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- |||||||||| Tecvayli (teclistamab) / Genmab, J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J, Talvey (talquetamab) / J&J
New P3 trial, Combination therapy: MajesTEC-7: A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - Sep 23, 2022
P3, N=1030, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- || Darzalex (daratumumab) / J&J, Tecvayli (teclistamab) / Genmab, J&J, linvoseltamab (REGN5458) / Regeneron
There are so many. It’s hard to choose. The regn-5458 is really interesting given the low rates of crs. The trimm protocols combining teclistamab and daratumumab are extremely interesting as the bispecifics are great on their own but likely far better in combination (Twitter) - Sep 22, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
FDA event, Interview: @RahulBanerjeeMD spoke with @szusmani, senior author on the MajesTEC-1 trial about the road ahead for teclistamab after FDA approval. Read the full interview on Nucleus: https://t.co/uJTYfTXW9t (Twitter) - Sep 21, 2022
- ||||| Tecvayli (teclistamab) / Genmab, J&J
FDA event, Interview: Pleasure interviewing @szusmani for this @ASTCT @Emerging_CAR_T piece about teclistamab. It’s been “TEC’ing” forever for FDA approval, but lots to learn about fixed-duration bsAbs in #MMsm, infectious PPx with BCMA, and more! https://t.co/JXOqdBEkfO (Twitter) - Sep 15, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Also EU approval mandates only '3 prior therapies' for Tecvayli, unlike CAR-T which need 4 lines of Rx failures.. So pts can get Tec before CAR-T ? Important in this age of frontline quad regimens.. (Twitter) - Sep 12, 2022
- || Tecvayli (teclistamab) / Genmab, J&J, Blenrep (belantamab mafodotin) / GSK
good point. Teclistamab REMS should be less onerous than Belantamab .. (Twitter) - Sep 12, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
Teclistamab gonna be used a lot in the community… (Twitter) - Sep 12, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
With Teclistamab approval soon, not a bad idea for general Onc to be aware of CRS mgmt . (Twitter) - Sep 10, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
Yes, not completely the same, but equal. Janssen or J&J seem to avoid the german benefit program for teclistamab at the moment. (Twitter) - Sep 9, 2022
- || Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
Enrollment change: RedirecTT-1: A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Sep 9, 2022
P1b, N=102, Recruiting, Sponsor: Janssen Research & Development, LLC
N=56 --> 102
- |||||||||| Tecvayli (teclistamab) / Genmab, J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
New P3 trial, Combination therapy: A randomized phase 3 study of Teclistamab in combination withdaratumumab and lenalidomide versus a combination of daratumumab, lenalidomide and dexamethasone in new multiple myeloma patients who cannot undergo stem cell transplant as the first therapy. (EUDRACT) - Sep 8, 2022
P3, N=1030, Ongoing, Sponsor: Janssen-Cilag International NV
- ||| Darzalex (daratumumab) / J&J, Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial completion date, Trial initiation date, Trial primary completion date: MASTER-2: Sequential Therapy in Multiple Myeloma Guided by MRD Assessments (clinicaltrials.gov) - Sep 1, 2022
P2, N=300, Not yet recruiting, Sponsor: University of Alabama at Birmingham
N=56 --> 102 Trial completion date: Apr 2027 --> Dec 2027 | Initiation date: Aug 2022 --> Dec 2022 | Trial primary completion date: Apr 2026 --> Dec 2026
- |||||| Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Tecvayli (teclistamab) / Genmab, J&J, talquetamab (JNJ-64407564) / J&J
Clinical: Started treatment of pts post Abecma using Teclistimab @KUcancercenter @KUHospital I am seeing positive results.A NEW HOPE. 🙏 @JanssenUS that made it easier to access it for our myeloma pts here at #Kansas; hopefully will have access to Talquetamab soon #mmsm #USMIRC #MedTwitter (Twitter) - Aug 30, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
