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1. Durvalumab plus platinum–etoposide versus platinum–etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN)

Author

Luis Paz-Ares, Mikhail Dvorkin, Yuanbin Chen, Niels Reinmuth, Katsuyuki Hotta, Dmytro Trukhin, Galina Statsenko, Maximilian J Hochmair, Mustafa Özgüroğlu, Jun Ho Ji, Oleksandr Voitko, Artem Poltoratskiy, Santiago Ponce, Francesco Verderame, Libor Havel, Igor Bondarenko, Andrzej Kazarnowicz, György Losonczy, Nikolay V Conev, Jon Armstrong, Natalie Byrne, Norah Shire, Haiyi Jiang, Jonathan W Goldman, Emilio Batagelj, Ignacio Casarini, Anea Viviana Pastor, Susana Noemi Sena, Juan Jose Zarba, Otto Burghuber, Sylvia Hartl, Bernd Lamprecht, Michael Studnicka, Luis Alberto Schlittler, Fabricio Augusto Martinelli de Oliveira, Aknar Calabrich, Gustavo Colagiovanni Girotto, Peo Dos Reis, Carlos Fausto Nino Gorini, Peo Rafael Martins De Marchi, Clarissa Serodio da Rocha Baldotto, Claudia Sette, Mauro Zukin, Assen Dudov, Rumyana Ilieva, Krassimir Koynov, Rositsa Krasteva, Ivan Tonev, Spartak Valev, Violetka Venkova, Minghong Bi, Chengshui Chen, Yuan Chen, Zhendong Chen, Jian Fang, Jifeng Feng, Zhigang Han, Jie Hu, Yi Hu, Wei Li, Zongan Liang, Zhong Lin, Rui Ma, Shenglin Ma, Kejun Nan, Yongqian Shu, Kai Wang, Mengzhao Wang, Gang Wu, Nong Yang, Zhixiong Yang, Helong Zhang, Wei Zhang, Jun Zhao, Yanqiu Zhao, Caicun Zhou, Jianying Zhou, Xiangdong Zhou, Vitezslav Kolek, Leona Koubkova, Jaromir Roubec, Jana Skrickova, Milada Zemanova, Christos Chouaid, Werner Hilgers, Hervé Lena, Denis Moro-Sibilot, Gilles Robinet, Pierre-Jean Souquet, Jürgen Alt, Helge Bischoff, Christian Grohe, Eckart Laack, Susanne Lang, Jens Panse, Christian Schulz, Krisztina Bogos, Eszter Csánky, Anea Fülöp, Zsolt Horváth, Judit Kósa, Ibolya Laczó, Gábor Pajkos, Zsuzsanna Pápai, Zsolt Pápai Székely, Veronika Sárosi, Attila Somfay, Éva Somogyiné Ezer, Anás Telekes, Jair Bar, Maya Gottfried, Norman Isaac Heching, Alona Zer Kuch, Roberta Bartolucci, Anna Cecilia Bettini, Angelo Delmonte, Marina Chiara Garassino, Mauro Minelli, Fausto Roila, Shinji Atagi, Koichi Azuma, Hisatsugu Goto, Koichi Goto, Yu Hara, Hidetoshi Hayashi, Toyoaki Hida, Kenya Kanazawa, Shintaro Kanda, Young Hak Kim, Shoichi Kuyama, Tadashi Maeda, Masahiro Morise, Yasuharu Nakahara, Makoto Nishio, Naoyuki Nogami, Isamu Okamoto, Haruhiro Saito, Masahiro Shinoda, Shigeki Umemura, Tatsuya Yoshida, Niels Claessens, Robin Cornelissen, Lizza Heniks, Jeroen Hiltermann, Egbert Smit, Agnes Staal van den Brekel, Dariusz Kowalski, Slawomir Mańdziuk, Robert Mróz, Marek Wojtukiewicz, Tudor Ciuleanu, Doina Ganea, Anei Ungureanu, Alexander Luft, Vladimir Moiseenko, Dina Sakaeva, Alexey Smolin, Alexander Vasilyev, Lyubov Vladimirova, Igor Anasina, Jozef Chovanec, Pavol Demo, Robert Godal, Peter Kasan, Marian Stresko, Michal Urda, Eun Kyung Cho, Joo-Hang Kim, Sang-We Kim, Gyeong-Won Lee, Jong-Seok Lee, Ki Hyeong Lee, Kyung Hee Lee, Yun Gyoo Lee, Maria Amelia Insa Molla, Manuel Domine Gomez, Juan Ignacio Delgado Mingorance, Dolores Isla Casado, Marta Lopez Brea, Margarita Majem Tarruella, Teresa Morán Bueno, Alejano Navarro Mendivil, Luis Paz-Ares Rodríguez, Santiago Ponce Aix, Maria Rosario Garcia Campelo, Gee-Chen Chang, Yen-Hsun Chen, Chao-Hua Chiu, Te-Chun Hsia, Kang-Yun Lee, Chien-Te Li, Chin-Chou Wang, Yu-Feng Wei, Shang-Yin Wu, Ahmet Alacacıoğlu, Irfan Çiçin, Ahmet Demirkazik, Mustafa Erman, Tuncay Göksel, Hryhoriy Adamchuk, Oleksii Kolesnik, Anna Kryzhanivska, Yuriv Ostapenko, Serhii Shevnia, Yaroslav Shparyk, Grygorii Ursol, Nataliia Voitko, Ihor Vynnychenko, Sunil Babu, Anne Chiang, Winston Chua, Shaker Dakhil, Afshin Dowlati, Basir Haque, Rodney Jamil, Jeanna Knoble, Shailena Lakhanpal, Kailhong Mi, Petros Nikolinakos, Steven Powell, Helen Ross, Eric Schaefer, Jeffrey Schneider, Joseph Spahr, David Spigel, Joseph Stilwill, Christopher Sumey, and Michael Williamson

