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1. Allogeneic Stem Cell Transplantation with Sequential Melphalan-Based Conditioning in AML: Residual Morphological Blast Count Determines the Risk of Relapse

Author

Sockel K, Stölzel F, Hönl F, Baldauf H, Röllig C, Wermke M, von Bonin M, Teipel R, Link-Rachner C, Brandt K, Kroschinsky F, Hänel M, Morgner A, Klesse C, Ehninger G, Platzbecker U, Bornhäuser M, Schetelig J, and Middeke JM

Subjects
acute myeloid leukemia, eln high risk, aml relapse/refractory, early allogeneic transplantation in aplasia, blast count, melphalan-based conditioning, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Katja Sockel,1 Friedrich Stölzel,1 Franziska Hönl,1 Henning Baldauf,2 Christoph Röllig,1 Martin Wermke,1 Malte von Bonin,1 Raphael Teipel,1 Cornelia Link-Rachner,1 Kalina Brandt,1 Frank Kroschinsky,1 Mathias Hänel,3 Anke Morgner,3 Christian Klesse,2 Gerhard Ehninger,1 Uwe Platzbecker,4 Martin Bornhäuser,1 Johannes Schetelig,1,2,* Jan Moritz Middeke1,* 1Medical Clinic and Policlinic I, University Hospital Carl Gustav Carus and Medical Faculty of the TU Dresden, Dresden, Germany; 2Clinical Trials Unit, DKMS, Dresden, Germany; 3Department of Medicine III, Chemnitz Hospital, Chemnitz, Germany; 4Department of Hematology, Cellular Therapy and Hemostaseology, Leipzig University Hospital, Leipzig, Germany*These authors contributed equally to this workCorrespondence: Jan Moritz Middeke, Medical Clinic and Policlinic I, University Hospital Carl Gustav Carus and Medical Faculty of the TU Dresden, Fetscherstr. 74, Dresden, 01307, Germany, Tel +49-0351-458-15603, Fax +49-0351-458-4373, Email JanMoritz.Middeke@uniklinikum-dresden.deIntroduction: Allogeneic hematopoietic cell transplantation (HCT) during chemotherapy-induced aplasia may offer long-term survival in acute myeloid leukemia (AML) with otherwise poor prognosis including ELN adverse risk, relapsed or refractory disease. However, the value of residual morphologic disease prior HCT in this context has not been conclusively settled until yet. Therefore, we aimed to investigate variables predicting outcome in this unique setting of sequential conditioning therapy, with a focus on pretreatment morphologic blast count. In contrast to the most popular FLAMSA-RIC protocol, we used a melphalan-based conditioning regimen during aplasia.Methods: We retrospectively analyzed data from 173 AML patients who underwent a sequential melphalan-based conditioning therapy between 2003 and 2015 at our centre. All patients participated either in the prospective Phase 2 BRIDGE trial (NCT01295307), the Phase 3 AML2003 study (NCT00180102) or were treated according to this protocol and underwent allogeneic HCT after melphalan-based conditioning in treatment-induced aplasia.Results: Median bone marrow blast count prior to conditioning was 10% (range, 0– 96%). Four year probabilities of EFS and OS were 34% (95% CI, 28– 43%) and 43% (95% CI, 36– 52%), respectively. In multivariate analysis, blast count > 20% was associated with worse EFS (HR = 1.93; p = 0.009) and OS (HR = 1.80; p = 0.026). This effect was not significant anymore for HCT during 1st line therapy.Conclusion: Allogeneic HCT in aplasia with a melphalan-based conditioning regimen has the potential to cure a subset of adverse risk AML patients, even with persistent morphological disease prior HCT. However, a high pre-transplant blast count still indicates patients with a dismal prognosis, especially in the relapsed patient group, for whom post-transplant strategies should be considered to further optimize post HCT outcome.Keywords: acute myeloid leukemia, ELN high risk, AML relapse/refractory, early allogeneic transplantation in aplasia, blast count, melphalan-based conditioning, sequential conditioning

