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Tianqing Chu
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OA07 - Immuno-biology and Novel Immunotherapeutics from Bench to Bed (ID 228)
- Event: WCLC 2020
- Type: Oral
- Track: Immuno-biology and Novel Immunotherapeutics (Phase I and Translational)
- Presentations: 1
- Moderators:
- Coordinates: 1/30/2021, 10:30 - 11:30, Scientific Program Auditorium
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OA07.09 - Sintilimab in Combination with Anlotinib as First-Line Therapy for Advanced NSCLC: Final Analysis of Primary Endpoints (ID 1480)
10:30 - 11:30 | Author(s): Tianqing Chu
- Abstract
- Presentation
Introduction
Evidence supporting the chemo-free combination of immune checkpoint inhibitors plus antiangiogenic TKIs in treatment naïve advanced NSCLC patients is insufficient. Our phase I study (NCT03628521) of sintilimab (anti-PD-1) combined with anlotinib (multi-target anti-angiogenesis TKI) had showed encouraging overall response as first line therapy for advanced NSCLC regardless of PD-L1 expressions. Here we present the updated efficacy and safety results and more sub-group analyses.
Methods
Eligible patients were treatment-naive, stage IIIB/IV NSCLC patients without EGFR/ALK/ROS1 mutations. Participants were given sintilimab (200mg IV day1 q3w) and anlotinib (12mg QD day1-14 q3w) till disease progression or unacceptable toxicity. The primary endpoints were ORR and safety, and the secondary endpoints included DCR, PFS and OS.
Results
From Sept. 2018 to Feb. 2019, 22 patients were enrolled and treated. As of Apr. 30th 2020, median follow-up was 15.8 months (range, 8.3-19.3), median treatment duration was 14.6 months (range, 3.7-19.3). In total, 16 patients achieved confirmed PR, ORR was 72.7% (49.8%, 89.3%) and DCR was 100% (84.6%, 100%). Patients with adenocarcinoma (n=9) seemed to have better response than squamous cell type (n=12, 88.9% vs 58.3%). The median TTR was 1.6 months (95% CI, 1.4, 2.9) and the median DOR was NR (95% CI: 3.2m, NC). The median PFS was 15 months (95% CI, 8.3 months-NR), and the 12-month PFS rate was 71.4% (95% CI, 47.2%, 86.0%). Patients with squamous cell carcinoma had similar 12m PFS rate with adenocarcinoma (77.8% vs 66.7%). 12m PFS rate was consistent across different biomarker status. OS data was immature and the estimated 12-month OS rate was 95.5% (95% CI, 71.9%, 99.3%). With more follow-up, grade ≥3 TRAE occurred in 54.4% patients, and grade ≥3 irAE was 4.5%. The most common irAE were hypothyroidism (50%), pneumonitis (13.6%), myositis (4.5%) and adrenal insufficiency (4.5%). Five patients required dose reduction of anlotinib and one patient had treatment discontinuation due to grade 3 rash.
ConclusionITT
（n=22）
PD-L1+
（n=13）
PD-L1 -
（n=8）
TMB ≥ 10
（n=6）
TMB ＜ 10
（n=10）
median PFS, m
(95% CI）
15
(8.3, NR)
NR
(7.7, NR)
14
(4.5, 15)
NR
(NR, NR)
14
(4.3, 15)
12 month PFS rate
(95% CI)
71.4%
(47.2%, 86.0%)
76.9%
(44.2%, 91.9%)
62.5%
(22.9%, 86.1%)
100%
(100%, 100%)
60.0%
(25.3%, 82.7%)
With longer follow-up, combination of sintilimab and anlotinib demonstrated durable efficacy and good tolerability. To our knowledge, this is the first study that assessed a PD-1 inhibitor plus an anti-angiogenesis TKI in first-line setting of advanced NSCLC. A phase II randomized trial (NCT04124731) is currently ongoing to further investigate this new chemo-free strategy.
