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Kai Li
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OA03 - Systemic Therapies for SCLC: Novel Targets and Patients' Selection (ID 121)
- Event: WCLC 2019
- Type: Oral Session
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Now Available
- Moderators:Christine Lee Hann, Makoto Nishio
- Coordinates: 9/08/2019, 13:30 - 15:00, Hilton Head (1978)
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OA03.02 - Effect of Anlotinib in Advanced Small Cell Lung Cancer Patients Previously Received Chemoradiotherapy: A Subgroup Analysis in ALTER 1202 Trial (Now Available) (ID 1698)
13:30 - 15:00 | Author(s): Kai Li
- Abstract
- Presentation
Background
The ALTER 1202 trial showed significant improvement in progress-free survival and well tolerant with anlotinib in advanced small cell lung cancer (SCLC) patients received at least two lines chemotherapy. Here, we reported the effect of anlotinib in patients previously received chemoradiotherapy.
Method
The ALTER 1202 was a randomized, double-blind phase 2 trial conducted at 11 centers in China. Patients with advanced SCLC that received at least two previous lines of chemotherapy were enrolled and randomized in a 2:1 ratio to receive either anlotinib or placebo until tumor progression or unacceptable toxicity. The subgroup analysis assessed the effect of anlotinib in patients with previous concurrent, sequential and alternate chemoradiotherapy. The primary outcome was progressive-free survival (PFS). The secondary outcomes were overall survival (OS), objective response rate, disease control rate and safety. Data are reported as per the 30 June 2018, data cutoff date. This trial is registered with ClinicalTrials.gov, number NCT03059797.
Result
Between March 30, 2017 and June 8, 2018, a total of 120 patients who met all eligibility criteria were randomly assigned to the anlotinib group (82 patients) or placebo group (38 patients). And 46 patients in anlotinib group and 22 patients in placebo group previously received chemoradiotherapy. Among them, the median PFS was 5.49 months (95% confidence interval [CI], 2.83 to 6.47) with anlotinib versus 0.69 months (95% CI, 0.66 to 0.76) with placebo (hazard ratio [HR], 0.14; 95% CI, 0.07 to 0.28; P<0.0001). Meanwhile, anlotinib significantly prolonged OS compared with placebo (9.49 months [95% CI, 7.29 to 12.68] versus 2.56 months [95% CI, 0.49 to 5.22]; HR, 0.46 [95% CI, 0.22 to 0.98]; P=0.0388) in patients previously received chemoradiotherapy. The most common adverse events were hypertension (39.13%), weight loss (39.13%), hypertriglyceridemia (36.96%) and leukopenia (30.43%). While, the most common grade 3 or worse adverse events were hypertension (15.22%), hypertriglyceridemia (10.87%), γ-glutamyl-transferase increased (8.70%).
Conclusion
Anlotinib improved PFS and OS in advanced SCLC patients previously received chemoradiotherapy and was well tolerated.
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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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P1.01-03 - Efficacy and Safety of Biosimilar QL1101 Compared with Avastin in Patients with Non-Squamous Non-Small Cell Lung Cancer (ID 738)
09:45 - 18:00 | Author(s): Kai Li
- Abstract
Background
QL1101 is a biosimilar molecule of bevacizumab (BEV, Avastin®), a monoclonal antibody (mAb) that binds and inhibits vascular endothelial growth factor (VEGF).The main purpose of the study is to evaluate whether the effectiveness of QL1101 is bioequivalent to that of Avastin®, and the secondary purpose is to evaluate the bioequivalence on safety and immunogenicity between QL1101 and Avastin®.
Method
Total 512 patients with locally metastatic or recurrent non-squamous cell non-small cell lung cancer were planned to recruit in the study (NCT03169335). The patients were divided into QL1101 (test group) or Avastin® (control group) at 1:1 ratio in combination respectively with paclitaxel/carboplatin (paclitaxel 175mg/m2, carboplatin AUC=5). QL1101 or Avastin was given every 3 weeks as one treatment cycle for 6 cycles with the same dose of 15mg/kg per time, then followed by QL1101 single-drug maintenance treatment. The primary endpoint was the best objective response rate (ORR) at week 18 as evaluated by the blind independent imaging review committee, and the secondary endpoints include DOR, PFS and OS.
