Johnson & Johnson Announces New Results from the Phase 2 RedirecTT-1 Study Evaluating the Investigational Combination of TALVEY®?

Johnson & Johnson announced new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY®? (talquetamab-tgvs), the first U.S. Food and Drug Administration (FDA)-approved GPRC5D-directed bispecific antibody, and TECVAYLI®? (teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific antibody.

In the clinical trial, CRS occurred in 76% of patients who received TALVEY®? at the recommended dose, with Grade 1 CRS occurring in 57% of patients, Grade 2 in 17%, and Grade 3 in 1.5%. In the clinical trial, neurologic toxicity, including ICANS, occurred in 55% of patients who received the recommended dosages, with Grade 3 or 4 neurologic toxicity occurring in 6% of patients.

TECVAY LI®? and TALVEY®? REMS: TALVEY®?

is available only through a restricted program under a REMS, called the TECVAYLI®®? and TALVEy®? REMS because of the risks of CRS and neurologic toxicity, including ICans.

In the clinical trial, 80% of patients had oral toxicity, with Grade 3 occurring in 2.1% of patients who received the proposed dosages. In the clinical trial, 62% of patients experienced weight loss, regardless of having an oral toxicity, including 29% of patients with Grade 2 (10% or greater) weight loss and 2.7% of patients with Grade 3 (20% or greater) weight loss. In the clinical trial, Grade 3 or 4 decreased neutrophils occurred in 35% of patients, and Grade 3 decreased platelets occurred in 22% of patients who received TECVAYLI®??.

In the clinical trial, skin reactions occurred in 62% of patients, with Grade 3 skin reactions in 0.3%. In the clinical trial, C RS occurred in 72% of patients who received TecVAYLI®? at the recommended dose.

In the clinical trial, neurologIC toxicity occurred in 57% of patients who received TACVAYLI®? at The recommended dose, with Grade 3 or 4 neurological toxicity occurring in 2.4% of patients. In the clinical trial, ICANS was reported in 6% of patients who received T ECVAYLI®?

atthe recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade3 or 4 decreased neutrophils in 56%. Systemic Reactions - In patients who received TECVayLI®? at the recommendeddose in the clinical trial, patients who received TECVaysLI®?

at the recommended doses in the clinical trial, there was one fatal case of hepatic failure. In patients who received TEC VAYLI®? at the proposed dose in the clinical trial, serious infections, including opportunistic infections, occurred in 30% of patients, with Grade 2 or 4 infections in 35%, and fatal infections in 4.2%.

In patients who received TECCAYLI®? at the recommend dose in the clinical trial, increased neutrophils occurred in 84%. Systemic Reactions - in patients who received TECVayaLI®?

at the recommended dosage in the clinical trial, with Grade 3 or 4 decreased neutophils in 56%. Systemic re-appointment of TECVAYLI® the,.