SUMMARY

• Johnson & Johnson does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• Data presented from OPTec/OPTal are only inclusive of TECVAYLI.
• OPTec/OPTal is an ongoing, phase 2, single-arm, non-randomized, multicenter, prospective clinical study. The study is evaluating the use of prophylactic tocilizumab in reducing the incidence and severity of cytokine release syndrome (CRS) associated with TECVAYLI, to allow safe outpatient administration of step-up TECVAYLI dosing in patients with relapsed/refractory multiple myeloma (RRMM).^1-5

• • Forsberg et al (2025)⁵ evaluated outpatient step-up administration of TECVAYLI in patients with RRMM in the phase 2 OPTec/OPTal study. A total of 2 patients (8%) experienced TECAVYLI-related grade 1 CRS. No patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). The best overall response rate (ORR) was 81% among the 16 evaluable patients.
  • Rifkin et al (2024)³ presented safety and efficacy results from 16 patients in the OPTec/OPTal study.
  • Rifkin et al (2024)² presented the preliminary safety and efficacy results from the first 11 patients in the OPTec/OPTal study.

CLINICAL DATA – optec/optal study

OPTec/OPTal (MM165; NCT05972135) is an ongoing, phase 2, single-arm, non-randomized, multicenter, prospective clinical study. The study is evaluating the use of prophylactic tocilizumab in reducing the incidence and severity of CRS associated with TECVAYLI, to allow safe outpatient administration of step-up TECVAYLI dosing in patients with RRMM.^1-4

Study Design/Methods

• The study design for the outpatient administration of TECVAYLI is presented in the Figure: OPTec/OPTal Study Design.^1-3
• A single dose of intravenous tocilizumab 8 mg/kg was administered 2-4 hours prior to the first step-up dosing (SUD) of TECVAYLI.^1,3 
• Protocol-defined patient safety measures⁵:
  • Premedication: administer corticosteroids, H₁ receptor antagonists, or antipyretics 1-3 hours prior to each SUD of TECVAYLI.
  • Investigator observation: monitor patients for 2 days after each TECVAYLI SUD and first full treatment dose; remote follow-up (eg, phone) permitted on weekends.
  • Home monitoring: instruct patients to record temperature and oxygen saturation twice daily (≥8 hours apart); report fever ≥38 °C (≥100.4 °F) immediately and hospitalization for CRS as determined by investigator.
  • IVIG support: recommend intravenous immunoglobulin (IVIG) if IgG <400 mg/dL.
  • Companion requirement: ensure the presence of a trained adult for 48 hours after each SUD and first full treatment dose.
  • Travel restriction: limit patient travel within 30 minutes of study site.

Forsberg et al (2025)⁵ evaluated outpatient step-up administration of TECVAYLI in patients with RRMM in the phase 2 OPTec/OPTal study.

Results

Patient Characteristics

• The median treatment duration was 10.7 months (range, 0.13-11.77). 
• Patient dispositions are presented in Table: OPTec/OPTal Study: Patient Disposition.
• Patient demographics are presented in Table: OPTec/OPTal Study: Patient Demographics (Treated Population).

Safety

• The most common treatment-related adverse events (TRAEs) were reported in ≥15% of patients.
  • TRAEs included injection site reactions (n=9 [37.5%]; grade 1, n=7; grade 2, n=2), neutropenia (grade ≥3, n=6 [25.0%]), headache (n=4 [16.7%]; grade 1, n=2; grade 2, n=2), and fatigue (n=4, 16.7%; grade 1, n=1; grade 2, n=3).
• Grade ≥3 TRAEs in addition to neutropenia were reported in 1 patient each (4.2%; pneumonia, back pain, febrile neutropenia, elevated alanine aminotransferase, anemia, and decreased platelet and neutrophil counts).
• A total of 2 deaths due to progressive disease were reported during the study.
• No treatment discontinuations were reported due to AEs.
• One patient was hospitalized due to treatment-related delirium, febrile neutropenia, and pneumonia events.

