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P3.02c-100 Nivolumab beyond First-Line (1L) Treatment in Metastatic Non-Small Cell Lung Cancer (NSCLC)
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system metastasis; 30 received 2 or more prior therapy lines and 62 had PS 1. Among 48 patients evaluated, 3% had complete response, 21% partial response, 27% disease stabilization and 21% disease progression. At the time of database lock, the median of PFS was 2.03 IC 95% (1.2-2.7) and OS was not reached. Grade 1-2 treatment related adverse events (AEs) occurred in 38 patients and the most common ones were asthenia (25), rash/pruritis (12), anorexia (7), endocrine (5) and diarrhea (4). Each of the toxicities were manageable and there were no grade 3-4 AEs or treatment-related deaths. Conclusion: Early data from this study suggests that Nivolumab is effective and well tolerated in patients with pretreated advanced NSCLC. Keywords: efficacy, anti-PD1, Nivolumab, advanced NSCLC
P3.02c-099 A Retrospective Study of the Efficacy and Safety of Nivolumab in Our Clinical Practice: A Single Institutional Experience Topic: IT Clinical Tadashi Sakaguchi,1 Osamu Hataji,1 Yuta Suzuki,1 Haruko Saiki,1 Kentaro Ito,1 Yoichi Nishii,1 Kosuke Hayashi,1 Fumiaki Watanabe,1 Tetsu Kobayashi,2 Esteban Gabazza,3 Osamu Taguchi2 1Respiratory Center, Matsusaka Municipal Hospital, Matsusaka,mie/Japan, 2Respiratory Division, Mie University Graduate School of Medicine, Tsu,mie/Japan, 3Department of Immunology, Mie University Graduate School of Medicine, Tsu,mie/Japan Background: Nivolumab is a fully humanized, IgG4 antibody that inhibits the programmed cell death protein 1 (PD-1) immune checkpoint. It has demonstrated durable responses and tolerability in patients with treatment resistant, advanced non-small-cell lung cancer (NSCLC). This retrospective study evaluates the efficacy and safety of nivolumab, which was approved for the treatment of advanced NSCLC in December 2015 in Japan. Methods: This study comprised 50 patients with advanced or recurrent NSCLC who were administered with nivolumab 3mg/kg IV every 2 weeks from December 2015 through April 2016 at Matsusaka Municipal Hospital. Results: Patient demographics were as follows: a median age of 69 years (range: 53e86); 17 females and 33 males; 12 non-smokers and 38 former or current
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smokers; 47 patients with ECOG performance status (PS) of 0 or 1 and three with a PS of 2; seven patients with postoperative recurrence, nine with post-definitive chemoradiotherapy, 31 with stage IV disease, and three with others; 14 patients with squamous cell carcinoma, 33 with adenocarcinoma, two with pleomorphic carcinoma, and one with NSCLC NOS; 17 patients received nivolumab as second-line and 33 patients as third-line therapy or later; and six patients with EGFR mutation and one with ALK rearrangement. Among 50 patients, nine showed partial response, 17 showed stable disease, and 22 showed progressive disease, 2 were not evaluated yet. Five patients experienced an initial increase in the size of their tumor lesions, but with a subsequent decrease in tumor burden. At the time of submission, the median PFS was 3.8 months, with OS yet to be evaluated. Grade 3e4 AEs occurred in seven patients, with Grade 5 AEs occurring in only one patient. Conclusion: Early data from this study suggests that nivolumab is effective and well tolerated in patients with advanced or recurrent NSCLC in a real clinical setting. Keywords: Nivolumab, NSCLC
P3.02c-100 Nivolumab beyond First-Line (1L) Treatment in Metastatic Non-Small Cell Lung Cancer (NSCLC) Topic: IT Clinical Miguel Sotelo,1 Luis Chara,2 Alejandro Riquelme,1 Piedad Toro,3 Cynthia López,2 Susana Hernando,4 Edinson Caviedes,2 Cristina Aguayo,4 Coralia Bueno,1 Xabier Mielgo Rubio4 1Medical Oncology, Hospital Universitario Infanta Cristina, Madrid/Spain, 2Medical Oncology, Hospital Universitario de Guadalajara, Guadalajara/Spain, 3Pharmacy, Hospital Universitario Fundación Alcorcón, Madrid/Spain, 4Medical Oncology, Hospital Universitario Fundación Alcorcón, Madrid/Spain Background: Patients with metastatic NSCLC progressing to 1L have a poor prognosis. Nivolumab is an antiPD-1 monoclonal antibody, which has shown to prolong overall survival (OS) in patients who have progressed to platinum-based chemotherapy. We report our experience with nivolumab in pretreated metastatic NSCLC patients. Methods: Retrospective study of patients with metastatic NSCLC treated with nivolumab (3 mg/kg every 2 weeks) in second line (2L) and subsequent lines (SL). We evaluate response rate (RR), progression-free survival (PFS), OS and toxicity.
