Pf628 O-12-M1: An Evaluation of Time to Next Treatment in Melflufen and Dexamethasone-Treated Patients With Relapsed/Refractory Multiple Myeloma

Bringhen, Sara; Richardson, Paul G.; Voorhees, Peter M.; Plesner, Trine Lindhardt; Mellqvist, U-H; Zonder, J.; Reeves, Brandi; Zavisic, Stojan; Harmenberg, Johan; Obermüller, Jakob; Sonneveld, Pieter

doi:10.1097/01.hs9.0000560796.93881.5c

Cited by 2 publications

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“…The Phase II part assessed the activity of melflufen in 45 patients with late-stage RRMM who had received a median of four prior lines of treatment and who were refractory to both lenalidomide (an IMiD) and bortezomib (a PI). Melflufen + dexamethasone treatment resulted in disease stabilization in the majority of patients, with a favorable median time to next treatment and ORR [26]. Furthermore, the clinical response observed in this study was durable, which is promising given the advanced nature of the disease in these patients [26].…”

Section: Clinical Development Of Melflufenmentioning

confidence: 58%

“…Melflufen + dexamethasone treatment resulted in disease stabilization in the majority of patients, with a favorable median time to next treatment and ORR [26]. Furthermore, the clinical response observed in this study was durable, which is promising given the advanced nature of the disease in these patients [26]. The safety profile of melflufen in the O-12-M1 study demonstrated predictable and manageable adverse events (AEs), with the most common being grade 3 and 4 hematological AEs and low rates of non-hematological AEs [26].…”

Section: Clinical Development Of Melflufenmentioning

confidence: 98%

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OCEAN: a randomized Phase III study of melflufen + dexamethasone to treat relapsed refractory multiple myeloma

et al. 2020

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Melflufen is a novel peptide–drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. It has emerged as a potential new multiple myeloma treatment, particularly for late-stage forms of the disease. Here we describe the rationale and design of OCEAN (NCT03151811), a randomized, head-to-head, superiority, open-label, global, Phase III study evaluating the efficacy and safety of melflufen + dexamethasone versus pomalidomide + dexamethasone. Eligible patients with relapsed refractory multiple myeloma have received 2–4 previous treatments and are refractory to both lenalidomide and their last treatment. Patients are excluded if they have previously received pomalidomide. The primary endpoint is progression-free survival, and key secondary endpoints include overall response rate, duration of response and overall survival.

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Section: Clinical Development Of Melflufenmentioning

confidence: 58%

Section: Clinical Development Of Melflufenmentioning

confidence: 98%

OCEAN: a randomized Phase III study of melflufen + dexamethasone to treat relapsed refractory multiple myeloma

et al. 2020

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“…Melflufen is generally well tolerated, with the most common grade 3–4 AEs being hematologic and low frequencies of non-hematologic AEs [ 1 , 41 , 45 , 46 ]. While rates of neutropenia (54–79%), thrombocytopenia (63–76%), and anemia (43%) were high, grade 3 (1–16%) and 4 (0–3%) bleeding events are low [ 2 , 42 ].…”

Section: Melflufenmentioning

confidence: 99%

The Role of Belantamab Mafodotin, Selinexor, and Melflufen in Multiple Myeloma

McCurdy

Visram

2022

Curr Hematol Malig Rep

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Purpose of Review Multiple myeloma (MM) is a hematologic malignancy of plasma cells that remains incurable with currently available therapies including proteosome inhibitors, immunomodulators, monoclonal antibodies, corticosteroids, and alkylators, in addition to autologous stem cell transplantation in patients who are eligible. Novel therapeutics are therefore required to improve patient outcomes. The goal of this paper is to review the role of three new agents in the MM treatment landscape: belantamab mafodotin, selinexor, and melflufen. Recent Findings All three agents have demonstrated clinical activity in patients with MM. Belamaf is the first FDA-approved anti-BCMA targeted agent, showing single-agent response rates of 60% and higher response rates of 48–100% in combinations. The majority of patients treated with belamaf experience corneal toxicity which remains the main challenge with its use; however, fortunately, the vast majority of patients recover. Selinexor is also FDA approved for the treatment of relapsed MM, with single-agent response rates of 26% and combination rates of 48–65%. Gastrointestinal side effects are common with selinexor use, with roughly 65% of patients experiencing nausea, 50% anorexia, 35% vomiting, and 42% diarrhea, the majority of which are grades 1–2. Both agents have a plethora of ongoing clinical trials with data forthcoming on various combinations with standard backbone agents as well as additional novel treatments. While melflufen showed promising initial data showing single-agent response rates of about 30%, inferior survival outcomes in patients previously treated with ASCT in the phase 3 OCEAN study lead to early termination of the trial and subsequent removal from the US market. Summary Belamaf, selinexor, and melflufen are active agents to treat myeloma. Belamaf and selinexor are current options for the treatment of relapsed multiple myeloma with improved response rates and durability when used in triplet combinations. The optimal timing of use and treatment combinations of both agents in the context of additional immunotherapeutics entering the MM landscape requires further study. Many prospective studies are in development and promise to afford further clarity in the near future.

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Pf628 O-12-M1: An Evaluation of Time to Next Treatment in Melflufen and Dexamethasone-Treated Patients With Relapsed/Refractory Multiple Myeloma

Abstract: Nausea/Vomiting and Diarrhea subscales, while consistently worse for ixazomib than placebo (LS mean [95% CI] change at interval 24, 5.

Cited by 2 publications

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OCEAN: a randomized Phase III study of melflufen + dexamethasone to treat relapsed refractory multiple myeloma

OCEAN: a randomized Phase III study of melflufen + dexamethasone to treat relapsed refractory multiple myeloma

The Role of Belantamab Mafodotin, Selinexor, and Melflufen in Multiple Myeloma

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