Loqtorzi (toripalimab)

To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies

FDA Approval: 10/27/2023

Research Synopsis

  • Recent research highlights Loqtorzi (toripalimab) as a humanized monoclonal antibody targeting PD-1, primarily aimed at enhancing immune response against cancer.
  • The first global approval of toripalimab occurred in December 2018 for patients with unresectable or metastatic melanoma who previously failed standard treatments.
  • Clinical trials involving toripalimab demonstrated encouraging safety profiles, with manageable side effects observed, particularly in advanced melanoma and gastric cancer cases.
  • A phase Ib/II trial focused on advanced gastric cancer found that higher tumor mutational burden (TMB) was associated with improved overall survival, suggesting TMB as a potential biomarker for effectiveness.
  • Combining toripalimab with other therapies, such as chemotherapy and VEGF inhibitors, has shown promising synergy, particularly in challenging cancer types like metastatic mucosal melanoma.
  • A significant body of evidence emphasizes toripalimab's potential use in treating various cancers, including neuroendocrine neoplasms and advanced non-small cell lung cancer, with varying success rates depending on genetic markers.
  • Research has also identified potential immune-related adverse effects, such as dermatomyositis, underscoring the need for thorough patient monitoring during treatment.
  • Overall, data suggests that specific patient characteristics, including PD-L1 expression and TMB, may enhance the predictive value of treatment outcomes when using toripalimab.
  • The continuous evaluation of toripalimab across diverse cancer settings points to its evolving role in immunotherapy, suggesting a need for personalized treatment approaches based on biomarkers.
  • Ongoing studies will likely further elucidate the scope and limitations of toripalimab in various populations, particularly in Asian cohorts compared to Western counterparts in terms of efficacy and response rates.

Related articles

Research articles about Loqtorzi (toripalimab)

Loqtorzi (toripalimab)

Safety and clinical activity with an anti-PD-1 antibody JS001 in advanced melanoma or urologic cancer patients.

London, UK

2 hours ago

1 Received

  • - JS001 is a humanized monoclonal antibody targeting the PD-1 receptor to enhance T cell activation in patients with advanced melanoma or urologic cancers who haven't responded to standard treatments.
  • - The study involved dose escalation and expansion cohorts where patients received intravenous infusions of JS001, with safety and clinical responses monitored over time according to specific criteria.
  • - Results showed that JS001 was well tolerated, with 22.2% of patients showing objective clinical responses, including one complete response and several partial responses, indicating potential effectiveness especially correlated with tumor characteristics.

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Safety, efficacy and tumor mutational burden as a biomarker of overall survival benefit in chemo-refractory gastric cancer treated with toripalimab, a PD-1 antibody in phase Ib/II clinical trial NCT02915432.

London, UK

2 hours ago

1 Received

  • The study evaluated the safety and efficacy of toripalimab, a PD-1 antibody, in treating advanced gastric cancer (AGC), focusing on its correlation with tumor mutational burden (TMB) and PD-L1 expression.
  • In a phase Ib/II trial, two groups of AGC patients (chemo-refractory and chemotherapy-naive) were treated with toripalimab, showing varying response rates and adverse effects, with TMB-H patients experiencing better overall survival.
  • Results indicated that toripalimab, especially when combined with chemotherapy, has a manageable safety profile and significant antitumor activity, highlighting TMB as a potential predictive marker for patient outcomes.

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Axitinib in Combination With Toripalimab, a Humanized Immunoglobulin G Monoclonal Antibody Against Programmed Cell Death-1, in Patients With Metastatic Mucosal Melanoma: An Open-Label Phase IB Trial.

London, UK

2 hours ago

1 Received

  • Metastatic mucosal melanoma has poor response rates to anti-PD-1 therapy alone, and combining VEGF inhibition with PD-1 blockade may improve treatment outcomes.
  • A phase IB trial tested the safety and initial effectiveness of the PD-1 antibody toripalimab combined with the VEGF inhibitor axitinib in patients with advanced melanoma, particularly those with chemotherapy-naïve mucosal types.
  • Results showed that while most patients reported treatment-related adverse events, 48.3% of those with chemotherapy-naïve mucosal melanoma had a measurable response, with a median progression-free survival of 7.5 months.

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Rapid advances in research on and development of anticancer drugs in China.

London, UK

2 hours ago

1 Received

  • Cancer poses a significant public health challenge in China, creating a strong demand for effective anticancer medications.
  • The country has seen advancements in innovative drug development due to policy reforms and economic growth, leading to the approval of five new anticancer drugs by 2018.
  • Future trends suggest a shift in China's pharmaceutical focus from generic medications to pioneering "first-in-class" and "best-in-class" drugs, with several more innovative treatments expected to gain approval soon.

