long-term real-world outcomes of first-line pembrolizumab monotherapy for metastatic non-small cell lung cancer with ≥50% expression of programmed cell death-ligand 1. Front Oncol. 2022;12:834761.
  8. Gandhi L, Rodríguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Eng J Med. 2018;378(22):2078-92.
  9. Mok TSK, Wu YL, Kudaba I, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019;393(10183):1819-30.
  10. Paz-Ares L, Luft A, Vicente D, et al. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med. 2018;379(21):2040-51.
  11. 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):1823-33.
  12. ClinicalTrials.gov. Study of pembrolizumab (MK-3475) in participants with progressive locally advanced or metastatic carcinoma, melanoma, or non-small cell lung carcinoma (KEYNOTE-001). Available at: https://clinicaltrials.gov/study/NCT01295827. Accessed September 2024.
  13. Food & Drug Administration. BLA 125514/S-8. Supplement approval. Fullfillment of postmarketing requirement. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s008,125514Orig1s012ltr.pdf. Accessed September 2024.
  14. Hendriks LE, Kerr KM, Menis J, et al. Non-oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4):358-76.
  15. O’Brien M, Paz-Ares L, Marreaud S, et al. Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB–IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial. Lancet Oncol. 2022;23(10):1274-86.
  16. Wakelee H, Liberman M, Kato T, et al. Perioperative pembrolizumab for early-stage non–small-cell lung cancer. N Engl J Med. 2023;389(6):491-503.
  17. European Organisation for Research and Treatment of Cancer. FDA approves KEYTRUDA® (pembrolizumab) as adjuvant treatment following surgical resection and platinum-based chemotherapy for patients with stage IB (T2a ≥4 Centimeters), II, or IIIA non-small cell lung cancer (NSCLC). Available at: https://www.eortc.org/blog/2023/01/30/fda-approves-keytruda-non-small-cell-lung-cancer. Accessed September 2024.
  18. Food & Drug Administration. Keytruda®. Prescribing information U.S. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125514s147lbl.pdf. Accessed September 2024.