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808 | PHASE 1b/2 STUDY OF MAPLIRPACEPT (PF‐07901801), TAFASITAMAB, AND LENALIDOMIDE IN TRANSPLANT‐INELIGIBLE RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA PARTICIPANTS
Adam J. Olszewski, Koichi Aizawa, Yasmin Karimi, Dahlia Sano, Sung Yong Oh, Alexander Neuhof, Dalila Bouyoucef‐Cherchalli, J. Wang, Andrew B. SyBing, Macarena Rodríguez‐Fraile, Victor T. G. Lin
Hematological Oncology
초록

A. J. Olszewski, K. Aizawa, Y. H. Karimi, D. Sano, S. Y. Oh, A. Neuhof, D. Bouyoucef-Cherchalli, J. Wang, A. SyBing, M. Rodriguez, and V. T. G. Lin equally contributing author. Introduction: Although advances in adaptive, T cell-engaging immunotherapy have improved the prognosis of patients (pts) with relapsed/refractory diffuse large B cell lymphoma (R/R DLBCL), activation of innate immunity is a novel therapeutic approach. Maplirpacept is a recombinant SIRPα-blocking fusion protein designed to enhance phagocytosis and antitumor activity by disrupting inhibitory CD47-SIRPα signaling and has shown preliminary efficacy against DLBCL. This Phase 1b/2 study (NCT05626322) aimed to evaluate the safety, tolerability, and clinical benefits of the maplirpacept, tafasitamab, and lenalidomide combination in R/R DLBCL pts who are ineligible for high-dose chemotherapy (HDC) and/or autologous stem cell transplantation (ASCT). Results from the Ph1b trial are presented. Methods: Pts were aged ≥ 18 years with histologically confirmed R/R DLBCL, had ≥ 1 line of prior systemic treatment (tx; including an anti-CD20 containing regimen), and were not candidates for HDC/ASCT. Pts received maplirpacept IV 4 mg/kg, 10 mg/kg or 18 mg/kg + tafasitamab IV 12 mg/kg + lenalidomide 25 mg orally. For Ph1b, the primary objective was evaluation of dose-limiting toxicities (DLTs) during the 28-day DLT observation period; secondary objectives were safety, antitumor activity, pharmacokinetics (PK) and immunogenicity. Results: At data cut-off (December 13, 2024), 6 pts were evaluable for safety, and 5 were evaluable for DLTs. Median age was 58.5 years (range 40–81), 3 pts were male, 2 had bulky disease (longest diameter ≥ 7.5 cm), 3 had > 1 prior lymphoma-directed tx. No pts experienced DLT. Tx-emergent adverse events (TEAEs) of grade (G) ≥ 3 experienced by ≥ 2 pts were neutropenia (4 pts), thrombocytopenia, sepsis, and urinary tract infection (2 pts each). Maplirpacept tx-related AEs (TRAEs) G ≥ 3 were neutropenia (2 pts), thrombocytopenia and anemia (1 pt each). Three pts experienced serious AE (SAE); sepsis was the only SAE reported in > 1 pt. One TR-SAE (leukemia) resulted in death, unrelated to maplirpacept; a second death (cardiac arrest) occurred > 28 days after the last tx dose and was deemed unrelated to study tx. No TEAEs led to study tx discontinuation. TRAEs leading to dose interruption of maplirpacept were reported in 2 pts. Objective responses were observed in 4 pts, and all were complete responses; 1 pt had stable disease. The median duration of response was 9.6 mos; median progression free survival was 11.4 mos; median duration of tx with maplirpacept was 37 wks. Maplirpacept PK concentrations were consistent with previous datasets. No pts experienced anti-drug antibodies. Conclusions: Addition of maplirpacept to tafasitamab and lenalidomide showed clinical activity and tolerable safety profile in pts with R/R DLBCL. Although this trial was discontinued due to enrollment challenges, further development of maplirpacept for R/R DLBCL continues in NCT05896163. A genAI tool (Feb25; Pfizer; GPT-4o) developed draft 1; authors assume content responsibility. Research funding declaration: The study is sponsored by Pfizer. Medical writing support was provided by Haniya Javaid, BSc, of Engage Scientific Solutions, and funded by Pfizer. A Pfizer proprietary AI tool was used with author review to develop the first draft (February 2025); authors take full responsibility for the content. Keyword: immunotherapy Potential sources of conflict of interest: A. J. Olszewski Consultant or advisory role: Genmab, Blue Cross and Blue Shield of Rhode Island, Schrodinger, ADC Therapeutics, BeiGene, Bristol-Myers Squibb Other remuneration: Research Funding: Genentech/Roche, Precision Biosciences, Genmab, Artiva, Pfizer, Kymera Y. H. Karimi Consultant or advisory role: Yes Honoraria: Yes Other remuneration: Speakers Bureau, and Research Funding A. Neuhof Employment or leadership position: Pfizer employee Stock ownership: Yes D. Bouyoucef-Cherchalli Employment or leadership position: Pfizer employee Stock ownership: Yes J. Wang Employment or leadership position: Pfizer employee A. SyBing Employment or leadership position: Pfizer employee M. Rodriguez Employment or leadership position: Pfizer employee Stock ownership: Yes

키워드
LenalidomideMedicineRefractory (planetary science)Diffuse large B-cell lymphomaLymphomaPhases of clinical researchOncologyInternal medicineMaterials scienceChemotherapy
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2025

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