Subjects
Male, medicine.medical_specialty, Lung Neoplasms, Durvalumab, Population, 030204 cardiovascular system & hematology, Antibodies, Monoclonal, Humanized, Gastroenterology, Drug Administration Schedule, Carboplatin, 03 medical and health sciences, chemistry.chemical_compound, Antineoplastic Agents, Immunological, 0302 clinical medicine, SDG 3 - Good Health and Well-being, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, 030212 general & internal medicine, Progression-free survival, education, Etoposide, Aged, education.field_of_study, Performance status, business.industry, Antibodies, Monoclonal, General Medicine, Middle Aged, Interim analysis, Antineoplastic Agents, Phytogenic, Small Cell Lung Carcinoma, Progression-Free Survival, chemistry, Female, Cisplatin, Prophylactic cranial irradiation, business, medicine.drug
Abstract

Background: Most patients with small-cell lung cancer (SCLC) have extensive-stage disease at presentation, and prognosis remains poor. Recently, immunotherapy has demonstrated clinical activity in extensive-stage SCLC (ES-SCLC). The CASPIAN trial assessed durvalumab, with or without tremelimumab, in combination with etoposide plus either cisplatin or carboplatin (platinum–etoposide) in treatment-naive patients with ES-SCLC. Methods: This randomised, open-label, phase 3 trial was done at 209 sites across 23 countries. Eligible patients were adults with untreated ES-SCLC, with WHO performance status 0 or 1 and measurable disease as per Response Evaluation Criteria in Solid Tumors, version 1.1. Patients were randomly assigned (in a 1:1:1 ratio) to durvalumab plus platinum–etoposide; durvalumab plus tremelimumab plus platinum–etoposide; or platinum–etoposide alone. All drugs were administered intravenously. Platinum–etoposide consisted of etoposide 80–100 mg/m2 on days 1–3 of each cycle with investigator's choice of either carboplatin area under the curve 5–6 mg/mL per min or cisplatin 75–80 mg/m2 (administered on day 1 of each cycle). Patients received up to four cycles of platinum–etoposide plus durvalumab 1500 mg with or without tremelimumab 75 mg every 3 weeks followed by maintenance durvalumab 1500 mg every 4 weeks in the immunotherapy groups and up to six cycles of platinum–etoposide every 3 weeks plus prophylactic cranial irradiation (investigator's discretion) in the platinum–etoposide group. The primary endpoint was overall survival in the intention-to-treat population. We report results for the durvalumab plus platinum–etoposide group versus the platinum–etoposide group from a planned interim analysis. Safety was assessed in all patients who received at least one dose of their assigned study treatment. This study is registered at ClinicalTrials.gov, NCT03043872, and is ongoing. Findings: Patients were enrolled between March 27, 2017, and May 29, 2018. 268 patients were allocated to the durvalumab plus platinum–etoposide group and 269 to the platinum–etoposide group. Durvalumab plus platinum–etoposide was associated with a significant improvement in overall survival, with a hazard ratio of 0·73 (95% CI 0·59–0·91; p=0·0047]); median overall survival was 13·0 months (95% CI 11·5–14·8) in the durvalumab plus platinum–etoposide group versus 10·3 months (9·3–11·2) in the platinum–etoposide group, with 34% (26·9–41·0) versus 25% (18·4–31·6) of patients alive at 18 months. Any-cause adverse events of grade 3 or 4 occurred in 163 (62%) of 265 treated patients in the durvalumab plus platinum–etoposide group and 166 (62%) of 266 in the platinum–etoposide group; adverse events leading to death occurred in 13 (5%) and 15 (6%) patients. Interpretation: First-line durvalumab plus platinum–etoposide significantly improved overall survival in patients with ES-SCLC versus a clinically relevant control group. Safety findings were consistent with the known safety profiles of all drugs received. Funding: AstraZeneca.

