 |
0 Diseases |  |
1 Trial |
|
1 Trial |  |
2 News |  |
| «12345678910111213...1718» |
- | Tecvayli (teclistamab) / Genmab, J&J
Journal, IO biomarker: CD8 effector T cells enhance response in BCMA-exposed and -na (Pubmed Central) - Oct 25, 2023
Teclistamab, a B-cell maturation antigen (BCMA)- and CD3-targeting bispecific antibody, is an effective novel treatment for relapsed/refractory multiple myeloma (RRMM), but efficacy in BCMA-exposed patients and mechanisms of resistance have yet to be fully delineated...Pre-treatment plasma cell BCMA expression levels had no bearing on response. However, comprehensive pre-treatment immune profiling identified that effector CD8+ T cell populations associated with response to therapy and a regulatory T cell population associated with non-response, indicating a contribution of immune status in outcomes with potential utility as a biomarker signature to guide patient management.
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial primary completion date: Outpatient Administration of Teclistamab for Multiple Myeloma (clinicaltrials.gov) - Oct 25, 2023
P2, N=50, Recruiting, Sponsor: SCRI Development Innovations, LLC
However, comprehensive pre-treatment immune profiling identified that effector CD8+ T cell populations associated with response to therapy and a regulatory T cell population associated with non-response, indicating a contribution of immune status in outcomes with potential utility as a biomarker signature to guide patient management. Trial primary completion date: Jan 2024 --> Jan 2025
- || Tecvayli (teclistamab-cqyv) / Genmab, J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J, Talvey (talquetamab-tgvs) / J&J
New P2 trial, Combination therapy, IO biomarker, Immuno-oncology: Teclistamab or Talquetamab in Combination With Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study) (clinicaltrials.gov) - Oct 25, 2023
P2, N=50, Not yet recruiting, Sponsor: University of Miami
- || Tecvayli (teclistamab-cqyv) / Genmab, J&J
Enrollment closed, Trial primary completion date: MajesTEC-1: A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Oct 11, 2023
P2, N=194, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Jan 2024 --> Jan 2025 Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2023 --> Mar 2025
- | Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial primary completion date: A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Oct 11, 2023
P1/2, N=38, Recruiting, Sponsor: Janssen Pharmaceutical K.K.
Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2023 --> Mar 2025 Trial primary completion date: Aug 2023 --> Mar 2025
- | 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) - Oct 11, 2023
P1b, N=140, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Aug 2023 --> Mar 2025 Trial completion date: Jun 2024 --> Feb 2025
- ||||| Tecvayli (teclistamab-cqyv) / Genmab, J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Enrollment closed, 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) - Oct 11, 2023
P3, N=587, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Jun 2024 --> Feb 2025 Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2024 --> Aug 2025
- Elrexfio (elranatamab) / Pfizer, Actemra IV (tocilizumab) / Roche, JW Pharma, Tecvayli (teclistamab) / Genmab, J&J
Promising Real-World Data of Treatment with Two BCMA-targeting Bispecific T-Cell Engagers in Extensively Pretreated Myeloma Patients (Hall E) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1516;
within extensively pretreated patients. Immune-mediated AEs were manageable using standard procedures for CRS.
- Tecvayli (teclistamab) / Genmab, J&J
BCMA x CD3 Bispecific Antibody Treatment with Teclistamab in Relapsed and/or Refractory Multiple Myeloma: A Real-World Monocentric Analysis (Hall E) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1513;
It yielded promising efficacy with an ORR of 44% and a median PFS of 73d in a heavily pretreated and highly refractory patient cohort. Despite adequate prophylactic measures, significant toxicity was observed with a high rate of severe infections.
- Tecvayli (teclistamab) / Genmab, J&J
Long-Term Follow-Up From MajesTEC-1 of Teclistamab, a B-cell Maturation Antigen (BCMA) x CD3 Bispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (Hall G) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1240;
P1, P2
Despite adequate prophylactic measures, significant toxicity was observed with a high rate of severe infections. Pts had a median of 5 prior LOT (range, 2
- Tecvayli (teclistamab) / Genmab, J&J, Blenrep (belantamab mafodotin-blmf) / GSK
Real-world experiences with detection of secondary resistance mechanisms against BCMA-targeting therapies by Whole Genome Sequencing and its association with clinical course in Multiple Myeloma patients (X5) - Sep 30, 2023 - Abstract #DGHO2023DGHO_186;
So far, limited data exist on mechanisms of resistance. Here, we report genetic alterations in the TNFRSF17 gene in 2 pts with underlying HR disease and early and atypical relapse after CAR-T treatment.
