Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that Wild type ALK and Wild type EGFR status confers therapeutic sensitivity to Carboplatin, Pembrolizumab, Pemetrexed in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of metastatic non-small cell lung carcinoma in adult patients whose tumors have no EGFR or ALK positive mutations. This indication is based on results from KEYNOTE-024, where patients received pembrolizumab in combination with investigator's choice of platinum-containing chemotherapy, including: pemetrexed with carboplatin, pemetrexed with cisplatin, gemcitabine and cisplatin, gemcitabine and carboplatin, or paclitaxel and carboplatin.

This statement is based on a regulatory approval from the European Medicines Agency:

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

Citation

Merck Sharp & Dohme B.V. Keytruda (pembrolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Revised January 2024. Accessed March 10, 2024.