Published
2019

2. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial

Author

Tony S K Mok, Yi-Long Wu, Iveta Kudaba, Dariusz M Kowalski, Byoung Chul Cho, Hande Z Turna, Gilberto Castro, Vichien Srimuninnimit, Konstantin K Laktionov, Igor Bondarenko, Kaoru Kubota, Gregory M Lubiniecki, Jin Zhang, Debra Kush, Gilberto Lopes, Grigory Adamchuk, Myung-Ju Ahn, Aurelia Alexandru, Ozden Altundag, Anna Alyasova, Orest Andrusenko, Keisuke Aoe, Antonio Araujo, Osvaldo Aren, Oscar Arrieta Rodriguez, Touch Ativitavas, Oscar Avendano, Fernando Barata, Carlos Henrique Barrios, Carlos Beato, Per Bergstrom, Daniel Betticher, Larisa Bolotina, Michiel Botha, Sayeuri Buddu, Christian Caglevic, Andres Cardona, Hugo Castro, Filiz Cay Senler, Carlos Alexandre Sydow Cerny, Alvydas Cesas, Gee-Chen Chan, Jianhua Chang, Gongyan Chen, Xi Chen, Susanna Cheng, Ying Cheng, Nelly Cherciu, Chao-Hua Chiu, Saulius Cicenas, Daniel Ciurescu, Graham Cohen, Marcos Andre Costa, Pongwut Danchaivijitr, Flavia De Angelis, Sergio Jobim de Azevedo, Mircea Dediu, Tsvetan Deliverski, Pedro Rafael Martins De Marchi, Flor de The Bustamante Valles, Zhenyu Ding, Boyan Doganov, Lydia Dreosti, Ricardo Duarte, Regina Edusma-Dy, Sergey Emelyanov, Mustafa Erman, Yun Fan, Luis Fein, Jifeng Feng, David Fenton, Gustavo Fernandes, Carlos Ferreira, Fabio Andre Franke, Helano Freitas, Yasuhito Fujisaka, Hector Galindo, Christina Galvez, Doina Ganea, Nuno Gil, Gustavo Girotto, Erdem Goker, Tuncay Goksel, Gonzalo Gomez Aubin, Luis Gomez Wolff, Hakan Griph, Mahmut Gumus, Jacqueline Hall, Gregory Hart, Libor Havel, Jianxing He, Yong He, Carlos Hernandez Hernandez, Venceslau Hespanhol, Tomonori Hirashima, Chung Man James Ho, Atsushi Horiike, Yukio Hosomi, Katsuyuki Hotta, Mei Hou, Soon Hin How, Te-Chun Hsia, Yi Hu, Masao Ichiki, Fumio Imamura, Oleksandr Ivashchuk, Yasuo Iwamoto, Jana Jaal, Jacek Jassem, Christa Jordaan, Rosalyn Anne Juergens, Diego Kaen, Ewa Kalinka-Warzocha, Nina Karaseva, Boguslawa Karaszewska, Andrzej Kazarnowicz, Kazuo Kasahara, Nobuyuki Katakami, Terufumi Kato, Tomoya Kawaguchi, Joo