KEY TAKEAWAYS
- Phase 3 trial of MagnetisMM-5 aimed to evaluate the efficacy and safety of elranatamab monotherapy in RRMM patients admitted to an emergency department.
- The study’s primary endpoint is progression-free survival according to the International Myeloma Working Group response criteria.
- The combination of ED is supported by the postulated dual mechanisms of action of daratumumab, which contributes to antitumor response and enhanced elranatamab efficacy.
The objective of the MagnetisMM-5 study is to evaluate the effectiveness and safety of elranatamab monotherapy in patients with RRMM who are inpatients at an emergency department. Part 1 of MagnetisMM-5, the safety lead-in cohort, demonstrated that ED is practical, well tolerated, and can be administered safely with the recommended single-agent dose (Grosicki et al., Blood, 2022).
Part 2 of MagnetisMM-5 (NCT05020236) is an ongoing, multicenter, open-label, randomized phase 3 study enrolling 555 patients. Patients are randomized 1:1:1 to receive subcutaneous elranatamab, ED, or daratumumab +pomalidomide + dexamethasone (DPd). Daratumumab is subcutaneously administered. Prior lines of therapy (1 vs. 2–3) and prior treatment with CD38-directed therapy (yes vs. no) are used to stratify patients. The primary endpoint is progression-free survival (PFS) according to the International Myeloma Working Group (IMWG) response criteria. Secondary endpoints include overall survival, progression-free survival (PFS) on second-line therapy according to IMWGresponse criteria, objective response rate, duration of response, complete response (CR) rate, duration of CR, time to reply, overall and sustained minimal residual disease negativity rates, safety, quality of life, immunogenicity, and pharmacokinetics. Essential inclusion criteria are age 18, an MM diagnosis with measurable disease per IMWG criteria, and an ECOG performance status of 0–2. Patients must have previously received anti-myeloma treatment, including lenalidomide and a proteasome inhibitor. Essential exclusion criteria include smoldering multiple myeloma, plasma cell leukemia, amyloidosis, POEMS syndrome, stem cell transplant within 12 weeks of enrollment or active graft versus host disease, active, uncontrolled bacterial, fungal, or viral infections, prior treatment with BCMA-directed therapy, and CD38-directed therapy within 6 months of the first dose of study treatment. MagnestisMM-5 is recruiting institutions from 23 nations.
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT05020236
Xavier Leleu, Shinsuke Iida, C. Ola Landgren, Alexander Lesokhin, Eric Leip, Arthur Kudla, Gregory Finn, lugui qiu/ELRANATAMAB MONOTHERAPY OR IN COMBINATION WITH DARATUMUMAB VS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE FOR PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: PHASE 3 MAGNETISMM-5 STUDY, PART 2/Inc, M. G. (n.d.). ELRANATAMAB MONOTHERAPY OR IN COMBINATION WITH DARATUMUMAB VS… by Dr. Xavier Leleu. Library.ehaweb.org. Retrieved July 15, 2023, from https://library.ehaweb.org/eha/2023/eha2023-congress/386759/xavier.leleu.elranatamab.monotherapy.or.in.combination.with.daratumumab.vs.html?f=menu%3D16%2Abrowseby%3D8%2Asortby%3D2%2Ace_id%3D2489%2Aot_id%3D27922%2Atrend%3D4016%2Amarker%3D4178
