Camrelizumab
(Synonyms: 卡瑞利珠单抗; SHR-1210) 目录号 : GC62253
卡瑞利珠单抗（Camrelizumab, 也称为SHR-1210）是一种高亲和力、人源化IgG4-κ单克隆抗体。
Cas No.:1798286-48-2
Sample solution is provided at 25 µL, 10mM.
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Quality Control & SDS
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Purity: >98.50%
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- SDS (Safety Data Sheet)
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| Cell experiment [1]: | |
Cell lines | Peripheral blood mononuclear cells |
Preparation Method | Camrelizumab reconstituted in water and diluted in 5% dextrose to a final concentration of 0.11 nM/ 0.38 nM. |
Reaction Conditions | 0.11 nM/ 0.38 nM |
Applications | In the T-cell proliferation assay using peripheral blood mononuclear cells stimulated with tuberculin, Camrelizumab induced T-cell proliferation at an EC50 of 0.11 nM. In a similar assay measuring the secretion of IFN-gamma, Camrelizumab induced the production of IFN-gamma at an EC50 of 0.38 nM. |
| Animal experiment [2]: | |
Animal models | Human PD-1 transgenic mice |
Preparation Method | Camrelizumab was provided as a lyophilized (freeze-dried) powder; it had to be reconstituted with a specified volume of an appropriate solvent, such as sterile water or saline, to achieve the desired concentration for injection (3 mg/kg). |
Dosage form | 3 mg/kg, intravenous (iv) injection |
Applications | The combination of Camrelizumab (at a dosage of 3 mg/kg) with Apatinib (at dosages of 200 mg/kg and 100 mg/kg) resulted in tumor growth inhibition rates of 63.1% and 87.3%, respectively, in human PD-1 transgenic mice. |
References: [1] Jason D Lickliter, et al. A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia. Drug Des Devel Ther. 2020 Mar 18:14:1177-1189. | |
Camrelizumab (also known as SHR-1210) is a high-affinity, humanized IgG4-κ monoclonal antibody. It exhibits a strong binding affinity to PD-1, with a Kd of 3 nM, and effectively prevents the engagement of PD-1 with its ligand PD-L1, achieving an IC50 of 0.70 nM. Functioning as an anti-PD-1/PD-L1 therapeutic, Camrelizumab is valuable in oncology research and treatment, with applications in various malignancies such as non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), Hodgkin's lymphoma, and advanced hepatocellular carcinoma (HCC), among others[1][2].
Camrelizumab induced T-cell proliferation at an EC50 of 0.11 nM in peripheral blood mononuclear cells treated with tuberculin, and it induced the production of IFN-gamma at an EC50 of 0.38 nM in a similar assay measuring IFN-gamma secretion[2].
Camrelizumab (dosed at 3 mg/kg) and apatinib (dosed at 200 mg/kg and 100 mg/kg) exhibited tumor growth inhibition rates of 63.1% and 87.3%, respectively, in human PD-1 transgenic mice. Camrelizumab blocked the binding of PD-1 to its ligand PD-L1, which relieved the immune suppression in the tumor microenvironment, enhanced the activity of T cells, and thus improved the immune response against tumors[1].
References:
[1] Kuimin Mei, et al. Camrelizumab in combination with apatinib in second-line or above therapy for advanced primary liver cancer: cohort A report in a multicenter phase Ib/II trial. J Immunother Cancer. 2021 Mar;9(3):e002191.
[2]Jason D Lickliter, et al. A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia. Drug Des Devel Ther. 2020 Mar 18:14:1177-1189.
