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