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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 mantle cell lymphoma (MCL) patients ineligible for bone marrow transplantation Presented By Franco Cavalli at 2014 ASCO Annual Meeting
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Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Feb 23, 2016

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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 mantle cell lymphoma (MCL) patients ineligible for bone marrow transplantation . Presented By Franco Cavalli at 2014 ASCO Annual Meeting. - PowerPoint PPT Presentation
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Page 1: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

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

Page 2: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Background

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 3: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Study Aim

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 4: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

LYM-3002 Study Design

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 5: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Endpoints

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 6: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Statistical Assumptions

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 7: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Demographics and Baseline Characteristics

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 8: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Treatment Exposure

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 9: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Superior PFS by IRC with VR-CAP vs R-CHOP: 59% improvement

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 10: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Depth and duration of response by IRC improved with VR-CAP

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 11: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Secondary outcomes:<br />TTP, TTNT, TFI, OS

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 12: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Secondary Outcome: OS

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 13: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Overall Safety Profile

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 14: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Grade ≥3 AEs and Serious AEs

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 15: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Hematologic AEs and Clinical Significance

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 16: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Peripheral Neuropathy

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 17: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Conclusions – Efficacy

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 18: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Conclusions – Safety

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 19: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Final Conclusion

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 20: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Acknowledgments

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 21: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Slide 21

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 22: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

PFS by Investigator

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 23: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

PFS by IRC – Subgroup Analyses

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 24: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

PFS by Stratification Factors

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 25: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

PFS by Geographic Region

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 26: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Efficacy in Patients Without Medical Reasons for Transplant Ineligibility

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 27: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Baseline MIPIb distribution and PFS by MIPIb

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 28: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Efficacy by Ki-67 expression (N=327)

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 29: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Responses by investigator

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 30: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

All-Grade AEs (≥20%, either arm)

Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Page 31: Presented By Franco Cavalli at 2014 ASCO Annual Meeting

Deaths

Presented By Franco Cavalli at 2014 ASCO Annual Meeting