 |
0 Diseases |  |
1 Trial |
|
1 Trial |  |
2 News |  |
| «12...56789101112131415...1718» |
- Darzalex (daratumumab) / J&J, Tecvayli (teclistamab) / Genmab, J&J
MajesTEC-7: A Phase 3, Randomized Study of Teclistamab + Daratumumab + Lenalidomide (Tec-DR) Versus Daratumumab + Lenalidomide + Dexamethasone (DRd) in Patients with Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_6385;
P1, P1b
The study will open for enrollment in Q4 2022. Results from this trial will provide insights into a possible new treatment regimen (Tec-DR) for patients with NDMM, which may provide improved outcomes.
- A Systematic Meta-Analysis of Cytokine Release Syndrome Incidence in B-Cell Maturation Antigen-Targeting Chimeric Antigen Receptor T-Cell Therapy and Bispecific Antibodies for Patients with Relapsed and/or Refractory Multiple Myeloma (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_6335;
The current analysis showed BCMA CAR-T therapies to be associated with higher CRS incidence, higher rates of Grade =3 CRS, longer CRS duration, and more prevalent tocilizumab and steroid use for CRS management compared to BsAb, possibly due to a) higher cytokine production following CAR-T therapies and/or b) use of premedication and priming regimens with BsAb which may improve the CRS profile (Table 1). Despite evaluation of a higher dose range, the proportion of CRS Grades =3 was higher with BsAb dosed IV vs. SC suggesting that the SC route of administration may allow exploration of higher doses while reducing the incidence of high-grade CRS.
- Tecvayli (teclistamab) / Genmab, J&J
MajesTEC-4 (EMN30): A Phase 3 Trial of Teclistamab + Lenalidomide Versus Lenalidomide Alone As Maintenance Therapy Following Autologous Stem Cell Transplantation in Patients with Newly Diagnosed Multiple Myeloma (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4620;
P1, P1b, P
The study opened for enrollment in May 2022. Results from this trial will provide insights into a possible new synergistic combination that could improve response and prolong survival versus current maintenance regimens for patients with NDMM.
- Tecvayli (teclistamab) / Genmab, J&J
Drug Interaction Potential As a Result of Cytokine Release Syndrome Using a Physiologically Based Pharmacokinetic Model: Case Study of Teclistamab (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_4605;
Drug-drug interaction (DDI) toward different CYP substrates (caffeine [CYP1A2], s-warfarin [CYP2C9], omeprazole [CYP2C19], midazolam and cyclosporine [CYP3A4 and CYP3A5], and simvastatin [CYP3A4]) were evaluated where substrates were administered as a single dose when the minimum (or the maximum for CYP1A2) enzymatic activity was reached...Then, prospective simulations were performed using observed IL-6 data following teclistamab administered at RP2D without or prior to tocilizumab administration in MajesTEC-1 as of a March 16, 2022, cut-off... PBPK modeling and simulation results suggested DDI from IL-6 effect on CYP450 activities to have little clinical significance with minimal or moderate impact on CYP substrates up to 7 days after teclistamab first treatment dose in cycle 1 or during a cytokine release syndrome event.
- Tecvayli (teclistamab) / Genmab, J&J
Teclistamab Population Pharmacokinetics and Exposure-Response Relationship Support 1.5 Mg/Kg Dose Regimen in Relapsed/Refractory Multiple Myeloma (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_2776;
P1, P2
The E-R analyses for ORR showed positive trend with a plateau at the RP2D, while there was no apparent E-R trend between teclistamab exposure and the grade =3 hematologic and infection treatment-emergent adverse events. These results support 1.5 mg/kg teclistamab SC weekly as the recommended dose regimen for the treatment of RRMM.
- Tecvayli (teclistamab) / Genmab, J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Teclistamab in Combination with Subcutaneous Daratumumab and Lenalidomide in Patients with Multiple Myeloma: Results from One Cohort of MajesTEC-2, a Phase1b, Multicohort Study (ENMCC - R02-R05) - Nov 4, 2022 - Abstract #ASH2022ASH_1543;
P1b
Promising ORR supports the potential for this combination to have enhanced early disease control through the addition of tec. These data warrant further investigation.
- ISB 2001 / Glenmark
ISB 2001, a First-in-Class Trispecific BCMA and CD38 T Cell Engager Designed to Overcome Mechanisms of Escape from Treatments for Multiple Myeloma By Targeting Two Antigens (New Orleans Theater C (Ernest N. Morial Convention Center)) - Nov 4, 2022 - Abstract #ASH2022ASH_1415;
However, despite exceptional overall response rates observed using CAR T cell therapies or bispecific antibodies, durable responses beyond 2 years are still limited (PFS below 40% for treatment with idecabtagene vicleucel1 or teclistamab2)...This low expression of targets in the MM population has been observed after treatment with CD38-targeted daratumumab4, and BCMA specific CAR T cells5...ISB 2001 was only modestly affected by soluble BCMA or APRIL when compared to EM801, demonstrating killing at 3 pM (EC50) in the presence of these soluble factors...Seckinger, A. et al. Cancer Cell 31, 396–410 (2017).