- Darzalex (daratumumab) / J&J, Tecvayli (teclistamab) / Genmab, J&J
Dysfunctional Death Receptor Signaling Pathway Contributes to Immunotherapy Resistance in Multiple Myeloma (X5) - Sep 30, 2023 - Abstract #DGHO2023DGHO_183;
Ranking the patients according to their their gene expression of FADD and BID revealed that the patients with the lowest values were predominantly Dara resistant (7/10 and 9/10, respectively) proposing that the FADD/ BID axis is indispensable for meaningful responses to novel immunotherapies in vivo. In conclusion, our study reveals induction of apoptosis as a mode of action of T-cell based immunotherapies in MM and low expression of FADD and BID is associated with intrinsic resistance to these agents.
- || Tecvayli (teclistamab) / Genmab, J&J
PK/PD data, Journal: Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. (Pubmed Central) - Sep 25, 2023
P1, P2
The exposure-response analyses for ORR showed a positive trend with increasing teclistamab systemic exposure, with a plateau at the RP2D, and there was no apparent exposure-response trend for safety or other efficacy endpoints. These analyses support the RP2D of teclistamab in patients with RRMM.
- MODULE 4: Bispecific Antibodies in the Treatment of MM (Omni San Diego, Grand Ballroom (Level 2), 4) - Sep 23, 2023 - Abstract #ASH2023ASH_274;
Supported by AbbVie Inc, GSK, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Karyopharm Therapeutics, Legend Biotech, Regeneron Pharmaceuticals Inc, and Sanofi. Similarities and differences in the cellular targets and mechanisms of action among bispecific antibodies for MM Antitumor activity observed with teclistamab in the Phase I/II MajesTEC-1 study leading to its recent FDA approval for R/R MM; optimal incorporation into the treatment paradigm Rate, depth and duration of response observed with elranatamab in the pivotal Phase II MagnetisMM-3 trial for patients with R/R MM; FDA approval and current clinical role Key findings with other promising anti-BCMA bispecific antibody constructions, such as alnuctamab, linvoseltamab and ABBV-383, for heavily pretreated MM Available efficacy and safety findings with non-BCMA-targeted bispecific antibodies for MM, such as talquetamab, cevostamab and RG6234; FDA approval of talquetamab for patients with R/R MM after at least 4 prior therapies Spectrum, incidence and severity of cytokine release syndrome and other toxicities with the various BCMA- and non-BCMA-directed bispecific antibodies; optimal mitigation and management strategies Rationale for and early-phase data with bispecific antibodies in combination with other systemic therapies for MM
- Nplate (romiplostim) / Amgen, Kyowa Kirin, Tecvayli (teclistamab) / Genmab, J&J
ASH Poster Walk on Time to Examine Time Toxicity in Hematology (Virtual Program) - Sep 23, 2023 - Abstract #ASH2023ASH_5;
Relevant studies also include interventions of decreased diagnostic monitoring and digital health tools to decrease patient time in clinic without compromising clinical outcomes. A concerted cross-disease poster walk focused on "time toxicity" will help the field understand how to define this concept broadly, how to design studies that address time toxicity (either directly through medication dosing frequency or indirectly by reducing healthcare resource utilization), and exploring the impact of time toxicity on patient quality of life.
- || Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Tecvayli (teclistamab) / Genmab, J&J, Carvykti (ciltacabtagene autoleucel) / J&J
Review, Journal, CAR T-Cell Therapy: Chimeric Antigen Receptor T-Cell and Bispecific Antibody Therapy in Multiple Myeloma: Moving Into the Future. (Pubmed Central) - Sep 18, 2023
We examine the factors that challenge equitable access to these novel therapies across minoritized racial, ethnic, and socioeconomic populations. Although it is evident that CAR T-cell and BsAb therapies will transform treatment paradigms in MM for years to come, significant work remains to identify the optimal utilization of these novel therapies and ensure equitable access.
