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Aiqin Gu
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MA13 - Going Back to the Roots! (ID 139)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:Maurice Perol, Kaoru Kubota
- Coordinates: 9/09/2019, 14:00 - 15:30, Vancouver (2003)
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MA13.11 - A Randomized Phase III Study of Cisplatin-Polymeric Micelle Paclitaxel vs Cisplatin-Solvent-Based Paclitaxel in 1st Line Advanced NSCLC (Now Available) (ID 696)
14:00 - 15:30 | Author(s): Aiqin Gu
- Abstract
- Presentation
Background
Cisplatin-sb-Pac is the one of current standard of chemotherapy in aNSCLC, It produced 15% to 32% objective response rate (ORR) and 7.9 to 10.6 months of median overall survival (OS). Alternative nab-paclitaxel to sb-Pac only increased ORR but not improved progression-free survival (PFS) and OS. Thus the unmet medical need for new chemo regimen remains.
Method
From May 2015 to Jan 2018 448 untreated patients (pts) with stage IIIB to IV NSCLC from 24 sites were randomly assigned 2:1 to receive 230 mg/m2 pm-Pac and cisplatin 70 mg/m2 on day 1 of a 3-week cycle, and then dose escalation of pm-Pac to 300 mg/m2 from the second cycle if no prespecified toxic effects observed or 175 mg/m2 sb-Pac plus cisplatin 70 mg/m2 once every 3 weeks. Pts were stratified by stage and histology. The primary end point was ORR by Independent review committee (IRC) and Investigator (INV) in the intent-to-treat population. The second endpoints included PFS, OS and safety. Data cutoff was Jan 26, 2019.
Result
300 pts were assigned to pm-Pac and 148 to sb-Pac. Baseline characteristic were balance in both arms. Nonsquamous carcinoma (non-squ) and stage IV were 57.3% and 81.0% in pm-Pac and 58.1% and 81.8% in sb-Pac respectively. 73.2% pts in pm-Pac arm escalated their dose to 300mg/m2, 0.7% down to 184mg/m2. ORR and PFS in pm-Pac were significant better than that in sb-Pac (table 1). OS was immature. For histology subgroup the ORR was 58.6% v 37.1% (P=0.0054) in squamous carcinoma (Squ) and 44.2% v 18.6% (P<0.0001) in non-squ. Grade ≥3 AEs was 80.0% for pm-Pac and 79.7% for sb-Pac. No new safety issues were identified.
Conclusion
The phase 3 trial met its primary endpoint. pm-Pac significantly improved ORR and PFS than sb-Pac, and pm-Pac regimen should be a new standard chemo for aNSCLC. (NCT 02667743).
Tab. Efficacies comparison between pm-Pac and sb-Pac
pm-Pac
sb-Pac
P value
ORR % (95% CI)
IRC
INV
50.3 (44.5-56.1)
52.0 (46.2-57.8)
26.4 (19.5-34.2)
28.4 (21.3-36.4)
<0.0001
<0.0001
PFS (months)
6.4 (6.2-6.9)
5.3 (4.6-6.0)
HR 0.66 (0.52-0.84), P=0.0006
OS at 12 months
67.3%
61.8%
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MA25 - Precision Medicine in Advanced NSCLC (ID 352)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:Sebastian Defranchi, Karen Kelly
- Coordinates: 9/10/2019, 14:30 - 16:00, Dublin (1997)
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MA25.09 - Navigating Anlotinib Precision Therapy Through the Genetic Profiling of Circulating DNA in Non-Small Cell Lung Cancer Patients (Now Available) (ID 1055)
14:30 - 16:00 | Author(s): Aiqin Gu
- Abstract
- Presentation
Background
Anlotinib is an oral multi-targeted anti-angiogenic drug, and its clinical predictor for non-small cell lung cancer (NSCLC) patients is still elusive. The aim of this study is to screen predictor for anlotinib via non-invasive genetic profiling of plasma cell free DNA and circulating tumor DNA (cfDNA & ctDNA).
