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- Extramedullary disease ([VIRTUAL]) - Mar 26, 2022 - Abstract #EMN2022EMN_38;
Currently the unmet need for treatment of high risk myeloma including patients presenting with EMD is still unanswered. Based on experience among advanced patients are promising and novel immunotherapeutic approaches integrated into the induction may provide a breakthrough in this area(4,12).
- Darzalex (daratumumab) / J&J, teclistamab (JNJ-64007957) / Genmab, J&J
COMBINATION OF SUBCUTANEOUS TECLISTAMAB WITH DARATUMUMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): RESULTS FROM A PHASE 1B MULTICOHORT STUDY ([VIRTUAL]) - Mar 26, 2022 - Abstract #EMN2022EMN_18;
P1b
The combination of Tec + Dara had a manageable safety profile and showed preliminary efficacy in pretreated pts with MM. These findings warrant further investigation, and the randomized phase 3 MajesTEC-3 study will evaluate Tec + Dara vs Dara, pomalidomide, and dexamethasone or Dara, bortezomib, and dexamethasone in pts with RRMM.
- ||| elranatamab (PF-06863135) / Pfizer, teclistamab (JNJ-64007957) / Genmab, J&J, TNB-383B / AbbVie
🗳️ POST-test poll 4️⃣#BonumCE 🆓#CME👉 https://t.co/56bTeu3UNB ❓Compared w MajesTEC-1 (Teclistamab) & NCT03486067 (ABBV-383) P1 studies, key diff in inclusion criteria MagnetisMM-1 (elranatamab) P1 study was… it allowed enrollment of WHICH of the following pt populations❓ (Twitter) - Mar 22, 2022
P1
- |||| elranatamab (PF-06863135) / Pfizer, teclistamab (JNJ-64007957) / Genmab, J&J, TNB-383B / AbbVie
🚨 PRE-test POLL 4️⃣ #BonumCE #MMSM 🆓#CME👉 https://t.co/K1Gf4hT18Y Compared w MajesTEC-1 (Teclistamab) & NCT03486067 (ABBV-383) P1 studies, key diff in inclusion criteria MagnetisMM-1 (elranatamab) P1 study was… it allowed enrollment of which of the following pt populations❓ (Twitter) - Mar 22, 2022
P1
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial completion date: MajesTEC-2: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov) - Mar 21, 2022
P1b, N=140, Recruiting, Sponsor: Janssen Research & Development, LLC
These findings warrant further investigation, and the randomized phase 3 MajesTEC-3 study will evaluate Tec + Dara vs Dara, pomalidomide, and dexamethasone or Dara, bortezomib, and dexamethasone in pts with RRMM. Trial completion date: Sep 2023 --> Mar 2024
- || teclistamab (JNJ-64007957) / Genmab, J&J
This has always been a pet peeve of mine haha, I think we need to evolve to steroid-free regimens...enter teclistamab + dara ;0 ) (Twitter) - Mar 3, 2022
- ||||| teclistamab (JNJ-64007957) / Genmab, J&J
FDA event: #BCMA Bispecific Antibodies in the pipeline with potential for Teclistamab being @usfda approved later in 2022. #mmsm #myleoma @szusmani (Twitter) - Feb 27, 2022
- || Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: TRIMM-2: A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma (clinicaltrials.gov) - Feb 25, 2022
P1b, N=290, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Sep 2023 --> Mar 2024 N=200 --> 290 | Trial completion date: Jun 2024 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Sep 2024
- |||||||||| Tecvayli (teclistamab-cqyv) / Genmab, J&J
New P3 trial, Combination therapy: MajesTEC-4: Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation (clinicaltrials.gov) - Feb 17, 2022
P3, N=1000, Not yet recruiting, Sponsor: European Myeloma Network
- || teclistamab (JNJ-64007957) / Genmab, J&J
Teclistamab in de behandeling van recidiverend of refractair multipel myeloom https://t.co/gPyOLyGbMj (Twitter) - Feb 15, 2022
- ||||| Darzalex (daratumumab) / J&J, Tecvayli (teclistamab-cqyv) / Genmab, J&J
New P2 trial: MASTER-2: Sequential Therapy in Multiple Myeloma Guided by MRD Assessments (clinicaltrials.gov) - Feb 9, 2022
P2, N=300, Not yet recruiting, Sponsor: University of Alabama at Birmingham
- Tecvayli (teclistamab-cqyv) / Genmab, J&J
Phase classification: A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Feb 4, 2022
P1/2, N=33, Recruiting, Sponsor: Janssen Pharmaceutical K.K.
