Merck & Co confirmed that its cancer drug Keytruda has successfully met the second of its two primary targets in a phase III clinical trial, showing significant improvement as a treatment administered before and after surgery for certain patients with non-small cell lung cancer (NSCLC).
Researchers found that when Keytruda was used alongside chemotherapy before surgery and then administered alone post-surgery, it led to a statistically significant and clinically meaningful enhancement in overall survival rates for patients with resectable stage II, IIIA, or IIIB NSCLC.
This announcement comes after Merck reported in March that the study had also met its other 'endpoint', which focused on improvement in event-free survival rates.
The Food and Drug Administration (FDA) is currently reviewing an application from Merck for expanded approval of Keytruda for this new indication. The agency has set a target action date of October 16 for its decision.
Keytruda, also known by its generic name pembrolizumab, is an immunotherapy drug that has garnered attention for its role in cancer treatment. It belongs to a class of medications known as programmed death receptor-1 (PD-1) inhibitors.
These inhibitors work by blocking the PD-1 pathway, a mechanism that tumour cells often exploit to suppress the body's immune response.