TARGET Phase 3 Clinical Trial Design & Results

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Nexavar Medical Information

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Proven Efficacy and Safety in the Largest Phase 3 Study for Advanced Renal Cell Carcinoma (RCC)1

Largest Phase 3, multi-center, randomized, double blind, placebo-controlled trial:

  • Compared the efficacy and safety of Nexavar vs placebo in patients with advanced RCC who had received one prior systemic therapy
  • Primary study end points included overall survival and progression-free survival (PFS).
  • Secondary endpoint was tumor response rate.
  • Best overall tumor rsponse rate defined by RECIST criteria *

Study design

Patient characteristics

Progression-free survival analysis: Well-balanced treatment arms.

  • Patient groups were well balanced for age, ECOG performance status, risk category, and prior cytokine therapy

* RECIST criteria: Complete response (CR) = disappearance of all target lesions, confirmed at 4 weeks; Partial response (PR) = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable Disease (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD) = at least a 20% increase in the sum of the LD of target lesions; no CR, PR, or SD documented before increased disease.

† Four patients were previously treated with chemotherapy.

‡ MSKCC: Memorial Sloan-Kettering Cancer Center (also known as Motzer criteria).


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Term
Explanation for term.

Indications and Usage


Nexavar is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) and for the treatment of patients with advanced renal cell carcinoma (RCC)

Important Safety Considerations


Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required.

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar.

Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction.

Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in unresectable HCC, respectively, were: diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and hand-foot skin reaction (21% vs 3%). Grade 3/4 adverse reactions were 45% vs 32%.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in advanced RCC, respectively, were: diarrhea (43% vs 13%), rash/desquamation (40% vs 16%), fatigue (37% vs 28%), hand-foot skin reaction (30% vs 7%), alopecia (27% vs 3%),and nausea (23% vs 19%). Grade 3/4 adverse reactions were 38% vs 28%.

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar. Caution is recommended when administering Nexavar with compounds that are metabolized/eliminated predominantly by the UGT1A9 pathway, UGT1A1 pathway (eg, irinotecan), doxorubicin, docetaxel, fluorouracil, and substrates of CYP2B6 and CYP2C8, and CYP3A4 inducers. Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time, INR, or clinical bleeding episodes.

Women of childbearing potential are advised to avoid becoming pregnant and against breastfeeding.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see the full prescribing information.