Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Talquetamab · 12 trials · 7 indications
PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first.
PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.
Will be described per American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Will be reported as a proportion together with 95% confidence intervals.
The primary outcome measure will evaluate the efficacy of talquetamab consolidation therapy, with or without the sequential use of teclistamab, by assessing the rate of minimal residual disease (MRD) negative response at a sensitivity level of 10\^-5. This evaluation will be conducted using the next-generation sequencing (NGS) ClonoSEQ assay. The primary endpoint is the proportion of participants who achieve MRD negativity at 10\^-5 sensitivity after consolidation therapy with talquetamab, with or without the sequential use of teclistamab, by 12 months from the start of treatment. MRD negative response is defined as the absence of detectable myeloma cells in bone marrow, as determined by the highly sensitive NGS ClonoSEQ assay. This measure aims to determine the depth of response and the potential of the treatment regimen to achieve sustained deep remission in participants with newly diagnosed multiple myeloma.
The primary outcome for this study, for the purposes of Clinical Trials.gov registration and results reporting, is the percentage of patients in complete response at 12 months.
Dysgeusia is defined as total WETT score of 25th percentile or below according to the Normative WETT-SA53 percentile table. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart.
Severe Dysgeusia is defined as a total WETT score of 10th percentile or below according to the normative WETT-SA53 percentile table. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart.
Time to the first onset of severe dysgeusia is defined as time from the first dose date of talquetamab to the first onset date of severe dysgeusia according to the total WETT score. For participants without severe dysgeusia, time to the first onset will be censored. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart.
Resolution/improvement is defined as 2 potential scenarios: 1) A dysgeusia downgraded to dysgeusia-free, that is (i.e.,) total WETT score of 25th percentile or below at visits prior to the end of month 3 becomes total WETT score above 25th percentile at the end of month 3. 2) Severe dysgeusia downgraded to non-severe dysgeusia, i.e., total WETT score of 10th percentile or below prior to the end of month 3 becomes total WETT score above 10th percentile at the end of month 3. Taste assessment will be performed using taste strips (WETT). Four concentrations will be used for each taste quality: sweet, sour, salty, bitter, \& umami. Each test kit contains 53 taste strips; numbered (1 through 53). Participants will use each strip sequentially and record flavor on score card provided. Test will result in maximum (i.e., best) total score of 53. Score will be graded by qualified staff into normative percentile score using provided chart.
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
Number of participants with abnormalities in clinical laboratory assessments (serum chemistry and hematology) will be reported.
The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE.
Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity.
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product, is medically important.
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
ORR is defined as the percentage of participants who have a partial response (PR) or better according Independent Review Committees (IRC).
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
| Arm | Type | Description |
|---|---|---|
| Arm A: Talquetamab + Pomalidomide (Tal-P) | EXPERIMENTAL | Participants will receive talquetamab as subcutaneous (SC) injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
| Arm B: Talquetamab + Teclistamab (Tal-Tec) | EXPERIMENTAL | Participants will receive teclistamab in combination with talquetamab both as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. |
| Arm C: Elotuzumab+ Pomalidomide+Dexamethasone (EPd) or Pomalidomide+Bortezomib+Dexamethasone (PVd) | ACTIVE_COMPARATOR | Participants will either receive elotuzumab intravenous (IV) injection in combination with pomalidomide and dexamethasone orally; or pomalidamide orally in combination with bortezomib SC injection and dexamethasone orally as per investigator choice. Dexamethasone will be administered as a pretreatment medication. |
| Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP) | EXPERIMENTAL | Participants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug Access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled. |
| Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd) | EXPERIMENTAL | Participants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled. |
| Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D) | EXPERIMENTAL | Participants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug. Upon sponsor notification, participants will enter the Long-Term Extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent or any other criteria specified is fulfilled. |
| Supportive care (Infliximab) | EXPERIMENTAL | Patients receive infliximab IV on day 1, two to four hours prior to treatment with standard of care teclistamab or talquetamab. Patients then receive teclistamab SC or talquetamab SC per treating physician discretion. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and may undergo an x-ray or PET-CT scan during screening and also blood sample collection throughout the study. |
| Arm 1 | EXPERIMENTAL | Talquetamab is a GPRC5DxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration. Teclistamab is a BCMAxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration. |
| Talquetamab | EXPERIMENTAL | Study participants will receive talquetamab (JNJ-64407564) for one cycle and a combination of talquetamab and lenalidomide for cycles 2-13 after autologous stem cell transplant (ASCT). |
| Cohort A: Talquetamab | ACTIVE_COMPARATOR | Participants with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed (previously exposed to at least 1 proteasome inhibitor \[PI\], 1 immunomodulatory drug(s) \[IMiD\]), and an anti-CD38 monoclonal antibody \[mAb\]) will be treated with talquetamab subcutaneously until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first. |
| Cohort B: Prophylaxis A and Talquetamab | EXPERIMENTAL | Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis A along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from Cycle 1 Day 1 (C1D1) until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first. |
| Cohort C: Prophylaxis B and Talquetamab | EXPERIMENTAL | Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis B along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first. |
| Cohort D: Prophylaxis C and Talquetamab | EXPERIMENTAL | Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis C along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first. |
| Cohort E: Prophylaxis D and Talquetamab | EXPERIMENTAL | Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis D along with talquetamab therapy. Participants will start the assigned prophylaxis 1 day before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first. |
| Cohort F: Ramantamig | EXPERIMENTAL | Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive single step-up dose of ramantamig subcutaneously followed by the treatment dose until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of ramantamig, or end of study, whichever occurs first. |
| Part 3: Cohort A (Talquetamab) | EXPERIMENTAL | Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (\>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment. |
| Part 3: Cohort B (Talquetamab) | EXPERIMENTAL | Cohort B will enroll participants with multiple myeloma who have previously received \>= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
| Part 3: Cohort C (Talquetamab) | EXPERIMENTAL | Cohort C will enroll participants with multiple myeloma who have previously received \>= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
| Part 3: Cohort D (Talquetamab) | EXPERIMENTAL | Cohort D will enroll participants with multiple myeloma who have previously received \>= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants in this cohort will receive tocilizumab prophylaxis for cytokine release syndrome (CRS) including all outpatient dosing. Participants will transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
| Part 3: Cohort E (Talquetamab) | EXPERIMENTAL | Cohort E will enroll participants with multiple myeloma who have previously received at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-cluster of differentiation 38 (CD38) monoclonal antibody. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants will receive tocilizumab prophylaxis for CRS with consolidated priming dose schedules as well as possible transition to outpatient priming dosing transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1. |
| Treatment Regimen A: Talquetamab + Carfilzomib | EXPERIMENTAL | Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. |
| Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib | EXPERIMENTAL | Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. |
| Treatment Regimen C: Talquetamab + Lenalidomide | EXPERIMENTAL | Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally. |
| Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide | EXPERIMENTAL | Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally. |
| Treatment Regimen E: Talquetamab + Pomalidomide | EXPERIMENTAL | Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally. |