- | 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) - Sep 13, 2023
P1, N=282, Recruiting, Sponsor: Janssen Research & Development, LLC
Although it is evident that CAR T-cell and BsAb therapies will transform treatment paradigms in MM for years to come, significant work remains to identify the optimal utilization of these novel therapies and ensure equitable access. Trial completion date: May 2025 --> Sep 2025
- Elrexfio (elranatamab) / Pfizer, Tecvayli (teclistamab) / Genmab, J&J, Blenrep (belantamab mafodotin-blmf) / GSK
Single Centre Experience with BCMA-directed Bispecific T Cell Engagers (BiTE) via the Compassionate Access Schemes in Patients with Heavily Pre-Treated Relapsed or Refractory Multiple Myeloma (RRMM) (In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_618;
The rate of significant anorexia in this study was higher than reported previously, so close attention should be paid to nutritional status. Infection rates were high, so further studies are needed to help us understand the optimal dosing schedule for patients in remission and infection prophylaxis regimens, particularly as two deaths in remission due to soft tissue infections were observed.
- Tecvayli (teclistamab) / Genmab, J&J
Comparative Effectiveness of Teclistamab vs Real-world Physician's Choice of Therapy in the LocoMMotion and MoMMent Studies for Patients With Triple-class Exposed Relapsed/Refractory Multiple Myeloma (In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_567;
P=N/A, P1,
Infection rates were high, so further studies are needed to help us understand the optimal dosing schedule for patients in remission and infection prophylaxis regimens, particularly as two deaths in remission due to soft tissue infections were observed. Teclistamab demonstrated significantly improved effectiveness over RWPC in LocoMMotion alone and pooled LocoMMotion + MoMMent, emphasizing its clinical benefit as a highly effective tx for pts with TCE RRMM.
- Tecvayli (teclistamab) / Genmab, J&J
Teclistamab Is Safe and Effective In Relapse Refractory Multiple Myeloma Patients with End Stage Renal Disease: A Case Series (In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_541;
Thus an efficacious bispecific antibody targeting BCMA is sorely needed. Cytopenias and CKD/ESRD would have made both of our patients above ineligible for the MajesTEC-1 trial.
- Tecvayli (teclistamab) / Genmab, J&J
Initial Report of a Single Institution Experience with Teclistamab for Relapsed or Refractory Multiple Myeloma Including Prior BCMA (In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_530;
Cytopenias and infections were reported but not significantly different from prior studies. No new safety signals were identified.
- Tecvayli (teclistamab) / Genmab, J&J
Teclistamab versus Belgian real-world clinical practice in triple-class exposed relapsed and refractory multiple myeloma patients using adjusted comparison. (In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_518;
Results were consistent across sensitivity analyses and confirm previous indirect comparisons vs other RWPC cohorts. These findings highlight teclistamab's clinical benefit as a novel and effective treatment in TCE RRMM patients.
- Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
Effectiveness of anti-B-cell maturation antigen (BCMA)-targeting therapy after selinexor treatment (In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_506;
P1b/2, P2b
In this cohort of heavily-pretreated pts with MM who received a selinexor regimen prior to NCA, overall survival was in the range of 1 year, akin to historical results seen with ADCs. The 8-week median time between administration of selinexor and NCAs suggests that selinexor, with various partner agents, did not negatively impact overall survival with subsequent NCA therapy
- Darzalex (daratumumab) / J&J, Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
Early Treatment With Bispecific T-cell Redirectors (Teclistamab or Talquetamab) + Daratumumab in Newly Diagnosed High-risk Multiple Myeloma: An Open-label, Phase 2, Pilot Study (GEM-TECTAL) (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_318;
50% of pts will be ultra-high risk: R-ISS stage 3 or "double hit" (?2 HR cytogenic abnormalities) or 1 HR cytogenic abnormality and EMD.Induction therapy will consist of dara, bortezomib, lenalidomide, and dexamethasone (D-VRd) and response evaluation, including MRD assessment by multiple techniques. This study will provide needed data on the effect of MRD-guided individualized tx approaches in management of pts with HRMM, an underrepresented population with a high unmet need.