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Glycosylation-independent binding of monoclonal antibody toripalimab to FG loop of PD-1 for tumor immune checkpoint therapy.

London, UK

2 hours ago

1 Received

  • Monoclonal antibodies targeting PD-1 show promise in enhancing T-cell immunity and treating various tumors, but the specifics of how they interact with PD-1 remain unclear.
  • The study presents the structure of PD-1 in complex with toripalimab, a mAb used in melanoma therapy, highlighting its unique binding site and the structure of its heavy chain.
  • Glycosylation patterns on PD-1 were mapped, showing minimal effect on toripalimab's binding, which aids in understanding the mechanics of their interaction and informs future treatments targeting PD-1.

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Discovery of New Immune Checkpoints: Family Grows Up.

London, UK

2 hours ago

1 Received

  • The first generation of immune checkpoint inhibitors (ICIs) including anti-CTLA-4 and anti-PD-1/anti-PD-L1 has shown remarkable success in cancer treatment, with nine drugs approved by Q1 2019.
  • Despite their benefits, challenges remain such as limited response rates in late-stage patients, ineffective results in certain tumor types, and serious immune-related side effects.
  • Clinicians have also noted cases where patients initially respond to treatment but later experience progression, prompting a search for next-generation immune checkpoint therapies.

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Safety and efficacy of toripalimab in advanced gastric cancer: A new clinical trial bringing hope for immunotherapy in gastric cancer.

London, UK

2 hours ago

1 Received

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An advanced non-small cell lung cancer patient with epidermal growth factor receptor sensitizing mutation responded to toripalimab in combination with chemotherapy after resistance to osimertinib: a case report.

London, UK

2 hours ago

1 Received

  • * Managing patients who develop resistance to osimertinib is becoming a significant clinical issue.
  • * A reported case showed that after osimertinib failure, a combination of toripalimab and chemotherapy provided an impressive progression-free survival (PFS) benefit of over 8 months, suggesting this approach may be a viable option for such patients.

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Efficacy, Safety, and Biomarkers of Toripalimab in Patients with Recurrent or Metastatic Neuroendocrine Neoplasms: A Multiple-Center Phase Ib Trial.

London, UK

2 hours ago

1 Received

  • A phase Ib trial tested toripalimab, a PD-1 antibody, on patients with recurrent or metastatic neuroendocrine neoplasms (NEN) who had failed first-line treatment, focusing on safety and effectiveness.
  • Of the 40 patients studied, the treatment resulted in a 20% objective response rate and a 35% disease control rate, with a median duration of response lasting approximately 15.2 months.
  • The findings indicated that patients with higher PD-L1 expression and tumor mutational burden had better responses, suggesting that certain genetic factors may enhance treatment efficacy and could be monitored for better patient outcomes.

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Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review.

London, UK

2 hours ago

1 Received

  • Conventional chemotherapy is largely ineffective for treating mucosal melanoma (MM), leading to a preference for immune checkpoint inhibitors (ICIs), though data on their use in MM remains limited.
  • The systematic review analyzed various studies on the efficacy and safety of ICIs, focusing on primary outcomes like overall response rates and survival rates.
  • Results indicated that anti-PD-1 therapies had better outcomes than anti-CTLA-4 alone, with combinations showing the most promise, highlighting a greater response rate when combined with treatments like axitinib or radiotherapy.

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Safety and clinical efficacy of toripalimab, a PD-1 mAb, in patients with advanced or recurrent malignancies in a phase I study.

London, UK

2 hours ago

1 Received

  • This phase I study evaluates toripalimab, a monoclonal antibody targeting the PD-1 receptor, for safety and effectiveness in Chinese patients with advanced cancer not responding to standard treatments.
  • A total of 33 patients participated, with diverse cancers and a history of multiple treatments, showing that toripalimab had manageable side effects and prompted some positive responses, particularly in lymphoma cases.
  • The results indicated a significant objective response rate, especially in lymphoma patients, and overall a well-tolerated treatment with potential long-lasting benefits, particularly for patients with alveolar soft part sarcoma (ASPS).

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Evaluation of I-JS001 for hPD1 immuno-PET imaging using sarcoma cell homografts in humanized mice.

London, UK

2 hours ago

1 Received

  • JS001 (toripalimab) is a humanized IgG monoclonal antibody that effectively inhibits PD1, a protein involved in immune response regulation.
  • In this study, a different iodine isotype (I) was used to label JS001, showing similar effectiveness in targeting the PD1 antigen and significantly higher uptake in activated T cells compared to nonactivated ones.
  • Immuno-PET imaging in humanized mice demonstrated that I-JS001 effectively targets PD1-positive tumors, suggesting its potential for noninvasive monitoring and personalized immunotherapy.