January 2017
Results: Twenty patients were included (2L: 17, SL: 13). Median age: 68 years. Histology: Adenocarcinoma (60%), Squamous cell (33%), Large cell (7%). ECOG PS: ECOG 0-1 (83%), ECOG 2 (17%). Median number of cycles: 8. RR (Twenty-three patients evaluable for response): Complete response (9%), partial response (35%), stable disease (26%), disease progression (30%). Objective response rate (ORR) in 2L vs SL: 55% vs 33%, p¼0.30. ORR in squamous vs non-squamous: 25% vs 47%, p¼0.40. Median follow-up: 6 months. PFS and OS events at the time of analysis: 43% and 33%, respectively. Median PFS and OS: 7 months and not reached (NR), respectively. PFS in 2L vs SL: NR vs 5 months, HR 0.81, p¼0.71. PFS in squamous vs non-squamous: 5 months vs NR, HR 1.39, p¼0.58. OS in 2L vs SL: NR vs NR, HR 1.53, p¼0.50. OS in squamous vs non-squamous: 7 months vs NR, HR 2.61, p¼0.14. The incidence of adverse events was low. The most frequent toxicity (any grade) was asthenia (67%). A patient with chronic liver disease had hepatotoxicity grade 1 and continued treatment. Three patients discontinued treatment due to toxicity: pneumonitis grade 3 (1), rash grade 3 (1), impaired renal function grade 3 (1). There were no toxic deaths. Conclusion: In clinical practice, nivolumab is effective and safe in 2L and SL in patients with metastatic NSCLC. Keywords: Nivolumab, NSCLC
P3.02c-101 Immunotherapy with Nivolumab in NSCLC Patients: One Centre Preliminary Results Topic: IT Clinical Sofia Lampaki, Efimia Boutsikou, Paul Zarogoulidis, Dionisios Spyratos, Ellada Eleptheriadou, Despoina Ioannidou, Christoforos Efthimiou, Theodoros Kontakiotis, Konstantinos Zarogoulidis Pulmonary Department, G.Papanikolaou Hospital, Aristotle University of Thessaloniki, Thessaloniki/Greece Background: Nivolumab is an IgG4 monoclonal antagonist antibody to PD-1 that is approved for the treatment of patients with advanced squamous and non-squamous NSCLC with progression of disease on or after standard platinum-based chemotherapy, regardless of tumor PDL1 protein expression. The aim of our study is to evaluate the efficacy and safety of nivolumab in this group of patients. Methods: We enrolled 23 patients with squamous and non-squamous NSCLC, stage IIIB-IV,19 males and 4
Abstracts
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females, with median age 68 years who had failed two or more lines of systemic platinum based chemotherapy. All patients received at least 4 doses of nivolumab as monotherapy, at a dose of 3 mg/kg once every 2 weeks intravenously, until disease progression or unacceptable toxicity. Results: 3 (13%) of 23 patients had an objective response as assessed by RECIST criteria and all of the responses were ongoing at the time of analysis. 19 (82.6%) of 23 patients had stable disease and one experienced progression of the disease. 2 (9%) of 23 patients reported treatment-related adverse events, including peripheral edema, one (4%) with pleural effusion and one (4%) with pericardial effusion, which all were well tolerated and treated. No deaths were attributed to nivolumab. Conclusion: Nivolumab has clinically meaningful activity and a manageable safety profile in previously treated patients with advanced, resistant, squamous and non-squamous non-small cell lung cancer. Keywords: Immunotherapy, Nivolumab, non-small cell lung cancer
P3.02c-102 Safety and Tolerability of Abemaciclib Combined with LY3023414 or with Pembrolizumab in Patients with Stage IV NSCLC Topic: IT Clinical Jonathan W. Goldman,1 Mariano Provencio,2 Shadia Jalal,3 Karen Kelly,4 Edward Kim,5 Ari Vanderwalde,6 Anwar Hossain,7 William John,7 Pilar Garrido8 1UCLA Medical Center, Santa Monica/CA/ United States of America, 2Servicio de Oncología Médica Hospital Universitario Puerta de Hierro, Madrid/ Spain, 3Indiana University School of Medicine, Indianapolis/IN/United States of America, 4UC Davis Comprehensive Cancer Center, Sacramento/CA/United States of America, 5Levine Cancer Institute, Carolinas Healthcare System, Charlotte/NC/United States of America, 6The West Clinic, Memphis/TN/United States of America, 7Eli Lilly and Company, Indianapolis/IN/ United States of America, 8Hospital Universitario Ramón Y Cajal, Madrid/Spain Background: Currently, treatment options are limited for patients with advanced and/or metastatic NSCLC particularly after initial treatment. In a prior phase 1 study, abemaciclib, a CDK4 & 6 inhibitor, demonstrated