Published
2022

4. Treatment outcome of atypical EGFR mutations in the German National Network Genomic Medicine Lung Cancer (nNGM)

Author

Simon, Ronald, Sauter, Guido, Volk, Alexander, Neumann, Jens, Klauschen, Frederick, Weichert, Wilko, Kalhori, Naser, Lüthen, Reinhard, Stöhr, Robert, Schubart, Chistoph, Wacker, Heidemarie, Fuchs, Florian, Hartmann, Nils, Graf, Stefanie, Brandts, Christian, Wild, Peter, Demes, Melanie, Reis, Henning, Rohde, Gernot, Janning, M., Süptitz, J., Albers-Leischner, C., Delpy, P., Tufman, A., Velthaus-Rusik, J.-L., Reck, M., Jung, A., Kauffmann-Guerrero, D., Bonzheim, I., Brändlein, S., Hummel, H.-D., Wiesweg, M., Schildhaus, H.-U., Stratmann, J.A., Sebastian, M., Alt, J., Buth, J., Esposito, I., Berger, J., Tögel, L., Saalfeld, F.C., Wermke, M., Merkelbach-Bruse, S., Hillmer, A.M., Klauschen, F., Bokemeyer, C., Buettner, R., Wolf, J., and Loges, S.

Published
2022
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5. 119O Long-term efficacy and patterns of response of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: A 4-year analysis of the C-144-01 study

Author

Medina, T., primary, Chesney, J.A., additional, Whitman, E., additional, Kluger, H., additional, Thomas, S., additional, Sarnaik, A., additional, Kirkwood, J.M., additional, Larkin, J., additional, Weber, J.S., additional, Hamid, O., additional, Wermke, M., additional, Finckenstein, F. Graf, additional, Chou, J., additional, Gastman, B., additional, Sulur, G., additional, Wu, X., additional, Shi, W., additional, and Domingo-Musibay, E., additional

Published
2023
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7. Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer

