SUMMARY

• Janssen does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• OPTec (MM165) 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).^1-4
  • Rifkin et al (2024)² presented the preliminary safety and efficacy results from the first 11 patients in the OPTec study. No patient experienced CRS or immune effector cell-associated neurotoxicity syndrome (ICANS). All 5 evaluable patients had responses after 2 cycles and 4 cycles of TECVAYLI treatment.
  • Rifkin et al (2024)³ presented the updated safety and efficacy results from 16 patients in the OPTec study. One patient experienced grade 1 CRS during cycle 1, which was considered related to TECVAYLI and no patient experienced ICANS. All 11 evaluable patients responded to TECVAYLI treatment.

CLINICAL DATA - optec study

OPTec (MM165; clinicaltrials.gov identifier: 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

• TECVAYLI will be administered in the outpatient setting. Enrollment is ongoing. The study design is presented in the Figure: OPTec Study Design.^1-3
  • Safety review by the data review committee will be conducted after the first 5 and 10 patients.¹
  • Prophylactic intravenous immunoglobulin (IVIG) for infections may be administered for serum immunoglobulin G (IgG) <400 mg/dL at the investigators discretion.^1,3 

Rifkin et al (2024)² presented the preliminary safety and efficacy results from the first 11 patients in the OPTec study.

Results

Patient Characteristics

• In the first 11 patients enrolled, the median age was 70 years (range, 53-83). In total, 6 patients were female, and 5 patients were male. The median number of prior lines of systemic therapy was 8 (range, 5-11).

Safety

• The first 11 patients did not meet the stopping criteria (grade >3 CRS or neurotoxicity/ICANS).
• Overall, 10 patients completed the step-up dosing regimen per protocol. One patient with diffuse bony lesions had a serious adverse event (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.
• No patient experienced CRS or ICANS.
• No patient required hospitalization due to tocilizumab or TECVAYLI.
• The most common AEs included headache (n=5), nausea (n=5), neutropenia (n=4), and injection site reaction (n=4).
• One patient had grade 2 infections of the upper respiratory tract and urinary tract, and 2 patients had 1 infection each (grade 2 candida infection, and grade 2 viral upper respiratory tract infection).

Efficacy

• All 5 evaluable patients had responses after 2 cycles (partial response [PR], n=3; very good partial response [VGPR], n=2) and 4 cycles (PR, n=1; VGPR, n=4) of TECVAYLI treatment.

Rifkin et al (2024)³ presented the updated 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 treatment-related adverse events (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 10 December 2024.