29 mei 2024:

Zie ook in gerelateerde artikelen over andere nieuwe medicijnen bij Myeloma - botkanker (Kahler)

29 mei 2024: Bron: Blood Cancer Journal 5 maart 2024

Uit een retrospectief onderzoek bij meerdere ziekenhuizen bij totaal 110 patiënten met zwaar voorbehandelde gevorderde Myeloma - botkanker (Kahler) geeft Teclistamab (CQYV)  ook in de klinische praktijk uitstekende resultaten. Van de 110 evalueerbare patiënten bereikte 51 procent van de patiënten een PR = gedeeltelijke remissie en zelfs 20 procent bereikten een CR = complete remissie binnen een tijdbestek van maximaal een jaar. In deze studie werden de resultaten al vrijgegeven na 3,5 maanden studie follow-up.

Dit is iets minder dan uit de twee studies bleek waarop de FDA - Food and Drug Administration hun toestemming in 2022 verleenden voor gebruik van Teclistamab (CQYV) in de klinische praktijk.

Uit twee studies met ook toen totaal 110 deelnemende patiënten met gevorderde zwaar voorbehandelde Multiple Myeloma - botkanker (Kahler) gaf Teclistamab (CQYV) een onafhankelijke remissie van 61,8% (95% BI: 52,1; 70,9).
Met een mediane follow-up van 7,4 maanden onder de patiënten waarbij een remissie optrad bedroeg het geschatte percentage dat de remissie duurde (DOR) 90,6% (95% BI: 80,3%, 95,7%) na 6 maanden en 66,5% (95% BI: 38,8%, 83,9%). %) na 9 maanden.  Klik hier voor het artikel waarbij de FDA toestemming verleende.

De toepassing van immunoglobuline verminderde het risico op infecties van graad 3 of hoger na 6 maanden (17% versus 43%). De mediane tijd tot zich ernstige infecties voordeden was 2 maanden. Maar door de immunoglobuline werden deze ernstige infecties grotendeels teruggedrongen en onder controle gebracht. (Zie ook dit artikel hoe infecties veroorzaakt door bispecifieke antilichamen kunnen worden voorkomen en behandeld) 

Zie deze grafiek voor de resultaten:

figure 1

Conclusie:

Al met al schrijven de onderzoekers dat ze met Teclistamab (CQYV)  een goed werkend en veelbelovend medicijn erbij hebben voor de behandeling van Myeloma - botkanker (Kahler) .

Het abstract van dit onderzoek is recent in Blood Cancer Journal en Nature gepubliceerd en als volledig verslag gratis te lezen of te downloaden.:

Mohan, M., Monge, J., Shah, N. et al. Teclistamab in relapsed refractory multiple myeloma: multi-institutional real-world study. Blood Cancer J. 14, 35 (2024). https://doi.org/10.1038/s41408-024-01003-z

Teclistamab in relapsed refractory multiple myeloma: multi-institutional real-world study

Blood Cancer Journal volume 14, Article number: 35 (2024) Cite this article



Abstract

The objective of our study was to report real-world data on the safety and efficacy of standard-of-care teclistamab in patients with relapsed/refractory multiple myeloma (MM). This is a multi-institutional retrospective cohort study and included all consecutive patients that received at least one dose of teclistamab up until August 2023. One hundred and ten patients were included, of whom, 86% had triple-class refractory disease, 76% penta-refractory disease, and 35% had prior exposure to B-cell maturation antigen (BCMA)-targeting therapies. The overall response rate (ORR) in our cohort was 62%, with a ≥ very good partial remission (VGPR) rate of 51%. The ORR in patients with and without prior BCMA-targeted therapies was 54% vs 67%, respectively (p = 0.23). At a median follow-up of 3.5 months (range, 0.39–10.92), the estimated 3 month and 6 month progression free survival (PFS) was 57% (95% CI, 48%, 68%) and 52% (95% CI, 42%, 64%) respectively. The incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) was 56% and 11% respectively, with grade ≥3 CRS and ICANS noted in 3.5% and 4.6% of patients respectively. 78 unique infections were diagnosed in 44 patients, with the incidence of all-grade and grade ≥3 infections being 40% vs 26% respectively. Primary prophylaxis with intravenous immunoglobulin (IVIG) was associated with a significantly lower infection risk on multivariate analysis (Hazard ratio 0.33; 95% CI 0.17, 0.64; p = 0.001).

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Article 17 May 2024

Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We thank our patients and families for the opportunity to be involved in their care and all the contribution to the advancement in the field. Acknowledgement of research support for the study: Advancing a Healthier Wisconsin Endowment-CTSI KL2 award (M.M). List of where and when the study has been presented in part elsewhere, if applicable: This work will be partly presented as an oral abstract at the 65th American Society of Hematology Annual Meeting and Exposition, Dec 9-12, 2023, San Diego, California.

Author information

Author notes

  1. These authors contributed equally: Meera Mohan, Jorge Monge, Nishi Shah.

  2. These authors jointly supervised this work: Carolina Schinke, Rajshekhar Chakraborty.

Authors and Affiliations

  1. Division of Hematology/Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA

    Meera Mohan, Vineel Bhatlapenumarthi, Anannya Patwari, Binod Dhakal & Anita D’Souza

  2. Division of Hematology/Oncology, Weill Cornell Medicine, New York, NY, USA

    Jorge Monge & Danny Luan

  3. Division of Hematological Malignancies, Department of Oncology, Montefiore Medical Center and Albert Einstein College of Medicine, New York, NY, USA

    Nishi Shah, Mark Forsberg & Dennis Cooper

  4. Multiple Myeloma and Amyloidosis Program, Columbia University, Herbert Irving Comprehensive Cancer Center, New York, NY, USA

    Metodi Balev, Divaya Bhutani, Suzanne Lentzsch & Rajshekhar Chakraborty

  5. Medical College of Wisconsin Medical School, Milwaukee, WI, USA

    Heloise Cheruvalath

  6. Myeloma Center, University of Arkansas for Medical Science, Little Rock, AR, USA

    Sharmilan Thanendrarajan, Maurizio Zangari, Samer Al-Hadidi & Carolina Schinke

  7. Division of Biostatistics, Institute of Health and Equity, Medical College of Wisconsin, Milwaukee, WI, USA

    Frits van Rhee & Aniko Szabo

Contributions

Conception and design: MM; JM; NS; CS; RC. Provision of study materials or patients: MM; JM; NS; DB; ST; BD; MZ; SA-H; DC; Sl; FvR; AD’S; AS; CS; RC. Collection and assembly of data: DL; MF; VB; MB; AP; HC. Data analysis and interpretation: MeM; CS; RC. Manuscript writing: MM; JM; NS; CS; RC. Final approval of manuscript: All authors.

Corresponding author

Correspondence to Rajshekhar Chakraborty.

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Competing interests

The authors declare no competing interests.

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multiple myeloma, botkanker, Kahler, Teclistamab (cqyv), intraveneus immunoglobuline, infecties, BCMA gerichte bispecifieke antilichamen (BiAb), CR - complete remissies, PR - gedeeltelijke remissies


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