Advanced NSCLC — Toripalimab SC vs IV bioequivalence — Junshi Biosciences
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JS001-SC is a phase III, randomized, open-label, multi-center trial evaluating the noninferiority of subcutaneous (SC) toripalimab versus intravenous (IV) toripalimab, each combined with platinum-pemetrexed chemotherapy, as first-line treatment for recurrent or metastatic non-squamous NSCLC. The study enrolled 396 patients (1:1 randomization) with EGFR/ALK wild-type tumors and ECOG PS 0-1. Toripalimab IV (Loqtorzi) is FDA-approved for nasopharyngeal carcinoma; the SC formulation in NSCLC remains investigational.
Phase III, randomized, open-label, multi-center noninferiority trial (NCT06505837). Patients received 4 cycles of induction therapy (Q3W) followed by maintenance therapy until progression or intolerable toxicity.
Untreated recurrent or metastatic non-squamous NSCLC patients (N=396, 1:1 randomized). Key eligibility: age 18+, no EGFR-sensitive mutation or ALK fusion, measurable disease per RECIST v1.1, ECOG PS 0-1.
Arm A: Toripalimab SC 360 mg + pemetrexed 500 mg/m2 + carboplatin AUC 5 or cisplatin 75 mg/m2. Arm B: Toripalimab IV 240 mg + pemetrexed 500 mg/m2 + carboplatin AUC 5 or cisplatin 75 mg/m2.
Primary endpoints: observed serum concentration at Cycle 1 (pre-dose Cycle 2) and model-predicted AUC at Cycle 1. Secondary endpoints: efficacy (ORR, PFS, DCR, DoR, 6-month PFS rate), safety, other PK parameters, and immunogenicity.
At median follow-up of 7.2 months (SC arm) and 7.0 months (IV arm), comparable efficacy was observed. Median PFS was 8.1 months (95% CI: 6.3, NE) in the SC arm and 8.1 months (95% CI: 6.0, 10.9) in the IV arm. The 6-month PFS rate was 59.3% (95% CI: 50.6, 67.0) for SC versus 56.8% (95% CI: 48.5, 64.3) for IV.
Overall survival data remain immature at this early analysis. The 6-month OS rate was 88.2% (95% CI: 82.1, 92.2) in the SC arm and 90.6% (95% CI: 85.2, 94.1) in the IV arm, demonstrating comparable early survival outcomes between the two formulations.
Similar safety profiles were observed between the SC and IV arms. Treatment-emergent adverse events (TEAEs) occurred in 98.5% of patients in both arms. Grade 3+ TEAEs were 62.6% (SC) vs 55.8% (IV). Treatment-related AEs (TRAEs) were 90.4% (SC) vs 91.4% (IV), with grade 3+ TRAEs of 37.9% vs 40.1%. Notably, injection/infusion-related reactions were lower with SC (1.0%) than IV (3.0%).
This trial demonstrates that subcutaneous toripalimab achieves pharmacokinetic noninferiority to the IV formulation, with comparable efficacy and a similar safety profile. If confirmed with longer follow-up, SC administration could offer a more convenient treatment option, reducing infusion time and healthcare resource utilization. Important context: toripalimab IV (Loqtorzi) is FDA-approved for nasopharyngeal carcinoma; the SC formulation in NSCLC is investigational and not yet approved for this indication.
