Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Oncology, Hikma, Excellmab, Dr. Reddy’s, Apotex, LEO Pharma - LARVOL DELTA

Bleed-versus-clot paradox under immune-checkpoint inhibition: A decade-long US faers analysis reveals divergent class-specific hemostatic phenotypes (ASH 2025) - "Atezolizumab had the strongest thrombotic signal (ROR 1.60, 95 % CI 1.44–1.78), whiletoripalimab and atezolizumab had the highest bleeding signals (2.08, 1.32–3.27; and 2.60, 2.31–2.93,respectively). FAERS data reveal divergent hemostatic profiles under ICI therapy: PD-L1 blockade favors thrombosis,while toripalimab, a novel PD-1 antibody, drives immune-mediated bleeding. These class-specifictoxicities appear mechanistically distinct and temporally early, often manifesting within the first 60 daysof treatment. This suggests that current approaches treating all ICIs as a uniform risk group may obscurecritical safety signals."

Checkpoint inhibition • Oncology • Thrombosis • CTLA4 • ROR1

Combination anti-PD1 antibody and rituximab followed by R-CHOP for newly diagnosed DLBCL in elderly patients: Updated results of the phase II TREND trial (ASH 2025) - P1/2 | "The current CR rate in our study exceeds the prespecified efficacy threshold. Toripalimab plus Rituximabas a first-line treatment then followed by R-CHOP yielded high CR rate and manageable toxicities in newlydiagnosed elderly DLBCL, especially for patients with extranodal disease and high grade lymphoma. Thistreatment strategy deserves further study."

Clinical • IO biomarker • P2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Otorhinolaryngology • Thrombocytopenia • PD-L1

Efficacy and safety of toripalimab combined with Lenvatinib as first-line treatment for unresectable/advanced non–clear cell renal cell carcinoma: A prospective, single-arm, phase II trial (ESMO Asia 2025) - P=N/A | "The KEYNOTE-B61 study showed that pembrolizumab plus lenvatinib offers favorable efficacy and safety in advanced nccRCC, yet evidence for alternative first-line regimens remains limited. Toripalimab combined with lenvatinib showed promising antitumor activity and manageable toxicities as a first-line treatment for unresectable or advanced nccRCC."

Clinical • Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Solid Tumor • TFE3

Final analysis and biomarker evaluation of JUPITER-06: A phase III trial of toripalimab plus chemotherapy in advanced or metastatic esophageal squamous cell carcinoma (ESMO Asia 2025) - P3 | "Here, we report the final outcomes and explore the potential genomic biomarkers predictive of long-term survival of JUPITER-06 trial. A total of 514 previously untreated patients with advanced or metastatic ESCC were randomly assigned in a 1:1 ratio to receive either toripalimab or placebo, in combination with paclitaxel and cisplatin. Final analysis of the JUPITER-06 trial confirms the sustained OS benefit of toripalimab plus chemotherapy as first-line treatment in advanced/metastatic ESCC, with a manageable safety profile. ccTMB and the extended EGIC scheme show promising predictive value for long-term survival in anti-PD-1-based combination therapies."

Biomarker • IO biomarker • Metastases • P3 data • Tumor mutational burden • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • PD-L1 • TMB

Long term overall survival follow-up of toripalimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (ESMO Asia 2025) - P3 | "Toripalimab plus GP chemotherapy demonstrated significant survival benefits over GP alone as a first-line treatment for RM-NPC. The median OS reached 64.8 months in the toripalimab arm, with a 31-month improvement over GP alone. Toripalimab plus GP chemotherapy represents the new standard care for patients with RM-NPC."

Clinical • Combination therapy • Metastases • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A phase I study of JS207, a PD-1/VEGF bispecific antibody, in patients with advanced malignancies (ESMO Asia 2025) - P1 | "JS207 is engineered on the backbone of toripalimab with a VEGFA-specific nanobody inserted between Fab and Fc domains. JS207 demonstrated acceptable safety and promising monotherapy efficacy in solid tumors. JS207 is being evaluated in multiple phase II studies as monotherapy or in combination with standard care."

