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JCES 01.07 Ongoing Trials in China on Checkpoint Inhibitors and Other Immunotherapies
ABSTRACTS JOINT IASLC e CSCO e CAALC SESSION JCSE 01 JOINT SESSION JCES 01.07 Ongoing Trials in China on Checkpoint Inhibitors and Other Immunotherapies Q. Zhou Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou/CN
Qingdao/CN, 6Liaoning Cancer Hospital & Institute, Shenyang/CN, Fujian Medical University Union Hospital, Fuzhou/CN, 8Jilin Provincial Cancer Hospital, Changchun/CN, 9Jiangsu Cancer Hospital, Nanjing/CN, 10 Peking University People’s Hospital, Beijing/CN, 11Shanghai Pulmonary Hospital, Shanghai/CN, 12The Fourth Military Medical University, Xi’An/ CN, 13Peking University Hospital, Beijing/CN, 14Fujian Provicial Cancer Hospital, Fuzhou/CN, 15Beijing Chest Hospital, Beijing/CN, 16The First Hospital of China Medical University, Shenyang/CN, 17Peking University Cancer Hospital, Beijing/CN, 18Harbin Medical University, Heilongjiang/ CN, 19West China Hospital of Sichuan University, Chengdu/CN, 20Sichuan Cancer Hospital, Chengdu/CN, 21The Northern Jiangsu People’s Hospital, Yangzhou/CN, 22The First Affiliated Hospital of Suzhou University, Suzhou/CN, 23Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhgou/CN 7
Immunotherapy gets the breakthrough after almost 100 years of silence. PD1/PD-L1 inhibitors as the representative has been extensively studied in various human malignant tumors and get promising long term response with relatively fewer adverse event. The first PD1 inhibitor indication was approved for melanoma in Japan on July 2014. By the end of December 2016, the US Food and Drug Administration had approved several PD-1 pathway blockade treatments including nivolumab, pembrolizumab and atezolizumab using in first line and second line of NSCLC. But In China, no PD-1 or PD-L1 inhibitors have received marketing approval from the Chinese Food and Drug Administration (CFDA) until July 2017. One sides, IO arena faces intense in-class competition from both MNC (Multi-National Corporation) and domestic pharmaceutical company in China. Now there are 20 IO antibodies from 7 MNCs and 10 pharmaceutical companies in China. But all the antibodies only confined to PD1/PD-L1 and CTLA4, no other hot IO drugs such as IDO or Lag3 et al. In the field of innovation, China is several years behind research in other areas of the world. The other sides various clinical trials are actively investigating MNC and domestic drugs in China. Between January 1, 2013 and April 6, 2017, Clinical Trials.-gov registered 270 international clinical trials using PD-1/PD-L1 therapies for NSCLC (e.g.nivolumab, pembrolizumab, atezolizumab, and durvalumab). These 270 trials included 61 studies that involved East Asian sites and 14studies that involved Chinese sites (12 multinational trials and 2 trials that only evaluated Chinese patients). These trials cover from second line and first line to adjuvant therapy in NSCLC. Most of the ongoing MNC NSCLC clinical trials joined in global study design that may accelerate the patient access to PD1/PD-L1. But Chinese population has relatively high rates of hepatitis B virus infection and much higher proportion of EGFR mutation. The delightful changing recently is some studies emerging to consider the characteristics of the Chinese or Asian populations. Domestic company clinical trials focus on GI (Gastrointestinal) and only 1 NSCLC study in China. Chinese clinical trials using IO remain in their early stages, and further efforts are needed to improve the design of future clinical trials. Meanwhile, the other hot IO drug phase I study need speed up in China. Keywords: ongoing clinical trials, Immunotherapy, China
Background: ADJUVANT (CTONG 1104) is the first randomized trial shows significantly prolonged disease-free survival (DFS) in completely resected stage II-IIIA (N1-N2) epidermal growth factor receptor (EGFR)-mutation positive non-small-cell lung cancer (NSCLC) through adjuvant gefitinib compare with vinorelbine plus cisplatin (VP). Further we aim to analyze the treatment failure pattern in ADJUVANT study. Method: In the ADJUVANT trial, a total of 222 patients with completely resected stage N1eN2 EGFR-mutation positive NSCLC were randomized 1:1 into gefitinib group (250mg, QD, 24 months ) or vinorelbine (25mg/m 2 Day 1/Day 8) plus cisplatin (75mg/m 2 Day 1) group (every 3 weeks for 4 cycles) respectively. Any recurrence or metastases occurred during the follow-up period was defined as treatment failure. Recurrent pattern in both group were analyzed with follow-up data (until Mar 9 th 2017) integrated. Result: At the Data cut-off date for the primary analysis of DFS, 124 progression events (55.9% maturity overall) had occurred; 114 patients had disease recurrence，10 patients died before disease recurrence. Analyzed recurrent pattern include lung, brain, liver, bone adrenal gland, pleura, pericardium, spleen and regional lymph nodes metastasis. Even no significant differences were found, highest proportion of patients in both group(18.9% for VP and 26.1% for gefitinib, p¼0.199) surfer brain metastasis with lung metastases being the second common recurrent site. Time to brain metastases showed no significantly difference between the two groups (not reach vs 40.8m, p>0.05). Among the 29 brain metastases patients with gefitinib, the brain metastases occurred in 17 patients during the gefitinib treatment, and 12 patients relapse after the gefitnib termination. Conclusion: Compared with other site metastases, lung, brain and regional lymph nodes metastases account for major proportion of recurrence in ADJUVANT study. (NCT01405079). Keywords: non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation
JCES 01.10 The Main Treatment Failure Pattern for Completely Resected Stage IIeIIIA (N1eN2) EGFR-Mutation Positive Lung Cancer
JCES 01.11 A Multicenter, Non-Interventional Study on Real World EGFR Testing and in Patients with IIIB/IV NSCLC in Northern China
S. Xu,1 W. Zhong,2 Y. Zhang,1 W. Mao,3 L. Wu,4 Y. Shen,5 Y. Liu,6 C. Chen,7 Y. Cheng,8 L. Xu,9 J. Wang,10 K. Fei,11 X. Li,12 J. Li,13 C. Huang,14 Z. Liu,15 S. Xu,16 K. Chen,17 S. Xu,18 L. Liu,19 P. Yu,20 B. Wang,21 H. Ma,22 H. Yan,2 X. Yang,2 Y. Wu,23 Q. Wang1 1Zhongshan Hospital Fudan University, Shanghai/CN, 2Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou/CN, 3Zhejiang Cancer Hospital, Hangzhou/CN, 4 Hunan Province Cancer Hospital, Changsha/CN, 5Qing Dao University,
Y. Cheng,1 Y. Wang,2 J. Zhao,3 Y. Liu,4 H. Gao,5 K. Ma,6 S. Zhang,7 H. Xin,8 J. Liu,9 H. Chengbo,10 Z. Zhu,11 Y. Wang,12 J. Chen,13 F. Wen,14 J. Li,12 Z. Jie,15 Z. Zheng,16 Z. Dai,13 H. Piao,17 X. Li,18 Y. Li,19 M. Zhong,20 R. Ma,18 Y. Zhuang,21 Y. Xu,22 Z. Qu,23 H. Yang,24 C. Pan,25 F. Yang,26 D. Zhang,27 B. Li28 1Jilin Provincial Cancer Hospital, Changchun/CN, 2Harbin Medical University Cancer Hospital, Harbin/CN, 3Beijing Cancer Hospital, Beijing/China, 4The First Hospital of China Medical University, Shenyang/CN, 5The 307Th Hospital of
Journal of Thoracic Oncology
Vol. 12 No. 11S2: S1734-S1740
Qingdao/CN, 6Liaoning Cancer Hospital & Institute, Shenyang/CN, Fujian Medical University Union Hospital, Fuzhou/CN, 8Jilin Provincial Cancer Hospital, Changchun/CN, 9Jiangsu Cancer Hospital, Nanjing/CN, 10 Peking University People’s Hospital, Beijing/CN, 11Shanghai Pulmonary Hospital, Shanghai/CN, 12The Fourth Military Medical University, Xi’An/ CN, 13Peking University Hospital, Beijing/CN, 14Fujian Provicial Cancer Hospital, Fuzhou/CN, 15Beijing Chest Hospital, Beijing/CN, 16The First Hospital of China Medical University, Shenyang/CN, 17Peking University Cancer Hospital, Beijing/CN, 18Harbin Medical University, Heilongjiang/ CN, 19West China Hospital of Sichuan University, Chengdu/CN, 20Sichuan Cancer Hospital, Chengdu/CN, 21The Northern Jiangsu People’s Hospital, Yangzhou/CN, 22The First Affiliated Hospital of Suzhou University, Suzhou/CN, 23Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhgou/CN 7
Immunotherapy gets the breakthrough after almost 100 years of silence. PD1/PD-L1 inhibitors as the representative has been extensively studied in various human malignant tumors and get promising long term response with relatively fewer adverse event. The first PD1 inhibitor indication was approved for melanoma in Japan on July 2014. By the end of December 2016, the US Food and Drug Administration had approved several PD-1 pathway blockade treatments including nivolumab, pembrolizumab and atezolizumab using in first line and second line of NSCLC. But In China, no PD-1 or PD-L1 inhibitors have received marketing approval from the Chinese Food and Drug Administration (CFDA) until July 2017. One sides, IO arena faces intense in-class competition from both MNC (Multi-National Corporation) and domestic pharmaceutical company in China. Now there are 20 IO antibodies from 7 MNCs and 10 pharmaceutical companies in China. But all the antibodies only confined to PD1/PD-L1 and CTLA4, no other hot IO drugs such as IDO or Lag3 et al. In the field of innovation, China is several years behind research in other areas of the world. The other sides various clinical trials are actively investigating MNC and domestic drugs in China. Between January 1, 2013 and April 6, 2017, Clinical Trials.-gov registered 270 international clinical trials using PD-1/PD-L1 therapies for NSCLC (e.g.nivolumab, pembrolizumab, atezolizumab, and durvalumab). These 270 trials included 61 studies that involved East Asian sites and 14studies that involved Chinese sites (12 multinational trials and 2 trials that only evaluated Chinese patients). These trials cover from second line and first line to adjuvant therapy in NSCLC. Most of the ongoing MNC NSCLC clinical trials joined in global study design that may accelerate the patient access to PD1/PD-L1. But Chinese population has relatively high rates of hepatitis B virus infection and much higher proportion of EGFR mutation. The delightful changing recently is some studies emerging to consider the characteristics of the Chinese or Asian populations. Domestic company clinical trials focus on GI (Gastrointestinal) and only 1 NSCLC study in China. Chinese clinical trials using IO remain in their early stages, and further efforts are needed to improve the design of future clinical trials. Meanwhile, the other hot IO drug phase I study need speed up in China. Keywords: ongoing clinical trials, Immunotherapy, China
Background: ADJUVANT (CTONG 1104) is the first randomized trial shows significantly prolonged disease-free survival (DFS) in completely resected stage II-IIIA (N1-N2) epidermal growth factor receptor (EGFR)-mutation positive non-small-cell lung cancer (NSCLC) through adjuvant gefitinib compare with vinorelbine plus cisplatin (VP). Further we aim to analyze the treatment failure pattern in ADJUVANT study. Method: In the ADJUVANT trial, a total of 222 patients with completely resected stage N1eN2 EGFR-mutation positive NSCLC were randomized 1:1 into gefitinib group (250mg, QD, 24 months ) or vinorelbine (25mg/m 2 Day 1/Day 8) plus cisplatin (75mg/m 2 Day 1) group (every 3 weeks for 4 cycles) respectively. Any recurrence or metastases occurred during the follow-up period was defined as treatment failure. Recurrent pattern in both group were analyzed with follow-up data (until Mar 9 th 2017) integrated. Result: At the Data cut-off date for the primary analysis of DFS, 124 progression events (55.9% maturity overall) had occurred; 114 patients had disease recurrence，10 patients died before disease recurrence. Analyzed recurrent pattern include lung, brain, liver, bone adrenal gland, pleura, pericardium, spleen and regional lymph nodes metastasis. Even no significant differences were found, highest proportion of patients in both group(18.9% for VP and 26.1% for gefitinib, p¼0.199) surfer brain metastasis with lung metastases being the second common recurrent site. Time to brain metastases showed no significantly difference between the two groups (not reach vs 40.8m, p>0.05). Among the 29 brain metastases patients with gefitinib, the brain metastases occurred in 17 patients during the gefitinib treatment, and 12 patients relapse after the gefitnib termination. Conclusion: Compared with other site metastases, lung, brain and regional lymph nodes metastases account for major proportion of recurrence in ADJUVANT study. (NCT01405079). Keywords: non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation
JCES 01.10 The Main Treatment Failure Pattern for Completely Resected Stage IIeIIIA (N1eN2) EGFR-Mutation Positive Lung Cancer
JCES 01.11 A Multicenter, Non-Interventional Study on Real World EGFR Testing and in Patients with IIIB/IV NSCLC in Northern China
S. Xu,1 W. Zhong,2 Y. Zhang,1 W. Mao,3 L. Wu,4 Y. Shen,5 Y. Liu,6 C. Chen,7 Y. Cheng,8 L. Xu,9 J. Wang,10 K. Fei,11 X. Li,12 J. Li,13 C. Huang,14 Z. Liu,15 S. Xu,16 K. Chen,17 S. Xu,18 L. Liu,19 P. Yu,20 B. Wang,21 H. Ma,22 H. Yan,2 X. Yang,2 Y. Wu,23 Q. Wang1 1Zhongshan Hospital Fudan University, Shanghai/CN, 2Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou/CN, 3Zhejiang Cancer Hospital, Hangzhou/CN, 4 Hunan Province Cancer Hospital, Changsha/CN, 5Qing Dao University,
Y. Cheng,1 Y. Wang,2 J. Zhao,3 Y. Liu,4 H. Gao,5 K. Ma,6 S. Zhang,7 H. Xin,8 J. Liu,9 H. Chengbo,10 Z. Zhu,11 Y. Wang,12 J. Chen,13 F. Wen,14 J. Li,12 Z. Jie,15 Z. Zheng,16 Z. Dai,13 H. Piao,17 X. Li,18 Y. Li,19 M. Zhong,20 R. Ma,18 Y. Zhuang,21 Y. Xu,22 Z. Qu,23 H. Yang,24 C. Pan,25 F. Yang,26 D. Zhang,27 B. Li28 1Jilin Provincial Cancer Hospital, Changchun/CN, 2Harbin Medical University Cancer Hospital, Harbin/CN, 3Beijing Cancer Hospital, Beijing/China, 4The First Hospital of China Medical University, Shenyang/CN, 5The 307Th Hospital of
Journal of Thoracic Oncology
Vol. 12 No. 11S2: S1734-S1740