The Food and Drug Administration (FDA) has expanded approval for an immunotherapy drug called Keytruda. The drug is now approved as the first course of treatment for squamous cell non-small cell lung cancer (NSCLC) that has spread into the body, when combined with chemotherapy.
Immunotherapy drugs, which harvest the body’s own immune system to fight off cancer, have changed the game when it comes to treating several cancers. And the developments in lung cancer treatment in the past year alone have been really amazing. The new Keytruda-chemo combo approval was based on findings from a trial, which showed an improved overall survival rate in people with NSCLC who were treated with the combination compared to people who were treated with just chemotherapy (15.9 months vs. 11.3 months). The Keytruda-chemo combo also increased the average person’s survival without progression of the disease from 4.8 months with chemo alone to 6.4 months. The sheer amount of benefit, or life extension may not be enormous, but immunotherapy is continuing to show increased impact.
Investigator Dr. Balazs Halmos, of the Montefiore Einstein Center for Cancer Care, said that the approval demonstrates the potential Keytruda has when combined with chemotherapy. “With this important approval, more patients will have the opportunity to benefit from immunotherapy,” he said.
It’s also important to keep in mind that while immunotherapy is an exciting area of development in cancer research, it doesn’t work for everyone – and these drugs can come with hefty price tags and major side effects. Keytruda costs about $150,000 and is made by the pharmaceutical company Merck.
Squamous cell lung cancers are found in the central part of the lung that is linked to smoking, and make up about 25% to 30% of all lung cancers. The newly approved Keytruda-chemo combo has the potential to help tens of thousands of Americans with lung cancer – but results are nowhere near guaranteed. “Lung cancer is not one disease, it’s not the same in everybody,” said thoracic oncologist Dr. Leena Ghandi during a discussion about immunotherapy in general. “Cancer drugs work differently in individuals, and every individual’s cancer is different, by definition.”
Unfortunately, many people still don’t respond to immunotherapy. “The ways cancer generally escapes the body’s immune system is by protecting itself by producing certain proteins,” said Dr. Vamsidhar Velcheti, the Director of Thoracic Oncology at NYU Perlmutter Cancer Center. “PD-L1 is one of those proteins that actually helps protect cancer from the body’s immune system. For patients that have high levels of PD-L1, you could potentially use a single-agent immunotherapy with good outcomes. The problem is that these proteins are constantly influx.”
The key takeaway from the new FDA approval, is that now more people will have the opportunity to have these good outcomes from immunotherapy. The improved overall survival and progression-free survival rates aren’t huge, but every little bit helps.