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Kangsheng Gu
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P78 - Immunotherapy (Phase II/III Trials) - Immune Checkpoint Inhibitor Single Agent (ID 255)
- Event: WCLC 2020
- Type: Posters
- Track: Immunotherapy (Phase II/III Trials)
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P78.16 - Real-World Outcomes of Camrelizumab (SHR-1210) in Treating Advanced Non-Small Cell Lung Cancer: A Multicenter Prospective Study (ID 1449)
00:00 - 00:00 | Presenting Author(s): Kangsheng Gu
- Abstract
Introduction
Lung cancer continues to be the leading cause of cancer-related morbidity and mortality whether in China or throughout the world according to the latest cancer statistical reports. Camrelizumab (SHR-1210), a potent humanized anti-programmed death-1 antibody, has been approved for the treatment of multiple malignancies in China. Herein, we disclose the data of effectiveness and safety profile of camrelizumab-based treatments for NSCLC in a real-world setting in Anhui, China.
Methods
Patients (age ≥ 18yrs) with pathologically or histologically diagnosed advanced NSCLC receiving camrelizumab treatment were enrolled in this prospective, multicenter, real-world study from August 2019. The target sample size was 300. Camrelizumab was given 200mg once every 2 weeks, alone or in combination with chemotherapy, antiangiogenic agent, or both, until disease progression, death, or intolerable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), overall response rate (ORR) and disease control rate (DCR). Treatment-related adverse events (AEs) were also recorded.
Results
As of August 2020, 183 patients from 69 centers were eligible, of whom 137(74.9%) were males and 46(25.1%) were females. The median age was 63 years old (range 31~91). Nearly one third (56, 30.6%) of the patients had received at least three lines of prior therapies. The majority of the patients (148, 80.9%) were diagnosed as stage IV lung cancer, among them, 40 (21.9%) underwent prior surgery and 136 (74.3%) received prior chemotherapy. Of all the patients, the majority had an ECOG PS of 1 and 79 (69.4%) were histologically classified as adenocarcinoma. Overall, 127 patients were eligible for effectiveness evaluation, and of them, no patient achieved CR, 26 achieved PR, 84 achieved SD, and 17 showed PD, resulting in an ORR of 20.5% and a DCR of 86.7%. The primary study endpoint (PFS) and secondary endpoint (OS) has not been reached. Subgroup analysis revealed that the ORR and DCR values were slightly higher in patients received less than three lines of prior therapies than those in patients received at least three lines of prior therapies (ORR: 21.6% vs 18.8%; DCR: 87.8% vs 84.9%) The incidence of treatment-related AEs was 53.0% and grade 3-4 AEs were not observed. The most common AE caused by camrelizumab was reactive cutaneous capillary endothelial proliferation (REECP) (24.4%).
Conclusion
In the real-world setting, advanced NSCLC patients with an older age, stage IV disease, cancer type of adenocarcinoma or ECOG PS 1 were more likely to be treated with camrelizumab. Camrelizumab monotherapy or in combination with chemotherapy and/or antiangiogenic agent were proved to be effective and safe in advanced NSCLC patients. Further study with a larger sample size is needed to explore the most potential camrelizumab-based therapeutic regimen for NSCLC patients.
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P83 - Immunotherapy (Phase II/III Trials) - Immunotherapy Plus Targeted Therapy (ID 260)
- Event: WCLC 2020
- Type: Posters
- Track: Immunotherapy (Phase II/III Trials)
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P83.01 - Updated Survival and Biomarker Analysis of Camrelizumab and Apatinib in Previously Treated pts of Advanced Non-Squamous NSCLC (ID 1657)
00:00 - 00:00 | Author(s): Kangsheng Gu
- Abstract
Introduction
Our previous report showed that camrelizumab combination with apatinib have showed promising results in previously chemotherapy-treated patients with advanced non-squamous NSCLC. We further report the updated survival data and biomarkers analysis here.
Methods
Results
We conduct a multi-center single-arm phase 1b/II study investigating the safety and efficacy of camrelizumab and apatinib in previously treated patients with advanced NSCLC. This study included phase 1b apatinib dose escalation phase and phase II population expansion cohort. The primary endpoints were safety and ORR respectively. Patients of non-squamous NSCLC who received apatinib 250 mg orally once daily in combination with camrelizumab 200 mg intravenously on day 1 every 2 weeks were included into this analysis (NCT03083041). 22C3 array was used for PD-L1 immunohistochemistry and OseqTM-pan cancer panel (including 636 genes and 1.95Mb) was used for the genomic alternation testing.
Between March 21, 2017 and October 11, 2018, 105 patients were enrolled, 91patients had PD-L1 expression testing and 46 had sufficient tissue for NGS. As the cutoff of Aug 15, 2019, one had a confirmed complete response, 28 had confirmed partial response, and 48 had stable disease, ORR was 30.9% (29/94, 95% CI, 21.7-41.2%) in the efficacy-evaluable population (n=94). Median progression-free survival was 5.7 months (95% CI, 4.5–8.8) and median overall survival was 19.2 months (95% CI, 11.2-24.5) in all patients. PD-L1 expression was positive in 25(27.4%) patients, median TMB is 9 mutations/Mb, while STK11 and KEAP1 mutation were found in 7 and 10 patients respectively. Patients with PD-L1 TPS>1% and high TMB could not predict higher ORR (36.0% vs 22.7%, P = 0.20; 29.2% vs 36.4%, p=0.564, respectively) or longer PFS (median 6.8 vs 5.1 months, P = 0.61; 7.8 vs 8.0 months, P = 0.98). Notably, patients with STK11/KEAP1 mutation had a numerically higher ORR (42.9% vs 28.1%, P =0.327), longer PFS (median 9.4 vs 5.3, P = 0. 592) and statistically significantly longer OS (median NR vs NR, P = 0. 047) than those of wild type. The most common treatment-related adverse events of grade 3 or higher were hypertension (18 [17.1%]), palmar-plantar erythrodysesthesia syndrome (14 [13.3%]), and increased gamma-glutamyltransferase (10 [9.5%]).
Conclusion
Combined camrelizumab and apatinib had promising antitumor activity and acceptable safety in previously treated patients with advanced non-squamous NSCLC, especially in these with STK11 or KEAP1 mutation, phase III trial is ongoing for further validation (NCT04203485).