- Tecvayli (teclistamab) / Genmab, J&J
Real World Evaluation of Teclistamab in Patients with RRMM: Results from the IMF Immunotherapy Database Project (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_307;
Responses were rapid and are expected to deepen over time (median f/u only 3m). CRS rates were similar to MajesTEC-1 and no unexpected toxicity was noted.
- Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
First Results From the RedirecTT-1 Study With Teclistamab (tec) + Talquetamab (tal) Simultaneously Targeting BCMA and GPRC5D in Patients (pts) With Relapsed/Refractory Multiple Myeloma (RRMM) (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_304;
P1b/2
In this first combination study of two bispecific antibodies in MM, targeting BCMA and GPRC5D, tec + tal at the RP2R has a manageable safety profile consistent with each of the monotherapies. A 92% ORR was observed in pts with advanced RRMM at the RP2R and an ORR of 83% was achieved in pts with EMD, a high-risk population with unmet need, supporting further evaluation of the combination.
- Tecvayli (teclistamab) / Genmab, J&J
Hotspot mutations in BCMA extracellular domain lead to differential susceptibility to anti-BCMA targeted immunotherapies (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_301;
Furthermore, these hotspot mutations do not equally confer resistance to all anti-BCMA TCEs or CAR Ts. Dynamic surveillance and functional evaluation of emerging mutant clones will be required to inform and guide therapy selection and sequence.
- Tecvayli (teclistamab) / Genmab, J&J
Early outcomes and therapy modification strategies in Multiple Myeloma patients treated with teclistamab, CD3XBCMA BITE; a single center experience. (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_298;
Despite treatment frequency modification, two patients achieved a CR with one patient achieving a stringent CR at the 3-month evaluation. Further studies are needed to assess response adapted treatment frequency modification as well as study genomic perturbations that can alter the function of immune cells (T cells) and impact response to BITE.
- DISPARITIES IN ACCESS AND PRACTICE PATTERNS OF BCMA-DIRECTED T-CELL ENGAGER (TCE) THERAPIES IN MULTIPLE MYELOMA: A GLOBAL PERSPECTIVE (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_290;
Keppra neurologic prophylaxis was used by 47.5% and 15% of responders for CAR-T and BiTE therapy, respectively... Trends of TCE use and supportive care in MM vary widely among academic centers across the globe, demonstrating a need for further understanding of disease and toxicity management among the international myeloma community, along with improved access beyond urban centers.
- Tecvayli (teclistamab) / Genmab, J&J
TECLISTAMAB IN RELAPSED AND REFRACTORY MULTIPLE MYELOMA: PATIENTS CHARACTERISTICS FROM POST MARKETING ACCES (ACCES PRECOCE) IN FRANCE (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_288;
French AP population was heavily pre-treated with clinically significant comorbidities and was slightly older, more frail than patients in the Majestec-1 study population. Academic and non-academic centers have included patients.
- Tecvayli (teclistamab) / Genmab, J&J
Patterns of Cytokine Release Syndrome with Teclistamab in Relapsed/Refractory Multiple Myeloma with or without Prior T-Cell Redirection Therapy. (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_287;
In our study cohorts, prior exposure to a TCRT was associated with a significantly lower incidence of CRS during Tec step-up dosing phase. This observation will allow for optimization of CRS prophylactic strategies for RRMM patients.
- Tecvayli (teclistamab) / Genmab, J&J
Safety and Efficacy of Standard of Care (SOC) Teclistamab (TEC) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM), a single center experience (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_286;
No new safety signals were identified. Results will be updated with continued follow up.
- Tecvayli (teclistamab) / Genmab, J&J
Managing Cytokine Release Syndrome in Relapsed/Refractory Multiple Myeloma: Experience With Teclistamab in the MajesTEC-1 Study (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_265;
Practical guidance is needed for nurses to recognize and monitor CRS and to anticipate when treatment and escalation are needed to ensure successful administration of teclistamab. Data previously presented at the 2023 Oncology Nursing Society (ONS) Annual Meeting.
