Camrelizumab in advanced or metastatic solid tumour patients with DNA mismatch repair deficient or microsatellite instability high: an open-label prospective pivotal trial

Chen, Jingde; Quan, Ming; Feng, Ying; Zeng, Tianmei; Li, Yandong; Zhou, Ying; Hai, Yanan; Gao, Yong

doi:10.1007/s00432-020-03251-5

Cited by 12 publications

(10 citation statements)

References 25 publications

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“…Camrelizumab is one of the most widely used anti-PD-1 antibodies for various solid tumors in real-time practice owing to drug accessibility and economic pressure for patients in China. It has shown promising clinical efficacy in several kinds of solid tumors, based on positive efficacy results in clinical trials ( 8 – 11 ), and has also been shown to be effective in MSI-H/dMMR solid tumors ( 12 ). The combination of regorafenib and camrelizumab achieved an ORR of 25% in 16 patients with MSS refractory mCRC, indicating the potential benefit of immunotherapy under an appropriately combined therapeutic strategy ( 13 ).…”

Section: Introductionmentioning

confidence: 99%

Preliminary Efficacy and Safety of Camrelizumab in Combination With XELOX Plus Bevacizumab or Regorafenib in Patients With Metastatic Colorectal Cancer: A Retrospective Study

et al. 2021

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BackgroundFor a majority of patients with metastatic colorectal cancer (mCRC) with MS stable (MSS) or mismatch repair proficient (pMMR), the role of immunotherapy is undetermined. This study investigated the efficacy and safety of camrelizumab when added to XELOX chemotherapy plus bevacizumab or regorafenib as first-line therapy for mCRC.Materials and MethodsMedical records of mCRC patients who received camrelizumab and XELOX plus bevacizumab or regorafenib at the First Hospital of Quanzhou Affiliated to Fujian Medical University between June 1, 2019, and April 30, 2021, were retrospectively collected. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and side effects of the drug were recorded and reviewed.ResultsTwenty-five eligible patients received combination therapy, including bevacizumab in 19 patients and regorafenib in 6. Twenty-one patients had pMMR/MSS and one MSI-H. Of the 25 patients who could be evaluated for efficacy, 18 (72%) achieved PR, 6 (24%) achieved SD, and 1 (4%) achieved PD. The ORR and DCR were 72% (18/25) and 96% (24/25), respectively. The median progression-free survival (PFS) was 11.2 months (95% CI 8.9–13.9), and OS had not yet been reached. The combination regimen of regorafenib in six (24%) patients was unassociated with treatment outcomes. Most AEs were either grade 1 or 2, and treatment-related grade 3 toxicities were observed in 8/25 (32%) patients.ConclusionCamrelizumab combined with XELOX plus bevacizumab or regorafenib was feasible, producing high rates of responses as first-line therapy in unselected Chinese patients with MSS mCRC. The toxicities were generally tolerable and manageable. Prospective randomized trials with large sample sizes are needed to evaluate these findings.

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Section: Introductionmentioning

confidence: 99%

Preliminary Efficacy and Safety of Camrelizumab in Combination With XELOX Plus Bevacizumab or Regorafenib in Patients With Metastatic Colorectal Cancer: A Retrospective Study

et al. 2021

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“…It has been approved by CFDA for the treatment of advanced non-small-cell lung cancer, advanced hepatic cancer, advanced esophageal cancer, and classic Hodgkin's lymphoma. Camrelizumab was also proved to have efficacy in MSI-H/dMMR advanced or metastatic colorectal cancer in a study with a small sample size [12]. However, the clinical benefit of camrelizumab to the therapy of MSS/pMMR mCRC has not yet been reported.…”

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confidence: 99%

Efficacy and safety of regorafenib or fruquintinib plus camrelizumab in patients with microsatellite stable and/or proficient mismatch repair metastatic colorectal cancer: an observational pilot study

Jiang¹,

Zhang²,

Yu³

et al. 2021

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This study was to investigate the efficacy and safety of regorafenib or fruquintinib combined with camrelizumab in patients with microsatellite stable (MSS) and/or proficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC).Medical records of MSS/pMMR mCRC patients who received regorafenib (80 mg) or fruquintinib (3 mg) once a day (21 days on/7 days off) plus camrelizumab (200 mg) every three weeks in Yuhuangding Hospital between January 2020 and June 2020 were retrospectively collected.Follow-up data up to November 1st, 2020 was gathered. The primary endpoint was the objective response rate (ORR) and disease control rate (DCR). The safety profile was the secondary endpoint.A total of 16 patients were enrolled. The ORR was 25.0% (4/16) and the DCR was 62.5% (10/16).The main adverse events (AEs) included reactive cutaneous capillary endothelial proliferation (RCCEP) (81.3%), fatigue (43.8%), hypertension (37.5%), hand-foot skin reaction (25.0%), and thyroid dysfunction (25.0%). Most AEs were grade 1 or 2, with only 1 patient of grade 3 liver dysfunction. All the AEs were ameliorated by effective symptomatic treatment.Regorafenib or fruquintinib plus camrelizumab exhibited promising efficacy in patients with MSS/pMMR mCRC. The toxicity was moderate and manageable.

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“…In clinical trials of camrelizumab in advanced solid tumors, some bladder carcinoma patients got a complete response[ 6 ]. Camrelizumab provided improved ORR and DCR in pre-treated patients with dMMR/MSI-H and advanced or metastatic solid tumor[ 7 , 8 ]. With the increase of approved immune checkpoint inhibitors, it is urgent to define patient subgroups that are more likely to have treatment benefits.…”

Section: Discussionmentioning

confidence: 99%

Successful response to camrelizumab in metastatic bladder cancer: A case report

Xie¹,

Xia²,

Chen³

et al. 2022

WJCC

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BACKGROUND There has been no report to use camrelizumab with chemotherapy for advanced bladder cancer patients with positive programmed death-ligand 1 (PD-L1) expression and high tumor mutational burden (TMB). More effective predictors of bladder cancer immunotherapy have yet to be explored, and the combination of multiple factors may be more predictive than a single factor. CASE SUMMARY We report the case of a 74-year-old male patient with recurrent metastatic bladder cancer, which demonstrated positive PD-L1 expression and high TMB. The immune checkpoint inhibitor camrelizumab was administered to the patient in combination with gemcitabine and cisplatin. The patient achieved a partial response with a progression-free survival of 11 mo. CONCLUSION This is the first report to use camrelizumab with chemotherapy for advanced bladder cancer patients with positive PD-L1 expression and high TMB.

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Camrelizumab in advanced or metastatic solid tumour patients with DNA mismatch repair deficient or microsatellite instability high: an open-label prospective pivotal trial

Cited by 12 publications

References 25 publications

Preliminary Efficacy and Safety of Camrelizumab in Combination With XELOX Plus Bevacizumab or Regorafenib in Patients With Metastatic Colorectal Cancer: A Retrospective Study

Preliminary Efficacy and Safety of Camrelizumab in Combination With XELOX Plus Bevacizumab or Regorafenib in Patients With Metastatic Colorectal Cancer: A Retrospective Study

Efficacy and safety of regorafenib or fruquintinib plus camrelizumab in patients with microsatellite stable and/or proficient mismatch repair metastatic colorectal cancer: an observational pilot study

Successful response to camrelizumab in metastatic bladder cancer: A case report

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