A New Oral Treatment Option For Patients With HER2+ Lung Cancer
- Sevabertinib was recently approved by the Food and Drug Administration (FDA) for people with HER2-positive (HER2+) non-small cell lung cancer whose disease has progressed after chemotherapy and/or immunotherapy.
- “This is not a super large population, but the impact should be incredible for the patients eligible for sevabertinib treatment,” Dr. Dominik Ruettinger, who leads oncology research and development at Bayer Pharmaceuticals, tells SurvivorNet.
- The drug’s approval is based on results from a clinical study called SOHO-1. In the study, about 70% of patients saw their tumors shrink or disappear, with many experiencing durable responses.
- The drug is taken orally, twice a day, and can be done from the comfort of a patient’s own home.
“This is a drug we call sevabertinib. It targets a certain type of lung cancer, non-small cell lung cancer, a subtype [with] tumors that carry an activating mutation in the HER2 gene,” Dr. Dominik Ruettinger, who leads oncology research and development at Bayer Pharmaceuticals, tells SurvivorNet.
Read More“This is not a super large population, but the impact should be incredible for the patients eligible for sevabertinib treatment,” Dr. Ruettinger says.
Who Is Eligible For Sevabertinib?
Sevabertinib received accelerated approval from the Food and Drug Administration (FDA) for people with HER2-positive (HER2+) non-small cell lung cancer who have already received prior treatment.
“This is … an accelerated approval and it’s approved in what we call second-line treatment,” Dr. Ruettinger explains. “So these are patients that have previously been treated with either a chemotherapy regimen and or immunotherapy, which is standard of care in first-line treatment.”
The approval is based on results from a clinical study called SOHO-1. “In terms of response rate, we saw very consistently around a 70% response rate,” Dr. Ruettinger says. “That does consist of both complete and partial responses, and we have seen a very meaningful duration of these responses.”
For patients, this means a strong chance that tumors will shrink or disappear, and that the benefit may last for a meaningful period of time.
Side Effects And Safety
The most common side effect seen with sevabertinib was diarrhea and other gastrointestinal symptoms, Dr. Ruettinger says.
Other common reported side effects included:
- Rash
- Paronychia (nail infection)
- Nausea
Doctors can help patients manage these side effects with dose adjustments, supportive medications, and close monitoring.
A Convenient Oral Treatment
Dr. Ruettinger stresses the convenience of sevabertinib, as it is a drug that can be taken orally at home.
“It’s an oral drug. You take two pills a day,” Dr. Ruettinger says. “You do not have to adjust it to the body weight of the patient. Patients can take it at home.”
For many people, this convenience can reduce the burden of frequent clinic visits and allow treatment to better fit into daily life.
Getting Promising Medicines To Patients Quickly
Speed and access are central to Bayer’s mission, Dr. Ruettinger says.
“We really aim to serve patients everywhere, bringing promising medicines to patients as fast as possible,” he notes.
For people with HER2+ lung cancer — a group that has waited years for a targeted option — sevabertinib represents an important step forward and a new reason for optimism.
Questions To Ask Your Doctor
- Am I a candidate for sevabertinib?
- How will I be monitored while taking this drug?
- What side effects should I look out for?
- What happens if I need to modify my treatment plan?
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