How effective is Nexavar? Does it shrink tumors?

In randomized, placebo-controlled studies, Nexavar has been shown to extend overall or progression-free survival as well as shrink or slow tumor progression in some patients.

Nexavar (sorafenib) is used to treat adults with:

• a type of kidney cancer (renal cell carcinoma or RCC).
• a type of liver cancer (hepatocellular carcinoma or HCC) that cannot be removed with surgery.
• a type of thyroid cancer called differentiated thyroid carcinoma (DTC).

Kidney Cancer

In the Phase 3 TARGET study, 769 patients with kidney cancer (advanced renal cell carcinoma [RCC]) received either oral Nexavar 400 mg twice daily or placebo. The primary endpoints were overall survival and progression-free survival (PFS). Tumor response rate was a secondary endpoint.

TARGET study: Progression-free survival

Progression-free survival is the time from when the patient entered the study (randomization) to disease progression or death from any cause, whichever occurred earlier.

Nexavar doubled median progression free survival in patients with advanced RCC receiving Nexavar when compared to placebo: 24 weeks compared to 12 weeks (HR: 0.44; p-value < 0.000001).

Overall survival

Overall survival (OS) evaluates the length of time patients are still alive after starting a new treatment, and is one way to see how well a treatment works.

In TARGET, overall survival was 28% longer for those randomized to Nexavar compared with placebo (hazard ratio of 0.72) but at the time of analysis did not meet statistical significance, meaning it cannot be said that Nexavar is better than placebo in prolonging survival.

Tumor progression

Tumor response was minimal. Overall, out of 672 patients, 7 patients (2%) in the Nexavar and no patients in the placebo arms had a confirmed partial response.

Liver Cancer

In the Phase 3 SHARP study, researchers looked at the overall survival in 602 patients using Nexavar with liver cancer that could not be removed with surgery (unresectable hepatocellular carcinoma).

Participants received either oral Nexavar 400 mg twice daily or a matching placebo. Demographics such as age, race, gender and baseline disease characteristics were similar between the Nexavar and placebo arms.

SHARP study: Overall survival

The trial was stopped early because those treated with Nexavar showed a statistically significant greater overall survival (OS) of 31% compared to those in the placebo group (HR: 0.69, p= 0.00058).

Median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. Median time period means that half the people were alive longer than 10.7 months, and the other half were alive less than 10.9 months.

Tumor progression

Nexavar also significantly lengthened the time before the tumor progressed by 42% in the Nexavar arm (HR: 0.58, p=0.000007). The median number of months to tumor progression was 5.5 months for Nexavar and 2.8 months for placebo.

Progression-free survival

Progression-free survival (PFS is the length of time during and after the treatment of the cancer that a patient lives with the disease and it does not get worse.

BAY43-9006

In BAY43-9006, another Nexavar trial in patients with kidney cancer, researchers looked at progression-free survival (PFS) at 24 weeks.

• After 24 weeks, the progression-free rate was significantly higher in patients receiving Nexavar (16 out of 32, 50% of patients) than in patients randomized to placebo (6 out of 33, 18% of patients) (p=0.0077).
• Progression-free survival was significantly longer in the Nexavar arm (163 days) than in the placebo arm (41 days) (p=0.0001, HR=0.29).

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Thyroid Cancer

Nexavar treatment was also studied in the DECISION trial with 417 patients who had progressive differentiated thyroid cancer that did not respond to radioactive iodine therapy. The cancer had either returned (recurrent) or spread in the body (metastatic). Patients were randomized to receive Nexavar 400 mg twice daily or a placebo.

DECISION study: Progression-free survival

The primary endpoint in the study was progression-free survival (PFS). Nexavar was shown to increase the length of time patients lived without the cancer progressing (progression-free survival) by 41%.

Half of patients receiving Nexavar lived without cancer progression for at least 10.8 months compared to at least 5.8 months for participants receiving a placebo. At 10.8 months 113 / 207 (55%) of patients had died or had disease progression compared to 136 / 210 (65%) patients on the placebo (HR 0.49; p<0.001).

Overall survival

No statistically significant difference was seen in the final overall survival (OS) analysis.

• In the Nexavar group, 103 / 207 (49.8%) of patients died vs. 109 / 210 (51.9%) in the placebo group.
• The median OS in months was 42.8 months in the Nexavar group (ranging from 34.6 to 52.6 months).
• OS in the placebo group was 39.4 months, and ranged from 32.7 to 51.4 months.

What is Nexavar prescribed for and how does it work?

Nexavar (sorafenib) is an oral cancer drug approved to treat 3 different types of cancer. In 2005 it was approved to treat advanced kidney cancer, and in 2007, the agency expanded the drug’s label to treat liver cancer that cannot be surgically removed. In November 2103, the FDA approved Nexavar to treat late-stage (metastatic) differentiated thyroid cancer.

It is thought to work by blocking certain proteins inside and on the surface of cancer cells, which may kill the cancer cell and keep it from growing and spreading in the body. It also helps to prevent the growth of new blood vessels that help to “feed” the tumor’s growth (called angiogenesis).

Nexavar is classified as a vascular endothelial growth factor (VEGF) inhibitor and angiogenesis inhibitor. It might also be called a multikinase inhibitor.

The most common side effects occurring in at least 20 out of every 100 patients (20%) are:

• diarrhea
• fatigue
• infection
• alopecia (hair loss or thinning)
• hand-foot skin reaction
• rash
• weight loss
• decreased appetite
• nausea
• gastrointestinal and abdominal pains
• hypertension (high blood pressure)
• hemorrhage (severe bleeding)

The brand name product Nexavar is manufactured by Bayer Healthcare. A generic product for Nexavar is also available.

Related: How much does Nexavar or its generic cost?

This is not all the information you need to know about Nexavar (sorafenib) for safe and effective use. Review the full drug product information and discuss this information and any questions you have with your doctor or other health care provider.