Author

Heather, W, Moishe, L, Terufumi, K, Masahiro, T, Se-Hoon, L, Shugeng, G, Ke-Neng, C, Christophe, D, Margarita, M, Ekkehard, E, Gastón L, M, Olivier, B, Delvys, R, Jamie E, C, Silvia, N, Jing, Y, Steven M, K, Ayman, S, Spicer, D Marcelo Tatangelo, J, Flores, M, Pastor, A, Puig, J, Martinengo, G, Varela, M, Brocca, C, Wong, M, Hui, R, Dooms, C, Vansteenkiste, J, Demedts, I, Sibille, A, Surmont, V, Deschepper, K, Lambrechts, M, Dias, J, Rafael Martins De Marchi, P, Alves, G, Henrique Araujo, L, Matias, D, Chaves, F, Franke, F, Teixeira, C, Tabacof, J, Faria, L, Morbeck, I, Henrique Cronemberger, E, Lima, I, Sardenberg, R, de Paiva Junior, T, Dutra, C, Luiz Guimaraes, J, Begin, P, Langleben, A, Liu, G, Liberman, M, Spicer, J, Gao, S, Zhao, G, Jiang, T, Yan, X, Hu, J, Chen, J, Tan, L, Wang, Q, Li, S, Chen, K, Yang, Y, Bai, J, Ma, S, Chen, H, Chen, Q, Wang, W, Zhang, L, Zhu, Y, Vanakesa, T, Zasadny, X, Duchemann, B, Girard, N, Bylicki, O, Berard, H, Thiberville, L, Mennecier, B, Mazieres, J, Eigendorff, E, Bonnet, R, Fix, P, Reck, M, Rittmeyer, A, Reinacher-Schick, A, Wehler, T, Lehmann, M, Serke, M, Wesseler, C, Täuscher, D, Lang, S, Wermke, M, Grohe, C, Wirtz, H, Kollmeier, J, Ritgen, M, Mueller, A, Frohling, K, Vogel, G, Faehling, M, Cuffe, S, Collins, D, Delmonte, A, Gilli, M, Piantedosi, F, Ogliari, F, Bulotta, A, Gregorc, V, Gianni, L, Grisanti, S, Intagliata, S, Roca, E, Ferrari, V, Berruti, A, Cortinovis, D, Lo Russo, G, Ferrara, R, Garassino, M, Rita Migliorino, M, Novello, S, Santoro, A, Signorelli, D, Tsuboi, M, Okada, M, Kato, T, Nishio, W, Kuroda, H, Shimizu, J, Sakao, Y, Sugio, K, Horinouchi, H, Takamochi, K, Saji, H, Tanaka, F, Ikeda, N, Muto, S, Shio, Y, Suzuki, H, Hegmane, A, Cicenas, S, Zemaitis, M, Kek Pang, Y, Yew Heng, F, Leong Yu, K, Lowczak, A, Makles, K, Bryl, M, Zurawski, B, Pawlak, I, Han, J, Lee, S, Kim, J, Yong Shim, B, Cebotaru, C, Ganea, D, Scheusan, R, Ciurescu, I, Mazilu, L, Ungureanu, A, Gal, C, Ciubotaru, E, Iordan, I, Berceanu-Ion, R, Ciuleanu, T, Laktionov, K, Karaseva, N, Smagina, M, Luft, A, Afanasyev, S, Nesterova, A, Levchenko, E, Arkhipov, A, Fedenko, A, Ruff, P, Jacobs, C, Fourie, S, Carcereny, E, Calles Blanco, A, Rodriguez Abreu, D, Majem Tarruella, M, Bosch Barrera, J, Bernabe Caro, R, Nadal Alforja, E, Martnez Marti, A, Liao, B, Huang, H, Chiu, C, Wang, C, Tsai, C, Voitko, N, Kryzhanivska, A, Kolesnik, O, Levenko, O, Bondarenko, I, Trukhin, D, Ursol, G, Paramonov, V, Sokur, I, Khan, S, Arora, A, Goranov, B, Greystoke, A, Ahmed, S, Pope, T, O'Brien, M, Charu, V, Cobb, P, Costin, D, Weksler, B, Schumacher, L, Finley, G, Furqan, M, Gentzler, R, Misleh, J, Guarino, M, Halmos, B, Keresztes, R, Jain, K, Yan Lou, Y, Molina, J, Liu-Dumlao, T, Zhao, Q, Niu, J, Taysir Hammoud, Z, Rybkin, I, Cuevo, R, Fernando, H, Schiller, J, Srkalovic, G, Koontz, M, Stampleman, L, Anderson, I, Villaruz, L, Wang, S, Komiya, T, Jain, S, Starodub, A, Wakelee, H, Kishor Ganti, A, Ernani, V, Kristedja, T, O'Day, S, Radhi, S, Sangal, A, Duvivier, H, Rich, P, Kazmi, S, Pollock, T, Chaft, J, Rathnasabapathy, C, Savvides, P, Costas, K, Kaywin, P, Villalona-Calero, M, Alekshun, T, Rao, S, Siegel, R, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Gao, Shugeng, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Keller, Steven M, Samkari, Ayman, Jonathan D Marcelo Tatangelo, Marcos Flores, Andrea Pastor, Juan Puig, Gaston Martinengo, Mirta Varela, Carlos Brocca, Mark Wong, Rina Hui, Christophe Dooms, Johan Vansteenkiste, Ingel Demedts, Anne Sibille, Veerle Surmont, Koenraad Deschepper, Marc Lambrechts, Josiane Dias, Pedro Rafael Martins De Marchi, Gustavo Alves, Luiz