Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-79635322 · 5 trials · 3 indications
CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment.
PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.
Overall response is defined as having achieved partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria, as assessed any time after first administration of study treatment, but prior to progression of disease (PD) or subsequent antimyeloma therapy.
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 clinical study participant 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.
Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.
An adverse event is any untoward medical occurrence in a clinical study participant 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 laboratory values (hematology and chemistry) will be reported.
| Arm | Type | Description |
|---|---|---|
| Arm A: JNJ-79635322 | EXPERIMENTAL | Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first). |
| Arm B: Teclistamab | ACTIVE_COMPARATOR | Participants will receive teclistamab as a SC injection until PD or intolerable toxicity. |
| JNJ-79635322 | EXPERIMENTAL | Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity. |
| Anti BCMAxCD3 Bispecific Antibody | ACTIVE_COMPARATOR | Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity. |
| Treatment Regimen A and C: JNJ-79635322+Daratumumab | EXPERIMENTAL | Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) (Treatment regimen A1 and A3) will receive JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D\[s\]) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment regimens A2, A4 and C). Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. |
| Treatment Regimen B: JNJ-79635322+Pomalidomide | EXPERIMENTAL | Participants who have received greater than or equal to (\>=)1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory or \>=2 prior lines of therapy, including a PI and lenalidomide will receive JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. |
| Treatment Regimen D and E: JNJ-79635322 + Daratumumab + Lenalidomide Combination | EXPERIMENTAL | Participants with NDMM will receive JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D\[s\] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. |
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-79635322 | DRUG | JNJ-79635322 will be administered as SC injection. |
| Teclistamab | DRUG | Teclistamab will be administered as SC injection. |
| Daratumumab | DRUG | Daratumumab will be administered subcutaneously. |
| Pomalidomide | DRUG | Pomalidomide will be administered orally. |
| Lenalidomide | DRUG | Lenalidomide will be administered orally. |
Inclusion criteria: * Documented diagnosis of multiple myeloma (MM) as defined by the criteria below: a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria, b. Measurable disease at screening as assessed by central laboratory * Received 1 to 3 prior lines o...
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JNJ-79635322 is an investigational small molecule being developed for multiple myeloma, including relapsed or refractory multiple myeloma. It is being studied in combination with other agents and as a monotherapy in clinical trials for patients aged 18 years and older.
JNJ-79635322 targets BCMA, the B-cell maturation antigen, which is expressed on myeloma cells. By targeting BCMA, the drug aims to interfere with the survival and growth of malignant plasma cells in multiple myeloma.
JNJ-79635322 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting multiple clinical trials to evaluate the drug in multiple myeloma.
JNJ-79635322 is in Phase 3 clinical development for multiple myeloma. It is also being studied in Phase 1 and Phase 2 trials. The drug is investigational and has not been approved by regulatory authorities.
JNJ-79635322 is being studied in four recruiting trials: NCT06768489 (Phase 1, combination with daratumumab and lenalidomide or pomalidomide), NCT07258511 (Phase 3, vs. a BCMA x CD3 bispecific antibody), NCT07266441 (Phase 2, monotherapy), and NCT07518186 (Phase 3, vs. teclistamab).
No, JNJ-79635322 is not the same as teclistamab. Teclistamab is a BCMA x CD3 bispecific antibody, while JNJ-79635322 is a small molecule targeting BCMA. A Phase 3 trial is directly comparing JNJ-79635322 with teclistamab in relapsed or refractory multiple myeloma.