in community , hands down Teclistamab .. (Twitter) - Aug 29, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
FDA event: It's only a matter of time and Teclistimab will receive approval this week from FDA. Though will what will be ur first choice in heavily treated RRMM? #mmsm #MedTwitter #medEd #USMIRC #Myeloma (Twitter) - Aug 29, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Janssen consigue la primera aprobación mundial de teclistamab 💊 para el tratamiento de pacientes con #mielomamúltiple ➡️Los resultados demuestran que el tratamiento produjo respuestas duraderas @JanssenESP @ComisionEuropea @mvmateos @DrEdmondChan https://t.co/2Uj7jFB70s (Twitter) - Aug 29, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
#Laboratorios 🧫 | Janssen consigue la primera aprobación mundial de #teclistamab 💊 para el tratamiento de #pacientes con #mielomamúltiple https://t.co/V9RSpm9Jf4 @mvmateos @JanssenEMEA @JanssenESP (Twitter) - Aug 28, 2022
- ||||| Tecvayli (teclistamab) / Genmab, J&J
NICE, P1 data: Great to see an effective immunotherapy drug like Teclistamab move from phase 1 to license for relapsed myeloma. Waiting for UK and NICE approvals now, in the meantime we still have lots to learn about how best to use this. #mmsm (Twitter) - Aug 27, 2022
- ||||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Teclistamab displayed deep and durable responses with a manageable safety profile in patients with prior exposure to BCMA-targeted agents @szusmani @MSKCancerCenter #mmsm #EHA22 https://t.co/GISz7t5VrR (Twitter) - Aug 27, 2022
- ||||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: @End_myeloma = Luciano Costa discussed MRD based treatment strategies in NDMM and presented his MASTER2 trial integrating Teclistamab and investigating the role of ASCT in MRD- patients @Myeloma_Society #IMS2022 (Twitter) - Aug 26, 2022
- |||||| Tecvayli (teclistamab) / Genmab, J&J
European regulatory: Earlier today, we had the opportunity to speak with Maria-Victoria Mateos (@mvmateos) of @usal about a range of topics including the practice-changing approval of teclistamab by the European Commission 💡 @Myeloma_Society #IMS2022 #MMSM #Myeloma #MultipleMyeloma #ImmunoOnc #CART (Twitter) - Aug 25, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Well done #myeloma RT @DrOlaLandgren: Teclistamab BCMA-CD3 targeted bispecific monoclonal antibody was just approved in Europe for the treatment of multi… https://t.co/TigZQDvcc1 (Twitter) - Aug 25, 2022
- ||||| Tecvayli (teclistamab) / Genmab, J&J
European regulatory, FDA event: The European Commission granted a Conditional Marketing Authorization for Teclistimab in myeloma. First in class bispecific antibody. Good news. Hope FDA approval follows soon. @Mohty_EBMT @szusmani #IMS2022 https://t.co/UUOw4UsboM (Twitter) - Aug 25, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Approval for teclistamab with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma | Great news for patients and for the myeloma community https://t.co/ouqLVJn1F1 (Twitter) - Aug 25, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Teclistamab BCMA-CD3 targeted bispecific monoclonal antibody was just approved in Europe for the treatment of multiple myeloma. A huge step forward for individual patients and for the field overall! #mmsm @IMFmyeloma @theMMRF @healthtreeforMM @SylvesterCancer (Twitter) - Aug 24, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: .@szusmani, of @MSKCancerCenter, discusses key efficacy findings that support the use of teclistamab in patients with relapsed/refractory multiple myeloma who have had prior exposure to BCMA-targeted agents. #mmsm #EHA22 https://t.co/gpePq8HA8c (Twitter) - Aug 24, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
Dara + Teclistamab ORR 76.5 VGPR 70.6 -prior CD38 exposure- ORR 70% MAJESTIC -3 data will be interesting (Twitter) - Aug 17, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamab Demonstrates Durable Response Rates in BCMA-Pretreated Multiple Myeloma @szusmani @MSKCancerCenter @EHA_Hematology #mmsm #EHA22 https://t.co/BAMCb20b45 (Twitter) - Aug 15, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
