Avmapki Fakzynja is a type of targeted medicine called a tyrosine kinase inhibitor (TKI). TKIs are used to treat many different types of cancers, including ovarian cancer. Avmapki Fakzynja is combination of two different TKIs and is the first approved medicine used to treat recurrent low-grade serous KRAS-mutated ovarian cancer. Avmapki Fakzynja was approved as an accelerated approval and is currently recruiting patients for a clinical trial, NCT06072781. Below you’ll find common questions and answers about Avmapki Fakzynja to help decide whether it’s right for you.
How Does Avmapki Fakzynja Work for Ovarian Cancer?
Avmapki Fakzynja works by targeting certain proteins in the body called kinases, which cause cancer cells to grow out of control. It blocks two different kinases (MEK1 and FAK) on the cancer cells that help the cells to grow and divide. Avmapki blocks the MEK kinase and Fakzynja blocks the FAK kinase. By blocking these proteins, Avmapki Fakzynja helps shut off signals that cause abnormal ovarian cancer cell growth, which can slow or stop the growth of the tumor.
What Kind of Ovarian Cancer Does Avmapki Fakzynja Treat?
Avmapki Fakzynja treats ovarian cancer that is:
- Low-grade serous type
- Has a KRAS-mutation, and
- Has come back (recurred) after previous treatment
How Will I Take Avmapki Fakzynja?
Avmapki Fakzynja is a combination of Avmapki capsules and Fakzynja tablets. Avmapki is taken by mouth twice per week and Fakzynja is taken by mouth twice per day. They are both taken for three weeks, followed by one week off. You should take both medicines with food and take each dose at your scheduled time on the days you take it. For example, if you take Avmapki on Mondays and Thursdays at 7 a.m., this is when you take it each week for the three of the four weeks. If you take Fakzynja at 7 a.m. and 7 p.m., you should take it at that time each day. If you vomit your dose or miss your dose of Avmapki by more than 24 hours or your dose of Fakzynja by more than six hours, you should not take an extra dose to make up for the missed dose. You should take it at your regularly scheduled time the next day. You should not open, crush, chew, or dissolve capsules or tablets.
Your health care provider may need to stop Avmapki Fakzynja 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 Avmapki Fakzynja is right for you.
How Was Avmapki Fakzynja Studied?
Avmapki Fakzynja was studied in people with ovarian cancer that had a KRAS mutation and had progressed after at least one other therapy. People in this trial got either Avmapki alone (monotherapy group) or both Avmapki and Fakzynja (combination group).
There were 57 people in the combination group and 31 in the monotherapy group. In the combination group, the median age was 60 (range 29-87), 75% were White, 3.5% were Asian, 3.5% were Black or African American, and 18% did not have race reported; 3.5% of patients were Hispanic or Latino. In the monotherapy group, the median age was 57 (range 27-74), 77% were White, 3% were Asian, 3% were Black or African American, and 16% were other or did not have race reported.
The study looked at objective response rate (ORR), which measured how many people had some type of response to their treatment. 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 study also looked at duration of response (dOR), which measured the amount of time that the treatment keeps working before the tumor grows again. It also looked at progression-free survival (PFS), which looks at how long people lived for without progression of cancer or death.
The ORR was higher in the combination group at 44% versus the monotherapy group at 23% (see Table 1). This means that 44% of people that got Avmapki Fakzynja had either a CR or PR to therapy. Most people had a DOR between 14.8 and 31.1 months and a PFS between 11.1 and 36.6 months.
Table 1:
Endpoint | Avmapki Fakzynja | Avmapki |
Response Rate | 44% | 23% |
Complete Response | 4% | 3% |
Partial Response | 40% | 20% |
What Are Other Unique Considerations or Serious Side Effects to Be Aware Of?
Avmapki Fakzynja can cause harm to a fetus. Your health care provider will discuss options for contraception while you take Avmapki Fakzynja. You should use an effective method of birth control while you are receiving Avmapki Fakzynja and for one month after your last dose if you are female or four months after your last dose if you are male. If you and your partner are pregnant or are planning to become pregnant, talk with your health care provider about your options. Avmapki Fakzynja may pass into your breast milk if you are breastfeeding. You should not breastfeed while you are getting Avmapki Fakzynjai and for two weeks after your last dose.
Avmapki Fakzynja may cause serious liver, eye, or muscle problems (rhabdomyolysis). These can sometimes be noticed on your laboratory tests before you have symptoms. Your doctor should monitor your laboratory tests often to see if you are developing any of these problems. They may also recommend that you see an eye doctor regularly. It is important that you keep all of your appointments for your tests and eye exams. 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; muscle or bone pain that does not go away; weakness or difficulty moving your arms and leg; eye problems such as changes in your vision, dry eyes, eye pain, or inflammation; or become sensitive to light (photosensitivity). If you have any of these symptoms, your dose of Avmapki Fakzynja may need to be lowered, temporarily held, or discontinued.
Severe or life-threatening skin reactions can be a side effect of Avmapki Fakzynja. If you develop a rash, blistering or peeling of the skin, dry or itchy skin, or swelling of your hands, face, or feet, 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 or an oral antibiotic to prevent serious skin problems. Avmapki Fakzynja 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 Avmapki Fakzynja.
What Are the Side Effects of Avmapki Fakzynja, and How Can I Prevent or Manage Them?
Avmapki Fakzynja can cause low blood cell counts, including low white blood cells (neutropenia). Neutropenia can cause severe 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 for 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 you medicine to treat your infection. You should contact your health care provider if you have these symptoms so your blood counts can be monitored.
Low red blood cells (anemia) can be a common side effect of Avmapki Fakzynja. Anemia can make you feel more tired than usual, but there are some things you can do to help 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. It is also important to get enough rest at night and take naps during the day if needed. Your doctor may be able to give you medicines to treat low blood counts, which may help with your fatigue.
Avmapki Fakzynja 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 have diarrhea, your health care provider may recommend that you take 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.
How Do I Know if Avmapki Fakzynja Is Working?
Your health care provider will regularly check how well Avmapki Fakzynja is working for your cancer through looking at results of tests such as blood tests and CT scans, ultrasounds, or MRI scans. You may notice improvements within a few weeks to months after starting Avmapki Fakzynja. The complete therapeutic effect can take longer, depending on individual 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 this treatment to decide how long to use this medicine.
Is there a Cost Savings Program for Avmapki Fakzynja?
You may be able to receive financial support to reduce out-of-pocket costs for Avmapki Fakzynja through the Verastem Cares Program. You can find more information by calling 866-351-8372.