- Tecvayli (teclistamab) / Genmab, J&J
Managing Infections, Hypogammaglobulinemia, and Neutropenia During Treatment With Teclistamab in Relapsed/Refractory Multiple Myeloma: Nurse-Led Experience From the MajesTEC-1 Study (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_264;
Teclistamab should not be given in case of any active infection; therefore, partnership between nurses, physicians, and patients is essential to facilitate prompt identification, monitoring, and management of infections, including appropriate use of antimicrobial prophylaxis, IVIG, and G-CSF. In particular, we recommend that patients are educated on the importance of reporting early signs and symptoms of infections, and that nurses and care teams are prepared and trained to implement appropriate infection management strategies.
- Tecvayli (teclistamab) / Genmab, J&J
Bispecific T-cell engager response is driven by pre-treatment CD8+ effector memory cells and inhibited by TIGIT+ Tregs in relapsed/refractory multiple myeloma (Mitropoulas; in Persion) - Sep 10, 2023 - Abstract #IMW2023IMW_255;
A pre-Tec T-cell population enriched with highly cytotoxic effector T-cells associates with response to therapy, while suppressive TIGIT+ Tregs associate with nonresponse, suggesting a potential therapeutic role for TIGIT blockade or CD25+ cell depletion to enhance the therapeutic efficacy of Tec and other bispecific antibodies. Clinical and translational data from additional enrolled patients will be presented at the meeting.
- Tecvayli (teclistamab) / Genmab, J&J
Real world experience of patients treated with teclistamab: a BCMA-directed bispecific t-cell engaging therapy for multiple myeloma (Skalkotas; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_247;
Overall, we observed that teclistamab treatment in a commercial setting generated comparable responses to the previously reported clinical trials without any new toxicity signals. While additional follow up with commercial Teclistamab use in the real-world is needed to validate these results, this study reveals the need for efficacious therapies in high-risk or ultra-high-risk disease.
- Elrexfio (elranatamab) / Pfizer, Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
Efficacy of Bispecific Antibodies in the Treatment of Extramedullary disease and High risk cytogenetics in Relapsed Multiple Myeloma: A Systematic Review (Skalkotas; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_200;
This needs to be improved and clinical trials should report EMD responses distinctly as it directly informs clinical decisions. EMD responses are significantly lower than the full cohort ORR however it is encouraging that responses to high risk multiple myeloma (HRMM) closely approximate ORR of these agents.
- Tecvayli (teclistamab) / Genmab, J&J
Preliminary Recommendations for Prevention and Management of Infections, Hypogammaglobulinemia, and Neutropenia During Treatment With Teclistamab Based on Experience From the MajesTEC-1 Study (Trianti; In Person; Virtual) - Sep 10, 2023 - Abstract #IMW2023IMW_185;
EMD responses are significantly lower than the full cohort ORR however it is encouraging that responses to high risk multiple myeloma (HRMM) closely approximate ORR of these agents. Based on MajesTEC-1, IVIG (administered every 3
- || Review, Journal: Management of Adverse Reactions for BCMA-Directed Therapy in Relapsed Multiple Myeloma: A Focused Review. (Pubmed Central) - Sep 9, 2023
All four agents (idecabtagene vicleucel, ciltacabtagene autoleucel, teclistamab, belantamab mafodotin) have received FDA approval for adult RRMM patients. We went through the FDA access data packages of the approved agents to outline stepwise management of the complications for better patient outcomes.
- || Tecvayli (teclistamab-cqyv) / Genmab, J&J
Enrollment open: Outpatient Administration of Teclistamab for Multiple Myeloma (clinicaltrials.gov) - Sep 8, 2023
P2, N=50, Recruiting, Sponsor: SCRI Development Innovations, LLC
We went through the FDA access data packages of the approved agents to outline stepwise management of the complications for better patient outcomes. Not yet recruiting --> Recruiting
- || Darzalex (daratumumab) / J&J, Tecvayli (teclistamab-cqyv) / Genmab, J&J, Talvey (talquetamab-tgvs) / J&J
Enrollment open, Trial initiation date: GEM-TECTAL: Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma (clinicaltrials.gov) - Sep 8, 2023
P2, N=30, Recruiting, Sponsor: PETHEMA Foundation
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Sep 2023
- Tecvayli (teclistamab) / Genmab, J&J
Real World Evaluation of Teclistamab: A Focus on Infections in Patients With Relapsed Refractory Multiple Myeloma (RRMM) () - Aug 31, 2023 - Abstract #SOHO2023SOHO_829;
Infections were common, but generally low grade and infrequently required anti-microbial treatment. However, infections may increase with longer follow-up.