N=200 --> 290 | Trial completion date: Jun 2024 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Sep 2024 Phase classification: P2 --> P1/2
- ||||| FDA event: 5/☀️Good news! There are 3️⃣ types of therapies #FDA approved or under inv🔬 🎯 #BCMA 1️⃣ #CART (idecabtagene vicleucel, ciltacabtagene autoleucel, CT103A) 2️⃣ #ADC (belantamab mafodotin) 3️⃣ #Bispecific antibody (teclistamab, elranatamab, ABBV-383B, CC-93269)👇 #mmsm #BonumCE (Twitter) - Feb 3, 2022
- ||| elranatamab (PF-06863135) / Pfizer, teclistamab (JNJ-64007957) / Genmab, J&J
Clinical: (9) Neue bispezifische Antikörper sind in der späten klinischen Evaluierung. #Teclistamab oder #Elranatamab, sowie weitere gegen BCMA-gerichtete Antikörper. Ansprechraten bei massiv vorbehandelten Patienten etwa 60%, komplette Remissionsrate >20%, Ansprechdauer >1 Jahr. (Twitter) - Feb 2, 2022
- |||| teclistamab (JNJ-64007957) / Genmab, J&J
Clinical, European regulatory: Janssen Submits Application to European Medicines Agency (EMA) Seeking Approval of Bispecific Antibody Teclistamab (targeting BCMA/CD3) for Treatment of Relapsed/Refractory Multiple Myeloma. Great for Patients! #mmsm @IMFmyeloma @theMMRF @SylvesterCancer https://t.co/31LlEe70zO (Twitter) - Feb 1, 2022
- |||| teclistamab (JNJ-64007957) / Genmab, J&J
Clinical, European regulatory: Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Bispecific Antibody Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma - https://t.co/TP0NsWaxWe (Twitter) - Feb 1, 2022
- || teclistamab (JNJ-64007957) / Genmab, J&J
#mmsm #caxtx teclistamab (Twitter) - Feb 1, 2022
- || Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial primary completion date, IO biomarker: MajesTEC-1: Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Jan 31, 2022
P1, N=204, Recruiting, Sponsor: Janssen Research & Development, LLC
Phase classification: P2 --> P1/2 Trial primary completion date: Dec 2022 --> Nov 2021
- Abecma (idecabtagene vicleucel) / BMS, 2seventy bio
SUBSEQUENT ANTI-MYELOMA THERAPY AFTER IDECABTAGENE VICLEUCEL (IDE-CEL, BB2121) TREATMENT IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) FROM THE KARMMA STUDY (ePoster Area [VIRTUAL]) - Jan 30, 2022 - Abstract #EBMT2022EBMT_1196;
P2
The PFS2 in this subgroup supports that disease control can be achieved by sequencing of sAMT after relapse from anti-BCMA CAR+ T therapy. Various classes of anti-myeloma drugs were used as sAMT.
- || Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial primary completion date: MajesTEC-1: A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Jan 28, 2022
P2, N=192, Recruiting, Sponsor: Janssen Research & Development, LLC
Various classes of anti-myeloma drugs were used as sAMT. Trial primary completion date: Apr 2023 --> Nov 2021
- ||| teclistamab (JNJ-64007957) / Genmab, J&J
You know the data is promising for a myeloma drug when @AaronGoodman33 and @VPrasadMDMPH both express approval of results. Tune in for our discussion on Teclistamab, iceberg plots, confidence of a sponsor in their drug, and trial design. https://t.co/1VkLRe1938 #mmsm (Twitter) - Jan 12, 2022
- | teclistamab (JNJ-64007957) / Genmab, J&J
Wrapping up @medpagetoday's four-part roundtable on #ASH21 with a discussion on teclistamab... https://t.co/uaC1QQaWyz (Twitter) - Jan 10, 2022
- ||| teclistamab (JNJ-64007957) / Genmab, J&J
Check this out #myeloma RT @DrOlaLandgren: Happy New Year! Janssen has filed bi-specific antibody (BCMA/CD3) “Teclistamab” to FDA for the treatment of relapse… https://t.co/eDpGlzdyeY (Twitter) - Jan 3, 2022
- || Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
Trial completion date, Trial primary completion date: RedirecTT-1: A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Jan 3, 2022
P1b, N=56, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Apr 2023 --> Nov 2021 Trial completion date: Jun 2023 --> Nov 2023 | Trial primary completion date: Nov 2021 --> Nov 2023
- |||| teclistamab (JNJ-64007957) / Genmab, J&J
Clinical: Happy New Year! Janssen has filed bi-specific antibody (BCMA/CD3) “Teclistamab” to FDA for the treatment of relapsed/refractory multiple myeloma: based on the results of the phase 1b MajesTEC-1 study (3+ prior lines of therapy). Great for patients! #mmsm https://t.co/Mnh1zmzb5X (Twitter) - Jan 2, 2022
