The U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab), an anti-PD-1 precision cancer medicine, in combination with Alimta® (pemetrexed) and carboplatin chemotherapy as first-line treatment of metastatic non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression.
Lung cancer remains the leading cause of cancer-related deaths worldwide. In the United States, NSCLC accounts for 75–80% of all lung cancers. Although progress has been made in recent years, the majority of patients with advanced stage lung cancer still die from their disease. New treatments are needed. Precision cancer medicines continues to impact the lives of lung cancer patients with research into genomics and genetics leading to unprecedented progress in improving outcomes. Tailored treatments have emerged to match a person’s genetic makeup or a tumor’s genetic profile. As a result, patients with lung cancer now typically receive molecular testing that guides their physicians in determining which therapies are more likely to boost the chances of survival while limiting the potential for adverse effects. Results from studies evaluating immunomodulatory approaches using anti-PD-1 and anti-PD-L1 antibodies have demonstrated promising results and are advancing the standard of care for lung cancer.
PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1, such as Keytruda may enhance the ability of the immune system to fight cancer. In earlier studies Keytruda has demonstrated anticancer activity in lung cancer and has been previously approved for the treatment of advanced melanoma.
Keytruda® is a monoclonal antibody that helps to restore the body’s immune system in fighting cancer. It creates its anti-cancer effects by blocking a specific protein used by cancer cells called PD-L1, to escape an attack by the immune system. Once PD-L1 is blocked, cells of the immune system are able to identify cancer cells as a threat, and initiate an attack to destroy the cancer. Keytruda is approved for the treatment of several types of cancer.
The approval was based on data from the Keynote-021 clinical trail evaluating 123 previously untreated patients with metastatic nonsquamous NSCLC with no EGFR or ALK genomic markers and irrespective of PD-L1 expression. In this trial, Keytruda + Alimta and carboplatin demonstrated an objective response rate of 55% which is nearly nearly double the 29% achieved with chemotherapy alone. The Keytruda regimen also delayed the time to cancer progression from 8.9 months to 13 months extending the overall cancer free survival.
These data suggests that combination of precision cancer immunotherapy with chemotherapy may become the new standard initial treatment for individuals with advanced NSCLC.