Talvey (talquetamab)

To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies Drug Trials Snapshot

FDA Approval: 8/9/2023

Research Synopsis

  • Talquetamab (Talvey) is a bispecific T-cell engager developed for the treatment of relapsed or refractory multiple myeloma, targeting the GPRC5D protein found in high amounts on malignant plasma cells.
  • The drug received accelerated approval in the U.S. and conditional marketing authorization in the EU in August 2023, marking a significant milestone in its development.
  • Clinical trials, including the MonumenTAL-1 study, demonstrated promising response rates, with nearly 75% of participants showing significant anticancer effects.
  • Common side effects associated with talquetamab include cytokine release syndrome and skin reactions, with most being of low severity, though serious adverse events were observed in a small percentage of patients.
  • Preclinical research shows that talquetamab effectively kills GPRC5D+ multiple myeloma cells, particularly in the presence of optimal T-cell ratios, indicating a tailored therapeutic approach could enhance efficacy.
  • Continued studies are ongoing to better understand the safety profile, optimal dosing regimens, and long-term outcomes related to talquetamab treatment in multiple myeloma patients.
  • The rise of bispecific antibodies such as talquetamab and teclistamab presents new hope for patients with difficult-to-treat forms of multiple myeloma.
  • Despite advancements, multiple myeloma remains largely incurable, underlining the need for ongoing research into potential new therapies and treatment strategies.
  • Talquetamab's development is part of a broader trend towards innovative immunotherapies and combination treatments designed to improve the survival rates and quality of life for patients with this challenging malignancy.
  • Monitoring for both therapeutic efficacy and adverse effects will be essential as more data becomes available from ongoing trials and expanded real-world use of talquetamab.

Related articles

Research articles about Talvey (talquetamab)

Talvey (talquetamab)

GPRC5D as a novel target for the treatment of multiple myeloma: a narrative review.

London, UK

2 hours ago

1 Received

  • Multiple myeloma is a type of cancer that affects the bone marrow and has a 5-year survival rate of about 60%, but there are challenges with treatment.
  • Researchers are focusing on a new target in the fight against this cancer called GPRC5D, which could help make therapies more effective.
  • Early trials with GPRC5D-targeting treatments show promising results, with many patients responding well and experiencing fewer infections compared to other treatments, but some side effects related to skin and mouth have been observed.

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Antibodies to watch in 2023.

London, UK

2 hours ago

1 Received

  • The 14th installment of the Antibodies to Watch series reviews significant developments in monoclonal antibody therapeutics in 2022 and predicts future events for 2023.
  • In 2022, 12 new antibody therapeutics were approved in the US and EU, including 4 bispecific antibodies and 1 antibody-drug conjugate (ADC), with additional approvals expected by year-end.
  • The late-stage clinical pipeline for antibody therapeutics grew by about 20%, now featuring nearly 140 investigational candidates, with at least 23 marketing submissions anticipated by the end of 2023.

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Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma.

London, UK

2 hours ago

1 Received

  • GPRC5D is an orphan receptor found in malignant plasma cells, and talquetamab is a bispecific antibody designed to activate T cells to target and eliminate these myeloma cells.
  • In a phase 1 study, various dosing regimens of talquetamab were tested on heavily pretreated patients with relapsed or refractory multiple myeloma to evaluate safety and determine recommended doses for further studies.
  • Results showed promising response rates of 70% and 64% in patients receiving two specific subcutaneous doses, with common side effects including cytokine release syndrome and skin-related issues, but mainly of low severity.

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The emerging therapeutic landscape of relapsed/refractory multiple myeloma.

London, UK

2 hours ago

1 Received

  • Treatment for relapsed/refractory multiple myeloma (R/R MM) has evolved significantly over the decades, with breakthroughs in immunomodulatory agents, proteasome inhibitors, monoclonal antibodies, and CAR-T therapies.
  • The surge of new therapies has led to challenges in therapy selection and sequencing due to a lack of consensus guidelines and complicated cross-trial comparisons.
  • This review discusses FDA-approved treatments like teclistamab, examines clinical trial data for optimal treatment sequencing, considers tolerability and financial factors, and highlights ongoing trials for new promising therapies like elranatamab and talquetamab.

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Onychomadesis and palmoplantar keratoderma associated with talquetamab therapy for relapsed and refractory multiple myeloma.

London, UK

2 hours ago

1 Received

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Effects of teclistamab and talquetamab on soluble BCMA levels in patients with relapsed/refractory multiple myeloma.

London, UK

2 hours ago

1 Received

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MonumenTAL Results for Talquetamab in Myeloma.

London, UK

2 hours ago

1 Received

  • * Talquetamab is a bispecific antibody that targets GPRC5D, a protein found in high amounts on cancerous plasma cells but limited on healthy cells.
  • * The drug works by enlisting CD3-expressing T cells to activate the immune system against the cancer cells.

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2-[ 18 F]FDG PET/CT Flare-up Phenomena Following T-Cell Engager Bispecific Antibody in Multiple Myeloma.

London, UK

2 hours ago

1 Received

  • - T-cell-redirecting bispecific antibodies are now a key treatment option for patients with hard-to-treat multiple myeloma, known as triple-class refractory myeloma.
  • - A 61-year-old woman with relapsed myeloma showed a significant reduction in monoclonal proteins after receiving talquetamab, but early imaging indicated a temporary inflammation in the bones.
  • - By day 84, additional assessments confirmed her complete response to treatment, supporting the initial observation of bone flare-up as part of the healing process.

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The Role of Bispecific Antibodies in Relapsed Refractory Multiple Myeloma: A Systematic Review.

