Orlowski, R.Z. (Robert Z.)

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    Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study
    (2020) Moreau, P. (Philippe); Lonial, S. (Sagar); Weisel, K. (Katja); Matsumoto, M. (Morio); Anderson, K. (Kenneth C.); You, Y.M. (Ying-Ming); Walter-Croneck, A. (Adam); Oakervee, H. (Heather); Magen, H. (Hila); Mateos, M.V. (María Victoria); Spicka, I. (Ivan); Beksac, M. (Meral); Shpilberg, O. (Ofer); Einsele, H. (Hermann); White, D.J. (Darrell J.); Reece, D. (Donna); Singhal, A.K. (Anil K.); Spencer, A. (Andrew); Dimopoulos, M.A. (Meletios A.); Ganetsky, A. (Alex); Richardson, P.G. (Paul G.); Wu, K.L. (Ka Lung); Orlowski, R.Z. (Robert Z.); Shpilberg, O. (Ofer); Taniwaki, M. (Masafumi); Röllig, C. (Christoph); Belch, A. (Andrew); San-Miguel, J.F. (Jesús F.)
    Prolonging overall survival (OS) remains an unmet need in relapsed or refractory multiple myeloma (RRMM). In ELOQUENT-2 (NCT01239797), elotuzumab plus lenalidomide/dexamethasone (ERd) significantly improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd) in patients with RRMM and 1–3 prior lines of therapy (LoTs). We report results from the pre-planned final OS analysis after a minimum follow-up of 70.6 months, the longest reported for an antibody-based triplet in RRMM. Overall, 646 patients with RRMM and 1–3 prior LoTs were randomized 1:1 to ERd or Rd. PFS and overall response rate were co-primary endpoints. OS was a key secondary endpoint, with the final analysis planned after 427 deaths. ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68–1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups. No additional safety signals with ERd at extended follow-up were reported. ERd is the first antibody-based triplet regimen shown to significantly prolong OS in patients with RRMM and 1–3 prior LoTs. The magnitude of OS benefit was greatest among patients with adverse prognostic factors, including older age, ISS stage III, IMWG high-risk disease, and 2–3 prior LoTs.
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    Overall survival with daratumumab, lenalidomide, and dexamethasone in previously treated multiple myeloma (POLLUX): a randomized, open-label, phase III trial
    (2023) Moreau, P. (Philippe); Carey, J. (Jodi); Ahmadi, T. (Tahamtan); Yoon, S.S. (Sung-Soo); Gai, X. (Xue); Usmani, S.Z. (Saad Z.); Ben-Yehuda, D. (Dina); Bahlis, N.J. (Nizar J.); Reece, D. (Donna); Nahi, H. (Hareth); Suzuki, K. (Kenshi); Rabin, N. (Neil); Goldschmidt, H. (Hartmut); Dimopoulos, M.A. (Meletios A.); Richardson, P.G. (Paul G.); Oriol, A. (Albert); Orlowski, R.Z. (Robert Z.); Garvin-Mayo, W. (Wendy); Carson, R. (Robin); Qin, X. (Xiang); Plesner, T. (Torben); San-Miguel, J.F. (Jesús F.)
    Purpose: With the initial analysis of POLLUX at a median follow-up of 13.5 months, daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly prolonged progression-free survival versus lenalidomide and dexamethasone (Rd) alone in patients with relapsed or refractory multiple myeloma (RRMM). We report updated efficacy and safety results at the time of final analysis for overall survival (OS). Methods: POLLUX was a multicenter, randomized, open-label, phase III study during which eligible patients with ¿ 1 line of prior therapy were randomly assigned 1:1 to D-Rd or Rd until disease progression or unacceptable toxicity. After positive primary analysis and protocol amendment, patients receiving Rd were offered daratumumab monotherapy after disease progression. Results: Significant OS benefit was observed with D-Rd (hazard ratio, 0.73; 95% CI, 0.58 to 0.91; P = .0044) at a median (range) follow-up of 79.7 months (0.0-86.5). The median OS was 67.6 months for D-Rd compared with 51.8 months for Rd. Prespecified analyses demonstrated an improved OS with D-Rd versus Rd in most subgroups, including patients age ¿ 65 years and patients with one, two, or three prior lines of therapy, International Staging System stage III disease, high-risk cytogenetic abnormalities, and refractoriness to their last prior line of therapy or a proteasome inhibitor. The most common (¿ 10%) grade 3/4 treatment-emergent adverse events with D-Rd versus Rd were neutropenia (57.6% v 41.6%), anemia (19.8% v 22.4%), pneumonia (17.3% v 11.0%), thrombocytopenia (15.5% v 15.7%), and diarrhea (10.2% v 3.9%). Conclusion: D-Rd significantly extended OS versus Rd alone in patients with RRMM. To our knowledge, for the first time, our findings, together with the OS benefit observed with daratumumab plus bortezomib and dexamethasone in the phase III CASTOR trial, demonstrate OS improvement with daratumumab-containing regimens in RRMM (ClinicalTrials.gov identifier: NCT02076009 [POLLUX]).