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Jinliang Wang
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P75 - Immunotherapy (Phase II/III Trials) - Misc. Topics (ID 248)
- 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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P75.17 - Baseline D-Dimer Levels Predict Prognosis in Advanced Non-Small Cell Lung Cancer Patients Treated With Immune Checkpoint Inhibitors (ID 3319)
00:00 - 00:00 | Presenting Author(s): Jinliang Wang
- Abstract
Introduction
Targeting immune checkpoints has provided an immense breakthrough in cancer treatment. The prognostic value of plasma D-dimer has been investigated in many malignancies. However, the predictive and prognostic role of baseline plasma D-dimer levels in advanced non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICIs) remains unclear.
Methods
A longitudinal prospective study on late-stage NSCLC patients who received ICIs therapy between January 2015 and March 2019 was carried out in Chinese People's Liberation Army (PLA) General Hospital. Patients’ clinicopathological characteristics and baseline plasma D-dimer levels were recorded. Optimization-based method was used to balance baseline covariates between D-dimer normal group and high group. The Kaplan-Meier analysis and the Cox proportional hazards model were used to analyze survival data, including progression-free survival (PFS), overall survival (OS), and hazard ratio (HR) with its 95% confidence interval (CI).
Results
A total of 277 late-stage NSCLC patients were enrolled in the study. The median age was 61 years, 76.9% of patients were male, 35.4% were squamous cell lung cancer and 79.4% were stage IV. The last follow-up date was July 6, 2020 and the median follow-up time was 15.0 months. Patients were grouped by baseline D-dimer level of £ 0.5 mg/mL (normal) and > 0.5 mg/mL (high). Multivariate analysis demonstrated that baseline D-dimer level, ECOG PS (0-1, ³ 2) and prior lines of therapy (1 line, 2 lines, ³ 3 lines) were independent influential factors for PFS and OS with all P < 0.01. After balancing the baseline covariates, the results shown that patients with baseline high plasma D-dimer levels had significantly shorter PFS (median: 6.6 vs 12.5 months, HR[95%CI]: 1.76[1.28-2.41]; P = 0.001) and OS (median: 12.9 vs 28.7 months, HR[95%CI]: 2.02[1.34-3.03]; P = 0.001) than those with baseline plasma normal D-dimer levels (Figure 1). Further, we measured PD-L1 expression of 70 patients at treatment initiation, 12 patients were 0%, 25 patients were 1-50% and 33 patients were ≥ 50%. The results shown that plasma D-dimer levels were not associated with PD-L1 expression (P > 0.05).
Conclusion
Our findings suggested that baseline D-dimer level could serve as a predictive and prognostic biomarker for advanced NSCLC patients treated with ICIs, and those with baseline high D-dimer levels would have worse outcomes than those with baseline normal D-dimer levels.
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P75.18 - Association of the LIPI With Survival and Response in Advanced NSCLC Patients Treated With Immune Checkpoint Inhibitors (ID 3388)
00:00 - 00:00 | Presenting Author(s): Jinliang Wang
- Abstract
Introduction
Immune checkpoint inhibitors (ICIs) have brought relative changes in the therapeutic model of non-small cell lung cancer (NSCLC). The lung immune prognostic index (LIPI) is critical for selecting advanced NSCLC patients for ICIs therapy as a new categorical blood-based biomarker. The purpose of this study is to investigate correlation between the LIPI scores and ICIs outcomes in advanced NSCLC patients.
Methods
A cohort of 305 advanced NSCLC patients at People’s Liberation Army General Hospital who received ICIs were identified retrospectively. The LIPI score was developed on the basis of derived neutrophil to lymphocyte ratio (dNLR) greater than 3 and lactate dehydrogenase (LDH) greater than the upper limit of normal (ULN), and assigned to 3 groups (good LIPI, 0 risk factors; intermediate LIPI, 1 risk factor; poor LIPI, 2 risk factors). We analyzed the influence of the baseline LIPI on overall survival (OS), progression-free survival (PFS), disease control rate (DCR).
Results
The OS (26.0, 12.8 and 6.6 months, P < 0.0001) and PFS (10.5, 6.2 and 3.3 months, P < 0.0001) were significantly longer in good LIPI group than those of the other two groups (Figure 1.). DCR for good, intermediate, and poor LIPI group was 79%, 65%, 47%, respectively (P=0.002). According to multivariate analysis, intermediate and poor LIPI were independently prognostic of OS compared to good LIPI, with hazard ratios (HR) of 1.56 (95% CI, 1.14-2.14, P=0.005) and 2.68 (95% CI, 1.56-4.61, P<0.001), respectively. Similar findings were observed in terms of PFS (intermediate vs good: HR=1.46, 95% CI, 1.12-1.91, P=0.006; poor vs good: HR=2.36, 95% CI, 1.37-4.07, P=0.002). Further, DCR was also associated with LIPI score (P =0.045).
Figure 1. OS and PFS According to Lung Immune Prognostic Index Groups
Conclusion
This study confirms LIPI score is related to the survival and response of ICIs in the treatment of patients with advanced NSCLC.
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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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P78.09 - Immunotherapy Beyond Progression for Patients with Advanced Non-Small Cell Lung Cancer (ID 3360)
00:00 - 00:00 | Presenting Author(s): Jinliang Wang
- Abstract
Introduction
Immune checkpoint inhibitors (ICIs) have made a great breakthrough in the treatment of advanced non-small cell lung cancer (aNSCLC). However, whether immunotherapy beyond progression (IBP) is effective for aNSCLC still remains unknown. Therefore, we conducted a retrospective clinical study under real-world condition to investigate the efficacy of IBP for patients with aNSCLC and further identify the potential benefit subgroups patients.
