Hyrnuo (sevabertinib) is a medicine called a kinase inhibitor. It is used to treat a certain type of lung cancer called non-small-cell lung cancer (NSCLC) that is caused by an abnormal human epidermal growth factor receptor 2 (HER2) gene. NSCLC is the most common form of lung cancer, but HER2 mutations occur in only about 2% to 4% of people with NSCLC. Hyrnuo is an oral tablet that works by targeting and blocking HER2 signals in NSCLC cells.
How Does Hyrnuo Work to Treat Lung Cancer?
In HER2-mutated NSCLC, a change in the HER2 gene can leave the HER2 growth signal stuck in the “on” position. This tells cancer cells to keep growing and dividing more than they should.
Hyrnuo works by blocking HER2, which helps interrupt the signals that tell the cancer cells to grow. Hyrnuo also has activity against another growth-related protein called EGFR. By blocking these growth signals, Hyrnuo can help slow or stop the growth of cancer cells with certain HER2 mutations.
What Kind of NSCLC Does Hyrnuo Treat?
Hyrnuo is FDA approved to treat NSCLC that has all of the following features:
- Nonsquamous, meaning the cancer began in the outer edges of the lung
- Has spread within your chest (locally advanced) or to other parts of your body (metastatic)
- Has an abnormal, or mutated, HER2 gene
Your health care provider can test your lung cancer for HER2 mutations to see if Hyrnuo may be a treatment option for you.
How Do I Take Hyrnuo?
Hyrnuo comes as a 10-milligram (mg) tablet that you take by mouth. Take Hyrnuo exactly as your health care provider tells you.
The recommended dose is 20 mg twice a day with food. Your health care provider may adjust your dose if needed. The typical schedule is one dose in the morning and one dose in the evening, and you should try to take your doses on the same schedule each day. Swallow the tablets whole. Do not cut, crush, or chew them.
You will usually continue taking Hyrnuo as long as it is working well and any side effects are manageable. Your health care provider may pause Hyrnuo, lower your dose, or stop treatment if you have certain side effects. Do not change your dose on your own.
You may need a lower dose of Hyrnuo if you have problems with your liver. Some medicines can also affect how much Hyrnuo is in your body and may require a dose adjustment. Tell your health care provider about all of your past or current medical conditions and let them know about any medicines or supplements you take. Sharing this information is important so they can decide the right dose of Hyrnuo for you.
How Was Hyrnuo Studied for NSCLC?
Hyrnuo was studied in people with locally advanced or metastatic nonsquamous NSCLC that had certain HER2 gene mutations. Participants were put into groups based on whether they had received cancer treatment before and what type of treatment they had received.
Before joining the study, participants were confirmed to have a HER2 mutation through testing of tumor tissue or blood. People with brain tumors that had already been treated, were stable, and were not causing symptoms could join the study. People with brain tumors that were causing symptoms, those with serious heart problems, or those with a history of certain serious lung problems could not participate.
The three main groups of participants included:
- HER2-naive: This group of 70 adults had received previous treatment but had not received HER2-targeted treatment. The median (midpoint) age was 59 years (range 29 to 77 years), and 67% were women. Seventy percent were Asian, 23% were White, 1.4% were Black or African American, and 6% did not have their race reported. There were 2.9% of people of Hispanic or Latino ethnicity.
- HER2-treated: This group of 52 adults had received previous treatment, including HER2-targeted treatment. The median age was 65 years (range 35 to 91 years), and 67% were female. Sixty-two percent were Asian, 27% were White, 6% were Black or African American, and 6% did not have their race reported. About 1.9% of people were of Hispanic or Latino ethnicity.
- Treatment-naive: This group of 69 adults had not previously received any systemic (body-wide) treatment for their NSCLC. The median age was 66 years (range 31 to 82 years). About 61% were women. Most (70%) were Asian, 28% were White, and about 3% did not have their race reported. No ethnicity details were published for this group.
Everyone took Hyrnuo by mouth twice a day until they had intolerable side effects or their cancer got worse.
The study looked at objective response rate (ORR), which measured how many people had some type of response to Hyrnuo. ORR includes partial response (PR), which is when the tumor size has decreased but not disappeared, and complete response (CR), which is when the tumor has disappeared. The study also looked at duration of response (DOR), which is how long Hyrnuo keeps working before the tumor grows again.