Clinical • Metastases • P1 data • Colorectal Cancer • Hepatocellular Cancer • Kidney Cancer • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer • MSI • PD-1 • PD-L1

Efficacy and safety of two bladder-preserving treatment durations with disitamab vedotin plus toripalimab combination in Her2-expressing muscle-invasive bladder cancer: A phase II, open-Label, randomized clinical trial (ESMO Asia 2025) - "The primary end point is one year BI-DFS. The secondary end points included overall survival (OS), recurrence-free survival (RFS), clinical complete responsec (cCR) and safety."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Efficacy and safety of neoadjuvant disitamab vedotin plus toripalimab, followed by response-adapted bladder sparing, in patients with muscle-invasive bladder cancer: A real-world study (ESMO Asia 2025) - "DV-toripalimab combination demonstrates promising neoadjuvant efficacy and manageable toxicity in HER2-expressing MIBC, enabling bladder-sparing in selected candidates."

Clinical • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2

SHOX2-Mediated lymphatic metastasis in pT1 non-clear cell renal carcinoma: Biomarker-driven risk stratification and combined-modality management (ESMO Asia 2025) - "SHOX2 drives lymphatic metastasis in pT1 nccRCC via ECM-EMT crosstalk. A precision perioperative strategy is proposed: (1) Preoperative mSHOX2 liquid biopsy for LNM risk assessment; (2) 99mTc-sulfur colloid lymphoscintigraphy-guided lymph node dissection in high-risk cases; (3) Postoperative adjuvant toripalimab-axitinib combination for SHOX2-positive patients. Multicenter validation of this biomarker-directed framework is warranted to optimize therapeutic precision in nccRCC."

Biomarker • Clear Cell Renal Cell Carcinoma • Kidney Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma • Solid Tumor • SHOX2

Comparative pathologic complete response of neoadjuvant chemotherapy with PD-1/PD-L1 inhibitors in locally advanced gastric or gastroesophageal junction adenocarcinoma: A systematic review and Bayesian network meta-analysis (ESMO Asia 2025) - "Moderate effects were seen with Camrelizumab + NCT (OR 4.65, CrI: 1.72–13.2; SUCRA 56.94) and Durvalumab + NCT (OR 3.09, CrI: 0.688–13.9; SUCRA 40.12). Atezolizumab + NCT (OR 2.20, CrI: 0.739–8.27; SUCRA 28.04) and Toripalimab + NCT (OR 3.23, CrI: 0.563–20.3; SUCRA 43.21) showed lower efficacy. The addition of PD-1/PD-L1 inhibitors to NCT may enhance pCR in locally advanced gastric or GEJ cancer. The addition of PD-1/PD-L1 inhibitors to NCT may enhance pCR in locally advanced gastric or GEJ cancer. Tislelizumab, Pembrolizumab, and Sintilimab demonstrated the most promising results, although wide credible intervals reflect substantial uncertainty for several regimens. Further comparative trials and long-term outcome data are needed to optimize NICT strategies."

Metastases • Retrospective data • Review • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

NALIRIFOX or AG chemotherapy plus PD-1 blockade sequenced By SBRT as first-line regimen for locally advanced pancreatic cancer (ESMO Asia 2025) - P=N/A | "Eligible pts were randomized 1:1 to experimental arm (PRNFX, Liposomal Irinotecan 50mg/m2 d1,15 + Oxaliplatin 60mg/m2 d1,15 + Leucovorin 200mg/m2 d1,15 + 5-fluorouracil 2400mg/m2 d1,15 + Toripalimab 160mg d1,15 q28d) or controlled arm (PRAG, Gemcitabine 1000mg/m2 d1,8 + nab-paclitaxel 125mg/m2 d1,8 + Toripalimab 240mg d1 q21d). Compared to the Gemcitabine-based counterpart, NALIRIFOX combined with PD-1 inhibitor followed by sequential SBRT+SIB demonstrated a potential efficacy advantage and tolerable safety for LAPC treatment."

Clinical • Metastases • Oncology • Pancreatic Cancer • Solid Tumor

Clinicopathologic features and outcomes in microsatellite instability-high (MSI-H) cancers: Real-world data from Western India community oncology (ESMO Asia 2025) - "Pembrolizumab (45%, n=9) was the most used ICI, followed by nivolumab (35%, n=7), dostarlimab (10%, n=2), toripalimab (0.5%, n=1); low-dose nivolumab (40mg) in n=6 showed 60% ORR. This study highlight a critical imperative for systematic MSI testing to enable timely precision immunotherapy, optimize survival, and bridge regional disparities in cancer care."

