| アブストラクト | Background: Teclistamab plus daratumumab (Tec-Dara) was approved in March 2026 for relapsed or refractory multiple myeloma, but infections are frequent. We hypothesized that dual BCMA- and CD38-directed immune depletion causes infectious toxicity exceeding that expected from either agent alone. Methods: In the FDA Adverse Event Reporting System (FAERS; Q4 2022-Q4 2025; all combination reports pre-approval), we compared reports listing both agents (n = 353) with teclistamab-only (n = 2774) and daratumumab-only (n = 19,230) reports. Interaction was quantified as Omega = ROR(combination)/(ROR(teclistamab) x ROR(daratumumab)), where ROR is the reporting odds ratio, with sensitivity analyses addressing calendar period, sparse counts, comparator, and confounding. Results: Pneumonia (Omega, 1.50; 95% CI, 1.06-2.12) and influenza (Omega, 2.63; 95% CI, 1.20-5.77) were reported more often than expected. The pneumonia estimate increased against a myeloma-restricted background and after covariate adjustment, but was no longer statistically significant after excluding reports co-listing immunomodulatory drugs or proteasome inhibitors or with a relapsed-disease daratumumab comparator. Cytokine release syndrome, neurotoxicity, and cytopenias were reported less often than expected, a reporting pattern rather than protection. A bone marrow failure signal rested on few reports and is hypothesis-generating only. Conclusions: Consistent with our hypothesis, Tec-Dara was associated with higher-than-expected reporting of respiratory infections, although confounding by treatment population cannot be excluded. Any new respiratory symptom or fever warrants same-day evaluation. |
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| ジャーナル名 | Cancers |
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| Pubmed追加日 | 2026/10/27 |
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| 投稿者 | Awadallah, Carmel; Irfan, Sohaib; Abdallah, Al-Ola; Bilal Abid, Muhammad |
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| 組織名 | Department of Internal Medicine, St. John's Episcopal Hospital, New York, NY;11691, USA.;Department of Internal Medicine, Landmark Medical Center, Woonsocket, RI 02895,;USA.;Division of Hematologic Malignancies and Cellular Therapeutics, Department of;Internal Medicine, University of Kansas Medical Center, Kansas City, KS 66160,;Stem Cell Transplantation and Cellular Immunotherapy Program, Department of;Hematology/Oncology, UMC TLC2 Foundation Cancer Center, Texas Tech University;Health Sciences Center, Lubbock, TX 79430, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42938920/ |
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