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Ying Cheng
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FP14 - Targeted Therapy - Clinically Focused (ID 252)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP14.12 - Quality of Life and Subgroup Analysis in a Phase 3 Randomized Study of Ensartinib vs Crizotinib in ALK–Positive NSCLC Patients: eXalt3. (ID 3852)
00:00 - 00:00 | Author(s): Ying Cheng
- Abstract
- Presentation
Introduction
Ensartinib (X-396) is a novel second-generation ALK tyrosine kinase inhibitor (TKI). In a phase 3 study interim analysis, ensartinib showed statistically significant improvement of median PFS over crizotinib in patients with ALK+ NSCLC who were ALK TKI naive or received up to one prior chemotherapy line, including higher efficacy against brain metastases. Ensartinib was well tolerated, with low grade rash, pruritus, edema, and transaminitis as the most frequent treatment-related AEs. Here we plan to present subgroups analyses and the quality of life outputs of the phase 3 eXalt3 study (NCT02767804).
Methods
Patients with locally tested ALK+ NSCLC (ITT population) were randomized 1:1 to ensartinib (225 mg QD orally) or crizotinib (250 mg BID orally). No crossover was allowed. Patients were stratified by prior chemotherapy, ECOG PS, brain metastases, and geographic region. The modified ITT (mITT) population was prespecified to include all centrally ALK+ patients by Abbott FISH test. The primary endpoint was blinded independent review committee (BIRC)–assessed progression-free survival (PFS; RECIST v.1.1). Secondary endpoints included overall survival (OS), overall response rate (ORR), and time to treatment failure (TTF) in the brain and patients reported outcomes (PRO). PRO data collection included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30). A linear mixed model for repeated measures was used to analyze change from baseline in the Global Health Status/Quality of Life subscale (GHS/QOL), with a change of greater than or equal to ten points deemed meaningful. Time to symptom deterioration will be presented.
Results
In total, 290 patients were randomized (ensartinib [n=143]; crizotinib [n=147]).Median age was 54.1 y, 26% of patients had prior chemotherapy, and 36% of patients had baseline CNS metastases (5% had prior brain radiotherapy). The mITT population included 247 patients (ensartinib [n=121]; crizotinib [n=126]). At the July 1, 2020, data cutoff, 139 BIRC-assessed PFS events (73%) occurred in the ITT population and 119 (63%) in the mITT population. Median PFS was 25.8 months with ensartinib vs 12.7 months with crizotinib (HR, 0.52; P=.0003 by log-rank test) with a median follow-up of 23.8 and 20.2 months in the ITT population. Median PFS was not reached with ensartinib vs 12.7 months with crizotinib in the mITT population (HR, 0.48; P=.0002 by log-rank test). New subgroup analyses in mITT for ensartinib showed a trend for higher efficacy by prior chemotherapy vs no chemotherapy (mPFS NR vs 25.8). Both global health status (GHS) as well as 5 functional and 9 symptom domains within EORTC QLQ-C30 had clinical meaningful improvement over time for ensartinib. Ensartinib delays the time to worsening of GHS with HR =0.83 (95% CI [0.57, 1.20]) vs crizotinib. Complete subgroup analyses (forest plot and multivariate analyisis) will be presented at the conference as well as OS updates. Comprehenive EORTC QLQ-C30 and Lung Cancer Symptom Scale scores will also be reported at the conference.
Conclusion
In ALK+ NSCLC patients ensartinib represents a new option in first-line setting. QOLs data support its favorable safety profile. Relevant subgroups analyses to evaluate its clinical impact will be presented at the meeting.
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JICC01 - Joint IASLC-CAALC-CSCO Session: The Truth and Myth of Oral Anti-VEGFR Inhibitors for Advance NSCLC (ID 276)
- Event: WCLC 2020
- Type: Workshop
- Track: N.A.
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 07:00 - 09:00, Scientific Program Auditorium
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JICC01.08 - Target Driver Gene and Target VEGFR: Could Prolong OS？ (ID 4267)
07:00 - 09:00 | Presenting Author(s): Ying Cheng
- Abstract
- Presentation
Abstract not provided
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P76 - Targeted Therapy - Clinically Focused - EGFR (ID 253)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P76.67 - Safety and Efficacy of First-Line Dacomitinib in Advanced Non-Small Cell Lung Cancer by EGFR Mutation SUBtype in ARCHER 1050 (ID 3335)
00:00 - 00:00 | Author(s): Ying Cheng
- Abstract
Introduction
ARCHER 1050 (NCT01774721) compared dacomitinib versus gefitinib in newly diagnosed patients with advanced EGFR-mutation positive non-small cell lung cancer (NSCLC). Updated overall survival (OS) analysis showed significant improvement in OS with dacomitinib versus gefitinib in the overall population and exon 21 L858R substitution mutation (L858R) subgroup. We report analysis of efficacy and safety by EGFR mutation subtype.
