Your kidneys are very important organs that help clean your blood, get rid of waste, and make urine (pee). Kidney cancer happens when abnormal cells grow out of control and form growths called tumors in one or both of your kidneys. Renal cell carcinoma (RCC) is the most common type of kidney cancer. Your treatment for renal cell carcinoma depends on things such as your overall health, age, and the stage of your cancer.
One of the treatment options may include Lenvima (lenvatinib). It is approved by the FDA to treat certain people with renal cell carcinoma. Your health care provider may prescribe Lenvima in combination with other medicines to treat RCC.
Continue reading to learn more about Lenvima, including how it works for RCC, how it was studied, its benefits, and how to take it.
Lenvima Side Effects and Interactions: What to Expect and How to Manage Them
How Does Lenvima Work for Kidney Cancer?
Lenvima is a type of medicine called a kinase inhibitor. Kinases are proteins in the body that cause cancer cells to grow and help form new blood vessels that feed tumors. Lenvima blocks these proteins, which helps slow the growth and spread of cancer cells.
Lenvima may also help your immune system fight certain cancers more effectively. In studies, Lenvima seemed to create conditions around the tumor more favorable for immune cells to attack cancer. This is one reason why Lenvima is sometimes given alongside other cancer medicines. Combining these treatments may work better than either treatment alone for RCC.
How Was Lenvima Studied for Kidney Cancer?
Initial Therapy
Lenvima was studied in a clinical trial in adults with advanced RCC that had a predominantly clear cell component, which is the most common subtype of kidney cancer. Lenvima plus pembrolizumab was compared with sunitinib. Pembrolizumab was continued for 24 months. Lenvima could be continued longer than 24 months until unacceptable side effects occurred or the RCC worsened. Sunitinib could also be continued until intolerable side effects showed up or the RCC worsened.
Below are the characteristics of the participants at the start of the clinical trial:
- Their ages ranged from 29 to 88 years old, with a median (midpoint) age of 62 years.
- 75% were male, while the rest were female (25%).
- Most participants were White (74%), followed by Asian (21%), Black (1%), and other races (2%).
- Memorial Sloan Kettering Cancer Center (MSKCC) risk categories: favorable (27%), intermediate (64%), and poor (9%). Note: MSKCC is a tool specific to RCC that is used to predict survival.
Tumors were checked every eight weeks throughout the study. The main goal of the trial was to see how long people lived before their cancer got worse, known as progression-free survival (PFS). The trial also looked at how long people lived, known as overall survival (OS), as well as whether the cancer got smaller (partial response) or went away completely (complete response) — together known as the objective response rate (ORR).
After a PD-1 or PD-L1 Inhibitor Treatment
Lenvima was also studied in a clinical trial in adults with advanced kidney cancer that has a clear cell component (ccRCC). This trial enrolled people whose cancer had gotten worse after being treated with a type of immunotherapy medicine called a PD-1 or PD-L1 inhibitor. It also included people whose cancer came back within 6 months of completing preventive (adjuvant) therapy with a PD-1 inhibitor.
In this trial, Lenvima plus belzutifan was compared with cabozantinib. Belzutifan works differently from Lenvima. It blocks a protein called HIF-2α that helps cancer cells grow in low-oxygen conditions. Using both medicines together may help attack the cancer in more than one way.
Below are the characteristics of the participants at the start of this clinical trial:
- Their ages ranged from 30 to 86 years old, with a median age of 63 years.
- 76% were male, while the rest were female (24%).
- Most participants were White (87%), followed by Asian (9%), American Indian or Alaska Native (1.6%), multiple races (1.1%), Black or African American (0.4%) or race not reported (0.8%).
- International Metastatic RCC Database Consortium (IMDC) risk categories: favorable (24%), intermediate (59%), and poor (17%).
- 72% of participants had received one prior treatment, and 28% had received two prior treatments.
- Bone metastases were present in 40% of participants, and liver metastases in 25%.
Tumors were checked every eight weeks for the first 80 weeks and then every 12 weeks after that. The main goals of the trial were to see how long people lived before their cancer got worse (PFS) and how long people lived overall (OS). The trial also looked at whether the cancer got smaller or went away (ORR).
After Other Treatments
Lenvima was also studied in a clinical trial in adults with advanced RCC. Lenvima plus everolimus was compared with everolimus alone.
Below are the characteristics of the participants at the beginning of this trial:
- Their median age was 60 years.
- 72% were male, while the rest were female (28%).
- Most participants were White (96%); the other races were not reported.
- RCC had spread to other areas of the body in 95% of the study participants.
- MSKCC risk categories included favorable (~27%), intermediate (~38%), and poor (~38%).