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Effective Treatment with PD-1 Antibody, Chidamide, Etoposide, and Thalidomide (PCET) for Relapsed/Refractory Natural Killer/T-Cell Lymphoma: A Report of Three Cases.

London, UK

2 hours ago

1 Received

  • Extranodal natural killer (NK)/T-cell lymphoma, nasal type (ENKTL) is a subtype of T-cell lymphoma with a poor outlook and no standard treatments for patients who relapse or do not respond to therapy.
  • A case study of three patients showed that a new treatment regimen combining the PD-1 antibody toripalimab, chidamide, etoposide, and thalidomide led to significant improvements, with two patients achieving complete remission and one showing partial remission.
  • While the treatment had manageable side effects like leukocytopenia and anemia, the findings suggest that the PCET regimen could be an effective option for treating R/R ENKTL and deserves more research.

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Study protocol for an open-label, single-arm, phase Ib/II study of combination of toripalimab, nab-paclitaxel, and gemcitabine as the first-line treatment for patients with unresectable pancreatic ductal adenocarcinoma.

London, UK

2 hours ago

1 Received

  • Pancreatic ductal adenocarcinoma (PDAC) is a severe cancer with poor outcomes from immune checkpoint inhibitors (ICIs), but combining ICIs with standard chemotherapy (gemcitabine and nab-paclitaxel) may improve treatment efficacy.
  • The study is a phase Ib/II trial evaluating a specific combination of toripalimab (an ICI) with gemcitabine and nab-paclitaxel in patients with unresectable PDAC, focusing on safety and overall survival among other outcomes.
  • This trial may be pivotal as it is the first to investigate the effectiveness of this combination therapy in PDAC patients and aims to identify predictive biomarkers for better treatment responses.

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Toripalimab-Induced Dermatomyositis in a Patient with Metastatic Melanoma.

London, UK

2 hours ago

1 Received

  • Toripalimab is a PD-1 targeting monoclonal antibody approved for treating metastatic melanoma as a second-line therapy.
  • It can lead to immune-related adverse events, including a specific case of dermatomyositis in a patient undergoing treatment.
  • Discontinuing toripalimab and administering intravenous methylprednisolone successfully relieved symptoms, highlighting the importance of early recognition and treatment of this irAE by clinicians.

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Safety, Efficacy, and Biomarker Analysis of Toripalimab in Previously Treated Advanced Melanoma: Results of the POLARIS-01 Multicenter Phase II Trial.

London, UK

2 hours ago

1 Received

  • A phase II study assessed the safety and effectiveness of toripalimab, a PD-1 inhibitor, in advanced melanoma patients in China, mainly focusing on acral and mucosal types, which are less common in Western populations.
  • Out of 128 patients treated, a significant number (90.6%) experienced treatment-related adverse events, but the overall response rate was 17.3%, suggesting some level of effectiveness.
  • Patients with positive PD-L1 expression had significantly better outcomes, including higher response rates and longer progression-free survival compared to those who were negative for PD-L1, indicating the potential for personalized treatment approaches in melanoma.

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Toripalimab for the treatment of melanoma.

London, UK

2 hours ago

1 Received

  • Immune therapies like ipilimumab, nivolumab, and pembrolizumab have revolutionized metastatic melanoma treatment, with toripalimab gaining approval in China as a second-line therapy in 2018.
  • This review covers toripalimab's role in melanoma, highlighting its effectiveness compared to pembrolizumab and examining various clinical trials and research findings.
  • Current predictive markers, such as PD-L1 expression and tumor mutational burden, need improvement, and toripalimab shows limited efficacy in specific melanoma subtypes, although promising results have been noted in combinations with other treatments for mucosal melanomas.

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PD-1 Blockade in Chinese versus Western Patients with Melanoma.

London, UK

2 hours ago

1 Received

  • A clinical trial tested the effects of toripalimab, a PD-1 blocker, on Chinese melanoma patients who had already undergone treatment.
  • The study found that the objective response rate in these patients was lower compared to Western populations, potentially due to distinct histologic and molecular characteristics.
  • The findings indicate the need for further research into how melanoma develops and why some patients resist PD-1 blockade therapies.

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A phase I study of toripalimab, an anti-PD-1 antibody, in patients with refractory malignant solid tumors.

London, UK

2 hours ago

1 Received

  • This study investigates the safety and effectiveness of toripalimab, an anti-PD-1 antibody, in Chinese patients with advanced malignant tumors, filling a gap in data previously focused on Western populations.
  • The research included a phase I trial with 25 patients, observing common side effects like fatigue and rash, but no serious adverse events or dose-limiting toxicities.
  • Results showed a 12.5% objective response rate, with most patients maintaining high PD-1 receptor occupancy, suggesting toripalimab could be an effective treatment option for difficult-to-treat cancers.

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