toripalimab subcutaneous (JS001sc)

Our network meta-analysis provides reliable evidence on the efficacy of perioperative immunotherapy in resectable NSCLC according to PD-L1 expression levels, and may favor competition between therapeutic alternatives. A sensitivity analysis supported these results.

P3, N=395, Active, not recruiting, Shanghai Junshi Bioscience Co., Ltd. | Trial primary completion date: Jun 2025 --> Jun 2026 | Recruiting --> Active, not recruiting

Our network meta-analysis provides reliable evidence on the efficacy of perioperative immunotherapy in resectable NSCLC according to PD-L1 expression levels, and may favor competition between therapeutic alternatives. A sensitivity analysis supported these results.

The combination of CIK cells and toripalimab, with or without chemotherapy, demonstrates promising efficacy and safety in patients with advanced PD-L1-positive NSCLC. The addition of chemotherapy may further enhance therapeutic outcomes, making it a potentially superior strategy compared to CIK cells combined with the anti-PD-1 antibody alone.

Baseline 68Ga-THP-APN09 PET/CT alone could predict efficacy and assist in patient screening for immunotherapy combined chemotherapy in resectable NSCLC, and the follow-up 68Ga-THP-APN09 PET/CT and their change rates could aid in therapy evaluation. Additionally, follow-up 68Ga-THP-APN09 PET/CT could be utilized to monitor the immunotherapy-related thyroiditis during the therapy.

Baseline 68Ga-NOTA-WL12 PET/CT has a potential to predict the pathological response of neoadjuvant immunotherapy combined with chemotherapy in patients with resectable NSCLC, whose efficacy is comparable to that of therapy evaluations employing baseline and follow-up CT and 18F-FDG PET/CT examinations.

Compared with chemotherapy alone, Sintilimab or camrelizumab plus chemotherapy seemed to achieve the best progression-free survival (hazard ratio = 0.56, 95% CI 0.46-0.68)...Nivolumab plus ipilimumab resulted in a relatively lower incidence of adverse events of grade ≥3 than other regimens. The combination of immune checkpoint inhibitors (ICIs) with chemotherapy provided a high probability of more effective treatment in comparison with chemotherapy alone for patients with advanced ESCC. Toripalimab and sintilimab plus chemotherapy were ranked as providing the highest OS and PFS benefit in the first-line setting, respectively.

Based on reconstructed patient-level data, the toripalimab, tislelizumab, and sintilimab group achieved the longest OS, whereas the sintilimab and tislelizumab group had the lowest risk of recurrence than other treatments. In patients with a combined positive score of ≥10, sintilimab had better OS efficacy than pembrolizumab (HR: 0.71, 95% CI: 0.52-0.96). In terms of tumor proportion score of ≥1%, camrelizumab, nivolumab, and toripalimab showed proximate survival benefits in both OS and progression-free survival...Sintilimab was strongly recommended for patients with high programmed cell death-ligand 1 abundance. [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42024501086].

P3, N=356, Not yet recruiting, hunan cancer hospital; hunan cancer hospital

From the perspective of the Chinese healthcare system, this study's findings suggested that first-line TC represents a cost-effective strategy for patients with advanced NSCLC. However, the cost-effectiveness of first-line TC varied across different subgroups when considering predictive biomarkers.

With the threshold of willingness to pay we set ($37,653 per QALY), toripalimab plus chemotherapy was cost-effective in these patient populations. For patients with advanced NSCLC, toripalimab plus chemotherapy was an optimal choice as first-line treatment, regardless of histology.