MedPath

Teclistamab

Generic Name
Teclistamab
Brand Names
Tecvayli
Drug Type
Biotech
CAS Number
2119595-80-9
Unique Ingredient Identifier
54534MX6Z9
Background

Teclistamab is an IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA) expressed on malignant multiple myeloma cells. Teclistamab consists of an anti-BCMA arm and an anti-CD3 arm connected via two interchain disulfide bonds, allowing the drug to recruit CD3-expressing T cells to BCMA-expressing cells to promote T cell–mediated cytotoxicity.

On August 24, 2022, the European Commission (EC) granted conditional marketing authorization of teclistamab as first-in-class bispecific antibody for the treatment of multiple myeloma, marking its first global approval. Teclistamab was later granted accelerated approval by the FDA on October 25, 2022.

Indication

Teclistamab is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Teclistamab is approved by the EC and FDA under conditional marketing authorization and accelerated approval, respectively. New evidence for this drug will be continuously monitored and reviewed, which will affect continued approval for the drug's indication.

Associated Conditions
Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Clinical Trials
Related News

DARZALEX Dominates Multiple Myeloma Market with $11.6 Billion in Global Sales

• DARZALEX (daratumumab), Janssen's CD38-targeting monoclonal antibody, has transformed multiple myeloma treatment across all lines of therapy, generating $11.6 billion in worldwide sales in 2024. • The drug's success stems from its versatility in combination regimens, expanded approvals for both newly diagnosed and relapsed/refractory patients, and the introduction of DARZALEX FASPRO, a convenient subcutaneous formulation. • Despite growing competition from emerging therapies like Sanofi's SARCLISA and novel BCMA-targeting agents, DARZALEX maintains market leadership through first-mover advantage and robust clinical efficacy data.

GSK's Blenrep Secures UK Approval for Multiple Myeloma Treatment in Combination Therapy

• The UK's medicines regulatory body has approved GSK's Blenrep (belantamab mafodotin) in combination with other drugs for multiple myeloma patients whose first treatment failed or caused severe side effects. • This approval marks a significant comeback for Blenrep, which was withdrawn from markets in 2022 after failing to outperform existing treatments when used as monotherapy. • Clinical trials demonstrated Blenrep's combination therapy extended progression-free survival and overall survival compared to standard care regimens, including those based on Darzalex (daratumumab).

TuHURA Biosciences Appoints Former J&J Oncology Executive Craig Tendler to Board of Directors

• TuHURA Biosciences has appointed Craig L. Tendler, M.D., former Vice President of Oncology Clinical Development at Johnson & Johnson, to its Board of Directors effective March 10, 2025. • Dr. Tendler brings extensive experience overseeing 30 major drug approvals and 13 FDA Breakthrough Designations, including transformational treatments for hematologic malignancies, prostate, lung, and bladder cancers. • The appointment comes as TuHURA prepares to advance its lead candidate IFx-2.0, designed to overcome resistance to checkpoint inhibitors, into a Phase 3 registrational trial in Q2 2025.

Lunsumio Shows Durable 3-Year Remission in Follicular Lymphoma, Setting New Benchmark for Bispecific Antibodies

• Lunsumio demonstrated a 60% complete response rate and 77.8% objective response rate in relapsed/refractory follicular lymphoma patients over a 37.4-month follow-up period. • The bispecific antibody therapy achieved an estimated 82.4% three-year overall survival rate with just eight cycles of fixed-duration treatment, maintaining durable remission in most complete responders. • As Korea's first GIFT-approved drug, Lunsumio's long-term data could potentially break the reimbursement barrier for bispecific antibodies, offering advantages of outpatient administration and minimal pretreatment requirements.

CAR T-cell Therapies Show Promise in Relapsed Multiple Myeloma

• Allogeneic BCMA CAR T-cell therapy demonstrates promising efficacy and reasonable safety in relapsed multiple myeloma, utilizing CRISPR technology to mitigate graft-versus-host disease. • A clinical trial targeting GPRC5D shows high efficacy in patients who have relapsed after BCMA-targeted therapy, potentially offering a more favorable treatment option. • The allogeneic approach allows for faster treatment delivery using "off-the-shelf" cells, addressing a key limitation of autologous CAR T-cell therapies. • Early results indicate high efficacy in minority patients, who are often underrepresented in clinical trials, highlighting the therapy's potential for broader impact.

Real-World Study Evaluates Bispecific Antibody Use in Relapsed/Refractory Multiple Myeloma

• A real-world study examined bispecific antibody use in relapsed/refractory multiple myeloma patients, revealing that 44.67% of evaluable patients received these agents in 2023. • The research integrates structured and unstructured data, using AI to convert visit notes into structured data, enhancing the analysis of treatment patterns. • Future analysis will focus on safety profiles and comparing real-world outcomes with prospective clinical trial data to assess effectiveness. • The study aims to understand the evolving patterns of care associated with bispecific antibodies in a larger cohort over the next few years.