Methods
In this ongoing, open-label, phase III trial, eligible patients were randomized 1:1 to dacomitinib 45 mg/day (n = 227) or gefitinib 250 mg/day (n = 225), stratified by race and EGFR mutation subtype (exon 19 deletion [Del19] or L858R). The primary endpoint was PFS (blinded independent radiologic central review). Post-hoc exploratory efficacy analyses for patients with dacomitinib dose reductions were also conducted.
Results
Improvements in PFS and updated OS with dacomitinib over gefitinib were observed in patients with dacomitinib dose reduction in both EGFR mutation subgroups (Table 1). In responding patients, duration of response was longer with dacomitinib versus gefitinib in both EGFR mutation subgroups. Dacomitinib dose reduction was reported in 66% (Del19) and 67% (L858R) of patients for PFS (data cutoff date July 29, 2016) and 68% (Del19 and L858R) of patients for updated OS (data cutoff date May 13, 2019; extended median follow-up 47.9 months). Median duration of treatment with dacomitinib was 16.5 months (range 0.2-35.0) and 13.2 months (range 0.1-37.4) in the Del19 and L858R subgroups, respectively. Safety data are in Table 2.
Conclusion
Dacomitinib is the first second-generation TKI to improve PFS and OS over gefitinib in patients with dose reduction in both Del19 and L858R subgroups. The difference in treatment durations of the dacomitinib subgroups may affect frequency of Grade ≥3 TEAEs. Potential differences in safety between EGFR mutation subgroups will warrant further exploration.
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P79 - Immunotherapy (Phase II/III Trials) - Immunotherapy Plus Chemotherapy (ID 256)
- 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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P79.08 - Sintilimab ± IBI305 Plus Chemotherapy for Patients With EGFR-Mutant Non-Squamous NSCLC Failed to EGFR-TKI Treatment (ID 1304)
00:00 - 00:00 | Author(s): Ying Cheng
- Abstract
Introduction
The standard treatment for advanced non-squamous non-small cell lung cancer (nsqNSCLC) patients with EGFR-mutation is osimertinib or other recommended tyrosine kinase inhibitors (TKIs). For those who failed to TKI treatment, the choice of systemic treatment is limited, including platinum-based chemotherapy, and new therapy regimens are needed to improve the efficacy. T-cell mediated cancer cell killing of anti-PD-1 antibody may be enhanced through reversal of vascular endothelial growth factor (VEGF)-mediated immunosuppression. Sintilimab is a humanized, monoclonal antibody that blocks the interaction between PD-1 and its ligands. IBI305 is a biosimilar candidate for bevacizumab which is a monoclonal antibody against VEGF. ORIENT-31 study is a randomized, double-blind, multi-center, phase 3 study to compare the efficacy and safety of sintilimab with or without IBI305 plus pemetrexed and cisplatin versus placebo plus pemetrexed and cisplatin. (NCT03802240).
Methods
Patients, who have failed to epidermal growth factor receptor (EGFR)-TKI treatment, with histologically/cytologically confirmed Stage IIIB-IV nsqNSCLC with EGFR mutations will be enrolled in this two-stage study. The total planned sample size is 600, with 480 patients in the common enrollment stage and 120 patients in the extension enrollment stage. In the common enrollment stage, 480 patients will be enrolled and randomized (1:1:1) into Group A (sintilimab + IBI305 + pemetrexed + cisplatin), Group B (sintilimab + placebo 2 + pemetrexed + cisplatin) and Group C (placebo 1 + placebo 2 + pemetrexed + cisplatin). In the extension enrollment stage, 120 patients will be enrolled and randomized (1:1) into Group A and Group B. Stratification factors include gender (male or female) and brain metastasis (with or without). Sintilimab 200 mg with or without IBI305 15 mg/kg will be administrated every 3 weeks (Q3W) until disease progression, unacceptable toxicity or voluntary patient withdrawal for up to 24 months. The pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 will be administrated Q3W for up to 4 cycles. The primary efficacy endpoint is progression-free survival per RECIST V 1.1 by Independent Radiographic Review Committee. The secondary efficacy endpoints include overall survival, objective response rate, disease control rate, time to response and duration of response per RECIST V1.1. By March 9, 2020, 112 patients have been enrolled in this study.
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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): Ying Cheng
- 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).