What Benefits Were Seen With Hyrnuo?
Overall, Hyrnuo helped shrink tumors in some people across all three study groups. How well it worked varied depending on whether people had received previous cancer treatments, including HER2-targeted treatment.
- In the HER2-naive group, 71% of people treated with Hyrnuo had some response. The median (midpoint) duration of response was 9.2 months. This means that about 7 out of 10 people saw either a decrease in their tumor or disappearance of their tumor. About 3% had their tumors disappear completely, while 69% had their tumors shrink. Among those who responded, 54% had a response lasting at least 6 months, and 18% had a response lasting at least 12 months.
- Of the people who were previously treated with a HER2-targeted medicine, 38% had some response. About 6% had their tumors disappear completely, while 33% had their tumors shrink. The median (midpoint) duration of response was 7 months. Among those who responded, 60% had a response lasting at least 6 months, and 10% had a response lasting at least 12 months.
- In the treatment-naive group (people who had not previously received systemic treatment for their advanced NSCLC), 75% responded to Hyrnuo. About 6% had their tumors disappear completely, while 70% had their tumors shrink. Among those who responded, 73% had a response lasting at least 6 months, and 38% had a response lasting at least 12 months.
Your response may be different from what was seen in the study.
What Are the Possible Side Effects of Hyrnuo, and How Can I Prevent or Manage Them?
Hyrnuo may cause gastrointestinal (GI) side effects such as nausea and diarrhea. Your health care provider may give you certain medicines to prevent these side effects from happening, as well as medicines to treat them if they occur. Eating bland food and smaller meals throughout the day can help with symptoms of nausea. If you have diarrhea, your health care provider may recommend that you start antidiarrheal medicine and drink more fluids to avoid losing too much of your body water (dehydration).
Rash is a common side effect of Hyrnuo. If you get a rash, you should contact your health care provider. They may recommend creams or an antihistamine to help with your rash and any itchiness. You may also be given a corticosteroid to treat your rash. Some things you can do to prevent a rash include keeping your skin moisturized and avoiding scratchy clothing or harsh soaps and detergents.
Hyrnuo can cause stomatitis, which is when your mouth gets sore and inflamed. Your health care provider may be able to give you medicine to treat your stomatitis, but there are some things you can do to help relieve pain and inflammation. Ask your health care provider if you can try an over-the-counter pain reliever, such as acetaminophen or ibuprofen. You should also try to avoid very hot food and beverages, as well as any spicy, salty, or citrusy foods. Gargling with cool water and sucking on ice cubes or ice pops may also help your symptoms.
Paronychia is a common side effect of Hyrnuo. This is when the skin around your fingernail or toenail becomes inflamed or infected, resulting in pain, redness, and swelling. You can help your symptoms by soaking your affected finger or toe in warm water a couple of times a day. Your health care provider may also prescribe you oral or topical (on the skin) antibiotics if you have an infection. To prevent this side effect, you should keep your hands and feet dry and avoid biting or picking your nails or cuticles or cutting them too short. You should also wear gloves if you are doing anything involving harsh chemicals, and be sure to cut your toenails straight so you do not get ingrown nails.
Other Hyrnuo side effects are possible. Tell your health care provider if side effects do not improve or if they get worse or severe. They may suggest changes to your treatment plan.
How Do I Know if Hyrnuo Is Working?
Your health care provider will regularly check how well Hyrnuo is working for your cancer by looking at the results of tests, such as CT scans or PET scans.
Improvements may be seen within a few weeks to months after starting Hyrnuo. The full effect can take longer, depending on your personal factors and disease progression. Your health care provider will look at how your tumor is responding and what kind of side effects you may have to decide how long to take Hyrnuo.
Is there a Cost Savings Program for Hyrnuo?
There is a copay savings program available from the drugmaker that may cost you as little as $0 for your monthly copay for your Hyrnuo prescription. Whether or not you are eligible depends on your insurance coverage. You can find out more by visiting www.hyrnuo-us.com/copay-program or by calling 833-423-5561.
If you cannot afford Hyrnuo, other financial assistance offers may be available for eligible patients, including access to the medicine at no cost. For more information, visit www.patientassistance.bayer.us or call 866-228-7723.