Clinical • IO biomarker • MSI-H • Real-world • Real-world evidence • Biliary Cancer • Cervical Cancer • Cholangiocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Microsatellite Instability • Oncology • ARID1A • CHEK2 • KRAS • MLH1 • MSH6 • MSI • PD-L1 • PTEN • TP53

Sacituzumab govitecan combined with toripalimab as first-line treatment for advanced triple-negative breast cancer: A prospective, single-arm, multicenter phase II clinical trial (ESMO Asia 2025) - P | "The primary endpoint is PFS per RECIST v1.1 and secondary endpoints including ORR, OS per RECIST v1.1, safety and exploration of efficacy-related biomarkers (Trop-2, PD-L1 expression, ctDNA mutations, etc.) . Imaging evaluations for efficacy assessment conducted every 2 treatment cycles up to 56 weeks."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

Updated results from a phase I study of JS107, a claudin 18.2 (CLDN18.2)-targeting antibody-drug conjugate (ADC), in combination with toripalimab and chemotherapy as the first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) (ESMO Asia 2025) - P1 | "JS107 in combination with toripalimab and XELOX as the first-line treatment for CLDN18.2-high advanced G/GEJA showed encouraging efficacy with a manageable safety profile, warranting further evaluation in phase 3 trials."

Clinical • Combination therapy • Late-breaking abstract • Metastases • P1 data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • HER-2

Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: Dan Feng

New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor

Toripalimab plus hepatic artery infusion chemotherapy in hepatocellular carcinoma patients of Barcelona Clinic Liver Cancer stage C: A biomolecular exploratory, phase II trial. (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT 03851939 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Phase Ib/II study of fruquintinib combined with SOX and toripalimab in advanced metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). (ASCO-GI 2026) - P1/2 | "Clinical Trial Registration Number: NCT05024812 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase II trial of adjuvant toripalimab in stage IIb, IIc, or III colon cancer with mismatch repair deficiency. (ASCO-GI 2026) - P2 | "Funded by Robert Winn Career Development Award (supported by Genentech), Emory University, Biostatistics Shared Resource of Winship Cancer Institute of Emory University and NIH/NCI Clinical Trial Registration Number: NCT07140679 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Mismatch repair • P2 data • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Perioperative PD-1 antibody toripalimab combined with chemotherapy versus chemotherapy alone in locally advanced gastric or gastroesophageal junction cancer: 3-year follow-up of the prospective, randomized, phase 2 NEOSUMMIT-01 trial. (ASCO-GI 2026) - P2 | "Funded by Shanghai Junshi Biosciences Clinical Trial Registration Number: NCT04250948 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Comparative efficacy and safety of immune checkpoint inhibitors-based strategies in advanced hepatocellular carcinoma: a systematic review and network meta-analysis. (PubMed, Int J Surg) - "This systematic review and NWA reveals substantial heterogeneity in efficacy and safety profiles among ICIs-based combinations for advanced HCC. These findings support individualized treatment selection matching patient profiles with regimen-specific risk-benefit patterns, with toxicity monitoring to optimize outcomes."

Checkpoint inhibition • Clinical • Journal • Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

Outcomes with first-line treatments for patients with locally advanced or metastatic triple negative breast cancer eligible for anti-PD-(L)1 therapy: A systematic literature review of randomized trials (SABCS 2025) - "Adding atezolizumab to taxane-based chemotherapies (7.2-7.5 vs. 5.3-6.4 months)—but not gemcitabine-carboplatin or capecitabine (4.2 vs. 3.6 months)—resulted in a significant PFS benefit...There were also statistically significant improvements in PFS with molecular subtyping-based treatments and a numerical improvement in PFS when replacing nab-paclitaxel with sacituzumab govitecan (SG) combined with immunotherapy...Conversely, trials evaluating the addition of oleclumab, nivolumab, or ipatasertib to chemotherapy and/or immunotherapy did not significantly improve PFS.Median OS ranged from 10.7-32.8 months across trials; most showed no significant differences between treatment arms... This review indicates an evolving treatment landscape, with the adoption of regimens with atezolizumab, toripalimab, pembrolizumab, and SG being associated with improved efficacy in patients with PD-(L)1-eligible LA/mTNBC. Specifically, the most recent publication revealed that SG in..."