Hang Kim, Kazuma Kishi, Vitezslav Kolek, Marchela Koleva, Petr Kolman, Leona Koubkova, Ruben Kowalyszyn, Dariusz Kowalski, Krassimir Koynov, Doran Ksienski, Takayasu Kurata, Gerli Kuusk, Lyudmila Kuzina, Ibolya Laczo, Guia Elena Imelda Ladrera, Konstantin Laktionov, Gregory Landers, Sergey Lazarev, Guillermo Lerzo, Krzysztof Lesniewski Kmak, Wei Li, Chong Kin Liam, Igor Lifirenko, Oleg Lipatov, Xiaoqing Liu, Zhe Liu, Sing Hung Lo, Valeria Lopes, Karla Lopez, Shun Lu, Gaston Martinengo, Luis Mas, Marina Matrosova, Rumyana Micheva, Zhasmina Milanova, Lucian Miron, Tony Mok, Matias Molina, Shuji Murakami, Yasuharu Nakahara, Tien Quang Nguyen, Takashi Nishimura, Adrian Ochsenbein, Tatsuo Ohira, Ronny Ohman, Choo Khoon Ong, Gyula Ostoros, Xuenong Ouyang, Elena Ovchinnikova, Ozgur Ozyilkan, Lubos Petruzelka, Xuan Dung Pham, Pablo Picon, Bela Piko, Artem Poltoratsky, Olga Ponomarova, Patrice Popelkova, Gunta Purkalne, Shukui Qin, Rodryg Ramlau, Bernardo Rappaport, Felipe Rey, Eduardo Richardet, Jaromir Roubec, Paul Ruff, Andrii Rusyn, Hideo Saka, Jorge Salas, Mario Sandoval, Lucas Santos, Toshiyuki Sawa, Kasan Seetalarom, Mesut Seker, Nobuhiko Seki, Freddy Seolwane, Lucinda Shepherd, Sergii Shevnya, Andrea Kazumi Shimada, Yaroslav Shparyk, Ivan Sinielnikov, Daniela Sirbu, Oren Smaletz, Joao Paulo Holanda Soares, Aumkhae Sookprasert, Giovanna Speranza, Virote Sriuranpong, Zinaida Stara, Wu-Chou Su, Shunichi Sugawara, Waldemar Szpak, Kazuhisa Takahashi, Nagio Takigawa, Hiroshi Tanaka, Jerry Tan Chun Bing, Qiyou Tang, Pavel Taranov, Hermes Tejada, Lye Mun Tho, Yoshitaro Torii, Dmytro Trukhyn, Maria Turdean, Hande Turna, Grygoriy Ursol, Jaroslav Vanasek, Mirta Varela, Marcela Vallejo, Luis Vera, Ana-Paula Victorino, Tomas Vlasek, Ihor Vynnychenko, Buhai Wang, Jie Wang, Kai Wang, Yilong Wu, Kazuhiko Yamada, Chih-Hsin Yang, Takuma Yokoyama, Toshihide Yokoyama, Hiroshige Yoshioka, Fulden Yumuk, Angela Zambrano, Juan Jose Zarba, Oleg Zarubenkov, Marius Zemaitis, Li Zhang, Xin Zhang, Jun Zhao, Caicun Zhou, Jianying Zhou, Qing Zhou, and Alfred Zippelius