J&J Boosts Neuroscience Pipeline with ITCI Acquisition, FDA Approves Spravato Monotherapy for TRD

• Johnson & Johnson (J&J) is set to acquire Intra-Cellular Therapies (ITCI) for $14.6 billion, adding Caplyta for bipolar disorder and schizophrenia to its neuroscience pipeline. • The FDA has approved J&J's Spravato as a monotherapy for treatment-resistant depression (TRD), based on positive data from the phase IV TRD4005 study. • AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) received FDA priority review for a lung cancer indication and was approved for previously treated breast cancer.

J&J's Alzheimer's Therapies, Posdinemab and JNJ-2056, Receive FDA Fast Track Designation

• Johnson & Johnson's posdinemab, a monoclonal antibody targeting phosphorylated tau, has received FDA Fast Track designation for early Alzheimer's treatment. • JNJ-2056, an anti-tau active immunotherapy, also received Fast Track status, marking the second such designation for J&J's Alzheimer's portfolio in 2024. • Both therapies are currently in Phase 2b trials, with posdinemab in the "AuTonomy" study and JNJ-2056 in the "ReTain" trial, aimed at slowing disease progression. • The FDA's Fast Track designation is designed to expedite the review of drugs addressing serious conditions with unmet medical needs, potentially accelerating patient access.

J&J's Carvykti Shows Promise in Earlier Myeloma Treatment

• The CARTITUDE-4 study indicates that Carvykti (ciltacabtagene autoleucel) significantly improves progression-free survival in multiple myeloma patients with 1-3 prior lines of therapy. • Carvykti, a BCMA-directed CAR-T therapy, may soon be used earlier in the treatment pathway, potentially leapfrogging Bristol-Myers Squibb's Abecma. • The study compared Carvykti to standard three-drug regimens, showing a significant benefit that led to unblinding of the trial. • Expansion of Carvykti's use is a key component of J&J's strategy in multiple myeloma, alongside other therapies like Darzalex and bispecific antibodies.

RYBREVANT and LAZCLUZE Combination Shows Significant Survival Improvement in EGFR-Mutated NSCLC

• Johnson & Johnson's RYBREVANT plus LAZCLUZE demonstrates statistically significant and clinically meaningful improvement in overall survival (OS) versus osimertinib in EGFR-mutated NSCLC. • The MARIPOSA Phase 3 study showed the chemotherapy-free combination is expected to improve median OS by over one year compared to the current standard of care. • RYBREVANT plus LAZCLUZE is approved in the U.S. and Europe as a first-line therapy for NSCLC patients with EGFR exon 19 deletions or L858R substitution mutations. • The safety profile of the combination was consistent with individual treatments, with venous thromboembolic events managed through prophylactic anticoagulants.

FDA Approvals in 2024: Advancing Treatment Paradigms in Solid Tumors and Hematologic Malignancies

• The FDA granted over 65 approvals in 2024, significantly impacting treatment paradigms across various cancers, including breast, gynecologic, skin, and genitourinary malignancies. • Several tumor-agnostic approvals, such as fam-trastuzumab deruxtecan-nxki (Enhertu) for HER2-positive solid tumors and repotrectinib (Augtyro) for NTRK fusion-positive tumors, marked advancements in precision medicine. • Immunotherapies like nivolumab (Opdivo) and pembrolizumab (Keytruda) received multiple approvals, including combinations with chemotherapy for urothelial and endometrial carcinomas, improving patient outcomes. • Targeted therapies like vorasidenib (Voranigo) for low-grade glioma and selpercatinib (Retevmo) for RET-mutated thyroid cancers addressed unmet needs and demonstrated high efficacy and tolerability.

Global Review Highlights Clinical Trial Landscape for Relapsed Multiple Myeloma

• A comprehensive review of global clinical trials for relapsed multiple myeloma (R/R MM) reveals key trends in trial locations, phases, and sponsor types. • The analysis identifies prominent drugs under investigation and highlights recent clinical trial news, including updates from ASH 2024 and other major meetings. • The review emphasizes the importance of understanding trial enrollment trends and success rates to inform business strategies and identify key opportunities in the R/R MM therapeutics market. • Recent data showcases promising results for novel combinations and CAR-T cell therapies, suggesting potential breakthroughs in treating R/R MM.

J&J's TALVEY® Navigates Regulatory Hurdles for Multiple Myeloma Treatment

• Johnson & Johnson's TALVEY® (talquetamab), a bispecific antibody targeting CD3 and GPRC5D, received regulatory approval for relapsed/refractory multiple myeloma. • Regulators balanced TALVEY's potential severe side effects, including neurotoxicity and hepatotoxicity, with the significant unmet need in heavily pre-treated patients. • TALVEY's approval pathways, similar to TECVAYLI (teclistimab), utilized Accelerated Approval and Conditional Marketing Authorization for faster patient access. • Ongoing studies, like RedirecTT-1, explore TALVEY and TECVAYLI in combination to treat triple-class exposed relapsed/refractory multiple myeloma patients.

