JCSE01.09 A Phase II Umbrella Study of Camrelizumab in Different PD-L1 Expression Cohorts in Pre-Treated Advanced/Metastatic Non-Small Cell Lung Cancer

Wu, Yi‐Long; Huang, Cheng; Fan, Ying; Feng, J.; Pan, Hong; Jiang, Long; Yang, Jin‐Ji; Li, X.; Liu, X.; Xiong, Jian; Zhao, Yajie; Cheng, Ying; Ma, Rui; Wang, J.; Wang, Y.; Liu, Y.; Lin, Dongmei; We, Shi; Lin, Xinhua

doi:10.1016/j.jtho.2019.08.267

Cited by 8 publications

(11 citation statements)

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“…In another trial of advanced BTC patients (NCT03486678), increased baseline LDH level was also associated with poor PFS (5.0 vs. 6.2 months, p 0.053) and shorter OS (6.8 vs. 12.6 months, p < 0.001) (Chen et al, 2020b). Besides, BTC patients with high TMB (cutoff value: 8.6 muts/Mb) had a significantly higher ORR (100 vs. 26%, p 0.0294) (Chen et al, 2019b;Wu et al, 2019). In NSCLC patients treated with camrelizumab and apatinib, high TMB (cutoff value: 1.54 muts/Mb) was associated with higher ORR (52.6 vs. 17.1%) and better PFS (7.8 vs. 5.2 months).…”

Section: Subgroup Analysismentioning

confidence: 95%

“…After carefully screening the full text or conference abstracts, 24 articles were eligible. Finally, 15 articles with 1,390 patients were included after removing nine articles with duplicate data (Fang et al, 2018;Huang et al, 2019a;Huang et al, 2019b;Liu et al, 2019;Qin et al, 2019;Shen et al, 2019;Wu et al, 2019;Xie et al, 2019;Xu et al, 2019;Zhang et al, 2019;Zhou et al, 2019a;Zhou et al, 2019b;Chen et al, 2020a;Lickliter et al, 2020;Qin et al, 2020). Trial NCT03121716 had both a single-agent cohort (camrelizumab alone) and a combination cohort (camrelizumab plus other therapies), and the two cohorts were enrolled separately as two studies (Fang et al, 2018).…”

Section: Study Selectionmentioning

confidence: 99%

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The Safety and Efficacy of Camrelizumab and Its Combination With Apatinib in Various Solid Cancers

Wang

et al. 2020

Front. Pharmacol.

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Background: Camrelizumab (SHR1210) is a high-affinity, humanized immunoglobulin programmed cell death 1 (PD-1) monoclonal antibody. It was developed by Jiangsu Hengrui Medicine Co. Ltd. and has been approved for relapsed or refractory classical Hodgkin lymphoma patients and hepatocellular carcinoma patients in China. Apatinib is an orally administered vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor and has been approved for advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma in China. Camrelizumab alone and its combination with apatinib have been used in the treatment of various solid cancers. Methods: We searched Embase, PubMed, and other databases with the keyword "camrelizumab" or "SHR1210," and evaluated the safety and efficacy data of the involved studies. Adverse events (AEs) mentioned in at least two studies were summarized, including any grade and grade ≥3 treatment-related AEs. Meanwhile, efficacy data were collected, such as overall response rate (ORR), disease control rate (DCR), duration of response, 6-month progression-free survival (PFS) rate, median PFS time, 12-month overall survival rate, and median overall survival time. Results: The major AEs of camrelizumab alone were reactive cutaneous capillary endothelial proliferation, fatigue, aspartate aminotransferase increase, proteinuria, pruritus, and alanine transaminase increase. The ORR and DCR were 20.2% (95% CI: 15.1-26.6%, p 0.000, I 2 70.360) and 45.8% (95% CI: 39.0-52.7%, p 0.256, I 2 58.661), respectively. In the three studies of combination therapy, two studies were combined with apatinib and one combined with chemotherapy. For these studies, common AEs were hypertension, platelet count decrease, nausea, proteinuria, aspartate aminotransferase increase, and white blood cell count decrease. The pooled

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Section: Subgroup Analysismentioning

confidence: 95%

Section: Study Selectionmentioning

confidence: 99%

The Safety and Efficacy of Camrelizumab and Its Combination With Apatinib in Various Solid Cancers

Wang

et al. 2020

Front. Pharmacol.

