SUMMARY

• Janssen does not recommend any practices, procedures or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• MajesTEC-1 (MMY1001) is an ongoing, phase 1/2, multicohort study evaluating the safety and efficacy of TECVAYLI in patients with relapsed or refractory multiple myeloma (RRMM).^1,2 
  • Cohort A (triple-class exposed) included 165 patients with RRMM who were triple-classed exposed to a proteasome inhibitor (PI), an immunomodulatory agent and an anti-CD38 monoclonal antibody.¹
  • Cohort C included 40 patients with RRMM, previously treated with a PI, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. All patients enrolled in Cohort C had prior exposure to B-cell maturation antigen (BCMA)-targeted therapies. Janssen does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.²
• There were no clinically significant differences in the pharmacokinetics of teclistamab-cqyv based on mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] with aspartate aminotransferase [AST] greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST). The effects of moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN with any AST) on the pharmacokinetics of teclistamab-cqyv are unknown.³

Clinical data - majestec-1 study

MajesTEC-1 (MMY1001; clinicaltrials.gov identifiers: NCT03145181; NCT04557098) is evaluating the safety and efficacy of TECVAYLI in patients with RRMM.^1,2

Study Design/Methods

The main objectives are as follows: Part 1 (dose escalation) to determine the recommended phase 2 dose (RP2D) for TECVAYLI; Part 2 (dose expansion) to distinguish safety and tolerability of TECVAYLI at the RP2D; Part 3 (the phase 2 component) to evaluate the efficacy of TECVAYLI at the RP2D.^1,4

Key Inclusion Criteria

Per study protocol, each patient must have satisfied all of the following criteria to be enrolled in the MajesTEC-1 study including:⁴

• Key pretreatment clinical laboratory values meeting the following criteria during the Screening Phase:⁴
  • AST and alanine aminotransferase (ALT): ≤3.0 x ULN.⁴
  • Total bilirubin: ≤2.0 x ULN; except in patients with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5 x ULN is required).⁴

Key Exclusion Criteria

Per study protocol, potential patients who met any of the following criteria were excluded from participation in any part of the MajesTEC-1 study including:⁴

• Hepatitis B infection or at risk for hepatitis B virus (HBV) reactivation as defined according to the American Society of Clinical Oncology guidelines. Eligibility was determined by the investigator as described in table: MajesTEC-1 Study Protocol: Hepatitis B Virus Screening. In the event the infection status was unclear, quantitative levels were necessary to determine the infection status.⁴
• Active hepatitis C infection was measured by positive hepatitis C virus-ribonucleic acid (HCV-RNA) testing. Patients with a history of HCV antibody positivity should have undergone HCV-RNA testing.⁴

• In patients with negative hepatitis B surface antigen (HBsAg) test, a hepatitis B virus-deoxyribonucleic acid (HBV-DNA) quantification test was required in the following patients to determine eligibility:⁴ 
  • Patients who were anti-hepatitis B surface (HBs) antibody positive and without history of vaccination.⁴ 
  • Patients with positive anti-hepatitis B core (HBc) antibody and either positive or negative anti-HBs.⁴ 
  • Patients with known HBV history regardless of anti-HBs/anti-HBc results.⁴ 
• For patients with known HBV infection history and negative Hep B serology findings, HBV-DNA was required and must have been negative for inclusion.⁴ 
• Patients with serologic findings suggestive of HBV vaccination (ie, anti-HBs positivity) as the only serologic marker) and a known history of prior HBV vaccination were not required to be tested for HBV-DNA by polymerase chain reaction (PCR).⁴ 
  • Note: Patients with negative HBV-DNA could be enrolled; however, HBV-DNA and AST/ALT laboratories should have been performed every 3 months ±1 month until 6 months post last dose of TECVAYLI.⁴ 

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 07 January 2025.