Roche's Vabysmo Prefilled Syringe Approved in EU for Retinal Conditions

• The European Medicines Agency (EMA) has approved Roche's Vabysmo prefilled syringe (PFS) for treating three retinal conditions: nAMD, DME, and RVO. • Vabysmo PFS offers a convenient, ready-to-use format for ophthalmologists, potentially reducing treatment burden for both patients and specialists. • This approval marks the EU's first prefilled syringe containing a bispecific antibody for vision-threatening retinal diseases, offering a CE-labelled needle for intravitreal injection. • Vabysmo targets Ang-2 and VEGF-A, stabilizing blood vessels and addressing key factors contributing to vision loss in these conditions.

Multispecific Antibodies Market Set to Exceed $40 Billion as Next-Generation Cancer Therapies Advance

• The multispecific antibodies market has surpassed $8.6 billion in sales as of Q3 2024, with 16 approved therapies demonstrating efficacy across oncology and other therapeutic areas. • Bispecific antibodies currently dominate the market, while more complex trispecific and tetraspecific antibodies are emerging in early development phases with potential for enhanced therapeutic advantages. • Over 900 multispecific antibodies are currently in clinical trials, reflecting substantial investment from pharmaceutical companies and biotechnology firms seeking to address complex diseases through multi-target approaches.

Teclistamab Maintenance Therapy Shows Promise in Newly Diagnosed Multiple Myeloma

• Maintenance therapy with teclistamab, alone or with lenalidomide, demonstrated a 100% minimal residual disease (MRD) negativity rate in evaluable patients with newly diagnosed multiple myeloma (NDMM). • Treatment responses deepened during maintenance, with high rates of complete remission (CR) or better observed across all three cohorts in the MajesTEC-4/EMN30 trial. • The safety run-in (SRI) data indicated manageable hematologic toxicities, with neutropenia being the most frequent adverse event, and rare instances of febrile neutropenia or treatment discontinuation. • The MajesTEC-4/EMN30 trial is actively recruiting patients to further evaluate teclistamab-based maintenance strategies in NDMM following autologous stem cell transplantation (ASCT).

Teclistamab Shows Promise as Frontline Therapy for Multiple Myeloma in Newly Diagnosed Patients

• Teclistamab-based regimens demonstrated high rates of MRD negativity in newly diagnosed multiple myeloma patients in the MajesTEC-5 study. • The MajesTEC-4 study highlighted teclistamab's potential as maintenance therapy post-autologous stem cell transplant, showing low TEAEs. • Both studies presented at ASH 2024 indicate a manageable safety profile for teclistamab in frontline settings, supporting its combinability. • Ongoing MajesTEC-7 trial will further evaluate teclistamab in combination with daratumumab and lenalidomide for NDMM patients.

FDA to Review Belantamab Mafodotin and Linvoseltamab Combinations for Multiple Myeloma

• The FDA has accepted a BLA for belantamab mafodotin combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for multiple myeloma treatment. • Regeneron's linvoseltamab BLA resubmission has been accepted by the FDA, with a decision expected by July 10, 2025, for relapsed/refractory multiple myeloma. • Clinical trials DREAMM-7 and DREAMM-8 support the belantamab mafodotin BLA, while LINKER-MM1 supports the linvoseltamab BLA, showcasing improved progression-free survival. • Both belantamab mafodotin and linvoseltamab are under review by other regulatory authorities, potentially expanding treatment options for multiple myeloma patients.

Talquetamab and Teclistamab Combination Shows Promise in Relapsed/Refractory Multiple Myeloma

• A Phase Ib/II trial of talquetamab plus teclistamab shows promising antitumor activity and durable responses in relapsed/refractory multiple myeloma patients. • The combination therapy demonstrated an 80% response rate in patients administered the recommended Phase II dose, including those with extramedullary disease. • The study also reported a higher incidence of grade 3 or 4 infections compared to either drug as monotherapy, warranting further investigation. • These results suggest the dual-targeting combination therapy may be a valuable option for heavily pretreated multiple myeloma patients.

GSK's Blenrep Demonstrates Significant Survival Benefit in Multiple Myeloma Trial, Paving Way for Potential Comeback

• GSK's Blenrep, combined with chemotherapy and a steroid, reduced the risk of death by 42% compared to a standard-of-care treatment in relapsed or refractory multiple myeloma. • The DREAMM-7 trial data showed a projected median overall survival of 84 months for the Blenrep combination versus 51 months for the comparator arm. • Blenrep, an antibody-drug conjugate targeting BCMA, is under regulatory review in multiple regions, potentially offering a new treatment option for myeloma patients. • Despite previous market withdrawal due to a failed trial, Blenrep's new data suggests a possible paradigm shift in treating relapsed or refractory multiple myeloma.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy