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Proffered Paper 1 – Non-metastatic NSCLC and other thoracic malignancies (SCLC)

3167 - Overall survival (OS) update in ALTER 1202: Anlotinib as third-line or further-line treatment in relapsed small-cell lung cancer (SCLC)

Date

28 Sep 2019

Session

Proffered Paper 1 – Non-metastatic NSCLC and other thoracic malignancies (SCLC)

Presenters

Ying Cheng

Citation

Annals of Oncology (2019) 30 (suppl_5): v710-v717. 10.1093/annonc/mdz264

Authors

Y. Cheng1, Q. Wang2, K. Li3, J. Shi4, Y. Liu1, L. Wu5, B. Han6, G. Chen7, J. He8, J. Wang9, D. Lou10, H. Yu10, H. Qin11, X. Li12

Author affiliations

  • 1 Medical Oncology, Jilin Cancer Hospital, 130012 - Changchun/CN
  • 2 Medical Oncology, Henan Cancer Hospital, 450008 - Zhengzhou/CN
  • 3 Medical Oncology, Tianjin Medical University Cancer Hospital, 300060 - Tianjin/CN
  • 4 Medical Oncology, Linyi Cancer Hospital, 276001 - Linyi/CN
  • 5 Medical Oncology, Hunan Cancer Hospital, 410006 - Changsha/CN
  • 6 Medical Oncology, Shanghai Chest Hospital, 200000 - Shanghai/CN
  • 7 Medical Oncology, Harbin Medical University Cancer Hospital, 150081 - Harbin/CN
  • 8 Medical Oncology, The First Affiliated Hospital of Guangzhou Medical University, 510120 - Guangzhou/CN
  • 9 Department Of Medical Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing/CN
  • 10 Department Of Biostatistics, School of public health, nanjing medical university, 211166 - Nanjing/CN
  • 11 Medical Oncology, The fifth medical center of chinese PLA general hospital, 100039 - Beijing/CN
  • 12 Medical Oncology, Cancer Hospital of China Medical University Liaoning Cancer Hospital & Institute, 110042 - Shenyang/CN
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Abstract 3167

Background

As a multicentre, randomized, double-blind phase II trial, ALTER 1202 (NCT03059797) suggests that anlotinib is a promising treatment option for patients with relapsed SCLC who failed ≥ 2 lines of chemotherapy. The median progress-free survival (PFS) was significantly longer in the anlotinib group compared with the placebo group (4.1 months vs 0.7 months; HR 0.19, 95% CI 0.12 to 0.32], P < 0.0001) as per the 30 June 2018, data cutoff date. Here we report updated OS results in the ITT population while OS events occurred in about 78% patients.

Methods

Eligible either limited- or extensive-stage SCLC patients with disease progression after ≥ 2 lines of chemotherapy were randomized 2:1 to anlotinib or placebo (12 mg PO QD from day 1 to 14, every 3 weeks). The primary endpoint was PFS. OS was a pre-specified secondary endpoint.

Results

Between March 2017 and May 2018, 120 patients from 11 centers were randomized to either anlotinib arm (n = 82) or placebo arm (n = 38). In the final analysis (04 APR 2019), median OS was significantly prolonged about 2.4 months in anlotinib arm (7.3 months vs 4.9 months). OS at this date showed 60 events in anlotinib arm and 33 events in placebo arm (HR 0.53, 95%CI 0.3-0.8; p = 0.0029). Six-month, 1-y survival rates were 63.9%, 30.6% in the anlotinib group and 32.7%, 13.1% in the placebo group. The hazard ratio for OS favored anlotinib in most subgroups, especially for patients with brain metastases (OS 6.3m vs 2.6m; HR 0.23, 95%CI 0.09-0.59; p = 0.0009) and patients that received study drug as third-line therapy (OS 7.3m vs 4.9m; HR 0.50, 95%CI 0.31-0.82; p = 0.0051). No newly adverse events were observed.

Conclusions

The updated results showed that anlotinib prolonged not only PFS but also OS significantly than placebo with favorable safety profile. These data suggested that anlotinib is a promising treatment option for patients with relapsed SCLC who have experienced treatment failure with two lines of chemotherapy.

Clinical trial identification

NCT03059797.

Editorial acknowledgement

Legal entity responsible for the study

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Funding

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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