- Tecvayli (teclistamab) / Genmab, J&J
Feasibility and Safety of Outpatient Model for Teclistamab Step?Up Dosing Administration: A Single Center Experience () - Aug 31, 2023 - Abstract #SOHO2023SOHO_625;
Outpatient teclistamab step-up dosing administration with close monitoring and prompt hospitalization for toxicity management is safe and feasible in heavily pre-treated RRMM patients. This approach allows a significant reduction of inpatient stay, resulting in significant healthcare resource savings and improvement of patients' experience.
- Tecvayli (teclistamab) / Genmab, J&J
Real World Evaluation of Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma (RRMM) () - Aug 31, 2023 - Abstract #SOHO2023SOHO_620;
This approach allows a significant reduction of inpatient stay, resulting in significant healthcare resource savings and improvement of patients' experience. CRS was seen in 49% (all Gr1 except 1 Gr2, 1 Gr4); it generally resolved ?24 hours and was managed with 1 dose of tocilizumab or 1
- Tecvayli (teclistamab) / Genmab, J&J
Real?World Patient Profile and Step?Up Dosing Process of Early Initiators of Teclistamab for Multiple Myeloma (MM) in a Hospital Setting in the US: Premier Healthcare Database Study () - Aug 31, 2023 - Abstract #SOHO2023SOHO_593;
Patients were diverse and elderly with significant comorbidities, and the majority completed SUD as scheduled without delay. More patients with longer follow-up are needed to update the data, as real-world profiles and treatment patterns may evolve over time.
- Tecvayli (teclistamab) / Genmab, J&J
Preliminary Recommendations for Prevention and Management of Infections, Hypogammaglobulinemia, and Neutropenia During Treatment With Teclistamab Based on Experience From the MajesTEC?1 Study () - Aug 31, 2023 - Abstract #SOHO2023SOHO_571;
Patients should be screened for hepatitis B and C and should receive all appropriate vaccinations (including COVID-19) before starting teclistamab. Prophylaxis for Pneumocystis jirovecii pneumonia and herpes viruses is recommended; other prophylactic antimicrobials should be administered per institutional guidelines.
- Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
First Results From the RedirecTT?1 Study With Teclistamab (Tec) + Talquetamab (Tal) Simultaneously Targeting BCMA and GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) () - Aug 31, 2023 - Abstract #SOHO2023SOHO_567;
P1b/2
First combination study tec+tal at RP2R has manageable safety profile consistent with each monotherapy. 92% ORR in patients with advanced RRMM at RP2R and 83% ORR in patients with EMD (high-risk population with unmet need) support further evaluation.
- Tecvayli (teclistamab) / Genmab, J&J
Long?Term Follow?Up From MajesTEC?1 of Teclistamab, a B?Cell Maturation Antigen (BCMA) () - Aug 31, 2023 - Abstract #SOHO2023SOHO_566;
P1, P2
92% ORR in patients with advanced RRMM at RP2R and 83% ORR in patients with EMD (high-risk population with unmet need) support further evaluation. After ~2 years mFU, patients receiving teclistamab demonstrated deep and durable responses, supporting teclistamab as a safe and effective off-the-shelf BCMA bispecific therapy for patients with RRMM.
- Tecvayli (teclistamab) / Genmab, J&J
Durability of Responses With Biweekly Dosing of Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma Achieving a Clinical Response in the MajesTEC?1 Study () - Aug 31, 2023 - Abstract #SOHO2023SOHO_565;
P1, P2
After ~2 years mFU, patients receiving teclistamab demonstrated deep and durable responses, supporting teclistamab as a safe and effective off-the-shelf BCMA bispecific therapy for patients with RRMM. Patients who transitioned from QW to less frequent Q2W dosing of teclistamab had sustained remission.
- | Tecvayli (teclistamab) / Genmab, J&J
Journal: Teclistamab in patients with multiple myeloma and impaired renal function. (Pubmed Central) - Aug 24, 2023
Patients who transitioned from QW to less frequent Q2W dosing of teclistamab had sustained remission. Robust anti-myeloma activity with teclistamab in patients with severe renal impairment.