卡瑞利珠单抗（Camrelizumab, 也称为SHR-1210）是一种高亲和力、人源化IgG4-κ单克隆抗体。它对PD-1具有强烈的结合亲和力，Kd值为3 nM，并且有效阻止PD-1与其配体PD-L1的结合，IC50达到0.70 nM。作为一种抗PD-1/PD-L1治疗剂，卡瑞利珠单抗在肿瘤学研究和治疗中具有重要价值，适用于多种恶性肿瘤，如非小细胞肺癌（NSCLC）、食管鳞状细胞癌（ESCC）、霍奇金淋巴瘤和晚期肝细胞癌（HCC）等[1][2]。
卡瑞利珠单抗在结核菌素处理的外周血单核细胞中诱导T细胞增殖的EC50为0.11 nM，以及在测量IFN-gamma分泌的类似测定中，以0.38 nM的EC50诱导IFN-gamma的产生[2]。
卡瑞利珠单抗（剂量为3 mg/kg）与阿帕替尼（剂量为200 mg/kg和100 mg/kg）在人PD-1转基因小鼠中的肿瘤生长抑制率分别为63.1%和87.3%，卡瑞利珠单抗通过阻断PD-1与其配体PD-L1的结合，解除肿瘤微环境中的免疫抑制，增强T细胞的活性，从而提高对肿瘤的免疫反应[1]。
| Cas No. | 1798286-48-2 | SDF | |
| 别名 | 卡瑞利珠单抗; SHR-1210 | ||
| 分子式 | 分子量 | ||
| 溶解度 | 储存条件 | -20°C, protect from light. | |
| General tips | 请根据产品在不同溶剂中的溶解度选择合适的溶剂配制储备液；一旦配成溶液，请分装保存，避免反复冻融造成的产品失效。 储备液的保存方式和期限：-80°C 储存时，请在 6 个月内使用，-20°C 储存时，请在 1 个月内使用。 为了提高溶解度，请将管子加热至37℃，然后在超声波浴中震荡一段时间。 |
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Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial
JAMA 2021 Sep 14;326(10):916-925.PMID:34519801DOI:10.1001/jama.2021.12836.
Importance: Standard first-line therapy for advanced or metastatic esophageal carcinoma is chemotherapy, but the prognosis remains poor. Camrelizumab (an anti-programmed death receptor 1 [PD-1] antibody) showed antitumor activity in previously treated advanced or metastatic esophageal squamous cell carcinoma. Objective: To evaluate the efficacy and adverse events of Camrelizumab plus chemotherapy vs placebo plus chemotherapy as a first-line treatment in advanced or metastatic esophageal squamous cell carcinoma. Design, setting, and participants: This randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (ESCORT-1st study) enrolled patients from 60 hospitals in China between December 3, 2018, and May 12, 2020 (final follow-up, October 30, 2020). A total of 751 patients were screened and 596 eligible patients with untreated advanced or metastatic esophageal squamous cell carcinoma were randomized. Interventions: Patients were randomized 1:1 to receive either Camrelizumab 200 mg (n = 298) or placebo (n = 298), combined with up to 6 cycles of paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). All treatments were given intravenously every 3 weeks. Main outcomes and measures: Coprimary end points were overall survival (significance threshold, 1-sided P < .02) and progression-free survival (significance threshold, 1-sided P < .005). Results: Of the 596 patients randomized (median age, 62 years [interquartile range, 56-67 years]; 523 men [87.8%]), 1 patient in the placebo-chemotherapy group did not receive planned treatment. A total of 490 patients (82.2%) had discontinued the study treatment. The median follow-up was 10.8 months. The overall survival for the camrelizumab-chemotherapy group was a median of 15.3 months (95% CI, 12.8-17.3; 135 deaths) vs a median of 12.0 months (95% CI, 11.0-13.3; 174 deaths) for the placebo-chemotherapy group (hazard ratio [HR] for death, 0.70 [95% CI, 0.56-0.88]; 1-sided P = .001). Progression-free survival for Camrelizumab plus chemotherapy was a median of 6.9 months (95% CI, 5.8-7.4; 199 progression or deaths) vs 5.6 months (95% CI, 5.5-5.7; 229 progression or deaths) for the placebo-chemotherapy group (HR for progression or death, 0.56 [95% CI, 0.46-0.68]; 1-sided P < .001). Treatment-related adverse events of grade 3 or higher occurred in 189 patients (63.4%) in the camrelizumab-chemotherapy group and 201 (67.7%) in the placebo-chemotherapy group, including treatment-related deaths among 9 patients (3.0%) and 11 patients (3.7%), respectively. Conclusions and relevance: Among patients with advanced or metastatic esophageal squamous cell carcinoma, the addition of Camrelizumab to chemotherapy, compared with placebo and chemotherapy, significantly improved overall survival and progression-free survival. Trial registration: ClinicalTrials.gov Identifier: NCT03691090.
Camrelizumab: First Global Approval
Drugs 2019 Aug;79(12):1355-1361.PMID:31313098DOI:10.1007/s40265-019-01167-0.
Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd, recently received conditional approval in China for the treatment of relapsed or refractory classical Hodgkin lymphoma. The drug is also being investigated as a treatment for various other malignancies, including B cell lymphoma, oesophageal squamous cell carcinoma, gastric/gastroesophageal junction cancer, hepatocellular carcinoma, nasopharyngeal cancer and non-squamous, non-small cell lung cancer. This article summarizes the milestones in the development of Camrelizumab leading to this first approval for classical Hodgkin lymphoma.
Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial
J Thorac Oncol 2022 Apr;17(4):544-557.PMID:34923163DOI:10.1016/j.jtho.2021.11.018.
Introduction: Camrelizumab, a humanized immunoglobulin G4-κ monoclonal antibody against programmed cell death protein 1, has exhibited antitumor activity and tolerability across various tumors, including lung cancers. We conducted this double-blind, randomized phase 3 trial to investigate the efficacy and safety of Camrelizumab or placebo plus chemotherapy as first-line treatment for patients with advanced squamous NSCLC. The predictive value of circulating tumor DNA (ctDNA) dynamics was also analyzed. Methods: CameL-sq, a double-blind, randomized phase 3 trial (NCT03668496), was conducted in 53 centers in the People's Republic of China. A total of 389 patients with stage IIIB-IV squamous NSCLC were randomized (1:1) to receive 4 to 6 cycles of carboplatin plus paclitaxel with Camrelizumab or placebo (every 3 wk), followed by maintenance therapy with Camrelizumab or placebo. Peripheral blood ctDNA samples were collected at baseline and the time after two cycles of treatment. Results: Of 389 eligible patients, 193 patients allocated Camrelizumab plus chemotherapy and 196 patients allocated placebo plus chemotherapy were included in the efficacy and safety analysis. The results revealed significantly prolonged progression-free survival (median, 8.5 vs. 4.9 mo; p <0.0001) and overall survival (median, not reached vs. 14.5 mo; p <0.0001) with camrelizumab-chemotherapy versus placebo-chemotherapy. No unexpected treatment immune-related adverse events were observed in both groups. Biomarker analysis revealed that ctDNA clearance after two cycles of treatment was independently associated with dramatically longer progression-free survival (p <0.0001) and overall survival (p <0.0001) in Camrelizumab plus chemotherapy group. Conclusions: Our findings support Camrelizumab plus chemotherapy as a first-line treatment option in advanced squamous NSCLC. On-treatment ctDNA dynamics exhibited the potency to predict the efficacy of Camrelizumab plus chemotherapy.
Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial
Lancet Respir Med 2021 Mar;9(3):305-314.PMID:33347829DOI:10.1016/S2213-2600(20)30365-9.
Background: Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations; however, there is scarce evidence of the effectiveness of the combinations in the Asian population. We evaluated Camrelizumab plus chemotherapy against non-squamous NSCLC in China. Methods: We did a randomised, open-label, multicentre, phase 3 trial (CameL) in 52 hospitals in China for patients with non-squamous NSCLC without EGFR and ALK alteration. Eligible patients were aged 18-70 years and had no previous systemic chemotherapy, Eastern Cooperative Oncology Group performance status of 0 or 1, and at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (version 1.1). Patients were randomly assigned (1:1) to receive 4-6 cycles of carboplatin (area under curve 5 mg/mL per min) plus pemetrexed (500 mg/m2) with or without Camrelizumab (200 mg) every 3 weeks, followed by maintenance therapy with Camrelizumab plus pemetrexed or pemetrexed alone. Medication was administered intravenously on day 1 of each 3-week treatment cycle. Randomisation was done using a centralised interactive web-response system with the block size randomly generated as four or six and stratified by sex and smoking history. The two primary endpoints were progression-free survival per blinded independent central review, in all patients and in patients who were PD-L1 positive. Primary analysis was done in the full analysis set that included all randomly assigned patients who received at least one dose of the study treatment. Herein, due to the primary endpoint being met at the interim analysis, we reported the findings of prespecified interim analysis, which only included confirmatory statistical testing for progression-free survival in all patients. Safety was assessed in the as-treated population. This study is registered with ClinicalTrials.gov, NCT03134872 (follow-up is ongoing). Findings: Between May 12, 2017, and June 6, 2018, of the 419 patients who were randomly assigned, seven did not receive assigned treatment and 412 received either Camrelizumab plus chemotherapy (n=205) or chemotherapy alone (n=207). At interim analysis, median follow-up duration was 11·9 months (IQR 9·0-14·9). Progression-free survival in this interim analysis was significantly prolonged with Camrelizumab plus chemotherapy than with chemotherapy alone (median 11·3 months [95% CI 9·6-15·4] vs 8·3 months [6·0-9·7]; hazard ratio 0·60 [0·45-0·79]; one-sided p=0·0001). Most common grade 3 or worse treatment-related adverse events were decreased neutrophil count (78 [38%] patients in the Camrelizumab plus chemotherapy group vs 63 [30%] patients in the chemotherapy alone group), decreased white blood cell count (40 [20%] vs 30 [14%]), anaemia (38 [19%] vs 23 [11%]), and decreased platelet count (34 [17%] vs 24 [12%]). Serious treatment-related adverse events occurred in 74 (36%) patients in the Camrelizumab plus chemotherapy group and 27 (13%) patients in the chemotherapy alone group. Interpretation: The primary endpoint was met at the interim analysis, showing a statistically significant and clinically meaningful improvement in progression-free survival with Camrelizumab plus carboplatin and pemetrexed versus chemotherapy alone in all patients, supporting Camrelizumab plus carboplatin and pemetrexed as a first-line treatment option for Chinese patients with advanced non-squamous NSCLC without EGFR and ALK alterations. The trial is being continued to collect long-term outcomes in all patients and carry out confirmatory statistical testing for progression-free survival in the PD-L1-positive population. Funding: Jiangsu Hengrui Medicine.
Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial
Lancet Oncol 2021 Aug;22(8):1162-1174.PMID:34174189DOI:10.1016/S1470-2045(21)00302-8.
Background: The addition of Camrelizumab to gemcitabine and cisplatin showed promising activity as first-line therapy in patients with recurrent or metastatic nasopharyngeal carcinoma in a phase 1 trial. We therefore compared Camrelizumab plus gemcitabine and cisplatin with placebo plus gemcitabine and cisplatin in a randomised phase 3 trial. Methods: In this randomised, double-blind, phase 3 trial done at 28 hospitals in China, patients were eligible if they were aged 18-75 years, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and had previously untreated recurrent or metastatic nasopharyngeal carcinoma. Patients were randomly assigned (1:1; using an interactive web-response system with a block size of four) to receive either Camrelizumab (200 mg on day 1) or matching placebo intravenously, plus gemcitabine and cisplatin (gemcitabine 1000 mg/m2 on days 1 and 8; cisplatin 80 mg/m2 on day 1) intravenously every 3 weeks for four to six cycles, followed by maintenance therapy with Camrelizumab or placebo, until radiographic progression, unacceptable toxicity, start of new anticancer treatment, investigator decision, or withdrawal of consent. Stratification factors used in randomisation were liver metastases, previous radical concurrent chemoradiotherapy, and ECOG performance status. The allocation sequence was generated by an independent randomisation group. The primary endpoint was progression-free survival per independent review committee. The significance threshold for independent review committee-assessed progression-free survival was p=0·0086 (one-sided) at the interim analysis. Efficacy and safety analyses included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT03707509, and is closed for enrolment but is ongoing. Findings: Between Nov 13, 2018, and Nov 29, 2019, 343 patients were screened and 263 were eligible and were randomly assigned to the Camrelizumab group (n=134) or placebo group (n=129). At the prespecified interim analysis (June 15, 2020), independent review committee-assessed progression-free survival was significantly longer in the Camrelizumab group (median 9·7 months [95% CI 8·3-11·4]) than in the placebo group (median 6·9 months [5·9-7·3]; hazard ratio 0·54 [95% CI 0·39-0·76]; one-sided p=0·0002). As of Dec 31, 2020, the most common grade 3 or worse adverse events of any cause were decreased white blood cell count (89 [66%] of 134 patients in the Camrelizumab group vs 90 [70%] of 129 patients in the placebo group), decreased neutrophil count (86 [64%] vs 85 [66%]), anaemia (53 [40%] vs 57 [44%]), and decreased platelet count (53 [40%] vs 52 [40%]). Serious adverse events were reported in 59 (44%) of 134 patients in the Camrelizumab group and 48 (37%) of 129 patients in the placebo group. Treatment-related deaths occurred in five (4%) patients in the Camrelizumab group (two unknown cause of death, one multiple organ dysfunction syndrome, one pharyngeal haemorrhage, and one arrhythmia) and one (<1%) patient in the placebo group (unknown cause of death). Interpretation: Our findings suggest that Camrelizumab plus gemcitabine and cisplatin could be a new standard of care for patients with recurrent or metastatic nasopharyngeal carcinoma in the first-line setting. Longer follow-up is needed to confirm this conclusion. Funding: Jiangsu Hengrui Pharmaceuticals (formerly Jiangsu Hengrui Medicine). Translation: For the Chinese translation of the abstract see Supplementary Materials section.