- elranatamab (PF-06863135) / Pfizer, Tecvayli (teclistamab) / Genmab, J&J
Role of TNFRSF17 and GPRC5D Structural and Point Mutations in Resistance to Targeted Immunotherapies in Multiple Myeloma (MM) (ENMCC - R06-R09) - Nov 4, 2022 - Abstract #ASH2022ASH_1403;
Importantly, we also identified a monoallelic loss of TNFRSF17 (del16p) coupled with BCMA extracellular domain point mutation [p.(R27P)] that confers resistance to two BCMAxCD3 TCEs in MM. Therefore, in addition to structural alterations (biallelic loss of TNFRSF17 or GPRC5D), antigen escape resulting from non-truncating missense point mutations in BCMA extracellular domain also mediate resistance to targeted-immunotherapies.
- Tecvayli (teclistamab) / Genmab, J&J
Teclistamab, a B-Cell Maturation Antigen (BCMA) x CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Correlative Analyses from MajesTEC-1 (ENMCC - R06-R09) - Nov 4, 2022 - Abstract #ASH2022ASH_1399;
Analysis of baseline correlatives for pivotal RP2D patients suggests an emerging profile for non-responders of unfavorable immune characteristics at baseline, including lower T-cell numbers; higher frequency of T cells at baseline expressing markers such as PD-1, TIM-3, and CD38; higher frequency of Tregs and CD38+ Tregs; and lower proportion of naïve T cells and more NK cells. These data support clinical combinations of teclistamab with agents such as daratumumab or checkpoint inhibitors.
- | 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) - Nov 4, 2022
P1b, N=146, Recruiting, Sponsor: Janssen Research & Development, LLC
These data support clinical combinations of teclistamab with agents such as daratumumab or checkpoint inhibitors. Trial completion date: Sep 2024 --> Apr 2024
- ||| Tecvayli (teclistamab) / Genmab, J&J
Not unique to teclistimab, all similar bispecific studies are obfuscated by investigator attribution. Covid exacerbated the uncertainty. Anyone who uses these drugs recognise that they result in profound hypogammaglobulinemia: with the +ve implications and the -ve consequences (Twitter) - Nov 3, 2022
- | Tecvayli (teclistamab) / Genmab, J&J
Journal: Teclistamab Approved for Myeloma. (Pubmed Central) - Nov 3, 2022
The FDA has approved the bispecific T-cell engager teclistamab for patients with relapsed or refractory multiple myeloma. In the clinical trial that led to its approval, patients had an overall response rate of 63% and a median duration of response of 18.4 months.
- |||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamab is an exciting CD3xBCMA bispecific antibody w impressive activity against myeloma. In @NEJM, we ask to explore its potential contribution to infection risk openly, aim to optimise dose & duration, & mitigate toxicity https://t.co/lvyOq2Z2CO #mmsm @ManniMD1 @HiraSMian (Twitter) - Nov 3, 2022
- | Tecvayli (teclistamab) / Genmab, J&J
What, Tecvayli is 40k$/mo??!! (Twitter) - Nov 2, 2022
- || Darzalex (daratumumab) / J&J, Tecvayli (teclistamab) / Genmab, J&J
We do not have a smooth access to daratumumab yet so we are so quite far for teclistamab😔😔😔 (Twitter) - Oct 31, 2022
- || bispecifics are coming. teclistamab, glofitamab, epcoritamab, odronextamab. any of them "game-changing" or at least practice changing? (Twitter) - Oct 28, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
What is published on teclistamab post CAR-T? Any data being presented at ASH this year or in the past? (Twitter) - Oct 28, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J, Lunsumio (mosunetuzumab) / Roche, Biogen
Clinical: Agreed - here, CRS rates roughly similar as CAR-T although ICANS lower. This would def be fascinating principle! As it stands, right now teclistamab will be almost as much inpatient time as CAR-T in the first month… More soon :) and hope mosunetuzumab is approved soon as well! (Twitter) - Oct 28, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J, Lunsumio (mosunetuzumab) / Roche, Biogen
Clinical: I think in terms of bispecifics, this is an issue unique to teclistamab. Mosunetuzumab should be approved soon - CRS rates significantly lower. And all patients get dex prophylactically at home for the first several injections (Twitter) - Oct 28, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical, FDA event, Interview: On October 25th, the FDA approved teclistamab for adult patients with relapsed/refractory (R/R) multiple myeloma - find out more about what this means for patients in our exclusive interview with @BrunoPaiva_UNAV: 👉https://t.co/qTjDImHlgj👈 #MMsm #HemOnc #IWWM11 #ImmunoOnc (Twitter) - Oct 28, 2022
- |||| Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Tecvayli (teclistamab) / Genmab, J&J, Blenrep (belantamab mafodotin) / GSK
