Subcutaneous Toripalimab Meets Primary End Points in Nonsquamous NSCLC

Treatment with subcutaneous toripalimab (JS001sc) plus chemotherapy exhibited noninferior drug exposure compared with toripalimab injection (JS001) for the frontline treatment of patients with metastatic or recurrent nonsquamous non–small cell lung cancer (NSCLC) in the phase 3 JS001sc-002-III-NSCLC trial (NCT06505837), according to a news release from the drug’s developer, Junshi Biosciences.¹

According to the developers, the intravenous agent displayed similar safety and efficacy compared to the subcutaneous indication, and the developers plan to present study data from the phase 3 trial at an upcoming international academic conference. Furthermore, they plan to submit a new drug application for JS001sc for all approved indications of JS001 to regulatory authorities.

“Since its launch as China’s first domestically developed PD-1 antibody drug, toripalimab has secured approvals for 12 indications, benefiting a significant number of patients. In clinical practice, we observed that patients undergoing immunotherapy, either as monotherapy or combination maintenance therapy, face challenges such as frequent intravenous catheterization and time-consuming infusions,” Jianjun Zou, MD, general manager and CEO of Junshi Biosciences, said in the news release.¹ “The recent success of the phase 3 study for JS001sc, achieved through the efforts of both patients and the research team, marks not only a pivotal breakthrough in transitioning [immuno-oncology] therapy from efficacy to convenience but also exemplifies Junshi Biosciences' patient-centric ambition.”

The study, led by Lin Wu, MD, from the Hunan Cancer Hospital in Changsha, China, sought to test the subcutaneous formulation of toripalimab and was the first phase 3 study to assess a domestic anti–PD-1 monoclonal antibody as a subcutaneous formulation. Most immunotherapy options are given intravenously in China. The developers express that this results in lengthy infusion times and inconveniences to patients.

The multicenter, open-label phase 3 trial randomly assigned patients with recurrent or metastatic nonsquamous NSCLC to receive subcutaneous toripalimab at 360 mg or intravenous toripalimab at 240 mg with chemotherapy.² Patients in the subcutaneous arm received four 21-day cycles of JS001sc plus pemetrexed/platinum-containing chemotherapy and continued to receive JS001sc and pemetrexed as maintenance in the absence of disease progression for a maximum of 35 cycles. The same dosing regimen was followed in the intravenous arm.

The primary end points were observed serum trough concentration at cycle 1 and model-predicted area under the concentration-time curve. Secondary end points included objective response rate, progression-free survival, disease control rate, duration of response, and safety.

Those eligible for entry in the phase 3 study included patients 18 years or older with histologically or cytologically confirmed recurrent or metastatic nonsquamous NSCLC, a confirmation of an absence of EGFR-sensitive mutations or ALK fusions, and no prior systemic therapy for advanced or metastatic disease. Additionally, patients with 1 measurable lesion per RECIST v1.1 criteria, an ECOG performance score of 0 or 1, an expected survival of at least 12 weeks, and adequate organ function were included in trial enrollment.

Exclusion criteria included confirmation of concomitant disease states, including small cell lung cancer component, sarcomatoid lesion, or squamous cell carcinoma component greater than 10%; known meningeal metastases and symptomatic or asymptomatic brain metastases; uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; or spinal cord compression not treated surgically or radiotherapeutically. Furthermore, those with unresolved toxicities from previous antitumor therapies, known hypersensitivity to study agents, active case or history of autoimmune disease, and severe infection within 4 weeks of first use of study drug were also deemed ineligible for trial enrollment.

References

1. Junshi Biosciences announces primary endpoints met in JS001sc’s phase 3 study for the 1st-line treatment of NSQ-NSCLC. News release. Shanghai Junshi Biosciences. November 24, 2025. Accessed November 25, 2025. https://tinyurl.com/mwx5tefa
2. JS001sc or JS001 plus chemotherapy is indicated for relapsed or metastatic first-line non-squamous non small cell lung cancer (NSCLC). ClinicalTrials.gov. Updated August 28, 2025. Accessed November 25, 2025. https://tinyurl.com/25y8yytt