system metastasis; 30 received 2 or more prior therapy lines and 62 had PS 1. Among 48 patients evaluated, 3% had complete response, 21% partial response, 27% disease stabilization and 21% disease progression. At the time of database lock, the median of PFS was 2.03 IC 95% (1.2-2.7) and OS was not reached. Grade 1-2 treatment related adverse events (AEs) occurred in 38 patients and the most common ones were asthenia (25), rash/pruritis (12), anorexia (7), endocrine (5) and diarrhea (4). Each of the toxicities were manageable and there were no grade 3-4 AEs or treatment-related deaths. Conclusion: Early data from this study suggests that Nivolumab is effective and well tolerated in patients with pretreated advanced NSCLC. Keywords: efficacy, anti-PD1, Nivolumab, advanced NSCLC
P3.02c-099 A Retrospective Study of the Efficacy and Safety of Nivolumab in Our Clinical Practice: A Single Institutional Experience Topic: IT Clinical Tadashi Sakaguchi,1 Osamu Hataji,1 Yuta Suzuki,1 Haruko Saiki,1 Kentaro Ito,1 Yoichi Nishii,1 Kosuke Hayashi,1 Fumiaki Watanabe,1 Tetsu Kobayashi,2 Esteban Gabazza,3 Osamu Taguchi2 1Respiratory Center, Matsusaka Municipal Hospital, Matsusaka,mie/Japan, 2Respiratory Division, Mie University Graduate School of Medicine, Tsu,mie/Japan, 3Department of Immunology, Mie University Graduate School of Medicine, Tsu,mie/Japan Background: Nivolumab is a fully humanized, IgG4 antibody that inhibits the programmed cell death protein 1 (PD-1) immune checkpoint. It has demonstrated durable responses and tolerability in patients with treatment resistant, advanced non-small-cell lung cancer (NSCLC). This retrospective study evaluates the efficacy and safety of nivolumab, which was approved for the treatment of advanced NSCLC in December 2015 in Japan. Methods: This study comprised 50 patients with advanced or recurrent NSCLC who were administered with nivolumab 3mg/kg IV every 2 weeks from December 2015 through April 2016 at Matsusaka Municipal Hospital. Results: Patient demographics were as follows: a median age of 69 years (range: 53e86); 17 females and 33 males; 12 non-smokers and 38 former or current
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smokers; 47 patients with ECOG performance status (PS) of 0 or 1 and three with a PS of 2; seven patients with postoperative recurrence, nine with post-definitive chemoradiotherapy, 31 with stage IV disease, and three with others; 14 patients with squamous cell carcinoma, 33 with adenocarcinoma, two with pleomorphic carcinoma, and one with NSCLC NOS; 17 patients received nivolumab as second-line and 33 patients as third-line therapy or later; and six patients with EGFR mutation and one with ALK rearrangement. Among 50 patients, nine showed partial response, 17 showed stable disease, and 22 showed progressive disease, 2 were not evaluated yet. Five patients experienced an initial increase in the size of their tumor lesions, but with a subsequent decrease in tumor burden. At the time of submission, the median PFS was 3.8 months, with OS yet to be evaluated. Grade 3e4 AEs occurred in seven patients, with Grade 5 AEs occurring in only one patient. Conclusion: Early data from this study suggests that nivolumab is effective and well tolerated in patients with advanced or recurrent NSCLC in a real clinical setting. Keywords: Nivolumab, NSCLC
P3.02c-100 Nivolumab beyond First-Line (1L) Treatment in Metastatic Non-Small Cell Lung Cancer (NSCLC) Topic: IT Clinical Miguel Sotelo,1 Luis Chara,2 Alejandro Riquelme,1 Piedad Toro,3 Cynthia López,2 Susana Hernando,4 Edinson Caviedes,2 Cristina Aguayo,4 Coralia Bueno,1 Xabier Mielgo Rubio4 1Medical Oncology, Hospital Universitario Infanta Cristina, Madrid/Spain, 2Medical Oncology, Hospital Universitario de Guadalajara, Guadalajara/Spain, 3Pharmacy, Hospital Universitario Fundación Alcorcón, Madrid/Spain, 4Medical Oncology, Hospital Universitario Fundación Alcorcón, Madrid/Spain Background: Patients with metastatic NSCLC progressing to 1L have a poor prognosis. Nivolumab is an antiPD-1 monoclonal antibody, which has shown to prolong overall survival (OS) in patients who have progressed to platinum-based chemotherapy. We report our experience with nivolumab in pretreated metastatic NSCLC patients. Methods: Retrospective study of patients with metastatic NSCLC treated with nivolumab (3 mg/kg every 2 weeks) in second line (2L) and subsequent lines (SL). We evaluate response rate (RR), progression-free survival (PFS), OS and toxicity.
