Loqtorzi (toripalimab-tpzi)

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

A 62-year-old man with metastatic PSA underwent splenectomy followed by first-line paclitaxel, achieving stable disease for 7 months...Sequential treatment with liposomal doxorubicin, eribulin, toripalimab, and lenvatinib failed to control the disease failed to control the disease...To our knowledge, this is the first reported use of inavolisib in angiosarcoma. The rapid biochemical and radiological response observed in this PIK3CA-mutated PSA supports early genomic profiling to identify actionable alterations and warrants prospective evaluation of combined phosphoinositide 3-kinase and vascular endothelial growth factor pathway inhibition in refractory angiosarcoma.

P2/3, N=90, Not yet recruiting, Peking University Cancer Hospital & Institute

P2, N=58, Recruiting, Peking University Third Hospital

P2, N=73, Completed, Sun Yat-sen University | Recruiting --> Completed | Trial completion date: Dec 2024 --> Apr 2026 | Trial primary completion date: Dec 2023 --> Oct 2025

P2, N=134, Recruiting, Sun Yat-sen University | N=200 --> 134 | Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Jan 2025 --> Jan 2027