Drugs / Talquetamab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed plasma cell myeloma 1 milestone | |||||
| Filed | US (FDA) | — | plasma cell myeloma | 2022-12-09 | “today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for talquetamab” jnj.com ↗ |
| Filed relapsed/refractory diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | US (FDA) | — | relapsed/refractory diffuse large B-cell lymphoma | — | “submitted a Biologics License Application (BLA) to the FDA seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma.” jnj.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Talvey | — | 2023-08-21 | europa.eu ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT07581704 | Jun 2026 → Jun 2029 expected | plasma cell myeloma | Christopher Strouse | Recruiting | No outcome recorded |
| Phase 1 | NCT07032714 | Dec 2025 → Jul 2027 expected | refractory plasma cell neoplasm | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT07093554 | Dec 2025 → Jul 2027 expected | plasma cell myeloma | Medical College of Wisconsin | Recruiting | No outcome recorded |
| Phase 1 | NCT06348108 | Jul 2025 → Jul 2027 expected | plasma cell myeloma | Alfred Chung, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT05338775 | May 2022 → May 2025 overdue | refractory plasma cell neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05050097 | Sep 2021 → Mar 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04773522 | May 2021 → Oct 2022 | plasma cell myeloma | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT04108195 | Feb 2020 → Apr 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03399799 | Dec 2017 → Jul 2022 overdue | hematopoietic and lymphoid cell neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06572605 | Aug 2025 → Jan 2030 | extramedullary plasmacytoma, plasma cell myeloma | City of Hope Medical Center | Suspended | No outcome recorded |
| Phase 1/2 | NCT04586426 | Dec 2020 → Mar 2025 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 216 trials | ||||||
| Phase 2 | NCT07029776 | Mar 2027 → Apr 2030 expected | plasma cell myeloma | University of Arkansas | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07107529 | Dec 2025 → Apr 2029 expected | plasma cell myeloma | European Myeloma Network B.V. | Recruiting | No outcome recorded |
| Phase 2 | NCT06827860 | Nov 2025 → Jan 2027 expected | plasma cell myeloma | Larysa Sanchez | Recruiting | No outcome recorded |
| Phase 2 | NCT06993675 | Aug 2025 → Aug 2029 expected | plasma cell myeloma | Noffar Bar | Recruiting | No outcome recorded |
| Phase 2 | NCT06461988 | Jun 2025 → Dec 2027 expected | disease related to hematopoietic stem cell transplant, plasma cell myeloma | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT06550895 | Sep 2024 → Aug 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06500884 | Aug 2024 → May 2030 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06577025 | Aug 2024 → Sep 2030 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06353022 | Jun 2024 → Apr 2028 expected | plasma cell myeloma | Nantes University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06505369 | Jun 2024 → Nov 2026 expected | plasma cell myeloma | North Estonia Medical Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT06100237 | Dec 2023 → Dec 2028 expected | plasma cell myeloma | Carl Ola Landgren, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT05972135 | Oct 2023 → Aug 2027 expected | plasma cell myeloma | SCRI Development Innovations, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06066346 | Sep 2023 → Oct 2027 expected | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05849610 | Sep 2023 → Mar 2026 overdue | — | PETHEMA Foundation | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05695508 | Dec 2022 → Sep 2028 expected | plasma cell myeloma | University of Heidelberg Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04634552 | Feb 2021 → Jun 2027 expected | hematopoietic and lymphoid cell neoplasm | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT07649525 | Jul 2026 → Jun 2033 expected | plasma cell leukemia, plasma cell myeloma | University of Leeds | Recruiting | No outcome recorded |
| Phase 3 | NCT06208150 | Jan 2024 → Apr 2026 overdue | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05552222 | Oct 2022 → Apr 2031 expected | plasma cell myeloma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT05461209 | Oct → Nov 2022 | refractory plasma cell neoplasm | Janssen Research & Development, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT05455320 | Oct 2022 → Jul 2027 expected | plasma cell myeloma | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07474961 | Mar 2027 → Dec 2036 expected | Waldenstrom macroglobulinemia, plasma cell myeloma | Anne Louise Tølbøll Sørensen | Not yet recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07499323 | Mar 2026 → Mar 2027 expected | generalized myasthenia gravis | First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT05757973 | — | refractory plasma cell neoplasm | Janssen Research & Development, LLC | Approved for marketing | No outcome recorded |