CRS and Neurotoxicity

• Two patients (8%) experienced grade 1 CRS related to TECVAYLI (n=1, after TECVAYLI SUD 2 [treated with dexamethasone 20 mg]; n=1, TECVAYLI SUD 1 [treated with dexamethasone 10 mg]).
• Neither event met protocol-defined stopping criteria (ie, >grade 3 CRS or neurotoxicity/ICANS).
• No patients developed ICANS on treatment.

Infections and Hypogammaglobulinemia

• A total of 11 patients (45.8%) experienced 32 infections: grade 4 (n=1; sepsis, not related), grade 3 (n=6), grade 2 (n=23), and grade 1 (n=2). Of these, 14 infections were considered related to TECVAYLI by the investigator and were reported in 4 patients (16.7%).
• A total of 7 grade ≥3 infections were reported in 3 patients (12.5%), none of whom had IgG <400 mg/dL or received IVIG.
• Two patients (8.3%) out of the 11 patients with infections had hypogammaglobulinemia: one with grade 2 shingles (related), and one patient with three grade 2 events (not related).
• A single patient experienced two grade 3 pneumonia events (related) classified as serious AEs.
• Quantitative IgG <400 mg/dL was observed in 11 patients (45.8%); 5 received IVIG. An additional 4 patients received IVIG.

Efficacy

• The best ORR was 81% among the 16 evaluable patients. See Table: OPTec/OPTal Study: Response Rate.

Rifkin et al (2024)³ presented safety and efficacy results from 16 patients in the OPTec study.

Results

Patient Characteristics

• The median treatment duration was 9.6 months (range, 0.03-11.08). 
• Details on patient demographics are presented in Table: OPTec Study: Patient Demographics.
• Details on patient disposition are presented in Table: OPTec Study: Patient Disposition.

Safety

• No patients met the stopping criteria (grade >3 CRS or neurotoxicity/ICANS).
• One patient (6.3%) developed grade 1 CRS during cycle 1, which was considered related to TECVAYLI and was treated with dexamethasone.
• No patient experienced ICANS due to the study treatment.
• One patient with diffuse bony lesions had a serious AE of bilateral leg weakness and pain (unrelated to tocilizumab or TECVAYLI). This patient was withdrawn due to the physician’s decision and died of unknown causes 2 weeks later (previously reported).
• Overall, 12 infections were reported in 7 patients (43.8%).
  • A total of 10 infections were grade 2 and 2 infections were considered related to TECVAYLI.
  • A total of 2 infections were grade ≥3 (grade 3 urinary tract infection and grade 4 sepsis [considered a serious AE]).
• Eight patients (50.0%) exhibited quantitative IgG levels of <400 mg/dL; 6 of these patients received IVIG.
• One patient was hospitalized due to treatment-related delirium with febrile neutropenia.
• The most common TRAEs reported in ≥15% of patients were injection site reactions (n=5 [31.3%]: grade 1, n=3; grade 2; n=2), headache and neutropenia (n=4 each [25.0%]), and fatigue and hypogammaglobulinemia (n=3 each [18.8%]).
• The most common grade ≥3 TRAEs reported in ≥5% of patients were neutropenia (n=4 [25.0%]) and febrile neutropenia, increased alanine aminotransferase (ALT), anemia, back pain, hypertension, and a decreased platelet count (n=1 each [6.3%]).
• Additional safety details are summarized in Table: OPTec Study: Safety Summary.

Efficacy

• A total of 11 of 16 patients (68.8%) were evaluable for response. All 11 evaluable patients responded to TECVAYLI, with 45% of patients having a stringent complete response (sCR) or complete response (CR) as their best overall response. Additional details on the best overall response in this evaluable population are presented in Table: OPTec Study: Best Overall Response.
• No patients had a best overall response of stable or progressive disease.
• Response based on the number of treatment cycles received was as follows: 3 cycles, PR (n=1); 7 cycles, PR (n=1); 8 cycles, CR (n=1); 9 cycles, CR (n=1) and sCR (n=2); 11 cycles, sCR (n=1) and VGPR (n=2); and 12 cycles, VGPR (n=2).

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 08 September 2025.