- |||| teclistamab (JNJ-64007957) / Genmab, J&J
Clinical, FDA event: J&J goes after another FDA approval with Teclistamab - good news for #mmsm patients as we kick off 2022! https://t.co/XkDj54Eaxe (Twitter) - Jan 2, 2022
- |||||| Tecvayli (teclistamab) / Genmab, J&J
New trial: Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957) (clinicaltrials.gov) - Dec 17, 2021
P=N/A, N=0, Temporarily Not Available, Sponsor: Janssen Research & Development, LLC
- ||||| teclistamab (JNJ-64007957) / Genmab, J&J, ABBV-383 / AbbVie
Clinical: BITE (BCMA/CD3) from today’s meeting #ASH21 (Elrantamab, Teclistamab, and ABBV-383) attention to the % of HR cytogenetics. EMD involvement, % of triple-refractory pts, and those who received prior BCMA therapy #mmsm #USMRC #medEd #medtwitter #Myeloma #ASH21 (Twitter) - Dec 13, 2021
- |||| teclistamab (JNJ-64007957) / Genmab, J&J
#ASH21 Teclistamab BCMA Bispecific Ab presented by Dr Moreau #mmsm 62% ORR, majority still responding at 6 months. CRS common, but almost all grade 1/2. It was great to have been involved in this study at @StanfordBMT_CT (Twitter) - Dec 13, 2021
- |||||| teclistamab (JNJ-64007957) / Genmab, J&J
P2 data: "It’s MajestTEC!...Boogie-woogie!" Phase 2 data from teclistamab: ORR 62%, >90% still in response at 6 mo, ICANS 3%. Will some docs just keep the CAR in the garage…? #mmsm #ASH21 (Twitter) - Dec 13, 2021
- |||||| teclistamab (JNJ-64007957) / Genmab, J&J
Clinical: The MajesTEC-1 study of teclistamab in 150 patients with median 5 prior lines had a 62% response rate. Median DOR not reached with 8 month follow up. CRS 72% but only one grade 3 - 50% grade 1 and 21% grade 2. 12% neurotoxicity with resolution of ICANS #ash21 #myelomawithmikhael (Twitter) - Dec 13, 2021
- ||| teclistamab (JNJ-64007957) / Genmab, J&J
PK/PD data: Yes, PK/PD considerations (eg teclistamab was developed both in IV & SC, and nex t dev is SC - same Cmax but higher Ctrough) & pot. higher equivalent RP2D. (Twitter) - Dec 10, 2021
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial completion date, IO biomarker: MajesTEC-1: Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Dec 3, 2021
P1, N=204, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Jun 2023 --> Nov 2023 | Trial primary completion date: Nov 2021 --> Nov 2023 Trial completion date: Sep 2024 --> Dec 2024
- | Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Trial completion date, Combination therapy: TRIMM-2: A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma (clinicaltrials.gov) - Dec 3, 2021
P1b, N=200, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Sep 2024 --> Dec 2024 Trial completion date: Dec 2023 --> Jun 2024
- || Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial primary completion date: MajesTEC-2: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov) - Dec 3, 2021
P1b, N=140, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Dec 2023 --> Jun 2024 Trial primary completion date: Oct 2022 --> May 2023
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial completion date: MajesTEC-1: A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Dec 3, 2021
P2, N=192, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Oct 2022 --> May 2023 Trial completion date: Sep 2024 --> Dec 2024
- ||| Clinical: Why would anyone use this when Teclistamab will be available in 12-18 months? Safer, better efficacy, easier, cheaper 🤔 I see no need for allo-CAR T in MM especially. What few patients would be better served by allo715 vs teclistamab, cilta-cel or Abecma? (Twitter) - Dec 2, 2021
- |||| teclistamab (JNJ-64007957) / Genmab, J&J
Clinical: 10) Updated Results from MajesTEC-1: Phase 1/2 Study of Teclistamab, a B-Cell Maturation Antigen x CD3 Bispecific Antibody, in Relapsed/Refractory Multiple Myeloma https://t.co/Zwu7bTK8R8 Strong results from BCMA-CD3 bispecific monoclonal SC antibody: great for patients! #ASH21 (Twitter) - Dec 1, 2021
- Bispecific T-Cell Engager Antibodies in Multiple Myeloma- a Systematic Review of Phase 1 Clinical Trials () - Nov 24, 2021 - Abstract #ASH2021ASH_6325;
It represents a whole new horizon of targeted approach towards RRMM. Phase II / III studies are being conducted to evaluate this potential treatment approach in patients with MM.
