How long does it take for lenvatinib to work?

How quickly lenvatinib will work for you depends upon many factors, such as your type of cancer, your cancer progression, other treatments you have received, and your overall health. Lenvatinib is usually given until your body no longer responds to the medication or the side effects become too severe to tolerate.

Lenvatinib (Lenvima) is a prescription medicine approved by the FDA for the treatment of:

• thyroid cancer usually given after radioactive iodine has been tried without success
• advanced renal cell carcinoma (kidney cancer): in combination with everolimus (Afinitor), following at least one other therapy that did not work; OR with pembrolizumab (Keytruda) as a first-line (initial) treatment
• inoperable hepatocellular (liver) carcinoma (HCC)
• certain types of endometrial cancer in combination with pembrolizumab (Keytruda)

Cancer treatment is always individual. Talk to your doctor about your expected results with treatment. Not all patients will respond to lenvatinib. Clinical studies provided the following results in these certain cancers:

Thyroid cancer: In one study, 392 patients with thyroid disease received either lenvatinib or a placebo (an inactive treatment). The results showed Lenvima-treated participants lived a median of 18.3 months without their disease getting worse (progression-free survival), compared to a median of 3.6 months for participants who received a placebo. This means that patients taking lenvatinib lived without their cancer getting worse for an average of 14.7 months longer than those taking placebo.

Kidney cancer (in combination with everolimus): Study results showed that lenvatinib and everolimus lengthened the time until the cancer got worse or death occurred by 14.6 months (with a range of 5.9 to 20.1 months). This compared to 5.5 months (with a range of 3.5 to 7.1 months) for patients only receiving everolimus. The combination regimen resulted in a 63% reduction in the risk of disease progression or death compared with everolimus alone.

Kidney cancer (in combination with pembrolizumab): In the Phase 3 CLEAR/KEYNOTE-581 trial, when Lenvima was given with pembrolizumab (Keytruda) in people with advanced kidney cancer, a significant improvement was seen when compared to sunitinib (Sutent) on progression-free survival (PFS), overall survival (OS) and confirmed objective response rate (ORR).

• For PFS, Keytruda plus Lenvima reduced the risk of disease progression or death by 61% with a median PFS of 23.9 months versus 9.2 months for sunitinib.
• In OS, Keytruda plus Lenvima reduced the risk of death by 34% when compared to sunitinib.
• The ORR was 71% (complete response (CR) rate of 16% + partial response (PR) rate of 55%) for patients who received Keytruda plus Lenvima versus 36% (a CR rate of 4% + a PR rate of 32%) with sunitinib.

Liver Cancer: Study results showed that lenvatinib was found to be non-inferior to (meaning no worse than) treatment with sorafenib (another drug used for liver cancer). Patients treated with lenvatinib experienced a median overall survival of 13.6 months compared to 12.3 months with sorafenib. In addition, the time patients lived without their disease getting worse (median progression-free survival, PFS) was doubled with lenvatinib (7.3 months) compared to sorafenib (3.6 months).

Endometrial cancer: Pembrolizumab plus lenvatinib showed an overall response rate of 38.3% (ranging from 29% to 49%), with a partial response rate of 27.7% and a complete response rate of 10.6%. The patients were followed up for a median of 18.7 months. At data cut-off, the median duration of response was not reached, but had a range of 1.2 to 33.1 months, or longer. Sixty-nine percent of patients had a response lasting 6 months or longer.

The FDA originally approved lenvatinib (Lenvima) in February 2015. Lenvatinib is classified as a multiple receptor tyrosine kinase (RTK) inhibitor that blocks certain proteins that boost cancer cell growth. It is also believed to block signals to help slow down the growth of blood vessels that support the tumor's growth.

Bottom Line

• How quickly lenvatinib will work for you depends upon many factors, such as your type and severity of cancer, your cancer progression, other treatments you receive, and your overall health.
• Lenvatinib is usually given until your body no longer responds to the medication or the side effects become too severe.
• It is approved by the FDA for the treatment of certain forms of thyroid cancer, kidney cancer, liver cancer and endometrial cancer.

This is not all the information you need to know about lenvatinib for safe and effective use. Review the full lenvatinib information here, and discuss this information and any questions with your doctor or other health care provider.