#Teclistamab in #Relapsed or Refractory #MultipleMyeloma 👇 A nice addition to existing therapies! 👉https://t.co/6OTuSXt4uf @CHUnantes🇫🇷| @Szusmani @DoctorAKrishnan #CD3 (Twitter) - Aug 15, 2022
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J, Talvey (talquetamab-tgvs) / J&J
Trial completion date, Combination therapy, Checkpoint inhibition: TRIMM-3: A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Aug 15, 2022
P1b, N=152, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Apr 2027 --> Dec 2027 | Initiation date: Aug 2022 --> Dec 2022 | Trial primary completion date: Apr 2026 --> Dec 2026 Trial completion date: Sep 2024 --> Oct 2025
- | Tecvayli (teclistamab) / Genmab, J&J
Journal: Teclistamab in Relapsed or Refractory Multiple Myeloma. (Pubmed Central) - Aug 14, 2022
P1, P2
Cytopenias and infections were common; toxic effects that were consistent with T-cell redirection were mostly grade 1 or 2. (Funded by Janssen Research and Development; MajesTEC-1 ClinicalTrials.gov numbers, NCT03145181 and NCT04557098.).
- Darzalex (daratumumab) / J&J, Tecvayli (teclistamab) / Genmab, J&J
Adjusted comparison of teclistamab versus physician’s choice of therapy in the long-term follow-up of daratumumab trials in patients with triple-class exposed relapsed or refractory multiple myeloma () - Aug 13, 2022 - Abstract #IMW2022IMW_517;
P2
(Funded by Janssen Research and Development; MajesTEC-1 ClinicalTrials.gov numbers, NCT03145181 and NCT04557098.). Teclistamab showed significantly improved effectiveness vs physician’s choice of therapy for all clinical outcomes, highlighting its clinical benefit in pts with TCE RRMM who have limited treatment options.
- Tecvayli (teclistamab) / Genmab, J&J
Matching-adjusted indirect treatment comparison (MAIC) of teclistamab vs approved therapies for the treatment of patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) () - Aug 13, 2022 - Abstract #IMW2022IMW_499;
P2, P2b
This study estimated the comparative efficacy of teclistamab vs belantamab mafodotin (bel) and selinexor-dexamethasone (sel-dex) for the treatment of patients (pts) with RRMM who were TCE to an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. These analyses demonstrated improved efficacy of teclistamab vs bel or sel-dex for most outcomes, highlighting the clinical benefit of teclistamab over these approved therapies in pts with TCE RRMM who received ≥3 prior LOT.
- Tecvayli (teclistamab) / Genmab, J&J
Comparative effectiveness of teclistamab versus real-world physician’s choice of therapy for patients with triple-class exposed relapsed/refractory multiple myeloma () - Aug 13, 2022 - Abstract #IMW2022IMW_487;
P2
Teclistamab showed improved effectiveness for OS, PFS, and TTNT compared with real-world physician’s choice of therapy in patients with TCE RRMM who received ≥3 prior LOT. These findings highlight the clinical benefit of teclistamab in patients with TCE RRMM who have limited treatment options.
- elranatamab (PF-06863135) / Pfizer, Tecvayli (teclistamab) / Genmab, J&J, talquetamab (JNJ-64407564) / J&J
Infectious toxicities in patients treated with bispecific antibodies in multiple myeloma () - Aug 13, 2022 - Abstract #IMW2022IMW_352;
In a population with a high number of prior lines, BsAbs are safe. The high mortality from COVID is striking.
- Tecvayli (teclistamab) / Genmab, J&J, Blenrep (belantamab mafodotin) / GSK
A novel anti-BCMA lipid-based nanoparticle for multiple myeloma therapy () - Aug 13, 2022 - Abstract #IMW2022IMW_336;
Belantamab mafodotin, Teclistamab, and BCMA-targeting CART cells are prime examples of such therapies. The data from this research confirm, for the first time in MM, the feasibility of an off-the-shelf, anti-BCMA, tubulin toxin-carrying lipid nanoparticle as a potential future treatment for MM.