London, UK

2 hours ago

1 Received

  • - Multiple myeloma is a complex cancer of plasma cells that is difficult to treat, but bispecific antibodies (BsAbs) offer a potential new therapy by targeting both T-cells and cancer cells simultaneously.
  • - A systematic review analyzed 18 clinical trials involving 1,283 patients, revealing that BCMA-targeting BsAbs have varied efficacy, with overall response rates (ORRs) from 25% to 100%, while non-BCMA-targeting agents showed ORRs between 60% and 100%.
  • - Common side effects of BsAbs include cytokine release syndrome, anemia, neutropenia, and thrombocytopenia, indicating a generally good safety profile, which is encouraging for future research on

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Siltuximab as a primary treatment for cytokine release syndrome in a patient receiving a bispecific antibody in a clinical trial setting.

London, UK

2 hours ago

1 Received

  • Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are frequent side effects of immunotherapies like T cell redirecting bispecific antibodies, and tocilizumab is recommended for their management, though siltuximab is less commonly reported.
  • A 77-year-old male with relapsed/refractory multiple myeloma developed CRS and ICANS after receiving talquetamab, a T cell redirecting bispecific antibody.
  • The patient was treated with siltuximab, leading to rapid recovery from CRS and ICANS, allowing him to tolerate further treatment with talquetamab without complications, highlighting siltuximab's potential in managing

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Bispecific Monoclonal Antibodies in Multiple Myeloma: Data from ASH 2022: A Podcast.

London, UK

2 hours ago

1 Received

  • Novel immunotherapies have significantly improved outcomes for multiple myeloma (MM) patients, but the disease remains mostly incurable and worse for heavily pretreated individuals.
  • The development of bispecific antibodies (BsAb) targeting factors like BCMA, GPRC5D, and FcRH5 provides new hope, as they aim to connect immune cells directly to myeloma cells.
  • A podcast summarizes recent clinical trial findings on several BsAb presented at the American Society of Hematology's 2022 meeting, highlighting their safety and effectiveness for relapsed or refractory MM patients.

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Talquetamab-Induced Grover's Disease.

London, UK

2 hours ago

1 Received

  • The article discusses a case of Grover’s disease, a skin condition, that appeared in a patient after treatment with talquetamab, a medication used in certain cancer therapies.
  • Grover’s disease is characterized by transient itchy red bumps on the skin, particularly in adults and often associated with warm weather.
  • The authors highlight the importance of monitoring skin reactions in patients undergoing treatment with new drugs like talquetamab, suggesting that healthcare providers should be aware of possible dermatological side effects.

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Bispecific antibodies targeting BCMA, GPRC5D, and FcRH5 for multiple myeloma therapy: latest updates from ASCO 2023 Annual Meeting.

London, UK

2 hours ago

1 Received

  • * Teclistamab received approval in 2022 for treating relapsed/refractory MM, while other antibodies like elranatamab and talquetamab are still undergoing trials.
  • * The study provides a summary of recent findings about these bsAbs presented at the ASCO 2023 Annual Meeting.

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Plain language summary of the MonumenTAL-1 study of talquetamab in people with relapsed or refractory multiple myeloma.

London, UK

2 hours ago

1 Received

  • The MonumenTAL-1 clinical trial evaluated the safety and efficacy of a new drug, talquetamab, for multiple myeloma patients who had not responded to previous treatments.
  • Conducted in two parts, the first part focused on identifying safe dosage levels, while the second part assessed how well the drug worked at those doses and monitored side effects.
  • Results indicated that two specific doses (405 μg/kg weekly and 800 μg/kg biweekly) were tolerable, though all participants experienced side effects, with serious adverse events occurring in about 34%-43% of participants.

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"A beacon of hope for relapsed multiple myeloma patients: TALVEY™".

London, UK

2 hours ago

1 Received

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Talquetamab (Talvey) for multiple myeloma.

London, UK

2 hours ago

1 Received

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Talquetamab: First Approval.

London, UK

2 hours ago

1 Received

  • Talquetamab (TALVEY) is a bispecific T-cell engager designed to target multiple myeloma, developed by Janssen.
  • In August 2023, it received accelerated approval in the USA and conditional marketing authorization in the EU for adults with relapsed or refractory multiple myeloma.
  • The article outlines key milestones in the drug's development leading to its first approval for treating this condition.

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Immunotherapy of Multiple Myeloma: Current Status as Prologue to the Future.

London, UK

2 hours ago

1 Received

  • - The treatment landscape for multiple myeloma has advanced significantly in the 21st century, thanks to new drugs like proteasome inhibitors and immunomodulators, as well as immunotherapies introduced in recent years.
  • - Recent immunotherapeutic agents include bispecifics and CAR T-cell therapies, which have greatly increased the five-year survival rate for patients to nearly 60% and improved their quality of life.
  • - Despite these advancements, multiple myeloma remains incurable as patients often become resistant to treatments and relapse, prompting ongoing research into new therapies and their potential benefits and challenges.

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Novel Immunotherapies and Combinations: The Future Landscape of Multiple Myeloma Treatment.

London, UK

2 hours ago

1 Received

  • New therapies for multiple myeloma, like monoclonal antibodies daratumumab and isatuximab, have significantly improved patient outcomes, but more patients are becoming resistant to treatments earlier in their disease.
  • The rise of triple- or multi-refractory multiple myeloma (MM) highlights a significant medical need, complicating treatment options for these patients.
  • Recent advancements in immunotherapy, such as conjugated and bispecific antibodies and CAR T cells, show potential but come with challenges in patient selection and therapy sequencing, prompting ongoing research and clinical trials.

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