Subjects
medicine.medical_specialty, Chemotherapy, education.field_of_study, Performance status, business.industry, medicine.medical_treatment, Hazard ratio, Population, Phases of clinical research, General Medicine, Pembrolizumab, 030204 cardiovascular system & hematology, medicine.disease, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Carcinoma, 030212 general & internal medicine, business, Lung cancer, education
Abstract

Background First-line pembrolizumab monotherapy improves overall and progression-free survival in patients with untreated metastatic non-small-cell lung cancer with a programmed death ligand 1 (PD-L1) tumour proportion score (TPS) of 50% or greater. We investigated overall survival after treatment with pembrolizumab monotherapy in patients with a PD-L1 TPS of 1% or greater. Methods This randomised, open-label, phase 3 study was done in 213 medical centres in 32 countries. Eligible patients were adults (≥18 years) with previously untreated locally advanced or metastatic non-small-cell lung cancer without a sensitising EGFR mutation or ALK translocation and with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, life expectancy 3 months or longer, and a PD-L1 TPS of 1% or greater. Randomisation was computer generated, accessed via an interactive voice-response and integrated web-response system, and stratified by region of enrolment (east Asia vs rest of world), ECOG performance status score (0 vs 1), histology (squamous vs non-squamous), and PD-L1 TPS (≥50% vs 1-49%). Enrolled patients were randomly assigned 1:1 in blocks of four per stratum to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles or the investigator's choice of platinum-based chemotherapy for four to six cycles. Primary endpoints were overall survival in patients with a TPS of 50% or greater, 20% or greater, and 1% or greater (one-sided significance thresholds, p=0·0122, p=0·0120, and p=0·0124, respectively) in the intention-to-treat population, assessed sequentially if the previous findings were significant. This study is registered at ClinicalTrials.gov, number NCT02220894. Findings From Dec 19, 2014, to March 6, 2017, 1274 patients (902 men, 372 women, median age 63 years [IQR 57-69]) with a PD-L1 TPS of 1% or greater were allocated to pembrolizumab (n=637) or chemotherapy (n=637) and included in the intention-to-treat population. 599 (47%) had a TPS of 50% or greater and 818 patients (64%) had a TPS of 20% or greater. As of Feb 26, 2018, median follow-up was 12·8 months. Overall survival was significantly longer in the pembrolizumab group than in the chemotherapy group in all three TPS populations (≥50% hazard ratio 0·69, 95% CI 0·56-0·85, p=0·0003; ≥20% 0·77, 0·64-0·92, p=0·0020, and ≥1% 0·81, 0·71-0·93, p=0·0018). The median surival values by TPS population were 20·0 months (95% CI 15·4-24·9) for pembrolizumab versus 12·2 months (10·4-14·2) for chemotherapy, 17·7 months (15·3-22·1) versus 13·0 months (11·6-15·3), and 16·7 months (13·9-19·7) versus 12·1 months (11·3-13·3), respectively. Treatment-related adverse events of grade 3 or worse occurred in 113 (18%) of 636 treated patients in the pembrolizumab group and in 252 (41%) of 615 in the chemotherapy group and led to death in 13 (2%) and 14 (2%) patients, respectively. Interpretation The benefit-to-risk profile suggests that pembrolizumab monotherapy can be extended as first-line therapy to patients with locally advanced or metastatic non-small-cell lung cancer without sensitising EGFR or ALK alterations and with low PD-L1 TPS. Funding Merck Sharp & Dohme.

Published
2019
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