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Keytruda Approval Offers ‘Another Form of Insurance’ to Keep Lung Cancer From Returning

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An expert discussed the recent approval of Keytruda for non-small cell lung cancer, and what patients with the disease need to know about the newly approved regimen.

The Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for patients with stage 1B, 2 or 3A non-small cell lung cancer that has been previously treated with surgery and platinum-based chemotherapy, offering this patient population “another form of insurance that they can take to keep their cancer from coming back and spreading,” explained Dr. Roy S. Herbst.

“It's very exciting because we're making great progress in the treatment of lung cancer. We're taking our best drugs and moving them into the earlier setting of disease,” Herbst, professor of medicine and deputy director and chief of medical oncology at the Yale Cancer Center and Smilow Cancer Hospital, said in an interview with CURE®.

Herbst noted that even when early-stage lung cancer is removed and treated with chemotherapy, there is still a chance of it coming back, and that’s why post-surgical/post-chemotherapy therapies (called adjuvant treatments) are important.

“We know that even when you can surgically remove lung cancer, there's still a 50% or more chance the tumor will recur, and in some cases the percentage is even higher. Keytruda is trying to keep the lung cancer from coming back,” Herbst said. “Often when lung cancer recurs, it comes back in the liver, the brain, the bones or in the patient’s other lung.”

The addition of Keytruda in this setting led to a 27% improvement in disease control and disease-free survival, according to findings from KEYNOTE-091, the clinical trial that led to the drug’s approval in January 2023.

With new treatments such as Keytruda becoming available to patients with lung cancer, it is essential for patients and providers to discuss the different drugs that can be used to ensure the best possible outcome for every individual patient, Herbst emphasized.

“There should be a discussion of all of the options, and the risks and benefits, so every patient has a personalized treatment plan developed for them based on their specific diagnosis and prognosis. I think most patients want shared decision-making between the patient and their physician,” he said.

These patient-provider conversations should also include risk for side effects.

Keytruda is an immunotherapy agent that works by making cancer cells more easily identified by the immune system which, in turn, will active, then find and attack the cancer. With that can come inflammation and immune-related side effects that patients should be aware of, according to Herbst.

READ MORE: Immunotherapy Side Effects: ‘No Organ System Potentially Unaffected’

“When you reactivate the immune system, you're getting the immune system revved up, so that's going to kill the tumor. It can also go against normal tissues, like the lung, the colon and the thyroid, so you can develop inflammation. For the most part it's skin rash or fatigue and other manageable things,” Herbst said. I think the results of this trial show that it was tolerated in a way that it could be prescribed for long periods of time.”

Though Keytruda did improve outcomes of patients with stage 1B, 2 or 3A non-small cell lung cancer, longer follow-up is still needed — as is a cure for the disease, Herbst noted.

“We've come so far, but there's still a lot more to do,” he said. “Even with the options we have, what we want is long-term cure for patients with lung cancer and that's not consistently been shown yet. I think many patients will respond to immunotherapy, but many won’t, and we have to better understand sensitivity and resistance to these drugs, who will benefit, and how long to treat. We still have lot of work to do but thankfully patients are benefiting as we make progress each year.”


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