January 2017
Results: Twenty patients were included (2L: 17, SL: 13). Median age: 68 years. Histology: Adenocarcinoma (60%), Squamous cell (33%), Large cell (7%). ECOG PS: ECOG 0-1 (83%), ECOG 2 (17%). Median number of cycles: 8. RR (Twenty-three patients evaluable for response): Complete response (9%), partial response (35%), stable disease (26%), disease progression (30%). Objective response rate (ORR) in 2L vs SL: 55% vs 33%, p¼0.30. ORR in squamous vs non-squamous: 25% vs 47%, p¼0.40. Median follow-up: 6 months. PFS and OS events at the time of analysis: 43% and 33%, respectively. Median PFS and OS: 7 months and not reached (NR), respectively. PFS in 2L vs SL: NR vs 5 months, HR 0.81, p¼0.71. PFS in squamous vs non-squamous: 5 months vs NR, HR 1.39, p¼0.58. OS in 2L vs SL: NR vs NR, HR 1.53, p¼0.50. OS in squamous vs non-squamous: 7 months vs NR, HR 2.61, p¼0.14. The incidence of adverse events was low. The most frequent toxicity (any grade) was asthenia (67%). A patient with chronic liver disease had hepatotoxicity grade 1 and continued treatment. Three patients discontinued treatment due to toxicity: pneumonitis grade 3 (1), rash grade 3 (1), impaired renal function grade 3 (1). There were no toxic deaths. Conclusion: In clinical practice, nivolumab is effective and safe in 2L and SL in patients with metastatic NSCLC. Keywords: Nivolumab, NSCLC
P3.02c-101 Immunotherapy with Nivolumab in NSCLC Patients: One Centre Preliminary Results Topic: IT Clinical Sofia Lampaki, Efimia Boutsikou, Paul Zarogoulidis, Dionisios Spyratos, Ellada Eleptheriadou, Despoina Ioannidou, Christoforos Efthimiou, Theodoros Kontakiotis, Konstantinos Zarogoulidis Pulmonary Department, G.Papanikolaou Hospital, Aristotle University of Thessaloniki, Thessaloniki/Greece Background: Nivolumab is an IgG4 monoclonal antagonist antibody to PD-1 that is approved for the treatment of patients with advanced squamous and non-squamous NSCLC with progression of disease on or after standard platinum-based chemotherapy, regardless of tumor PDL1 protein expression. The aim of our study is to evaluate the efficacy and safety of nivolumab in this group of patients. Methods: We enrolled 23 patients with squamous and non-squamous NSCLC, stage IIIB-IV,19 males and 4
Abstracts
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females, with median age 68 years who had failed two or more lines of systemic platinum based chemotherapy. All patients received at least 4 doses of nivolumab as monotherapy, at a dose of 3 mg/kg once every 2 weeks intravenously, until disease progression or unacceptable toxicity. Results: 3 (13%) of 23 patients had an objective response as assessed by RECIST criteria and all of the responses were ongoing at the time of analysis. 19 (82.6%) of 23 patients had stable disease and one experienced progression of the disease. 2 (9%) of 23 patients reported treatment-related adverse events, including peripheral edema, one (4%) with pleural effusion and one (4%) with pericardial effusion, which all were well tolerated and treated. No deaths were attributed to nivolumab. Conclusion: Nivolumab has clinically meaningful activity and a manageable safety profile in previously treated patients with advanced, resistant, squamous and non-squamous non-small cell lung cancer. Keywords: Immunotherapy, Nivolumab, non-small cell lung cancer
P3.02c-102 Safety and Tolerability of Abemaciclib Combined with LY3023414 or with Pembrolizumab in Patients with Stage IV NSCLC Topic: IT Clinical Jonathan W. Goldman,1 Mariano Provencio,2 Shadia Jalal,3 Karen Kelly,4 Edward Kim,5 Ari Vanderwalde,6 Anwar Hossain,7 William John,7 Pilar Garrido8 1UCLA Medical Center, Santa Monica/CA/ United States of America, 2Servicio de Oncología Médica Hospital Universitario Puerta de Hierro, Madrid/ Spain, 3Indiana University School of Medicine, Indianapolis/IN/United States of America, 4UC Davis Comprehensive Cancer Center, Sacramento/CA/United States of America, 5Levine Cancer Institute, Carolinas Healthcare System, Charlotte/NC/United States of America, 6The West Clinic, Memphis/TN/United States of America, 7Eli Lilly and Company, Indianapolis/IN/ United States of America, 8Hospital Universitario Ramón Y Cajal, Madrid/Spain Background: Currently, treatment options are limited for patients with advanced and/or metastatic NSCLC particularly after initial treatment. In a prior phase 1 study, abemaciclib, a CDK4 & 6 inhibitor, demonstrated