Ibtrozi is a medicine called a kinase inhibitor that is used to treat a certain type of lung cancer called non-small-cell lung cancer (NSCLC) that is caused by an abnormal ROS1 gene. NSCLC is the most common type of lung cancer, but ROS1-positive NSCLC happens in less than 2% of people with NSCLC. Ibtrozi is a non-chemotherapy treatment that works by targeting and blocking ROS1 markers on NSCLC cells.
How Does Ibtrozi Work for NSCLC?
Ibtozi targets certain proteins in the body called kinases, which cause the cancer cells to grow out of control. It blocks the ROS1 proteins on the cancer cells that help the cells to grow and divide. By blocking these proteins, Ibtrozi helps shut off signals that cause abnormal cancer cell growth, which can slow or stop the growth of the tumor.
What Kind of NSCLC Does Ibtrozi Treat?
Ibtrozi treats NSCLC that is positive for the ROS1 gene and has spread within your chest (locally advanced) or has spread to other parts of the body (metastatic).
How Will I Take Ibtrozi?
Ibtrozi is taken as a capsule that you swallow. It is usually taken by mouth once a day. You should take your dose on an empty stomach and should not eat any food for two hours before or after taking Ibtrozi. You should try to take your dose around the same time every day. If you miss a dose or vomit after your dose, you should take it at your regularly scheduled time the next day. You should not open, crush, chew, or dissolve capsules.
Your health care provider may need to stop Ibtrozi or lower your dose if you have problems with your liver or experience other severe side effects. Talk to your health care provider about all of your medical history so they can decide if Ibtrozi is right for you.
How Was Ibtrozi Studied?
Ibtrozi was studied in two trials in people with ROS1-positive NSCLC that was locally advanced or metastatic. People could be either tyrosine kinase inhibitor (TKI) naive, which means they have not had a drug like Ibtozi before, or TKI-pretreated, which means they have been treated before with a TKI.
People in both studies got Ibtrozi once daily for 21-day cycles. There were 160 people in the TKI-naive group; 106 (66%) were from Study 1 and 54 (34%) were from Study 2. There were 113 people in the TKI-pretreated group; 66 (58%) were from Study 1 and 47 (42%) were from Study 2. Among the 273 people, the median (middle) age was 56.0 years (range 26-83), 57.1% were female, 66.7% had never smoked, and most patients had stage IV adenocarcinoma. In the TKI-naive group, 23.1% had baseline brain metastasis (cancer that has spread to the brain), and in the TKI-pretreated group, 48.7% had baseline brain metastasis. All of the people in Study 1 were Asian. In Study 2, 56.4% were Asian, 27.6% were White, 2% were Black or African American, and 13.9% were unknown or other races.
What Benefits Were Seen With Ibtrozi?
Both studies looked at objective response rate (ORR), which is how many people had some type of response to Ibtrozi. ORR is made up of 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 studies also looked at duration of response (dOR), which is the amount of time that Ibtrozi keeps working before the tumor grows again.
In both trials, people who were TKI-naive had a strong response to Ibrotzi, with almost 90% achieving an overall response (see Table 1 below). The dOR for this group was about 44 months, which means that in the people who responded to Ibtrozi, the response lasted an average of 44 months. In the TKI-pretreated group, 56% of people achieved an overall response and the dOR was 16.6 months. The time it took to achieve any type of response was 1.4 months for both groups.
Table 1
Endpoint | TKI-Naive | TKI-Pretreated |
Response Rate | 89% | 56% |
Complete Response | 5% | 4% |
Partial Response | 84% | 51% |
Median Duration of Response | 44.2 months | 16.6 months |
Time to Response | 1.4 months | 1.4 months |
What Are Other Unique Considerations to Be Aware Of?
Ibtrozi can cause harm to a fetus. Your health care provider will discuss options for contraception while you take Ibtrozi. You should use an effective method of birth control while you are receiving Ibtrozi and for three weeks after your last dose. If you and your partner are or are planning to become pregnant, talk with your health care provider about your options. Ibtrozi may pass into your breast milk if you are breastfeeding. You should not breastfeed while you are getting Ibtrozi and for three weeks after your last dose.
Ibtrozi may cause serious liver problems. You should call your health care provider if you develop any symptoms of liver problems such as dark urine (pee), nausea, vomiting, stomach pain, tiredness, rash, or yellowing of your skin or whites of your eyes.
Ibtrozi can cause serious lung problems. You should tell your health care provider if you have trouble breathing, shortness of breath, cough, or fever.
You may have changes in the electrical activity of your heart (QTc prolongation) while taking Ibtrozi. You should tell your health care provider if you feel faint, lightheaded, dizzy, or a fast or irregular heartbeat.
You should tell your health care provider if you have gout before starting Ibtrozi. Ibtrozi can cause an increase in uric acid levels in your body, which can make your gout worse. Tell your health care provider if you have joints or a big toe that is red, hot, or swollen, dark urine, belly pain, or nausea and vomiting.
What Are the Side Effects of Ibtrozi, and How Can I Prevent or Manage Them?
Ibtrozi can cause low blood counts, including low white blood cells (neutropenia). Neutropenia can make it harder for your body to fight and prevent infections. You can help reduce your risk of developing an infection by washing your hands often and staying away from people with infections, colds, or the flu. If you are at high risk of getting an infection, your health care provider may prescribe a medicine to help prevent infections. You should contact your health care provider right away if you develop a fever or any other signs of an infection such as a sore throat or cough. They may prescribe medicine to treat your infection.
Feeling tired is a common side effect of Ibtrozi, but there are some things you can do to increase your energy. Exercising each day, even if it is just for a short time, can help boost your energy. Eating a healthy diet of fruits, vegetables, lean protein, and whole grains while avoiding sugary foods may also help you fight fatigue. Your health care provider may be able to give you medicines to treat other side effects such as pain or low blood counts, which may help with your fatigue.
Ibtrozi may cause gastrointestinal (GI) side effects such as nausea, vomiting, diarrhea, and constipation. 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 experience diarrhea, your health care provider may recommend that you start taking diarrhea medicine and drink more fluids to avoid losing too much of your body water (dehydration). Drinking more fluids can also help to prevent constipation, as well as eating foods that are high in fiber.
Skin reactions are a common side effect of Ibtrozi. If you develop a rash, you should contact your health care provider. They may recommend creams or antihistamines to help with your rash and itchiness. You may also be given a corticosteroid to treat your rash. Ibtrozi can also make your skin more sensitive to the sun than it usually is. You should try to stay out of the sun or cover yourself with protective clothing and sunscreen while you are taking Ibtrozi.
You may also experience muscle pain while taking Ibtrozi. Your health care provider may recommend that you use over-the-counter pain relievers such as acetaminophen or ibuprofen, or topical (on the skin) creams or gels. You should contact your health care provider if you have pain that does not go away with over-the-counter medicines.
Is there a Cost-Savings Program for Ibtrozi?
There is a copay savings program available from the drugmaker that may cost you as little as $0 for your monthly copay for your Ibtrozi prescription. Whether or not you are eligible depends on your insurance coverage. You can find out more by visiting www.ibtrozi.com/patient-support or calling 877-688-2661.
