Loqtorzi (toripalimab-tpzi)

In patients with dMMR or MSI-H locally advanced colorectal cancer, neoadjuvant toripalimab plus celecoxib significantly increased the proportion of patients attaining pathological complete response compared with toripalimab monotherapy, with a similar safety profile. These findings support further investigation of this combination strategy in larger phase 3 trials.

P2, N=65, Not yet recruiting, Dongguan People's Hospital

P3, N=600, Recruiting, NingBo Junyan Hongshi Biosciences Co., Ltd | Not yet recruiting --> Recruiting

P1/2, N=52, Recruiting, Nanjing Immunophage Biotech Co., Ltd | Not yet recruiting --> Recruiting

The patient received various treatment regimens, including toripalimab monotherapy, combination therapy with anlotinib, and combination therapy with temozolomide. Ultimately, surgical resection of the pancreatic and spleen metastases revealed a BRAF V600 mutation, permitting successful transition to targeted therapy with dabrafenib plus trametinib...This case report, along with the subsequent literature review, emphasizes the need for continued treatment and vigilance of molecular monitoring in patients with advanced melanoma, as well as the critical role of multidisciplinary team collaboration in managing complex metastases. Surgical resection and targeted therapy might yield favorable outcomes for select patients with melanoma and pancreatic and splenic metastases.

P3, N=570, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.

P2, N=32, Recruiting, Shanghai Pudong Hospital | Not yet recruiting --> Recruiting | Trial completion date: Jul 2027 --> Jul 2028 | Trial primary completion date: Jul 2026 --> Jul 2027

P2, N=27, Recruiting, Xijing Hospital | Trial primary completion date: Apr 2026 --> Dec 2026

Toripalimab combined with chemotherapy (Toripa-chemo) showed the greatest OS benefit in the overall population (HR = 0.58, 95% CI: 0.38-0.87). Atezolizumab combined with Entinostat and chemotherapy (Atezo-Entino-chemo) showed a trend toward improved OS (HR = 0.49, 95% CI: 0.22-1.12) and ORR (OR = 5.14, 95% CI: 0.70-37.94)...Toripa-chemo and Pembro-chemo demonstrate a balanced profile of efficacy and safety, suggesting that they may be suitable options for first-line treatment of mTNBC. Among these, Toripa-chemo may be considered a preferred first-line regimen for PD-L1 positive patients. https://www.crd.york.ac.uk/prospero/, identifier ID: CRD420251138714.

In contrast, the same regimen showed inferior OS relative to many comparators (HR range for comparators vs. toripalimab plus chemotherapy: 0.47-0.65) and had the lowest OS ranking in SQ-NSCLC (SUCRA = 0.09). In the PD-L1 < 1% subgroup, nivolumab plus ipilimumab demonstrated a trend toward better OS compared with pembrolizumab plus chemotherapy (HR = 0.59) and ranked as the best regimen for SQ-NSCLC (SUCRA = 0.83), whereas pembrolizumab plus chemotherapy provided the greatest OS benefit for non-SQ-NSCLC (SUCRA = 0.90). In the PD-L1 ≥ 50% subgroup, atezolizumab plus chemotherapy ranked second for OS benefit in SQ-NSCLC but was the least effective combination in non-SQ-NSCLC; conversely, cemiplimab plus chemotherapy was the least effective combination in SQ-NSCLC but ranked second in non-SQ-NSCLC. The efficacy of individual first-line ICI regimens appear to vary by histological subtype across PD-L1 expression levels. These findings suggest that PD-L1 status alone might not be sufficient to guide treatment selection, and that histological subtype could be considered in clinical decision-making for advanced NSCLC.

This case suggests that disitamab vedotin combined with toripalimab may have activity in selected patients with advanced urothelial carcinoma, including those with low HER2 expression. However, the findings should be interpreted cautiously, and further studies are needed to clarify the role of this regimen and the value of predictive biomarkers.

P=N/A, N=110, Recruiting, Tianjin Medical University Second Hospital