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Shengxiang Ren
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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: 2
- 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 | Presenting Author(s): Shengxiang Ren
- 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).
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P83.03 - Efficacy of Camrelizumab (SHR-1210) Plus Apatinib in Advanced NSCLC with EGFR Mutation (ID 1864)
00:00 - 00:00 | Author(s): Shengxiang Ren
- Abstract
Introduction
Treatment options are still limited for pts with advanced EGFR mutated NSCLC and resistant to EGFR-TKI. Here, we reported preliminary efficacy and safety of PD-1 camrelizumab (SHR-1210) plus apatinib in pts with EGFR mutation.
Methods
In this open-label, multi-center phase Ib/II study, pts aged 18-70 years, with EGFR mutation, and had disease progression on or after one line of platinum-based chemotherapy and at least one kind of EGFR-TKI were enrolled in dose escalation phase Ib and in dose expansion phase II. All pts received apatinib 250mg orally once daily plus camrelizumab 200mg every two weeks until disease progression or intolerable toxicity ( NCT03083041). Primary endpoint was objective response rate (ORR). Exploratory analyses of response and survival were conducted in pts classified by EGFR mutation types.
Results
Between Nov, 2017 and Jan, 2019, 40 NSCLC pts (3 in phase Ib and 37 in phase II) with EGFR mutation were enrolled. As the cutoff of December 15, 2019, the median follow-up was 10.8 months (range, 0.5-18.6). Four pts were still receiving treatment at the time of analysis. Among all 40 pts, 22 (55.0%) had EGFR 19 deletion (19del), 14 (35.0%) had L858R mutation, and 3 (7.5%) had EGFR 20 insertion (20ins). ORR was 20.0% (8/40, 95% CI, 9.1%-35.6%) and disease control rate (DCR) 62.5% (25/40, 95% CI, 45.8%-77.3%) in the whole population. Median duration of response was not reached (95% CI, 3.5-NR), median progression-free survival (mPFS) was 3.2 months (95% CI, 1.5-6.4m), and overall survival was not reached. Subgroup analysis showed that the ORR in pts with EGFR 20ins (n=3) or EGFR L858R(n=14) was higher than those with EGFR 19del (n=22) (33.3% vs. 21.4% vs. 13.6%, p=0.65). Similarly, longer mPFS was seen in pts with EGFR 20ins or L858R than in those with EGFR 19del (8.3m vs. 5.4m vs. 2.8m, p=0.94) . The most common treatment-related adverse events of grade 3 or higher were hypertension (7 [16.3%]), proteinuria (5 [11.6%]), palmar-plantar erythrodysesthesia syndrome (4 [9.3%]), and hypertriglyceridemia (3 [7.0%]).
Table 1. Efficacy of camrelizumab and apatinib combination treatment in advanced NSCLC pts with EGFR mutation
ConclusionPts
ORR
DCR
mPFS (mos)
mOS (mos)
All pts
40
20.0%
62.5%
3.2
NR
EGFR 19del
22
13.6%
59.1%
2.8
NR
EGFR L858R
14
21.4%
64.3%
5.4
NR
EGFR 20ins
3
33.3%
66.7%
8.3
NR
Camrelizumab plus apatinib showed a moderate benefit in pts with EGFR mutated NSCLC and showed better efficacy in pts with EGFR 20ins or L858R mutation sub-types, warrant further investigation.