Now that we have BCMA directed CAR-Ts (ide-cel, cilta cel), ADC (belantamab), & bispecific (teclistamab) how do we approach refractory myeloma?👇 For triple class refractory, its either alkylator based or BCMA directed therapy. For penta class refractory, some options promising. (Twitter) - Oct 28, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: I sat down with @jmikhaelmd to discuss the impact the recent of approval of teclistamab will have on the treatment of patients with heavily relapsed #mmsm (Twitter) - Oct 28, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
I’m excited about the idea of set duration teclistamab in SMM (can’t wait for the phase 2 data): https://t.co/FWm1mKKSuM (Twitter) - Oct 28, 2022
- ||||| Tecvayli (teclistamab) / Genmab, J&J
FDA event: Always a pleasure to catch up with @BrunoPaiva_UNAV, who spoke with us on the importance of genomics in Waldenström’s, the recent FDA approval of teclistamab, and more! #IWWM11 #MMsm #HemOnc #ImmunoOnc (Twitter) - Oct 28, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J, Carvykti (ciltacabtagene autoleucel) / J&J, Blenrep (belantamab mafodotin) / GSK
Clinical, FDA event, Combination therapy: Different BCMA-directed therapies are FDA approved (Cilta-Cel/Idea-Cel/Belantamab and Teclistimab) I think we need a new strategy on how to utilize a new & effective combination therapy in heavily treated pts! It's fair to have a RCT now #mmsm #myeloma #USMIRC #MedTwitter (Twitter) - Oct 27, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
"Now for the 1st time I'm ever able to give this talk ... we have an approved bispecific antibody and that's teclistamab" @TomBmt133 during @SocietyofHemOnc Highlights SANQ #MM (Twitter) - Oct 27, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Clinical, HEOR: Achieving prolonged remission with good quality of life reduces costs. In this case, combine teclistamab with antiCD38, what do you think???? or with another bi-specific (Twitter) - Oct 27, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
40.000 Dollar monatliche Therapiekosten für das neue Myelommedikament Teclistamab ist ein unanständiger Preis. (Twitter) - Oct 27, 2022
- ||||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Teclistimab and similar bispecifics can have a prolific impact on patients with heavily relapsed multiple myeloma in the short term and possibly in earlier relapses in the long term, according to Joseph Mikhael, MD. #mmsm | @jmikhaelmd @US_FDA https://t.co/jRvK847o1R (Twitter) - Oct 27, 2022
- |||| Actemra IV (tocilizumab) / Roche, JW Pharma, Kineret (anakinra) / SOBI, Tecvayli (teclistamab) / Genmab, J&J
Clinical: Fascinatingly, no mention of tocilizumab in teclistamab #MMsm FDA label. I love toci! But it’s IV, expensive, sometimes back-ordered, and doesn’t cross into CNS 🧠 Might this be the time for multicenter trial of 1st-line #anakinra for CRS mgmt? (I’d love to help write if so!) (Twitter) - Oct 27, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical, Real-world evidence: Important point 👇 I’m willing to wager 💰cost of a one-time tec infusion to say that, in real-world practice, we will use MRD-guided decision making with teclistamab in #MMsm. Or, at least, space out to q2wk maintenance as now done in MajesTECs even if label is q1wk until PD! (Twitter) - Oct 27, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Pricing: Clearly the pricing of teclistimab is ridiculous (Twitter) - Oct 27, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
FDA event: #FDAApproved ✅ Treatment options for relapsed/refractory #multiplemyeloma continue to expand with FDA's #acceleratedapproval of #teclistamab (#Tecvayli). "These are remarkable results," said principal investigator @szusmani of @MSKCancerCenter. https://t.co/Rso0M3wBLA (Twitter) - Oct 27, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: The drug, teclistamab, has been proven effective in treating people with multiple myeloma for whom previous therapies have not worked. This could help improve the prognosis (outcome) @DrPMPGI @IndianYoungOnco https://t.co/tDKQaBYBXZ (Twitter) - Oct 26, 2022
- ||||| Darzalex (daratumumab) / J&J, Tecvayli (teclistamab) / Genmab, J&J, Carvykti (ciltacabtagene autoleucel) / J&J
Pricing: Me after finding out that I will cause a US recession in the next few years after finding out the price of Teclistimab ($40k) in addition to daratumumab and Cilta-Cel in relapse myeloma $$$$! #mmsm #MedTwitter #medEd (Twitter) - Oct 26, 2022
- ||| lenalidomide / Generic mfg., Tecvayli (teclistamab) / Genmab, J&J