| — | NCT05503550 | — | refractory plasma cell neoplasm | Janssen Research & Development, LLC | No longer available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT07657312 Background | Jul 2026 → Dec 2027 expected | cytokine release syndrome, plasma cell myeloma | Naresh Bumma | Recruiting | No outcome recorded |
| Phase 2 | NCT03601078 Background | Dec 2018 → Jan 2026 | plasma cell myeloma | Celgene Corporation | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 41
| Date | Issuer | Release |
|---|---|---|
| 2026-07-23 | Janssen Research & Development, LLC | Results TECVAYLI® + TALVEY® reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myeloma jnj.com ↗
The study demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival for both investigational arms compared with investigator’s choice standard of care. |
| 2026-07-23 | Janssen Research & Development, LLC | Results TECVAYLI® + TALVEY® reduced the risk of disease progression or death by 89% and the risk of death by 62% in earlier-line relapsed/refractory multiple myeloma jnj.com ↗ |
| 2026-06-13 | Janssen Research & Development, LLC | Results New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma jnj.com ↗
Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months. |
| 2026-06-13 | Janssen Research & Development, LLC | Results New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-line relapsed or refractory multiple myeloma jnj.com ↗
TALVEY plus DARZALEX FASPRO with or without pomalidomide showed progression-free survival of up to 81% and overall survival of up to 89% at 24 months |
| 2025-06-15 | Janssen Research & Development, LLC | Results Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease jnj.com ↗
The results show a high overall response rate (ORR) with durability in patients withtriple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD). |
| 2025-06-15 | Janssen Research & Development, LLC | Results Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease jnj.com ↗
The results show a high overall response rate (ORR) with durability in patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD). |
| 2024-12-08 | Janssen Research & Development, LLC | Results TECVAYLI® (teclistamab-cqyv) demonstrates potential as frontline combination therapy for patients with newly diagnosed multiple myeloma jnj.com ↗
All evaluable patients in cohort 1 who underwent MRD assessment after 12 months of therapy were MRD negative, and 100 percent of evaluable patients assessed in cohorts 2 and 3 were also MRD negative at cycle 6. |
| 2024-09-27 | Janssen Research & Development, LLC | Results TALVEY® (talquetamab-tgvs) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based combination shows deep and durable responses in patients with relapsed or refractory multiple myeloma jnj.com ↗
RIO DE JANEIRO (September 27, 2024)– Johnson & Johnson (NYSE: JNJ) today announced updated results from the investigational Phase 1b TRIMM-2 study evaluating the combination of TALVEY®(talquetamab-tgvs) with DARZALEXFASPRO®(daratumumab and hyaluronidase-fihj) and pomalidomide in patients with relapsed or refractory multiple myeloma that demonstrated an overall response rate (ORR) of 82 percent, further supporting the investigation of this combination. |
| 2024-09-27 | Janssen Research & Development, LLC | Results Novel combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv) suggests high response rates and durable responses in triple-class refractory patients with relapsed or refractory multiple myeloma, including those with extramedullary disease jnj.com ↗
These results reflect promising efficacy and a manageable safety profile for this combination of two first-in-class, innovative bispecific therapies and provide a potentially promising off-the-shelf option for patients with advanced multiple myeloma. |
| 2024-09-27 | Janssen Research & Development, LLC | Results TALVEY® (talquetamab-tgvs) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) based combination shows deep and durable responses in patients with relapsed or refractory multiple myeloma jnj.com ↗ |
