1004OFinal overall survival results of frontline bortezomib plus rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) vs R-CHOP in transplantation-ineligible patients (pts) with newly diagnosed mantle-cell lymphoma (MCL): A randomized, open-label, phase III (LYM-3002) study

Background: The LYM-3002 study compared the efficacy and safety of frontline VR-CAP versus R-CHOP in transplant-ineligible pts with untreated mantle-cell lymphoma (MCL). We report the final overall survival and safety outcomes of pts in the long-term follow-up phase after the primary progression-free survival endpoint was achieved. Methods: Between May 2008 and July 2017, adult pts with confirmed stage II–IV MCL diagnosis, ECOG score of ≤ 2, who were treatment-naïve and ineligible for bone marrow transplantation, were randomized (1:1) to 6 or 8 (21-day) cycles of VR-CAP (rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, prednisone 100 mg/m2 plus bortezomib 1.3 mg/m2) or R-CHOP (rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, prednisone 100 mg/m2 and vincristine 1.4 mg/m2 [2 mg max]). Results: A total of 487 pts (VR-CAP: 244; R-CHOP: 243) were included in the ITT population. With a median follow-up of 82 months (241 events: VR-CAP, 42% versus R-CHOP, 57%), median overall survival improved significantly (Table) and was approximately 3 years longer in VR-CAP (90.7 months) vs R-CHOP group (55.7 months; HR 0.66 [0.51; 0.85]; P = 0.001). Fewer pts treated with VR-CAP (n = 104; 43%) required subsequent treatments versus R-CHOP (n = 151; 62%), twenty pts had second primary malignancies. A total of 268 pts (VR-CAP: 140; R-CHOP: 128) were included in the follow-up analysis. In addition to 3 adverse events (VR-CAP: grade 4 lung adenocarcinoma and grade 4 gastric cancer; R-CHOP: grade 2 pneumonia), three and five pts from the VR-CAP and R-CHOP groups, respectively, were reported to have a fatal outcome. Conclusions: VR-CAP demonstrated a statistically significant and robust survival benefit for transplant-ineligible patients with untreated MCL, along with an expected and manageable safety profile in this patient population. Clinical trial identification: NCT00722137. Editorial acknowledgement: Editorial assistance provided by Dr. Namit Ghildyal, Janssen R&D. Legal entity responsible for the study: Janssen Research & Development, LLC, USA. Funding: Janssen Research & Development, LLC, USA. Disclosure: N. Siritanaratkul: Research grants: Roche, Janssen-Cilag, during the conduct of the study. M. Raderer: Research grant: Celgene; Personal fees: Ipsen, Novartis. J. Mayer: Research grant: Janssen; Research and Development: Novartis, Eisai. R. Okamoto: Honoraria: Chugai, Kissei. S. Nakahara: Employee: Janssen Pharmaceutical K.K., Japan; Stock: Johnson & Johnson. P. Hu, C. Appiani, S. Nemat: Employee: Janssen R&D; Stock: Johnson & Johnson. T. Robak: Grant funding: Janssen Research and Development. All other authors have declared no conflicts of interest.