Reimbursement: The price of teclistamab is even more outrageous than the prices of lenalidomide and pom. Those of us who pay taxes and directly or indirectly fund insurance should insist that the price come down. I am sure Dr. Rajkumar agrees. (Twitter) - Oct 26, 2022
- ||| lenalidomide / Generic mfg., Tecvayli (teclistamab) / Genmab, J&J
Pricing: $40k/month is $480/12 months. Is Jansen indexing the teclistamab drug price to CART, in essence? It’s a truly shocking price. Can’t disagree re: lenalidomide, which is outrageous. (Twitter) - Oct 26, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical, FDA event: The FDA recently approved teclistamab-cqyv for relapsed/refractory multiple myeloma. Congrats to the teams and patients @PennMedicine who participated in the trials, including @AlGarfall! (Twitter) - Oct 26, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
Clinical, Licensing / partnership: Patients need some reserve to safely use #teclistamab. Exciting to have the option but a 45% rate of grade 3/4 infection will make selection and follow up critical. Partnership between the community and tertiary centers will be critical @oncologyCOA (Twitter) - Oct 26, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
HEOR: I will speak up on teclistamab cost once I get a sense from ICER evaluation on cost per QALY. This thread is not mean to justify the price of this drug. (Twitter) - Oct 26, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Pricing: I’m continuing to advocate for reform and value based pricing. Teclistamab is no exception. As I note in this thread we have to work out the dose and schedule. With this drug I expect we can treat and stop and get prolonged benefit. That’s one way to reduce cost. (Twitter) - Oct 26, 2022
- ||| lenalidomide / Generic mfg., Tecvayli (teclistamab) / Genmab, J&J
I agree that price cannot be set based on what the market will bear. Or what other companies are getting away with their products. That’s not what I’m advocating. Im using the teclistamab price issue to shine a light at the billions we are spending on Lenalidomide for myeloma. (Twitter) - Oct 26, 2022
- ||| lenalidomide / Generic mfg., Tecvayli (teclistamab) / Genmab, J&J
Reimbursement, Medicare: It’s hard to keep a straight face and criticize teclistamab when we are willing to spend 16-18k a month on Lenalidomide, a 16 year old drug to the extent that Medicare spends more on it than just about any other drug besides apixban is pretty hard. (Twitter) - Oct 26, 2022
- ||| lenalidomide / Generic mfg., Tecvayli (teclistamab) / Genmab, J&J, pomalidomide / Generic mfg.
Pricing: Considering we are paying a fortune for old drugs like lenalidomide and pomalidomide due to our broken patent and pricing system, teclistamab is a bargain. #MedTwitter (Twitter) - Oct 26, 2022
- |||| lenalidomide / Generic mfg., Tecvayli (teclistamab) / Genmab, J&J, pomalidomide / Generic mfg.
Pricing: Teclistamab cost of $40,000 a month may seem high. But its a highly active new & novel treatment we desperately need for myeloma. If lenalidomide & pomalidomide cost $100/month as in other countries compared to the >$17,000/month we pay, it will more than make up for teclistamab (Twitter) - Oct 26, 2022
- ||||| Tecvayli (teclistamab) / Genmab, J&J
Clinical: Teclistamab’s approval is great news for patients. But, logistically, how can we admit all these patients for all our MM therapies? Hospitals are full and patients dont like to be admitted. Lets find ways to move these therapies to outpatient safely #mmsm (Twitter) - Oct 26, 2022
- |||| Tecvayli (teclistamab) / Genmab, J&J
FDA event: J&J's #teclistamab, branded as Tecvayli, has been approved by the FDA for treating adults with multiple #myeloma that is hard to treat or has come back after receiving four or more prior lines of certain classes of therapies. https://t.co/r9Z42n0qhb (Twitter) - Oct 26, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Now that #teclistimab is approved in the US, the #sequencing of #CART, bi-specifics and other approved therapies is more important than ever.EARLY #myeloma referrals to a center with these therapies is critical! #mmsm @IMFnurseMyeloma @khouri_jack @FaizAnwerMD1 @LouisWilliamsMD (Twitter) - Oct 26, 2022
- || Tecvayli (teclistamab) / Genmab, J&J
What data say better to use teclistamab over ciltacel depending on cytogenetics? None (Twitter) - Oct 26, 2022
- ||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamab’s target is BCMA. BCMA is found on both normal and malignant plasma cells(myeloma) -therefore normal plasma cells that make antibodies are killed off too- that is why all the infections #mmsm (Twitter) - Oct 26, 2022