Keytruda Trail Results Suggest Change in Management of Squamous Non-Small Cell Lung Cancer

An interim analysis of the phase III KEYNOTE-407 trial evaluated combined chemotherapy and immunotherapy showed a more than four-month longer median overall survival for metastatic squamous non–small-cell lung cancer (NSCLC) patients who received keytruda (pembrolizumab) plus traditional chemotherapy compared with those who received placebo plus chemotherapy.

About Lung Cancer

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 immune-modulatory approaches using anti-PD-1 and anti-PD-L1 antibodies have demonstrated promising results and are advancing the standard of care for lung cancer.

About Keytruda Checkpoint Inhibitors

Keytruda belongs to a new class of medicines called “checkpoint inhibitors.”  Checkpoint inhibitors are a novel precision cancer immunotherapy that helps to restore the body’s immune system in fighting cancer by releasing checkpoints that cancer uses to shut down the immune system. PD-1 and PD-L1 are proteins that inhibit certain types of immune responses, allowing cancer cells to evade detection and attack by certain immune cells in the body. A checkpoint inhibitor can block the PD-1 and PD-L1 pathway and enhance the ability of the immune system to fight cancer. By blocking the binding of the PD-L1 ligand these drugs restore an immune cells’ ability to recognize and fight the colon cancer cells.  A diagnostic test to measure the level of PD-L1 is available.

For the KEYNOTE-407 clinical trial a total of 559 patients with untreated metastatic squamous NSCLC were enrolled and treated with either keytruda plus chemotherapy or chemotherapy alone and directly compared. At the time of interim analysis, 204 participants were available for analyses and the average duration of survival was improved to 15.9 months for the Keytruda treated patients compared to  only 11.3 months for chemotherapy alone.

Learn More About Advances in the Management of Lung Cancer

These data suggest that keytruda plus chemotherapy should become a new standard of care for the first-line treatment of metastatic squamous NSCLC across all the different levels of PDL1 expression, said study investigator, Luis Paz-Ares, MD, PhD, professor of medicine at the Hospital Universitario 12 de Octubre.

“Not only was there a PFS benefit, but there was a significant overall survival benefit with a hazard ratio of .6. There is no doubt in my mind that this benefits patients and that we need to adopt this starting today, if available,” said Dr. Aggarwal.


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