Henrique Araujo, Danielli Matias, Fabio Chaves, Fabio Franke, Carlos Teixeira, Jacques Tabacof, Luiza Faria, Igor Morbeck, Eduardo Henrique Cronemberger, Iane Lima, Rodrigo Sardenberg, Tadeu de Paiva Junior, Carolina Dutra, Jose Luiz Guimaraes, Paul Begin, Adrian Langleben, Geoffrey Liu, Moishe Liberman, Jonathan Spicer, Shugeng Gao, Guofang Zhao, Tao Jiang, Xiaolong Yan, Jian Hu, Jun Chen, Lijie Tan, Qun Wang, Shanqing Li, Keneng Chen, Yue Yang, Jie Bai, Shaohua Ma, Haiquan Chen, Qixun Chen, Wenxiang Wang, Lanjun Zhang, Yuming Zhu, Tonu Vanakesa, Xavier Zasadny, Boris Duchemann, Nicolas Girard, Olivier Bylicki, Henri Berard, Luc Thiberville, Bertrand Mennecier, Julien Mazieres, Ekkehard Eigendorff, Reiner Bonnet, Peter Fix, Martin Reck, Achim Rittmeyer, Anke Reinacher-Schick, Thomas Wehler, Markus Lehmann, Monika Serke, Claas Wesseler, Dagmar Täuscher, Susanne Lang, Martin Wermke, Christian Grohe, Hubert Wirtz, Jens Kollmeier, Mathias Ritgen, Annette Mueller, Klaus-Peter Frohling, Gunther Vogel, Martin Faehling, Sinead Cuffe, Dearbhaile Collins, Angelo Delmonte, Marina Gilli, Francovito Piantedosi, Francesca Ogliari, Alessandra Bulotta, Vanesa Gregorc, Luca Gianni, Salvatore Grisanti, Salvatore Intagliata, Elisa Roca, Vittorio Ferrari, Alfredo Berruti, Diego Cortinovis, Giuseppe Lo Russo, Roberto Ferrara, Marina Garassino, Maria Rita Migliorino, Silvia Novello, Armando Santoro, Diego Signorelli, Masahiro Tsuboi, Morihito Okada, Terufumi Kato, Wataru Nishio, Hiroaki Kuroda, Junichi Shimizu, Yukinori Sakao, Kenji Sugio, Hidehito Horinouchi, Kazuya Takamochi, Hisashi Saji, Fumihiro Tanaka, Norihiko Ikeda, Satoshi Muto, Yutaka Shio, Hiroyuki Suzuki, Alinta Hegmane, Saulius Cicenas, Marius Zemaitis, Yong Kek Pang, Fook Yew Heng, Kong Leong Yu, Anna Lowczak, Krytsyna Makles, Maciej Bryl, Bogdan Zurawski, Ireneusz Pawlak, Ji-Youn Han, Se-Hoon Lee, Jhingook Kim, Byoung Yong Shim, Cristina Cebotaru, Doina Ganea, Roxana Scheusan, Ioana Ciurescu, Laura Mazilu, Andrei Ungureanu, Cristian Gal, Elena Ciubotaru, Ingrid Iordan, Radu Berceanu-Ion, Tudor Ciuleanu, Konstantin Laktionov, Nina Karaseva, Maria Smagina, Alexander Luft, Sergey Afanasyev, Alfiya Nesterova, Evgeny Levchenko, Alexander Arkhipov, Alexander Fedenko, Paul Ruff, Conrad Jacobs, Samuel Fourie, Enric Carcereny, Antonio Calles Blanco, Delvys Rodriguez Abreu, Margarita Majem Tarruella, Joaquim Bosch Barrera, Reyes Bernabe Caro, Ernest Nadal Alforja, Alex Martnez Marti, Bin-Chi Liao, Hsu-Ching Huang, Chao-Hua Chiu, Chin-Chou Wang, Chen-Liang Tsai, Nataliia Voitko, Anna Kryzhanivska, Olena Kolesnik, Oleh Levenko, Oleksii Kolesnik, Igor Bondarenko, Dmytro Trukhin, Grygorii Ursol, Viktor Paramonov, Iryna Sokur, Sarah Khan, Arvind Arora, Bojidar Goranov, Alastair Greystoke, Samreen Ahmed, Tony Pope, Mary O'Brien, Veena Charu, Patrick Cobb, Dan Costin, Benny Weksler, Lana Schumacher, Gene Finley, Muhammad Furqan, Ryan Gentzler, Jamal Misleh, Michael Guarino, Balazs Halmos, Roger Keresztes, Kirti Jain, Yan Yan Lou, Julian Molina, Theresa Liu-Dumlao, Qing Zhao, Jiaxin Niu, Zane Taysir Hammoud, Igor Rybkin, Raymund Cuevo, Hiran Fernando, Joan Schiller, Gordan Srkalovic, Michael Koontz, Laura Stampleman, Ian Anderson, Liza Villaruz, Sarah Wang, Takefumi Komiya, Sushil Jain, Alexander Starodub, Heather Wakelee, Apar Kishor Ganti, Vinicius Ernani, Timothy Kristedja, Steven O'Day, Saba Radhi, Ashish Sangal, Herbert Duvivier, Patricia Rich, Shayma Kazmi, Theodore Pollock, Jamie Chaft, Chenthilmurugan Rathnasabapathy, Panayiotis Savvides, Kimberly Costas, Paul Kaywin, Miguel Villalona-Calero, Todd Alekshun, Kevin Chen, Suman Rao, Robert