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Subcutaneous toripalimab generated non-inferior efficacy and safety outcomes vs the IV formulation in recurrent/metastatic non squamous NSCLC.
Treatment with subcutaneous toripalimab (JS001sc) in combination with chemotherapy generated comparable pharmacokinetics (PK) compared with intravenous (IV) toripalimab (Loqtorzi) plus chemotherapy in patients with recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC), meeting the primary end points of the phase 3 JS001sc-002-III-NSCLC trial (NCT06505837).1,2
In an announcement, Shanghai Junshi Biosciences explained that the study met both its primary end points: observed serum Ctrough concentration at cycle 1 and model-predicted area under the concentration time curve from 0 to 21 days at cycle 1.1,2 Findings also demonstrated that subcutaneous toripalimab produced comparable efficacy and safety outcomes compared with the IV formulation.1
Full trial data will be presented at an upcoming international medical conference, and Junshi Biosciences intended to submit new drug applications to global regulatory authorities seeking the approval of subcutaneous toripalimab in all approved indications of the IV formulation.
“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, PhD, general manager and chief executive officer of Junshi Biosciences, stated in a news release. “The recent success of the phase 3 study for [subcutaneous toripalimab], 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. By innovating drug delivery methods, we enhance treatment accessibility: simplifying procedures for patients, reducing their healthcare burden, and alleviating pressure on medical resources. We are committed to advancing the registration of [subcutaneous toripalimab] and providing more patients with a better treatment experience alongside clinical benefits.”
Along with 12 approved indications in China, toripalimab-tpzi has been approved by the FDA in combination with cisplatin and gemcitabine for first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC); and as a single agent for the treatment of adult patients with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.3
The phase 3, open-label, randomized trial enrolled patients at least 18 years of age with histologically or cytologically confirmed, relapsed or metastatic nonsquamous NSCLC who did not harbor EGFR sensitive mutations or ALK fusions.2 No prior systemic antitumor therapy in the advanced or metastatic setting was permitted, although patients who received neoadjuvant/adjuvant therapy for recurrent nonsquamous NSCLC were allowed to participate if they had a treatment-free interval of more than 6 months. Other key inclusion criteria comprised at least 1 measurable lesion per RECIST 1.1 criteria, an ECOG performance status score of 0 or 1, an expected survival of at least 12 weeks, and adequate organ function.
Patients were randomly assigned to received subcutaneous toripalimab at 360 mg in combination with pemetrexed and platinum-based chemotherapy for 4 cycles, followed by subcutaneous toripalimab plus pemetrexed maintenance; or the same treatment regimen using the IV formulation of toripalimab. In both arms, toripalimab treatment could not exceed 35 cycles, which were 21 days each.
Along with the PK end points, secondary end points comprised objective response rate, progression-free survival (PFS), 6-month PFS rate, disease control rate, duration of response, and safety.
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