Method
Tumor-specific target capture to profile the circulating DNA of ALTER0303 (Evaluating NSCLC clinical anti-tumor efficacy through anlotinib therapy) study participants. Acquired mutations were screened out via comparing genetic profiling between baseline (BL) and progression disease (PD), and were used for anlotinib stratification. Based on the sequencing data at BL, tumor mutation index (TMI) was established from three independent predictors germline and somatic mutation burden (G+S MB), nonsynonymous and synonymous mutation burden (N+S MB) and unfavorable mutation score (UMS), and was used for predicting anlotinib responders. In addition, TMI combined with IDH1Exon4 mutation status also be examined for serving as predictor for anlotinib stratification.
Result
Our data firstly indicated no benefit (NB, PFS ≤ 45 days) patients can be mainly excluded via analysis of ARID1A and BRCA2 genetic profiling. Secondly, for the no durable benefit (NDB, 45 days < PFS ≤ 130 days) and durable clinical benefit (DCB, PFS > 130 days) patients, harboring lower mutation burden (G+S MB, N+S MB, and UMS) received more benefit from anlotinib therapy. Subsequently, we found the predictor-TMI can predict anlotinib responders upon discovery cohort (Median PFS: 210 days vs 126 days; p = 0.0238; AUC = 0.77), and validation cohort (Median PFS: 210 days vs 127 days; p = 0.0352) and all patients (Median PFS: 210 days vs 127 days; p = 0.0044) more effectively. Furthermore, the IDH1Exon4 mutation was identified as an unfavorable factor to anlotinib therapy under TMI-based stratification. Lastly, the TMI plus IDH1Exon4 mutation status predict response to anlotinib significantly (Median PFS: 210 days vs 127 days, p < 0.0001, AUC = 0.90; Median OS: 423 days vs 162 days, p < 0.0001, AUC = 0.80).
Conclusion
This study provides circulating DNA sequencing-based stratification for underlying anlotinib responders via non-invasive approach, and thus potentially improve clinical outcome for NSCLC patients at 3rd line.
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P1.01 - Advanced NSCLC (ID 158)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.01-95 - Efficacy and Safety of Anlotinib in Combination with Chemotherapy as First-Line Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients (ID 2296)
09:45 - 18:00 | Author(s): Aiqin Gu
- Abstract
Background
Anlotinib (AL3818) is a novel multi-target angioenesis TKI targeting the VEGFR, FGFR, PDGFR and c-Kit. In the ALTER0303 trial, Anlotinib as third-line treatment significantly improved progress-free survival (PFS) and overall survival (OS) in advanced NSCLC patients. This is the first trial evaluating the combination of chemotherapy and anlotinib in treatment-naive advanced NSCLC and is one arm of Phase II anlotinib-based trial (NCT03628521).
Method
Patients with previously untreated EGFR/ALK/ROS1 negative advanced NSCLC were enrolled. Eligible patients received anlotinib (12 mg QD from day 1 to 14 of a 21-day cycle) combined with carboplatin (AUC 5) and pemetrexed (adenocarcinoma, 500mg/m2)/gemcitabine (squamous, 1.0g/m2，day1&8) for four to six cycles (21-day cycle). Maintenance treatment was followed by using pemetrexed and anlotinib (anlotinib alone for squamous) until disease progression or treatment intolerance. The primary outcome was objective response (ORR) and secondary outcomes were PFS, disease control rate (DCR) and OS.
Result
Until the 21st March 2019, the curative effect was assessed in 30 enrolled patients according to the RECIST 1.1. Among these patients, eighteen of them achieved PR (all confirmed), eleven of them achieved SD and only one patient developed to disease progression. The objective response rate was 60.0 % while the disease control rate was 96.7 %. The most common Grade 3 adverse events were decreased platelet count (20 %), hypertriglyceridemia (10 %) and oral mucositis (6.67 %). 3 patients showed Grade 4 decrease of platelet count (10 %), and both of them belong to the gemcitabine group.
Conclusion
The combination of anlotinib and chemotherapy showed the potential effect and a manageable safety profile in patients with previously untreated EGFR/ALK/ROS1 negative advanced NSCLC.
Table 1: Response rates
Response
Assessed
CR
0
PR
18/30（60.0%）
SD
11/30（36.7%）
PD
1/30 （3.3%）
ORR, n/N（%）
18/30 （60.0%）
DCR, n/N（%）
29/30 （96.7%）