Methods
Chinese patients with aNSCLC who experienced progressive disease (PD) after receiving monotherapy or combination therapy based on PD-1/PD-L1 checkpoint inhibitors between January 2015 and March 2019 were screened in this study. Patients who were treated with ICIs exceeding 6 weeks after PD were defined as IBP, while those who received ICIs treatment less than 6 weeks after PD or discontinued subsequent ICIs therapy at the time of PD were defined as non-IBP. Clinical characteristics of patients were evaluated. Optimization-based method was applied to balance the clinical baseline characteristics between the two groups. Kaplan-Meier curves and log-rank test were used to analyze overall survival (OS) and progression-free survival (PFS).
Results
A total of 125 patients were included (IBP group, n=39; non-IBP group, n=86). Patients in IBP group had longer OS than that in non-IBP group (median OS, 26.6 vs 9.5 months; HR, 0.40; 95%CI, 0.23-0.69; P<0.001). The median PFS was 8.9 months in IBP group and 4.1 months in non-IBP group (HR, 0.41; 95% CI, 0.26-0.65, P<0.001). DCR was significantly higher in IBP group than in non-IBP group (89.7% vs 61.6%, P< 0.001). After balancing baseline covariates, the IBP group also showed longer PFS (median PFS: 9.7 vs 4.3 months , P<0.001) and OS (median OS: 26.6 vs 10.7 months, P=0.011). Similar results were also observed in both subgroups of initial immune monotherapy and combination therapy. Moreover, IBP therapy showed promising curative effects regardless of the patients’ response to prior line.
Conclusion
Immunotherapy beyond progression is associated with longer overall and progression-free survival for patients with aNSCLC. Our findings may provide new options for the treatment of Chinese patients with aNSCLC who experienced disease progression after initial immunotherapy.
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P84 - Targeted Therapy - Clinically Focused - ALK (ID 261)
- 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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P84.15 - Alectinib in Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer as First-Line or Sequential Treatment in China (ID 2478)
00:00 - 00:00 | Author(s): Jinliang Wang
- Abstract
Introduction
Alectinib is a highly selective inhibitor of anaplastic lymphoma kinase (ALK) with superior systemic and central nervous system (CNS) efficacy. In ALEX study,alectinib yielded confirmed objective response rate(ORR) of 72.4%.The first-time real-world study aims to evaluate the efficacy and safety profile of alectinib in ALK-positive non-small cell lung cancer (NSCLC) Chinese patients.
Methods
A national retrospective cohort study of patients with ALK-positive NSCLC initiating alectinib(600 mg twice daily) was conducted in 7 centers in China between 01-Dec-2017 and 01-Sept- 2019.The last follow-up was to 31st December 2019.
Results
One hundred and two patients were enrolled.During a median follow-up of 10.6 months, an event of disease progression or death occurred in 21 of 102 patients (20.5%) .Patient Characteristics were shown in Table 1.
For alectinib in the first-line setting, 39 patients were eligible for tumor evaluation.The ORR was 89.7%(35/39) and 2 patients had a complete response.Among 23 patients with measurable CNS lesions at baseline, a CNS response occurred in 22 of 23 patients (95.6%);4 patients had a complete CNS response.
For alectinib in the sequential setting, 58 patients were eligible for tumor evaluation,of whom 37 patients received crizotinib as first-line therapy.The most common progression mode of crizotinib was CNS progression(24/37,64.9%).Fourty-four patients received alectinib as second-line treatment.The ORR was 75.9%(44/58) and 2 patients had a complete response. Among 51 patients with measurable CNS lesions, a CNS response occurred in 42 of 51 patients (82.4%);4 patients had a complete CNS response.
Data of adverse events(AEs) were available in all patients.The most common AEs were increased blood bilirubin (23.5%),constipation(23.5%) and abnormal ALT and AST levels(22.5%).Other AEs that occurred in at least 10% of the patients included myalgia (12.7%), peripheral edema(11.8%) and rash(11.8%). Grade 3 AEs occurred in 8.8% of the patients.No grade 4 or 5 AEs were observed in this study. The most common grade 3 AEs were laboratory abnormalities(6/9,66.7%),of which was increased blood bilirubin leading to dose reduction to alectinib 300 mg twice daily.
Table 1 Baseline Patient Characteristics
Characteristics
N%
Age
Medium (Range)
51(24-81)
Gender
Male
Female
44（43.1%）
58（56.9%）
ECOG
0-1
≥2
82（80.3%）
20（19.7%）
Smoking history
Yes
No
16（15.7%）
86（84.3%)
Histology
Adenocarcinoma
Squamous -cell carcinoma
Large-cell carcinoma
99（97.1%）
2（2.0%）
1（0.9%）
Stage
IIIB
IV
6（5.9%）
96（94.1%）
Metastasis site
Brain
Bone
Liver
44（43.1%）
44（43.1%）
15（14.7%）
Alectinib treatment line
First-line
Second-line
Beyond second-line
41（40.2%）
44（43.1%）
17（16.7%）
Previous Crizotinib treatment
Yes
No
37（36.3%）
65（63.7%）
Previous chemotherapy
Yes
No
24（23.5%）
78（76.5%）
Conclusion
This study confirms the efficacy and safety of alectinib in real-world advanced ALK+ NSCLC in China, which is consistent with data reported in clinical trials.
