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Randomized phase 3 study of rituximab, cyclophosphamide, doxorubicin, and prednisone plus vincristine (R-CHOP) or bortezomib (VR-CAP) in newly diagnosed.

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Presentation on theme: "Randomized phase 3 study of rituximab, cyclophosphamide, doxorubicin, and prednisone plus vincristine (R-CHOP) or bortezomib (VR-CAP) in newly diagnosed."— Presentation transcript:

1 Randomized phase 3 study of rituximab, cyclophosphamide, doxorubicin, and prednisone plus vincristine (R-CHOP) or bortezomib (VR-CAP) in newly diagnosed mantle cell lymphoma (MCL) patients ineligible for bone marrow transplantation Presented By Franco Cavalli at 2014 ASCO Annual Meeting

2 Background Presented By Franco Cavalli at 2014 ASCO Annual Meeting

3 Study Aim Presented By Franco Cavalli at 2014 ASCO Annual Meeting

4 LYM-3002 Study Design Presented By Franco Cavalli at 2014 ASCO Annual Meeting

5 Endpoints Presented By Franco Cavalli at 2014 ASCO Annual Meeting

6 Statistical Assumptions Presented By Franco Cavalli at 2014 ASCO Annual Meeting

7 Demographics and Baseline Characteristics Presented By Franco Cavalli at 2014 ASCO Annual Meeting

8 Treatment Exposure Presented By Franco Cavalli at 2014 ASCO Annual Meeting

9 Superior PFS by IRC with VR-CAP vs R-CHOP: 59% improvement Presented By Franco Cavalli at 2014 ASCO Annual Meeting

10 Depth and duration of response by IRC improved with VR-CAP Presented By Franco Cavalli at 2014 ASCO Annual Meeting

11 Secondary outcomes: TTP, TTNT, TFI, OS Presented By Franco Cavalli at 2014 ASCO Annual Meeting

12 Secondary Outcome: OS Presented By Franco Cavalli at 2014 ASCO Annual Meeting

13 Overall Safety Profile Presented By Franco Cavalli at 2014 ASCO Annual Meeting

14 Grade ≥3 AEs and Serious AEs Presented By Franco Cavalli at 2014 ASCO Annual Meeting

15 Hematologic AEs and Clinical Significance Presented By Franco Cavalli at 2014 ASCO Annual Meeting

16 Peripheral Neuropathy Presented By Franco Cavalli at 2014 ASCO Annual Meeting

17 Conclusions – Efficacy Presented By Franco Cavalli at 2014 ASCO Annual Meeting

18 Conclusions – Safety Presented By Franco Cavalli at 2014 ASCO Annual Meeting

19 Final Conclusion Presented By Franco Cavalli at 2014 ASCO Annual Meeting

20 Acknowledgments Presented By Franco Cavalli at 2014 ASCO Annual Meeting

21 Slide 21 Presented By Franco Cavalli at 2014 ASCO Annual Meeting

22 PFS by Investigator Presented By Franco Cavalli at 2014 ASCO Annual Meeting

23 PFS by IRC – Subgroup Analyses Presented By Franco Cavalli at 2014 ASCO Annual Meeting

24 PFS by Stratification Factors Presented By Franco Cavalli at 2014 ASCO Annual Meeting

25 PFS by Geographic Region Presented By Franco Cavalli at 2014 ASCO Annual Meeting

26 Efficacy in Patients Without Medical Reasons for Transplant Ineligibility Presented By Franco Cavalli at 2014 ASCO Annual Meeting

27 Baseline MIPIb distribution and PFS by MIPIb Presented By Franco Cavalli at 2014 ASCO Annual Meeting

28 Efficacy by Ki-67 expression (N=327) Presented By Franco Cavalli at 2014 ASCO Annual Meeting

29 Responses by investigator Presented By Franco Cavalli at 2014 ASCO Annual Meeting

30 All-Grade AEs (≥20%, either arm) Presented By Franco Cavalli at 2014 ASCO Annual Meeting

31 Deaths Presented By Franco Cavalli at 2014 ASCO Annual Meeting


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