| Part 3: Phase 2 | EXPERIMENTAL | Participants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2. Upon sponsor notification, participants will enter the LTE Phase or DA-LTE Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program. |
| Part 1: Dose Escalation (Talquetamab) - Intravenous (IV) | EXPERIMENTAL | Participants will receive IV infusion of Talquetamab at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data. Participants receiving IV dosing can transition to SC dosing through-out the study upon sponsor consultation. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment. |
| Part 1: Dose Escalation (Talquetamab) - Subcutaneous (SC) | EXPERIMENTAL | Participants will receive Talquetamab SC. The dose levels will be selected to identify safe and tolerable putative RP2D(s). All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
| Part 2: Dose Expansion (Talquetamab) | EXPERIMENTAL | Participants will receive IV infusion or SC injection of Talquetamab at each putative recommended Phase 2 dose(s) (RP2D\[s\]) as determined in Part 1. Participants receiving IV dosing can transition to SC dosing through-out the study upon sponsor consultation. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment. |
| Name | Type | Description |
|---|---|---|
| Talquetamab | DRUG | Talquetamab will be administered as a SC injection. |
| Pomalidomide | DRUG | Pomalidomide will be administered orally. |
| Teclistamab | DRUG | Teclistamab will be administered as a SC injection. |
| Elotuzumab | DRUG | Elotuzumab will be administered intravenously. |
| Dexamethasone | DRUG | Dexamethasone will be administered either orally or intravenously. |
| Bortezomib | DRUG | Bortezomib will be administered as a SC injection. |
| Daratumumab | DRUG | Daratumumab will be administered subcutaneously. |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Computed Tomography | PROCEDURE | Undergo PET-CT |
| Infliximab | BIOLOGICAL | Given IV |
| Positron Emission Tomography | PROCEDURE | Undergo PET-CT |
| X-Ray Imaging | PROCEDURE | Undergo x-ray |
| Talquetamab and Lenalidomide | DRUG | Lenalidomide 10 mg, 3 weeks on 1 week off, until PD/ intolerance, C2-13 (Lenalidomide 5 mg for creatinine clearance 30-60 ml/min) |
| Prophylaxis A | DRUG | Prophylaxis A will be administered orally. |
| Prophylaxis B | DRUG | Prophylaxis B will be administered orally. |
| Prophylaxis C | DRUG | Prophylaxis C will be administered orally. |
| Prophylaxis D | DRUG | Prophylaxis D will be administered topically. |
| Ramantamig | DRUG | Ramantamig will be administered subcutaneously. |
| PD-1 Inhibitor | DRUG | The PD-1 inhibitor will be administered as an intravenous injection. |
| Carfilzomib | DRUG | Carfilzomib will be administered as an IV infusion. |
| Daratumumab SC | DRUG | Daratumumab will be administered subcutaneously. |
| Lenalidomide | DRUG | Lenalidomide will be self-administered orally. |
Inclusion Criteria: * Documented multiple myeloma as defined by the criteria below: (a) multiple myeloma diagnosis according to the international myeloma working group (IMWG) diagnostic criteria (b) measurable disease at screening as assessed by central laboratory, defined by any of the following: ...
Top 20 of 25 competitors
Talquetamab is an investigational bispecific monoclonal antibody being developed for the treatment of multiple myeloma, including relapsed or refractory multiple myeloma, as well as other hematological malignancies and cytokine release syndrome. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Talquetamab targets GPRC5D, a receptor highly expressed on myeloma cells, and CD3E, CD3G, and CD3D, components of the T-cell receptor complex. By binding both targets, it redirects T cells to attack GPRC5D-expressing tumor cells, a mechanism being studied in clinical trials for multiple myeloma.
Talquetamab is being developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker JNJ. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy in patients with multiple myeloma and other hematological malignancies.
Talquetamab is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still being studied in clinical trials. The most advanced trial, NCT04634552, is a Phase 2 study recruiting participants with relapsed or refractory multiple myeloma.
Talquetamab is being studied in several clinical trials, including NCT03399799 (Phase 1 dose escalation in relapsed or refractory multiple myeloma), NCT04634552 (Phase 2 in relapsed or refractory multiple myeloma), NCT05050097 (Phase 1 in combination with other anticancer therapies), and NCT05338775 (Phase 1 in combination with a PD-1 inhibitor). These trials are active across multiple countries.
Talquetamab is a distinct investigational drug and is not known to be the same as any other approved or investigational therapy. It is a bispecific antibody targeting GPRC5D and CD3, and it is being developed by Johnson & Johnson under the Chembl ID CHEMBL4594503.