Clinical • Metastases • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

First line PD-L1/1 inhibition based therapies in elderly patients with ES-SCLC: a Systematic Literature Review and Network Meta-Analysis (ESMO-IO 2025) - "Currently, PD-1/PD-L1 inhibitors with platinum and etoposide (EP) have been adopted as standard first-line therapy and idemonstrated survival benefits in the overall population, while the magnitude of benefit and optimal agent in elderly patients remain unclear.Methods Following PRISMA-NMA guidelines, PubMed and ClinicalTrials.gov were searched up to 29 August 2025. Eligible RCTs compared first-line PD-L1 or PD-1 inhibitors—atezolizumab, durvalumab, serplulimab, adebrelimab, tislelizumab, pembrolizumab, socazolimab, benmelstobart(+anlotinib), nivolumab, or toripalimab with or without EP in ES-SCLC...Atezolizumab-EP ranked highest for OS (SUCRA=0.88), followed by Benmelstobart + anlotinib -EP (SUCRA = 0.86) and serplulimab-EP (SUCRA = 0.77), whereas durvalumab-EP (SUCRA = 0.36) and socazolimab-EP (SUCRA = 0.29) showed relatively modest effects.Conclusions First-line PD-L1/PD-1 inhibition plus EP confers a clinically meaningful survival advantage in elderly patients with..."

Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Immune checkpoint inhibitors and hemophagocytic lymphohistiocytosis: Disproportionality analysis from FAERS (ESMO-IO 2025) - "Cases were grouped by PD-1 inhibitors (pembrolizumab, nivolumab, cemiplimab, sintilimab, tislelizumab, camrelizumab, retifanlimab, toripalimab) and PD-L1 inhibitors (atezolizumab, durvalumab, avelumab). Clinicians should remain vigilant for HLH—especially early fever, cytopenias, and rising ferritin—and seek prompt hematology input with diagnostic workup, which may be lifesaving. Differences may reflect pharmacodynamics, indication mix, combinations, and reporting bias; prospective, mechanism-focused studies are needed to clarify causality and guide mitigation strategies.Legal entity responsible for the study The authors."

Checkpoint inhibition • Breast Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Magnesium Is Associated with Favorable Outcomes of Cancer Patients Treated with Immune Checkpoint Inhibitors (ASH 2024) - "Included in the study were patients who received various ICIs treatments, such as IBI318, pembrolizumab, nivolumab, atezolizumab, durvalumab, cemiplimab, tislelizumab, toripalimab, and sintilimab, with monitoring of their serum magnesium ion levels. These findings underscore the predictive value of serum magnesium levels in evaluating clinical outcomes among patients receiving ICIs therapy.Conclusion : This multicenter study demonstrates that patients receiving ICIs exhibit significantly improved outcomes among those with elevated serum magnesium levels compared to those with low levels. Further prospective validation studies are essential to evaluate magnesium levels in ICI-treated patients and to supplement magnesium preparations in patients with magnesium deficiency to confirm these findings."

Checkpoint inhibition • Clinical • Esophageal Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Oncology • Solid Tumor • CD8

Disitamab vedotin (RC48-ADC) combined with immunotherapy as neoadjuvant therapy for localized muscle-invasive bladder cancer: a multicenter real-world study. (PubMed, NPJ Precis Oncol) - "Neoadjuvant cisplatin-based combination chemotherapy or perioperative durvalumab with neoadjuvant gemcitabine-cisplatin has been the primary treatment for localized muscle-invasive bladder cancer (MIBC)...Twenty-five patients (cT2-4aN0-2M0) received at least four cycles of RC48 (2.0 mg/kg, Q2W or Q3W) with toripalimab, tislelizumab, or pembrolizumab, followed by radical cystectomy...Treatment-related adverse events were manageable. These findings suggest that RC48 combined with PD-1 inhibitors is a promising neoadjuvant strategy for localized MIBC and warrants further validation in biomarker-selected populations."

IO biomarker • Journal • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • HER-2