Toripalimab: First Global Approval

Keam, Susan J.

doi:10.1007/s40265-019-01076-2

Cited by 111 publications

(85 citation statements)

References 13 publications

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“…In August 2018, nivolumab and pembrolizumab were approved by the China Food and Drug Administration (CFDA) as therapies for locally advanced or metastatic NSCLC and unresectable or metastatic melanoma, respectively, while ipilimumab had not yet been used in China. Since the end of 2018, three PD-1 inhibitors made in China (toripalimab, sintilimab, and camrelizumab) [11,12] have entered the domestic market. However, Chinese doctors generally lack a basic knowledge of immunotherapy, and there are phenomena such as abuse, contraindications, and use of off-label medication in clinical practice.…”

Section: Introductionmentioning

confidence: 99%

Current status of the clinical use of PD-1/PD-L1 inhibitors: a questionnaire survey of oncologists in China

Zhang

Song

et al. 2020

BMC Cancer

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Background: The purpose of the present study was to obtain information on the use of PD-1/PD-L1 inhibitors by oncologists in China through a national questionnaire survey. Methods: Between the 7th and 25th of July in 2019, a questionnaire designed by the Chinese Society of Clinical Oncology Immuno-Oncology (CSCO IO) Committee on the current status of the use of PD-1/PD-L1 inhibitors was distributed online and offline to cancer-related medical departments in thirty different provinces and autonomous regions of China. The national questionnaire consisted of three sections as follows: general information, current status of the application of PD-1/PD-L1 inhibitors in the clinic, and oncologists' concerns regarding utilization. Results: The valid response rate of the current status survey was 76.3%. The proportion of senior doctors (physician-in-charge or a more superior position for more than 3 years) among the respondents was relatively high (67.0% in 588). Of the respondents, 59.2% had prescribed PD-1/PD-L1 inhibitors during clinical treatment, and the most frequent reason for not prescribing these inhibitors was the choice "do not understand the mechanism and the efficacy of PD-1/PD-L1 inhibitors". In addition, 77.9% of the prescribers used the medications in an off-label situation, and the most important motivation for this use was the fact that "there were indications abroad but not domestically". In addition, 77.9% of the prescribers believed that "immunotherapy-related adverse effects could be controlled or intervened through follow-up management". The prescribers were mostly concerned about "how to identify pseudoprogression and hyperprogression" and "immunity-related adverse effects management". Conclusion: The present study highlights the current status of PD-1/PD-L1 inhibitors in China. Increasing numbers of medical oncologists are interested in PD-1/PD-L1 inhibitors, and they are in need of immunotherapy education.

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Section: Introductionmentioning

confidence: 99%

Current status of the clinical use of PD-1/PD-L1 inhibitors: a questionnaire survey of oncologists in China

Zhang

Song

et al. 2020

BMC Cancer

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“…11 Since then, many patients with advanced STS in China started to use PD-1 inhibitors offlabel, particularly due to the introduction of local and cheaper PD-1 inhibitors into the market. 21,22 However, as shown in the phase 2 trial of pembrolizumab in STS, PD-1 inhibitor monotherapy has limited efficacy in most patients with advanced STS.…”

Section: Discussionmentioning

confidence: 99%

<p>Safety and Efficacy of PD-1 Inhibitors Plus Chemotherapy in Advanced Soft Tissue Sarcomas: A Retrospective Study</p>

Tian

Yang

et al. 2020

CMAR

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Purpose: Programmed cell death 1 (PD-1) inhibitors are ineffective as monotherapy for the treatment of soft tissue sarcomas (STS). However, increasing evidence shows that the combination of PD-1 inhibitors and chemotherapy is efficacious and safe for many types of malignancies, including STS. This study aimed to assess the safety and efficacy of doxorubicin chemotherapy plus PD-1 inhibitor in the treatment of metastatic STS. Patients and Methods: We retrospectively reviewed 21 patients with metastatic STS who received doxorubicin chemotherapy plus a PD-1 inhibitor between November 2017 and October 2018. Results: The objective response rate was 47.6%, the disease control rate was 71.40%, and the median progression-free survival was 6 months (95% CI, 2-8 months). The average change in target lesion diameter from baseline was −25.15 ± 41.61. Majority of the patients experienced grade 1/2 adverse events (AEs), the grade 3/4 AEs were few. The most common grade 3/4 AEs were as follows: leukopenia (23.8%) and anemia (19.0%). Immune-related AEs were common and included hypothyroidism (14.3%) and pneumonitiss (9.5%). No drug related deaths occurred. Conclusion: This study provides preliminary evidence that the combination of doxorubicin chemotherapy and PD-1 inhibitor for advanced STS is safe and effective. We plan to conduct randomized clinical trials to confirm and characterize the activity of the chemotherapyimmunotherapy combinations in the treatment of sarcomas.

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“…They have demonstrated similar anti-cancer activities as those developed in the USA although some of them demonstrated higher in vitro binding affinity to the PD-1. Three of them have been approved for treating classical Hodgkin's lymphoma whereas one has been approved for treating melanoma [34][35][36][37][38][39][40]. None of them have been approved for more common types of malignancies such as NSCLC.…”

Section: Simple Addition: the Traditional Methods Of Combination Ici Dmentioning

confidence: 99%

Next-generation immuno-oncology agents: current momentum shifts in cancer immunotherapy

et al. 2020

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Cancer immunotherapy has reached a critical point, now that immune checkpoint inhibitors and two CART products have received market approval in treating 16 types of cancers and 1 tissue-agnostic cancer indication. Accompanying these advances, the 2018 Nobel Prize was awarded for the discovery of immune checkpoint pathways, which has led to the revolution of anti-cancer treatments. However, expanding the indications of immuno-oncology agents and overcoming treatment resistance face mounting challenges. Although combination immunotherapy is an obvious strategy to pursue, the fact that there have been more failures than successes in this effort has served as a wake-up call, placing emphasis on the importance of building a solid scientific foundation for the development of next-generation immuno-oncology (IO) agents. The 2019 China Cancer Immunotherapy Workshop was held to discuss the current challenges and opportunities in IO. At this conference, emerging concepts and strategies for IO development were proposed, focusing squarely on correcting the immunological defects in the tumor microenvironment. New targets such as Siglec-15 and new directions including neoantigens, cancer vaccines, oncolytic viruses, and cytokines were reviewed. Emerging immunotherapies were discussed in the areas of overcoming primary and secondary resistance to existing immune checkpoint inhibitors, activating effector cells, and targeting immunosuppressive mechanisms in the tumor microenvironment. In this article, we highlight old and new waves of IO therapy development, and provide perspectives on the latest momentum shifts in cancer immunotherapy.

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Toripalimab: First Global Approval

Cited by 111 publications

References 13 publications

Current status of the clinical use of PD-1/PD-L1 inhibitors: a questionnaire survey of oncologists in China

Current status of the clinical use of PD-1/PD-L1 inhibitors: a questionnaire survey of oncologists in China

<p>Safety and Efficacy of PD-1 Inhibitors Plus Chemotherapy in Advanced Soft Tissue Sarcomas: A Retrospective Study</p>

Next-generation immuno-oncology agents: current momentum shifts in cancer immunotherapy

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