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
Background
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Study Aim
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
LYM-3002 Study Design
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Endpoints
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Statistical Assumptions
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Demographics and Baseline Characteristics
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Treatment Exposure
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
Depth and duration of response by IRC improved with VR-CAP
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
Secondary Outcome: OS
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Overall Safety Profile
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Grade ≥3 AEs and Serious AEs
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Hematologic AEs and Clinical Significance
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Peripheral Neuropathy
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Conclusions – Efficacy
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Conclusions – Safety
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Final Conclusion
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Acknowledgments
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Slide 21
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
PFS by Investigator
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
PFS by IRC – Subgroup Analyses
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
PFS by Stratification Factors
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
PFS by Geographic Region
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
Baseline MIPIb distribution and PFS by MIPIb
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
Responses by investigator
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
All-Grade AEs (≥20%, either arm)
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
Deaths
Presented By Franco Cavalli at 2014 ASCO Annual Meeting
