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Cobimetinib Alone a...
Cobimetinib Alone and Plus Venetoclax With/Without Atezolizumab in Patients With Relapsed/Refractory Multiple Myeloma
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Schjesvold, F. (författare)
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Paiva, B. (författare)
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Ribrag, V. (författare)
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Rodriguez-Otero, P. (författare)
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San-Miguel, J. F. (författare)
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Robak, P. (författare)
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- Hansson, Markus (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition
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Onishi, M. (författare)
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Hamidi, H. (författare)
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Malhi, V. (författare)
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Dail, M. (författare)
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Javery, A. (författare)
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Ku, G. (författare)
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Raab, M. S. (författare)
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(creator_code:org_t)
- Elsevier BV, 2023
- 2023
- Engelska.
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Ingår i: Clinical Lymphoma, Myeloma and Leukemia. - : Elsevier BV. - 2152-2650. ; 23:1
- Relaterad länk:
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Introduction: Mitogen-activated protein kinase pathway mutations are present in >50% of patients with relapsed/refractory (R/R) multiple myeloma (MM). MEK inhibitors show limited single-agent activity in R/R MM; combination with B-cell lymphoma-2 (BCL-2) and programmed death-ligand 1 inhibition may improve efficacy. This phase Ib/II trial (NCT03312530) evaluated safety and efficacy of cobimetinib (cobi) alone and in combination with venetoclax (ven) with/without atezolizumab (atezo) in patients with R/R MM. Patients and Methods: Forty-nine patients were randomized 1:2:2 to cobi 60 mg/day on days 1–21 (n = 6), cobi 40 mg/day on days 1–21 + ven 800 mg/day on days 1–28 with/without atezo 840 mg on days 1 and 15 of 28-day cycles (cobi-ven, n = 22; cobi-ven-atezo, n = 21). Safety run-in cohorts evaluated cobi-ven and cobi-ven-atezo dose levels. Results: Any-grade common adverse events (AEs) with cobi, cobi-ven, and cobi-ven-atezo, respectively, included diarrhea (33.3%, 81.8%, 90.5%) and nausea (16.7%, 50.0%, 66.7%); common grade ≥3 AEs included anemia (0%, 22.7%, 23.8%), neutropenia (0%, 13.6%, 38.1%), and thrombocytopenia (0%, 18.2%, 23.8%). The overall response rate for all-comers was 0% (cobi), 27.3% (cobi-ven), and 28.6% (cobi-ven-atezo), and 0%, 50.0%, and 100%, respectively, in patients with t(11;14)+. Biomarker analysis demonstrated non-t(11;14) patient selection with NRAS/KRAS/BRAF mutation or high BCL-2/BCL-2-L1 ratio (>52% of the study population) could enrich for responders to the cobi-ven combination. Conclusions: Cobi-ven and cobi-ven-atezo demonstrated manageable safety with moderate activity in all-comers, and higher activity in patients with t(11;14)+ MM, supporting a biomarker-driven approach for ven in MM.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Nyckelord
- B-cell lymphoma-2
- Programmed death-ligand 1
- Biomarker
- Mitogen-activated protein kinase pathway
- Immunotherapy
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Schjesvold, F.
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Paiva, B.
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Ribrag, V.
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Rodriguez-Otero, ...
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San-Miguel, J. F ...
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Robak, P.
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visa fler...
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Hansson, Markus
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Onishi, M.
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Hamidi, H.
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Malhi, V.
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Dail, M.
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Javery, A.
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Ku, G.
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Raab, M. S.
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visa färre...
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