| 2024-09-27 | Janssen Research & Development, LLC | Results Novel combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv) suggests high response rates and durable responses in triple-class refractory patients with relapsed or refractory multiple myeloma, including those with extramedullary disease jnj.com ↗ |
| 2024-06-14 | Janssen Research & Development, LLC | Results TALVEY® (talquetamab-tgvs) demonstrates highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma jnj.com ↗
At a median follow-up of 23.4 months, patients in the Q2W cohort demonstrated a median duration of response (DOR) of 17.5 months, with median DOR not reached in patients with complete response (CR) or better. |
| 2024-06-14 | Janssen Research & Development, LLC | Results TALVEY® (talquetamab-tgvs) demonstrates highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma jnj.com ↗
Weight loss, as assessed by vital signs, was evident early but stabilized and improved over time, including in patients with oral toxicities. |
| 2024-05-23 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗ |
| 2024-05-23 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗
Long-term efficacy and safety results from the Phase 1/2 MonumenTAL-1 study of TALVEY® (talquetamab-tgvs) in patients with relapsed/refractory multiple myeloma (Poster Abstract #P915) |
| 2023-12-11 | Janssen Research & Development, LLC | Results New Analyses Demonstrate Versatility and Continued Efficacy of TALVEY™ in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
Additional results from the MonumenTAL-1 study, also featured in a poster presentation, support the overall versatility of TALVEY™ by showing continued strong efficacy among patients with prior exposure to T-cell redirection therapy (TCR) (Abstract #3377). |
| 2023-12-11 | Janssen Research & Development, LLC | Results New Analyses Demonstrate Versatility and Continued Efficacy of TALVEY™ in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
These results show the potential of modifying the TALVEY™ dose, after a response is achieved, as a strategy to manage oral-, nail-, and skin-related TEAEs and improve patient experience without compromising efficacy. |
| 2023-08-22 | Janssen Research & Development, LLC | Regulatory European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted conditional marketing authorisation (CMA) of TALVEY®▼(talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) 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.1 |
| 2023-08-22 | Janssen Research & Development, LLC | Regulatory European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma jnj.com ↗ |
| 2023-08-10 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma jnj.com ↗
This indication is approved under accelerated approval based on response rate and durability of response. |
| 2023-08-10 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma jnj.com ↗
U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma |
| 2023-07-21 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinions for Novel Bispecific Antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation (CMA) for TALVEY®(talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) 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. |
| 2023-06-03 | Janssen Research & Development, LLC | Results Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the pivotal Phase 1/2 MonumenTAL-1 study of the investigational bispecific antibody talquetamab in the treatment of patients with relapsed or refractory multiple myeloma (RRMM). |
| 2023-06-03 | Janssen Research & Development, LLC | Results Janssen Presents First-Ever Results from Dual Bispecific Combination Study Showing 96 Percent Overall Response Rate in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
The investigational combination immunotherapy regimen demonstrated an ORR of 86.6 percent (71/82) across all dose levels, and an ORR of 96.3 percent (26/27) among patients receiving the recommended Phase 2 regimen (RP2R). |
| 2023-06-03 | Janssen Research & Development, LLC | Results Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma |
| 2023-06-03 | Janssen Research & Development, LLC | Results Janssen Presents First-Ever Results from Dual Bispecific Combination Study Showing 96 Percent Overall Response Rate in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗ |
| 2022-12-10 | Janssen Research & Development, LLC | Results Janssen Presents New Data for Talquetamab, a First-in-Class GPRC5DxCD3 Bispecific Antibody, Suggesting Durable Responses in Patients with Heavily Pretreated Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the Phase 1/2 MonumenTAL-1 study of talquetamab, an investigational, off-the-shelf (ready to use), bispecific T-cell engager antibody. |