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P15 - Immuno-biology and Novel Immunotherapeutics (Phase I and Translational) - Novel Immunotherapeutics (Phase I) (ID 154)
- Event: WCLC 2020
- Type: Posters
- Track: Immuno-biology and Novel Immunotherapeutics (Phase I and Translational)
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P15.07 - Safety and Efficacy Profile of TQB-2450 Alone/with Anlotinib in Previously-Treated Advanced NSCLC: A Phase IB Single-Arm Trial (ID 3489)
00:00 - 00:00 | Author(s): Tianqing Chu
- Abstract
Introduction
TQB-2450 is a novel humanized antibody, blocking programmed death-ligand 1 (PD-L1). Anlotinib, an oral multi-target tyrosine kinase inhibitor (TKI) approved by China National Medical Products Administration (NMPA), improved progression-free survival (PFS) and overall survival (OS) in advanced non-small cell lung cancer (NSCLC) in the phase 3 trial ALTER0303. Here, we report the safety and anticancer activity of TQB-2450 alone/with anlotinib hydrochloride in 3 cohorts for advanced/metastatic NSCLC patients without driver mutations.
Methods
Patients (18-75 ys, WHO PS 0/1, ≥1 measurable lesion defined by RECIST v1.1, ≥1 prior systemic therapy) without driver mutations were enrolled in this study (CTR20190336). Eligible patients received TQB-2450 (1200mg IV on Day 1 Q21D) alone/with anlotinib hydrochloride (10/12 mg QD from day 1 to 14 of a 21day cycle) until disease progression or treatment intolerance. The primary endpoint was PFS, secondary endpoints included safety, objective response (ORR), disease control rate (DCR) and OS.
Results
Until the 21st August 2020, a total of 51 pts were screened and 26 were finally enrolled. Median age was 62.5 years (range, 50-77); 84.62% male and 5/26 (19.23%) brain metastasis. 24/26 (92.31%) pts were response-evaluable. Among these pts, there was 0 CR, 6 PR, 18 SD and no disease progression, resulting in the objective response rate 25.00% and disease control rate 100.00 %. The most common Grade 3 treatment-related adverse effects (TRAE) were hypertension (12.00 %), pulmonary infection (12.00%), chest discomfort (8.00%), hypercalcemia (4.00%), vomiting (4.00%), poor appetite (4.00%) and chest pain (4.00%), and there were no grade 4/5 toxicities.
Conclusion
TQB-2450 alone/with anlotinib demonstrated a tolerable safety profile without grade 4/5 TRAE. Our results suggest that TQB-2450 alone/with anlotinib may represent a novel and safe treatment for advanced/metastatic NSCLC pts with prior systemic therapy.
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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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P76.10 - Erlotinib Plus Anlotinib as First-Line Therapy in Advanced Non-Small-Cell Lung Cancer Harboring EGFR Mutations: An Open-Label, Phase 2 Study (ID 1030)
00:00 - 00:00 | Presenting Author(s): Tianqing Chu
- Abstract
Introduction
The combination of erlotinib and bevacizumab significantly improved progression-free survival (PFS) compared with erlotinib monotherapy in NEJ026 and ARTEMIS study for advanced EGFR mutation-positive NSCLC patients. However, data of antiangiogenic multi-target tyrosine kinase inhibitor (TKI) plus EGFR TKI remains unknown. We aimed to firstly evaluate the efficacy and safety of the combination of erlotinib and anlotinib (an antiangiogenic multi-target TKI) in Chinese patients with advanced EGFR-mutated NSCLC.
Methods
In this open-label, phase 2 study, NSCLC patients with previously untreated, EGFR mutation (exon 19 deletion or L858R) received anlotinib (10 mg QD from day 1 to 14 of a 21-day cycle) and erlotinib (at a dose of 150 mg once daily) until disease progression or treatment intolerance. The primary outcome was objective response (ORR) and secondary outcomes were PFS, disease control rate (DCR) and overall survival (OS).
Results
A total of 60 patients were enrolled from October 2018 to November 2019. Among these patients, 35 (58.3%) patients were female. And 14 (23.3%) of them had brain metastasis. Till August 2020, 57 of the patients received at least once tumor assessment. 51 of them achieved partial response, 6 of them had stable disease and no patients had disease progression. The ORR was 89.5%, while the DCR was 100 %. The most common grade 3 adverse event (AE) are rash (15.3 %), oral mucositis (10.2%) and diarrhea (8.5 %). A grade 4 hypertension were observed.
Conclusion
This is the first study of the new combination of anlotinib plus erlotinib. The results suggest that this strategy could be a new first-line therapy in EGFR-mutated NSCLC patients. The long-term outcomes will be revealed in the future.
