Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that Wild type ALK, Wild type EGFR status confers therapeutic sensitivity to Carboplatin, Gemcitabine, Pembrolizumab 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.