The main goal of this trial was to see how long people lived before their cancer got worse, known as PFS. The trial also looked at how long people lived (known as OS) and whether the cancer got smaller (partial response) or was gone completely (complete response) — together known as the ORR.
What Benefits Were Seen?
Initial Therapy
Participants taking Lenvima with pembrolizumab had a 21% lower risk of death than those taking sunitinib. At three years, about 66% of participants taking Lenvima with pembrolizumab were alive, compared to about 60% of participants taking sunitinib. You can see the specifics in the table below.
Lenvima + (355 people) | Sunitinib (357 people) | |
|---|---|---|
| Median progression-free survival (PFS) | 23.9 months | 9.2 months |
| 36-month overall survival (OS) | 66.4%
| 60.2% |
| Objective response rate (ORR) |
|
|
After a PD-1 or PD-L1 Inhibitor
Participants taking Lenvima with belzutifan lived longer before their cancer grew or spread (about 14.6 months) compared to those taking cabozantinib (about 10.6 months). This means the combination of Lenvima with belzutifan reduced the risk of the cancer getting worse by 26% compared to cabozantinib.
More than half of participants taking Lenvima with belzutifan saw their cancer shrink or disappear (53%), compared to 40% of participants taking cabozantinib. Among those who responded to treatment, 63% had their response last 12 months or longer.
You can see the specifics in the table below.
Lenvima + Belzutifan (371 people) | Cabozantinib (376 people) | |
|---|---|---|
| Median progression-free survival (PFS) | 14.6 months | 10.6 months |
| Median overall survival (OS) | 33.7 months | 28.6 months |
| Objective response rate (ORR) |
|
|
It is important to note that overall survival results did not reach statistical significance in this trial, meaning the difference in survival between the two treatment groups may have been due to chance.
After Other Treatments
Participants taking Lenvima with everolimus went nearly 15 months before their cancer grew or spread, compared to about 5.5 months for participants taking everolimus alone. This means Lenvima with everolimus reduced the risk of the cancer getting worse by 63% compared to everolimus alone. Participants taking Lenvima with everolimus lived about 25.5 months, compared to about 15.4 months for participants taking everolimus alone. You can see the specifics in the table below.
Lenvima + (51 people) | Everolimus (50 people) | |
|---|---|---|
| Median progression-free survival (PFS) | 14.6 months | 5.5 months |
| Median overall survival (OS) | 25.5 months | 15.4 months |
| Objective response rate (ORR) |
|
|
Keep in mind your results may be different from those seen in studies.
Is Lenvima Right for Me?
A health care provider can help decide if this medicine is right for you based on your health history and previous treatments. Lenvima is approved by the FDA to treat certain people with renal cell carcinoma. Your health care provider may prescribe Lenvima in combination with other medicines to treat RCC.
Before you start Lenvima, you should talk to your health care provider about all of your health conditions and any medicines you take. This information can help your health care provider decide which treatment may be best for you. It is especially important for you to tell your health care provider if any of these apply to you now or in the past.
- Upcoming surgery
- High blood pressure or heart problems, including heart failure
- History of blood clots, including heart attack, stroke, or changes in vision
- Liver or kidney problems
- A tear in your stomach or intestines (perforation) or an abnormal connection between two or more body parts (fistula)
- Headaches, seizures, or vision problems
- Bleeding problems
How Do I Take Lenvima?
General instructions
Lenvima is a capsule that you can swallow. You can take it with or without food. You should take it once a day, exactly as your health care provider recommends. If you can, swallow the capsule whole. If you can’t, there are instructions available to help you dissolve the capsules.
When you can’t swallow capsules
Below are the instructions on how to dissolve the Lenvima capsules.
- Do not break or crush the capsules. Place the number of capsules you are supposed to take for one dose in a small container.
- Add 3 milliliter (mL) of water or apple juice to the container.
- Wait 10 minutes for the capsule shell (outer surface) to dissolve completely.
- Stir or shake the mixture for three minutes until the capsules are fully dissolved.
- Drink the liquid mixture.
- Add 2 mL of water or apple juice to the container.
- Swirl or shake and swallow the liquid mixture.
- Repeat steps 6 and 7 at least once, and until you cannot see any more of the Lenvima mixture left in the container to make sure all of the medicine is taken.
Note: If your dose requires you to use six capsules, you will need to follow these instructions twice, using three capsules at a time. If your dose requires five or fewer capsules, you can dissolve all five capsules at once.
Is There Any Cost Assistance Available?
Financial support programs are available that may help lower the cost of Lenvima. To see if you qualify for patient assistance or copay savings, you can visit this website or call 866-613-4724 for more information.