- Carvykti (ciltacabtagene autoleucel) / J&J
Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to BCMA-targeting bispecific antibody treatment (Petree Hall C) - Aug 13, 2022 - Abstract #IMW2022IMW_242;
P2
Cilta-cel induced favorable responses, DOR, and PFS in heavily pretreated MM patients with prior anti-BCMA BsAb exposure. These initial results may inform treatment plans, including sequencing and washout periods between agents targeting BCMA.
- ||| Tecvayli (teclistamab-cqyv) / Genmab, J&J
Enrollment open, IO biomarker: Immuno-PRISM (PRecision Intervention Smoldering Myeloma) (clinicaltrials.gov) - Aug 12, 2022
P2, N=51, Recruiting, Sponsor: Irene Ghobrial, MD
These initial results may inform treatment plans, including sequencing and washout periods between agents targeting BCMA. Not yet recruiting --> Recruiting
- |||| Tecvayli (teclistamab) / Genmab, J&J
Hematopoietic Cell Transplantation and Cell therapy - Issue #18 https://t.co/7dNFglzYDn Teclistamab for R/R MM @NEJM Vit D and CART @ASTCT_journal @RShouval @DrMiguelPerales TPO agonists post CART @BloodAdvances Toxicity for Idecel Race, ethnicity, obesity in CART @NiraliShahMD (Twitter) - Aug 11, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
Teclistamab + Dara? (Twitter) - Aug 11, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamab ( soon to be approved in Myeloma ) ancillary medicines - https://t.co/vnchTIbJWQ (Twitter) - Aug 8, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
Yea sounds like multi agent chemo or bispecifics. Heard Teclistamab May get approved next month or so.. (Twitter) - Aug 6, 2022
- | Tecvayli (teclistamab) / Genmab, J&J
Clinical Trial,Phase I, Journal: Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. (Pubmed Central) - Aug 6, 2022
P1
Not yet recruiting --> Recruiting Our findings show that PK simulations of early clinical data together with ex vivo cytotoxicity estimates can inform the identification of a bispecific antibody's therapeutic range.
- ||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamab in Relapsed or Refractory Multiple Myeloma | NEJM https://t.co/Rol8gviYPa (Twitter) - Aug 3, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
European regulatory, HEOR: "CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision" https://t.co/CPgAoqAK1x via @pharmaphorum.com #HEOR #MarketAccess (Twitter) - Aug 2, 2022
- || Tecvayli (teclistamab) / Genmab, J&J, talquetamab (JNJ-64407564) / J&J, Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
What's new in MM? Teclistamab, selinexor, and talquetamab updates! https://t.co/Sm33dwpUOC (Twitter) - Jul 31, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical, HEOR, Real-world evidence: Teclistamab Elicits Survival Benefit vs Real-World Treatment in Multiple Myeloma https://t.co/rR5kOHjFkj via @onclive (Twitter) - Jul 28, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
Einstein na #ASCO22 @hosp_einstein Falamos neste podcast sobre os trabalhos em Mieloma Multiplo na ASCO, incluindo o Determination e um pouco sobre Teclistamab! Isso tudo com nossa @NkMariana, medica do Grupo de Medicina de Precisão em MM. https://t.co/XZD6ecpxAV (Twitter) - Jul 27, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
FDA event, Monotherapy: Do you think FDA approval will have the same criteria for Teclistimab use: monotherapy and after 3 LOT? (Twitter) - Jul 23, 2022
- |||| Tecvayli (teclistamab-cqyv) / Genmab, J&J
New P2 trial, IO biomarker: Immuno-PRISM (PRecision Intervention Smoldering Myeloma) (clinicaltrials.gov) - Jul 23, 2022
P2, N=51, Not yet recruiting, Sponsor: Irene Ghobrial, MD