- |||| teclistamab (JNJ-64007957) / Genmab, J&J
Clinical: @ASH_hematology The Times They Are a-Changin' in Myeloma therapy #curemyeloma #mmsm #myeloma @TheLancet MajesTEC-1 Robust safety and efficacy data at #ASH21 #Teclistamab @szusmani @AlGarfall @TomBmt133 @mvmateos @NBahlis @DrRakeshPopat (Twitter) - Nov 20, 2021
- || teclistamab (JNJ-64007957) / Genmab, J&J
We are going to hear a lot about a variety of bispecific antibodies at #ASH21. Many of these target BCMA. Results with teclistamab published in @TheLancet look very promising: 65% response rate. Congrats to authors. @szusmani @mvmateos et al. https://t.co/wdUhV0lywz (Twitter) - Nov 11, 2021
- |||| teclistamab (JNJ-64007957) / Genmab, J&J
Coming soon! #MYELOMA panel - @grpetersen1 @JackMAiello @MyelomaTeacher discusses off-the-shelf #immune drug teclistamab w/ @AlGarfall @PennMedicine https://t.co/0UvJDcAplp (Twitter) - Nov 8, 2021
- Darzalex IV (daratumumab) / J&J, teclistamab (JNJ-64007957) / Genmab, J&J
Subcutaneous Teclistamab in Combination with Daratumumab for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma: Results from a Phase 1b Multicohort Study (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3228;
P1b
The combination of Tec + Dara had a manageable safety profile, consistent with the monotherapies, and showed preliminary efficacy in pretreated pts with MM; with longer follow-up, responses may continue to deepen, as has been seen with Tec monotherapy. These promising data warrant further investigation; the randomized phase 3 MajesTEC-3 study will evaluate Tec + Dara vs Dara, pomalidomide, and dexamethasone or Dara, bortezomib, and dexamethasone in pts with RRMM.
- teclistamab (JNJ-64007957) / Genmab, J&J
Updated Results from MajesTEC-1: Phase 1/2 Study of Teclistamab, a B-Cell Maturation Antigen x CD3 Bispecific Antibody, in Relapsed/Refractory Multiple Myeloma (GWCC - A411-A412, Level 4) - Nov 5, 2021 - Abstract #ASH2021ASH_2418;
P1, P2
Evaluation of teclistamab at the RP2D in 159 pts provides robust data to support safety; inclusion of phase 2 pts at the time of presentation will provide more robust efficacy data. Data from MajesTEC-1 continue to show that teclistamab monotherapy induces deep and durable responses in heavily pretreated pts with RRMM with a manageable safety profile.
- || Tecvayli (teclistamab-cqyv) / Genmab, J&J
Enrollment change, Trial completion date: MajesTEC-2: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov) - Nov 4, 2021
P1b, N=140, Recruiting, Sponsor: Janssen Research & Development, LLC
Data from MajesTEC-1 continue to show that teclistamab monotherapy induces deep and durable responses in heavily pretreated pts with RRMM with a manageable safety profile. N=100 --> 140 | Trial completion date: Jul 2023 --> Nov 2023
- |||||| Tecvayli (teclistamab-cqyv) / Genmab, J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Enrollment open, Trial primary completion date, Combination therapy: MajesTEC-3: A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Nov 4, 2021
P3, N=560, Recruiting, Sponsor: Janssen Research & Development, LLC
N=100 --> 140 | Trial completion date: Jul 2023 --> Nov 2023 Not yet recruiting --> Recruiting | Trial primary completion date: Jan 2025 --> Jul 2024
- || teclistamab (JNJ-64007957) / Genmab, J&J
By the time this all gets worked out...Teclistamab probably available shortly thereafter... (Twitter) - Nov 2, 2021
- ||| dexamethasone / Generic mfg., Darzalex IV (daratumumab) / J&J, teclistamab (JNJ-64007957) / Genmab, J&J
Clinical: I would think the absence of dexamethasone in the teclistamab-daratumumab arm would be very attractive to some patients? (Twitter) - Oct 30, 2021