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“…11,12 Camrelizumab (SHR-1210), a humanized immunoglobulin G4-k monoclonal antibody against programmed cell death protein 1 (PD-1), has exhibited antitumor activity and tolerability across multiple tumor types, including lung cancers. [13][14][15][16][17] In a single-arm phase 2 trial in pretreated patients with advanced NSCLC, camrelizumab monotherapy improved the objective response rate and survival outcomes compared with historical data of standard second-line chemotherapy. 17 In our previous phase 3 CameL study, camrelizumab plus pemetrexed and platinum was compared with chemotherapy alone as first-line therapy for advanced nonsquamous NSCLC without sensitizing EGFR or ALK alterations.…”

Section: Introductionmentioning

confidence: 99%

Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial

Ren

Chen

et al. 2022

Journal of Thoracic Oncology

161

126

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“…Interestingly, reactive cutaneous capillary endothelial proliferation (RCCEP), a common skin AE induced by camrelizumab, occurred in only 2 (8.0%) patients with this combination regimen, and all these RCCEPs were grade 1 or 2, which was considerably reduced compared with treatment with camrelizumab monotherapy (74.0%) (26) or camrelizumab plus chemotherapy (77.6%) (27). Our results indicated that RCCEP incidence was decreased when combined with apatinib, which is also in line with findings obtained regarding multiple solid tumors, suggesting that that the VEGFA/VEGFR-2 signaling pathway may be involved in the pathogenesis of RCCEP (15,21).…”

Section: Discussionmentioning

confidence: 98%

Efficacy and safety of camrelizumab plus apatinib as second-line treatment for advanced squamous non-small cell lung cancer

Gao¹,

Zhao²,

Ren³

et al. 2022

Ann Transl Med

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Background: Limited data are available for the combination regimen of anti-programmed cell death protein 1 (PD-1) inhibitor and anti-angiogenic agents as second-line therapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC), especially in patients with squamous NSCLC. This study assessed the efficacy and safety of camrelizumab plus apatinib (a vascular endothelial growth factor receptor 2 inhibitor) as second-line treatment in patients with advanced squamous NSCLC.Methods: In the Cohort 3 from a phase II dose-expansion trial, patients with advanced non-central squamous NSCLC who were immunotherapy naïve and had failed prior first-line platinum-based chemotherapy received 200 mg of camrelizumab intravenously every 2 weeks plus oral apatinib at the recommended dose of 250 mg once daily. The primary endpoint was objective response rate (ORR) assessed by the investigators as per the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.Results: Cohort 3 was prematurely terminated because of slow accrual after 25 patients with advanced squamous NSCLC had been enrolled between 10 October 2018, and 3 March 2019. At the data cutoff date of 12 June 2020, the median follow-up was 13.3 (range, 1.6 to 19.2) months. Among all 25 participants, the ORR was 32.0% (95% CI: 14.9% to 53.5%), the clinical benefit rate was 44.0% (95% CI: 24.4% to 65.1%), and the disease control rate (DCR) was 84.0% (95% CI: 63.9% to 95.5%). Median progression-free survival (PFS) was 6.0 (95% CI: 3.5 to 8.1) months, and median overall survival (OS) was 13.3 (95% CI: 6.4 to 18.8) months.Furthermore, clinical benefits from this combination regimen were evident across all tumor PD ligand 1 (PD-L1) expression subgroups. The most common treatment-related adverse events (TRAEs) of grade 3 or higher were hypertension (44.0%) and palmar-plantar erythrodysesthesia (16.0%). As reported by the investigators, 3 participants (12.0%) died due to TRAEs (interstitial pneumonia, hemorrhage, and unknown reason; n=1 each, 4%).Conclusions: Camrelizumab plus apatinib as second-line therapy showed satisfactory antitumor activity in patients with non-central squamous NSCLC, regardless of tumor PD-L1 expression. Camrelizumab plus apatinib had a manageable safety profile in this patient population, and the toxic reactions observed were generally consistent with those in previously reported studies. Interstitial pneumonia and hemorrhage are important risks requiring careful monitoring and prompt intervention. the TREND reporting checklist (available at https://atm. amegroups.com/article/view/10.21037/atm-21-4792/rc). Methods Study design and patients

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JCSE01.09 A Phase II Umbrella Study of Camrelizumab in Different PD-L1 Expression Cohorts in Pre-Treated Advanced/Metastatic Non-Small Cell Lung Cancer

Cited by 8 publications

References 0 publications

The Safety and Efficacy of Camrelizumab and Its Combination With Apatinib in Various Solid Cancers

The Safety and Efficacy of Camrelizumab and Its Combination With Apatinib in Various Solid Cancers

Camrelizumab Plus Carboplatin and Paclitaxel as First-Line Treatment for Advanced Squamous NSCLC (CameL-Sq): A Phase 3 Trial

Efficacy and safety of camrelizumab plus apatinib as second-line treatment for advanced squamous non-small cell lung cancer

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