KEYTRUDA® has 5 indications in NSCLC, and an efficacy and safety profile demonstrated by 6 pivotal trials encompassing a total of 4,797 patients. Learn more about when to consider KEYTRUDA® for your NSCLC patients, either as monotherapy or in combination with chemotherapy.
KEYTRUDA® is indicated for:
- First-line treatment, as monotherapy, of adult patients with metastatic non-small cell lung carcinoma (NSCLC) or stage III disease where patients are not candidates for surgical resection or definitive chemoradiation, expressing PD-L1 [Tumour Proportion Score (TPS) ≥1%] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations.
- Treatment of adult patients with metastatic non-squamous NSCLC in combination with pemetrexed and platinum chemotherapy, with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.
- Treatment of adult patients with metastatic squamous NSCLC in combination with carboplatin and either paclitaxel or nab-paclitaxel, with no prior systemic chemotherapy treatment for metastatic NSCLC.
- Treatment of adult patients with metastatic NSCLC as monotherapy, whose tumours express PD-L1 [Tumour Proportion Score (TPS) ≥1%] as determined by a validated test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received authorized therapy for these aberrations prior to receiving KEYTRUDA®.
- Adjuvant treatment of adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.
ASCO and OH (CCO) joint guideline recommendations2
Stage IV NSCLC without driver alterations in EGFR or ALK
Non-SCC patients
- For patients with high PD-L1 expression (TPS ≥50%) and PS 0 to 1, clinicians may offer pembrolizumab/carboplatin/pemetrexed
- For patients with negative (0%) or low positive PD-L1 expression (TPS 1% to 49%) and PS 0 to 1, and who are eligible for chemotherapy and pembrolizumab, clinicians should offer pembrolizumab/carboplatin/pemetrexed
SCC patients
- For patients with high PD-L1 expression (TPS ≥50%) and PS 0 to 1, clinicians may offer pembrolizumab/carboplatin/paclitaxel or nab-paclitaxel
- For patients with negative (0%) or low positive PD-L1 expression (TPS 1% to 49%) and PS 0 to 1, clinicians should offer pembrolizumab/carboplatin/paclitaxel or nab-paclitaxel
Biomarker testing
- KEYTRUDA® in monotherapy requires PD-L1 biomarker testing for adult patients with metastatic non-small cell lung carcinoma (NSCLC) or stage III disease or unresectable when they are not candidates for surgical resection or definitive chemoradiation expressing with no EGFR or ALK genomic tumor aberrations.
- KEYTRUDA® in monotherapy requires PD-L1 biomarker testing for adult patients with metastatic NSCLC and who have disease progression on or after platinum-containing chemotherapy.
- Learn more about PD-L1 expression testing for your patients and KEYTRUDA® eligibility
ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; SCC=squamous cell caricinoma
References:
1. Merck Canada Inc. KEYTRUDA® Product Monograph. April 19, 2023.
2. ASCO and OH (CCO) Joint Guideline Update. Available at: https://www.cancercareontario.ca/en/guidelines-advice/types-of-cancer/62681
3. Hanna, N et al. (2020). Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations: ASCO and OH (CCO) Joint Guideline Update. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 38(14), 1608–1632. https://doi.org/10.1200/JCO.19.03022
4. Rastogi M, et al. (2016). An unusual response with long term survival using erlotinib in NSCLC lung with brain metastases. BMJ Case Rep. bcr2015213239. https://doi.org/10.1136/bcr-2015-213239
5. Medline. Available at: https://medlineplus.gov/ency/imagepages/1183.htm
6. Dromain C, Beigelman C, Pozzessere C, Duran R, Digklia A. Imaging of tumour response to immunotherapy. Eur Radiol Exp. 2020 Jan 3;4(1):2.
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