Tyverb Slide Kit
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Tyverb (lapatinib) is approved for use in combination with capecitabine for treatment of ErbB2-positive advanced or metastatic breast cancer in patients who have progressed on prior therapies including anthracyclines, taxanes, and trastuzumab. A pivotal study found that the combination of Tyverb and capecitabine significantly increased time to progression and overall response rate compared to capecitabine alone with manageable side effects. Quality of life was maintained with the combination therapy.
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![ErbB2-positive breast cancer 1.Cancer Research UK. UK breast cancer incidence and mortality statistics. www.cancerresearchuk.org (accessed May 2008) 2. Penault-Llorca F, Vincent-Salomon A, Mathieu MC et al. J Clin Oncol 2005; 23 (16S):764. 3. NICE. Technology Appraisal Guidance Number 34. London: NICE, 2002 ,[object Object],[object Object],[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)
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Tyverb Slide Kit
- 5. Tyverb ® (lapatinib): Mode of Action TYV/SLK/08/39072/1 Date of preparation: Nov 2008 Prescribing information can be found at the end of the full slide set
- 6. Tyverb is an oral, small-molecule, dual-targeted agent
- 8. Tyverb ® (lapatinib): EGF100151 Study (Pivotal Registration Study) TYV/SLK/08/39072/1 Date of preparation: Nov 2008 Prescribing information can be found at the end of the full slide set
- 9. EGF100151 study design 1,2 Treatment continued until progression or unacceptable toxicity Patients with ErbB2-positive locally advanced or metastatic breast cancer that progressed after prior anthracycline, taxane and trastuzumab (N=399 ) RANDOMISATION 1. Cameron D et al. Breast Cancer Res Treat 2008 ; 2. Geyer GE et al. N Engl J Med 2006 Tyverb 1250 mg po od continuously + capecitabine 2000 mg/m 2 /d po days 1-14 q 3 wk Capecitabine 2500 mg/m 2 /day po days 1-14 q 3 wk po = oral; od = once daily; q 3 wk = once every 3 weeks
- 13. EGF100151: prior therapy Cameron D et al. Breast Cancer Res Treat 2008 Tyverb + capecitabine (N=198) Capecitabine (N=201) Anthracyclines 194 (98) 199 (>99) Taxanes 198 (100) 199 (>99) Trastuzumab Metastatic Adjuvant Neoadjuvant 196 (99) 187 (95) 9 (5) 0 197 (98) 189 (94) 7 (4) 1 (<1) Median duration of trastuzumab, weeks (range) 44 (3-296) 45 (0-329) Time from discontinuation of trastuzumab to randomisation – no. < 4 weeks 4 - 8 weeks > 8 weeks Missing 196 55 (28) 62 (32) 79 (40) 0 197 52 (27) 65 (33) 77 (39) 3 (2)
- 14. EGF100151: independently assessed time to progression 1
- 15. EGF100151: key efficacy results 1 a Primary endpoint of the study 1 ; CI = confidence interval; TTP = time to progression; ORR = overall response rate (PR or CR); CR = complete response; PR = partial response Investigator assessment 2,3 Independent assessment 1 1. Cameron D et al. Breast Cancer Res Treat 2008; 2. Tyverb Summary of Product Characteristics; 3. GSK data on file (TYV/DOF/08/34764/1) Outcome Tyverb + capecitabine (N=198) Capecitabine (N=201) Hazard ratio (95% CI) Odds ratio (95% CI) p - value Median TTP [weeks (months)] a 27.1 (6.2) 18.6 (4.3) 0.57 (0.43, 0.77) – 0.00013 ORR (%) 23.7 13.9 – 1.9 (1.1, 3.4) 0.017 Outcome Tyverb + capecitabine (N=198) Capecitabine (N=201) Hazard ratio (95% CI) Odds ratio (95% CI) p - value Median TTP [weeks (months)] 23.9 (5.5) 18.3 (4.2) 0.72 (0.56, 0.92) – 0.008 ORR (%) 31.8 17.4 - 2.2 (1.3, 3.6) 0.002
- 16. EGF100151: overall survival by independent assessment 1. Cameron D et al. Breast Cancer Res Treat 2008 ; 2. Tyverb Summary of Product Characteristics September 2007 cut-off – after cross-over 2 April 2006 cut-off – before cross-over 1 Tyverb + capecitabine Capecitabine No. of patients 198 201 Median overall survival (weeks [months]) 67.7 (15.6) 66.6 (15.4) Hazard ratio (95% CI) 0.78 (0.55, 1.12) p-value 0.177 Tyverb + capecitabine Capecitabine No. of patients 207 201 Median overall survival (weeks [months]) 74.0 (17.1) 65.9 (15.2) Hazard ratio (95% CI) 0.9 (0.71, 1.12) p-value 0.3
- 17. EGF100151: effect of interval from last administration of trastuzumab to randomization on TTP Cameron D et al. Breast Cancer Res Treat 2008 Interval between last trastuzumab dose and randomization Tyverb + capecitabine Capecitabine alone Hazard ratio (95% CI) P value No. of pts Median TTP, wk No. of pts Median TTP, wk < 8 weeks 117 27.1 117 18.6 0.59 (0.40, 0.86) 0.004 > 8 weeks 79 26.1 77 14.6 0.56 (0.35, 0.91) 0.012
- 20. EGF100151: six most common adverse events (all grades)
- 26. Tyverb ® (lapatinib): Practical considerations TYV/SLK/08/37076/1 Date of preparation: Nov 2008 Prescribing information can be found at the end of the full slide set
- 27. Tyverb ® (lapatinib): Dosage and administration TYV/SLK/08/39072/1 Date of preparation: Nov 2008 Prescribing information can be found at the end of the full slide set
- 28. Tyverb (lapatinib) 250mg tablets
- 32. Tyverb ® (lapatinib): Information for patients Practical advice on administering/dosing TYV/SLK/08/39072/1 Date of preparation: Nov 2008 Prescribing information can be found at the end of the full slide set