Result
A total of 675 subjects were screened and 532 were finally enrolled and treated including 266 in the trial group and 266 in the control group. At week 18, the ORR of the QL1101 group and Avastin group were 52.26% (CR: 0, PR: 139) and 56.02% (1 cases CR, 148 PR), respectively, and risk ratio (RR) value and 90% CI was 0.933 (0.818-1.064), which met the pre-specified equivalence margins (0.75-1.33). The mDOR in QL1101 group and Avastin group was 5.88 and 6.93 month (P=0.5044）respectively, and mPFS were 7.88 and 8.34 months (P=0.2760) accordingly, the 12-month OS in the two groups was 69.18% and 75.10% respectively. The incidence of CTCAE≥ grade 3 adverse events was 31.20 % in QL1101 group and 24.06 % in Avastin group, respectively (P = 0.0808). The immunogenicity (ADA and Nab tested) of the two groups was similar.
Conclusion
QL1101 and Avastin are equivalent in clinical efficacy, and the safety profile (including immunogenicity) is quite similar in patients with non-squamous cell non-small cell lung cancer. There are no unexpected serious adverse reactions were found during the study.
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P2.12 - Small Cell Lung Cancer/NET (ID 180)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 2
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.12-11 - Quality of Life in ALTER1202 Trial of Anlotinib as Third-or Further Line Therapy for Advanced Small Cell Lung Cancer (SCLC): A Post-Hoc Analysis (ID 1300)
10:15 - 18:15 | Presenting Author(s): Kai Li
- Abstract
Background
Anlotinib significantly improved progress-free survival of advanced small cell lung cancer (SCLC) patients in ALTER1202 trial. In this post-hoc analysis, we assessed the effect of anlotinib on health-related quality of life in ALTER1202 trial.
Method
In the randomised, phase 2, multicentre ALTER1202 trial, patients with advanced SCLC that received at least two previous lines of chemotherapy were enrolled from 11 centers in China. Eligible patients were randomly assign (2:1) to receive anlotinib or placebo. Health-related quality of life was assessed by EQ-5D scores. Patients filled out questionnaires at screening period and the end of each treatment cycle.
Result
Between March 30, 2017 and June 8, 2018, a total of 120 patients were enrolled. There were 119 patients with completed questionnaires at screening period, and 106 patients completed questionnaires at the end of the first treatment cycle (76 in anlotinib group, 30 in placebo group). EQ-5D scores had no significant difference between baseline and the end of the first treatment cycle in patients with anlotinib (0.85 versus 0.85, P=0.706). The median EQ-5D VASscores were 80.0 versus 85.0 in anlotinib and placebo group respectively (P=0.323) at screening period, and 90.0 versus 82.5 at the end of the first treatment cycle (P=0.273). The change of EQ-5D VAS scores from baseline to the end of the first treatment cycle was statistically significant (P=0.001) in patients with anlotinib compared to patients with placebo.
Conclusion
This post-hoc analysis showed that anlotinib maintained health-related quality of life in advanced SCLC patients.
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P2.12-26 - The Impact of Anlotinib for Relapsed SCLC Patients with Brain Metastases: A Subgroup Analysis of ALTER 1202 (ID 489)
10:15 - 18:15 | Author(s): Kai Li
- Abstract
Background
ALTER1202 trial (NCT03059797), a multicentre, randomized, double-blind phase II study has demonstrated that anlotinib significantly prolonged progress-free survival (PFS) in relapsed SCLC patients as 3rdor further line treatment. Here, we performed a comparative analysis for patients with brain metastases in the placebo and anlotinib arms.
Method
Eligible either limited- or extensive-stage SCLC pts who failed ≥2 lines of chemotherapy (n=120) were randomized 2:1 to receive anlotinib or placebo (12 mg QD from day 1 to 14 of a 21-day cycle) till progression or intolerable toxicity. The primary endpoint was PFS. This subgroup analysis was based on patients with brain metastases at baseline.
Result
There are 30 pts with brain metastases in anlotinib and placebo groups (n=21 vs 9). Anlotinib significantly improved PFS (3.84 vs 0.76 months; HR = 0.15; 95% CI, 0.04–0.51; P = 0.0005) and OS (6.08 vs 2.56 months; HR = 0.26; 95% CI, 0.09–0.73; P = 0.0061) comparing to placebo in patients with brain metastases at baseline. In anlotinib group, loss of appetite (47.62%), loss of weight (42.86 %), leukopenia (38.10%) and hypertriglyceridemia (38.10%) were the most common adverse events (AEs); then, in placebo group were emesis (44.44%) and loss of appetite (33.33 %).
Conclusion
For patients with brain metastases in ALTER1202 trial, significant improvement in OS and PFS were found in anlotinib treated group with a manageable safety profile.
