FDA’s Enhertu Approval is ‘Even More Important’ for a Group of Patients With Difficult to Treat Lung Cancer, Says Expert

An expert discusses what patients need to know about the recent FDA approval of Enhertu for HER2-mutant non-small cell lung cancer, an aggressive subtype of the disease.

The August 2022 Food and Drug Administration (FDA) approval of Enhertu (fam-trastuzumab-deruxtecan-nxki) for unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC) marks the first targeted option for patients with this difficult to treat subset of cancer, according to an expert.

“(This subset of lung cancer) is a little bit more aggressive, meaning that it grows faster, and also has an increased chance to metastasize, or spread from the lung to the brain, which can make it difficult to treat,” Andrew Ciupek, associate clinical director of clinical research at GO2 Foundation for Lung Cancer, said in an interview with CURE®. “This makes this new therapy even more important.”

Unlike more generalized regimens such as chemotherapy, targeted drugs like Enhertu are more specialized, attaching directly to the HER2 protein found on cancer cells. However, that does not mean that the treatment is without side effects that patients should be aware of.

Who Is Eligible for Enhertu?

Ciupek mentioned that about 2 to 4% of all patients with NSCLC will have a HER2 mutation. Since Enhertu targets that mutation specifically, patients must first determine if their disease harbors the mutation — or has any other biomarker that could make them eligible for one of the multiple targeted treatments that are now available in the NSCLC space.

READ MORE: Targeted Therapy Advances in Lung Cancer Space Over Past 2 Decades 'Simply Remarkable'

“The way we find this out is receiving what’s called comprehensive biomarker testing,” Ciupek said. “That means that doctors will take a biopsy of the tumor or a blood sample and run some tests to look for these mutations, or changes called biomarkers.”

Comprehensive biomarker testing is the best type of testing, according to Ciupek, because it allows clinicians to look for a wide array of biomarkers to help match patients with the best therapy for their individual cancer type.

“Knowing what biomarkers or mutations your tumor might have is a really important part of lung cancer treatment now, as we’ve had a lot of targeted therapy approvals in the past few years,” Ciupek said. “So if you aren’t sure if you’ve had comprehensive biomarker testing, then it’s probably a good idea to ask your doctor and find out.”

Palliative Care Can Help Ease Side Effects

In the clinical trial that led to Enhertu’s approval for HER2-mutant NSCLC, common side effects that were observed were nausea, decreased blood cell counts, fatigue, constipation, decreased appetite, vomiting and hair loss.

“It’s always a good thing to mention to your doctor new things that you are feeling after starting treatment,” Ciupek said.

However, a few patients also experienced lung inflammation.

“It's important to let your doctors know if you experience symptoms that might be associated with (lung inflammation,)” Ciupek said. “(Symptoms include) a worse-than-normal cough, a fever that you haven't had before, or you feel more shortness of breath than you usually feel.”

Ciupek mentioned that patients experiencing severe side effects can speak with their doctors about getting a referral to palliative care — a service where clinicians focus on alleviating side effects or the negative effects that cancer treatment can have on patients’ lives.

“They will really help focus specifically on improving quality of life, either during or after treatments,” Ciupek said. “They can help with a lot of these (side effects) too.”

Unmet Needs Remain in the Lung Cancer Space

While the availability of drugs like Enhertu can offer better options for patients who are eligible, there are still many genetic mutations and biomarkers that do not have targeted treatment options, Ciupek said.

“More research can help develop new therapies for patients with these mutations,” he said. “Also, there’s a need for additional targeted therapy options (to prescribe) if the existing targeted therapy available is no longer working for someone.”

From a health equality viewpoint, Ciupek said that certain patient populations still tend to be underrepresented in cancer clinical trials, and once drugs are approved, some patients are unable to access them, because of financial burdens or not living close enough to a treatment center that offers the latest therapies.

“I'd like to continue to see research that explores how to really make sure we're reaching all members to lung cancer community with our new treatment advances,” he said.

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