IMPORTANT SAFETY INFORMATION

Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer. 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. An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider permanent discontinuation of Nexavar. continue reading below »

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TARGET* efficacy

Overall survival (OS) results

  • Final median OS (uncensored)1
    • 17.8 months with Nexavar (n=451) vs 15.2 months with placebo (n=452)
      HR: 0.88; 95% CI, 0.74-1.04 (P=.146)
    • Did not meet criteria for statistical significance
  • Final OS results confounded due to crossover1
    • 48% (n=216) of placebo patients crossed over to Nexavar therapy

Important Safety Consideration

  • An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider permanent discontinuation of Nexavar
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Nexavar—Doubled progression-free survival (PFS)2

Progression-free survival (PFS) in second-line patients HR=hazard ratio; CI=confidence interval.
αIndependently assessed data.

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, if required
  • 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. Nexavar should be discontinued if Stevens-Johnson Syndrome or toxic epidermal necrolysis are suspected as these may be life-threatening
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PFS was consistent across all subsets analyzed2†

PFS benefit MSKCC=Memorial Sloan-Kettering Cancer Center.
† The study was not powered to assess differential patient response to treatment by subsets and no adjustments were made for multiple comparisons. The subset analyses were based on data collected before placebo patients were allowed to cross over to Nexavar therapy, were made to be descriptive only, and cannot be used to conclude whether a real difference in treatment effect exists between subsets.
  • A series of patient subsets were examined in exploratory univariate analyses of PFS
  • PFS benefit demonstrated regardless of2:
    • Age
    • Presence of lung or liver metastases
    • Risk category
    • Prior cytokine therapy
    • Time since diagnosis
  • No differences in safety or efficacy were observed between older and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out

Important Safety Consideration

  • Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar. Discontinue Nexavar in the event of a gastrointestinal perforation
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The majority of patients achieved stable disease2

  • The gain in PFS for Nexavar-treated patients primarily reflects the stable disease population
  • Tumor response was determined by independent radiological review by RECIST criteria
Clinical Benefit
  • Of 672 patients evaluable for response2:
    • PR with Nexavar: 2% (7/335) vs 0% (0/337) with placebo
    • SD with Nexavar: 78% (261/335) vs 55% (186/337) with placebo
    • PD with Nexavar: 9% (29/335) vs 30% (102/337) with placebo
CR=complete response; PR=partial response; SD=stable disease.
Independent review according to RECIST.
RECIST=Response Evaluation Criteria In Solid Tumors.
*TARGET (Treatment Approaches in Renal Cancer Global Evaluation Trial): A randomized, double-blind, placebo-controlled, multicenter, phase 3 study in patients with advanced RCC who had received 1 prior systemic therapy (N=903).1 Read more about:


References: 1. Escudier B, Eisen T, Stadler WM, et al; TARGET Study Group. Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009;27(20):3312-3318. 2. Escudier B, Eisen T, Stadler WM, et al; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356(2):125-134.