| 2022-12-10 | Janssen Research & Development, LLC | Results Janssen Presents First Data from MajesTEC-2 Trial of TECVAYLI™ (teclistamab-cqyv) in Combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and Lenalidomide in Relapsed or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the Phase 1/2 MonumenTAL-1 study of talquetamab, an investigational, off-the-shelf (ready to use) , bispecific T-cell engager antibody. |
| 2022-12-09 | Janssen Research & Development, LLC | Regulatory Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma. |
| 2022-12-09 | Janssen Research & Development, LLC | Regulatory Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗ |
| 2022-06-29 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma jnj.com ↗ |
| 2022-06-29 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma jnj.com ↗
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma |
| 2022-06-10 | Janssen Research & Development, LLC | Results Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
Results from the study showed encouraging responses in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM) who received talquetamab at the recommended subcutaneous Phase 2 dose (RP2D) administered weekly (QW) or every two weeks (Q2W). |
| 2022-06-10 | Janssen Research & Development, LLC | Results Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1 MonumenTAL-1 first-in-human dose-escalation study of talquetamab (NCT03399799), an investigational, off-the-shelf, T cell redirecting bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3 on T cells. |
| 2021-12-11 | Janssen Research & Development, LLC | Results Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today updated results from the MonumenTAL-1 Phase 1 first-in-human dose-escalation study of talquetamab (NCT03399799). |
| 2021-12-11 | Janssen Research & Development, LLC | Results Janssen Presents Updated Results Evaluating First-in-Class Talquetamab (GPRC5DxCD3 Bispecific Antibody) in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗ |
| 2021-05-24 | Janssen Research & Development, LLC | Results Janssen’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma jnj.com ↗
both bispecific therapies induced changes in levels of sBCMA that correlated with clinical activity. |
| 2021-05-24 | Janssen Research & Development, LLC | Results Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma jnj.com ↗
The median time to first confirmed response was one month (range, 0.2–3.8 months). |
| 2021-05-24 | Janssen Research & Development, LLC | Results Janssen’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma jnj.com ↗
both bispecific therapies induced changes in levels of sBCMA that correlated with clinical activity. |
| 2020-12-05 | Janssen Research & Development, LLC | Results Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
At the SC recommended Phase 2 dose (RP2D), the overall response rate (ORR) was 69 percent (9/13) and 39 percent achieved a very good partial response (VGPR) or better. |
| 2020-12-05 | Janssen Research & Development, LLC | Results Janssen Presents First Data from the Phase 1 Study of the GPRC5DxCD3 Bispecific Talquetamab in Patients with Relapsed or Refractory Multiple Myeloma jnj.com ↗
At the SC recommended Phase 2 dose (RP2D), the overall response rate (ORR) was 69 percent (9/13) and 39 percent achieved a very good partial response (VGPR) or better. |
All press releases naming this drug 42 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Talquetamab | “Talquetamab is a bispecific antibody that binds the CD3 receptor on T-cells and the GPRC5d receptor on multiple myeloma cells.” NCT07581704 ↗ |
| Known as | JNJ-63483043 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594503 ↗ |
| Known as | JNJ-64407564 | “Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)” NCT06461988 ↗ |
| Known as | Talquetamab-tgvs | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594503 ↗ |
| Known as | Talvey | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594503 ↗ |
| Action | Activate | “Talquetamab (anti-G protein-coupled receptor family C group 5 member D) and teclistamab (anti-B-cell maturation antigen) are bispecific antibodies that activate T cells by targeting CD3” PMID 39778168 ↗ Jan 2025 |
| Modality | Monoclonal antibody | “Talquetamab, a bispecific antibody against CD3 and GPRC5D” PMID 36507686 ↗ Dec 2022 |
| Route | Intravenous | “Participants will receive IV infusion or SC injection of Talquetamab.” NCT03399799 ↗ |
| Route | Subcutaneous | “Participants will receive IV infusion or SC injection of Talquetamab.” NCT03399799 ↗ |
| Target | GPRC5D | “Talquetamab, a bispecific antibody against CD3 and GPRC5D” PMID 36507686 ↗ Dec 2022 |