TECVAYLI and TALVEY – NORTHSTAR Study

SUMMARY  

• Johnson & Johnson does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by regulatory agencies.
• NORTHSTAR (Navigating Bispecifics Outpatient step-up dosing: A Roadmap To Help improve SafeTy and Access in the Real-world) is a real-world, three-round modified Delphi (mDelphi) study with a panel of hematologist-oncologists and/or pharmacists to establish United States (US) expert consensus recommendations for the administration of outpatient step-up dosing (OP SUD) of TECVAYLI and TALVEY in patients with relapsed or refractory multiple myeloma (RRMM).¹
  • Baljevic et al (2026)¹ presented consensus results from rounds 1 and 2 of the mDelphi study supporting OP SUD of TECVAYLI and TALVEY in patients with RRMM.

PRODUCT LABELING

• TECVAYLI (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf.
• TALVEY (talquetamab-tgvs) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf.

REAL-WORLD DATA – NORTHSTAR STUDY

NORTHSTAR is a real-world, three-round mDelphi study designed to establish expert consensus recommendations supporting OP SUD of TECVAYLI and TALVEY in patients with RRMM.¹

Study Design

• The study design is presented in Figure: NORTHSTAR Study: Study Design.

Baljevic et al (2026)¹ presented consensus statements from rounds 1 and 2 of the mDelphi study supporting OP SUD of TECVAYLI and TALVEY in patients with RRMM.

Methods

Study Population

• NORTHSTAR was initiated in January 2026.
• Eligible panelists included US hematologist-oncologists and/or pharmacists who cared for patients with RRMM and led bispecific antibody (BsAb) programs at their practice site. Additional criteria included:
  • Six or more months of experience managing multiple myeloma (MM).
  • Managed ≥5 adult patients with RRMM requiring TECVAYLI or TALVEY SUD within the last 12 months.

Analysis

• Agreement with consensus statements was assessed using a 5-point Likert scale. (1=strongly disagree; 5=strongly agree).
• Consensus was defined as ≥80% concordance among panel responses, achieved when ≥80% selected either agree/strongly agree or disagree/strongly disagree on the 5-point Likert scale.

Results

Modified Delphi Panel Participant Characteristics

• The mDelphi panel included 15 US healthcare providers (HCPs) who led BsAb programs at their respective practice sites. Panel characteristics are summarized in Table: NORTHSTAR Study: Modified Delphi Panel Participant Characteristics.
  • Nine providers had experience administering TECVAYLI or TALVEY OP SUD.
  • Six providers shared insights on the perceived challenges to implementing OP SUD.

Expert Consensus Statements

Patient Selection for OP SUD

• Experts reached consensus on patient eligibility criteria for OP SUD of TECVAYLI or TALVEY in patients with RRMM. Clinical characteristics, risk factors, and caregiver availability were assessed to determine whether OP SUD or inpatient (IP) SUD is appropriate. Additional details are provided in Figure: NORTHSTAR Study: Patient Eligibility Decision Tree for OP SUD.

Access to Care Considerations for OP SUD

• Based on expert consensus, access-to-care factors, including proximity-to-care, transportation, and monitoring capabilities, were identified as considerations relevant to OP SUD. A consensus access-to-care assessment is presented in Figure: NORTHSTAR Study: Access to Care Decision Tree for OP SUD.

Care Team Roles and Responsibilities for OP SUD

• Based on expert consensus, members of the multidisciplinary team (MDT) included, but were not limited to, a hematologist-oncologist, HCP or advanced practice provider (APP), on-site pharmacist, and social worker or financial coordinator.
• Responsibilities of the core team included determining OP SUD eligibility, managing treatment authorizations, administering SUD on treatment days, and monitoring for AEs.
• A more comprehensive breakdown of the roles and responsibilities of each member of the MDT are presented below in Figure: NORTHSTAR Study: Roles and Responsibilities for SUD Administration and AE Monitoring.

Adverse Event Monitoring and Mitigation Strategies

• Experts recognized that patient education on AE monitoring, including manual and remote symptom monitoring, can play an important role in OP treatment with BsAbs.
• Experts reached consensus on the administration of pre-medications and prophylactic therapy for patients. Institutions may also refer to their institutional guidelines, as appropriate.
• Infrastructure that may assist in AE monitoring included pre-built order sets and electronic medical record (EMR) alerts for CRS and ICANS monitoring. EMR profiles for patients on BsAb therapy could contain educational resources and guidance for monitoring and emergency care.
• Monitoring may occur via phone, in-person, or remotely.
• AE monitoring and risk mitigation strategies based on expert consensus are shown in Figure: NORTHSTAR Study: AE Monitoring and Risk Mitigation.

Management of CRS and ICANS and Escalation to IP Care

• Panelists reached consensus on management strategies for CRS and ICANS. Patients experiencing higher grade CRS and ICANS may require IP management or treatment discontinuation.
• Additional triggers for IP admission included grade ≥3 infection, infection requiring intravenous (IV) antibiotics, or major social destabilization.
• CRS and ICANS management pathways by grade are presented in Figure: NORTHSTAR Study: AE Management Pathways and Escalation to IP Admission.

Caregiver Support Requirements for OP SUD

• Experts reached consensus on caregiver eligibility for OP SUD, including reliable support, communication, continuous presence, symptom monitoring, and appointment participation throughout the OP SUD period.
• Consensus criteria regarding caregiver responsibilities and capabilities are outlined in Figure: NORTHSTAR Study: Caregiver Eligibility for OP SUD.

Patient and Caregiver Preparedness for OP SUD

• Panelists reached consensus that providing an education package on OP SUD monitoring may assist patients and caregivers in preparing for OP SUD. The package can include, but is not limited to, information on post-treatment medications, site contact information, when to seek assistance, identifying CRS/ICANS-capable emergency rooms (ERs), and a wallet care card or patient bracelet.
• Additional details, based on expert consensus, regarding patient and caregiver education prior to OP SUD are provided in Figure: NORTHSTAR Study: Patient and Caregiver Education for OP SUD.

Literature Search

A literature search of Ovid MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 12 October 2026.