Target BCMA and CD3! Johnson and Johnson announces the first clinical data for the treatment of recurrent/difficult multiple myeloma by bispecific antibody teclistamab, ORR- 67%!

2020 May 19 News /BioValleyBIOON / - Johnson & Johnson (JNJ) subsidiary Janssen Pharmaceutica Inctoday reported its first teclistamab (JNJ-64007957, JNJ- 7957) I dose escalation results of human studies (NCT03145181) isteclistamab bispecific antibody is a kind of B-cell maturation antigen (BCMA) and the CD3 T cell receptor target, the study evaluated the teclistamab overtreatment pretreatment (heavily-pretreated) in relapsed or refractory multiple myeloma tumor (RRMM) patientspreliminary results show, all in the dose range evaluated, teclistamab have security manageablePharmacokinetics (PK) results show, teclistamab half-life to support once-weekly dosingThe researchers reported that patients have a profound and lasting remission, including the level of minimal residual disease-negative (MRD-) 10E-6 of complete remission (CR), one patient kept MRD-CR over 12 monthsThese data (ASCO) Annual Meeting published onvirtual meetingin tumorAmerican Society of Clinical2020, held May 30The study enrolledis relapsed or refractory to these treatments after conventional therapy, multiple myeloma patients previously treated with proteasome inhibitor (PI) and immunomodulatory drugs (IMiDs) treated tumorBefore start of the study before receiving therapy median into six patients (range 2-14); 3 received 92% based therapy, 86% of the final refractory therapy, 80% of the refractory three therapy, 41% of the five kinds of drug-refractory, which means a cancer patient using ≥2 immunomodulators, species ≥2 PI, 1 kind of anti-CD38 therapy in the treatment of non-responsive or relapse within 60 days Three types of therapy in patients with refractory multiple myeloma and refractory tumors five drugs due to the limited treatment options, survival prognosis is poor principal investigator of the study, Levine Cancer Institute / tumor and blood disease of Medicine, Dr Carolina Medical Systems blood SaadUsmani said: "Although in recent years, multiple myeloma treatment with significant progress, but patients who relapse and drug resistance to existing treatments are still looking for additional treatment options is essential in this pre-treatment of over-population, teclistamab preliminary findings support further study of this dual target "Vice president Janssen R & D center, malignant tumor blood global head YusriElsayed MD, said:" we are committed to immunotherapy using multi-platform approach in our scientific strategy to to meet the needs of patients and provide treatment for all patients with multiple myeloma .teclistamab is a dual antibody specificity of our example, we want to use our expertise in immunotherapy offers the potential to seriously ill patients who are deteriorating new choice "
BCMA as a target for immunotherapy in MM research (literature sources -PMID: 31277554) this phase I study in two parts: agent Incremental amount (first part) and the extended dose (Part II) The results of Study I display section, teclistamab treated patients (n = 78) depth between remission 0.3μg / kg-720μg / kg dose groups at 270μg / kg dose (n = 12), the overall response rate (ORR) was 67% (8/12), 50% (6/12) of patients achieved a very good partial response better (≥VGPR), 3 patients achieved complete remission (CR) patients exhibit a profound and lasting relief When data is turned off, in all dose groups of patients in remission in 76% (16/21) of the patients maintained remission; MRD evaluable patients, a 80% (4/5) of MRD-negative patients, 2 MRD-negative patients had CR, these two patients were confirmed to maintain an MRD negative Extra dose increment and expansion of research in progress In a Phase I study, the most common adverse events (the AE) (all levels) is a anemia (58%), cytokine release syndrome (CRS, 56%), the neutropenia (45%), thrombocytopenia (40%) and fever (31%) And the patient experiences grade 3 or more adverse events, most commonly (≧ 20%) is a neutral neutropenia (38%), anemia (36%) and thrombocytopenia (24%) One case five adverse events are respiratory failure caused by the pneumonia, but the researchers considered unrelated to treatment CRS events were mild or moderate (grade 1-2), usually limited to the initial dose teclistamab (JNJ-7957) is a bispecific antibody targeting both BCMA and CD3 Involved in activation of the immune system against the CD3 response to infection, BCMA expression levels in the multiple myeloma cells was significantly increased teclistamab CD3T cells will be redirected to the myeloma cells express BCMA to induce cytotoxicity against target cells Preclinical studies indicate that, teclistamab can kill myeloma cell lines and myeloma bone marrow cells from heavily pretreated patients a present, teclistamab is I clinical study evaluated the efficacy of the treatment of relapsed or refractory multiple myeloma (RRMM), but also in the joint research to explore teclistamab production and development follows a licensing agreement to use DuoBody® technology platform with Janssen Biotech company Genmab signed (Biovalley Bioon.com) ORIGINAL: JanssenPresentsFirstDatafromPhase1StudyofBCMAxCD3BispecificTeclistamabinPatientswithHeavilyPretreatedRelapsedorRefractoryMultipleMyeloma