Siegel, Heather, W, Moishe, L, Terufumi, K, Masahiro, T, Se-Hoon, L, Shugeng, G, Ke-Neng, C, Christophe, D, Margarita, M, Ekkehard, E, Gastón L, M, Olivier, B, Delvys, R, Jamie E, C, Silvia, N, Jing, Y, Steven M, K, Ayman, S, Spicer, D Marcelo Tatangelo, J, Flores, M, Pastor, A, Puig, J, Martinengo, G, Varela, M, Brocca, C, Wong, M, Hui, R, Dooms, C, Vansteenkiste, J, Demedts, I, Sibille, A, Surmont, V, Deschepper, K, Lambrechts, M, Dias, J, Rafael Martins De Marchi, P, Alves, G, Henrique Araujo, L, Matias, D, Chaves, F, Franke, F, Teixeira, C, Tabacof, J, Faria, L, Morbeck, I, Henrique Cronemberger, E, Lima, I, Sardenberg, R, de Paiva Junior, T, Dutra, C, Luiz Guimaraes, J, Begin, P, Langleben, A, Liu, G, Liberman, M, Spicer, J, Gao, S, Zhao, G, Jiang, T, Yan, X, Hu, J, Chen, J, Tan, L, Wang, Q, Li, S, Chen, K, Yang, Y, Bai, J, Ma, S, Chen, H, Chen, Q, Wang, W, Zhang, L, Zhu, Y, Vanakesa, T, Zasadny, X, Duchemann, B, Girard, N, Bylicki, O, Berard, H, Thiberville, L, Mennecier, B, Mazieres, J, Eigendorff, E, Bonnet, R, Fix, P, Reck, M, Rittmeyer, A, Reinacher-Schick, A, Wehler, T, Lehmann, M, Serke, M, Wesseler, C, Täuscher, D, Lang, S, Wermke, M, Grohe, C, Wirtz, H, Kollmeier, J, Ritgen, M, Mueller, A, Frohling, K, Vogel, G, Faehling, M, Cuffe, S, Collins, D, Delmonte, A, Gilli, M, Piantedosi, F, Ogliari, F, Bulotta, A, Gregorc, V, Gianni, L, Grisanti, S, Intagliata, S, Roca, E, Ferrari, V, Berruti, A, Cortinovis, D, Lo Russo, G, Ferrara, R, Garassino, M, Rita Migliorino, M, Novello, S, Santoro, A, Signorelli, D, Tsuboi, M, Okada, M, Kato, T, Nishio, W, Kuroda, H, Shimizu, J, Sakao, Y, Sugio, K, Horinouchi, H, Takamochi, K, Saji, H, Tanaka, F, Ikeda, N, Muto, S, Shio, Y, Suzuki, H, Hegmane, A, Cicenas, S, Zemaitis, M, Kek Pang, Y, Yew Heng, F, Leong Yu, K, Lowczak, A, Makles, K, Bryl, M, Zurawski, B, Pawlak, I, Han, J, Lee, S, Kim, J, Yong Shim, B, Cebotaru, C, Ganea, D, Scheusan, R, Ciurescu, I, Mazilu, L, Ungureanu, A, Gal, C, Ciubotaru, E, Iordan, I, Berceanu-Ion, R, Ciuleanu, T, Laktionov, K, Karaseva, N, Smagina, M, Luft, A, Afanasyev, S, Nesterova, A, Levchenko, E, Arkhipov, A, Fedenko, A, Ruff, P, Jacobs, C, Fourie, S, Carcereny, E, Calles Blanco, A, Rodriguez Abreu, D, Majem Tarruella, M, Bosch Barrera, J, Bernabe Caro, R, Nadal Alforja, E, Martnez Marti, A, Liao, B, Huang, H, Chiu, C, Wang, C, Tsai, C, Voitko, N, Kryzhanivska, A, Kolesnik, O, Levenko, O, Bondarenko, I, Trukhin, D, Ursol, G, Paramonov, V, Sokur, I, Khan, S, Arora, A, Goranov, B, Greystoke, A, Ahmed, S, Pope, T, O'Brien, M, Charu, V, Cobb, P, Costin, D, Weksler, B, Schumacher, L, Finley, G, Furqan, M, Gentzler, R, Misleh, J, Guarino, M, Halmos, B, Keresztes, R, Jain, K, Yan Lou, Y, Molina, J, Liu-Dumlao, T, Zhao, Q, Niu, J, Taysir Hammoud, Z, Rybkin, I, Cuevo, R, Fernando, H, Schiller, J, Srkalovic, G, Koontz, M, Stampleman, L, Anderson, I, Villaruz, L, Wang, S, Komiya, T, Jain, S, Starodub, A, Wakelee, H, Kishor Ganti, A, Ernani, V, Kristedja, T, O'Day, S, Radhi, S, Sangal, A, Duvivier, H, Rich, P, Kazmi, S, Pollock, T, Chaft, J, Rathnasabapathy, C, Savvides, P, Costas, K, Kaywin, P, Villalona-Calero, M, Alekshun, T, Rao, S, Siegel, R, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Gao, Shugeng, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Keller, Steven M, Samkari, Ayman, Jonathan D Marcelo Tatangelo, Marcos Flores, Andrea Pastor, Juan Puig, Gaston Martinengo, Mirta Varela, Carlos Brocca, Mark Wong, Rina Hui, Christophe Dooms, Johan Vansteenkiste, Ingel Demedts, Anne Sibille, Veerle Surmont, Koenraad Deschepper, Marc Lambrechts, Josiane Dias, Pedro Rafael Martins De Marchi, Gustavo Alves, Luiz Henrique Araujo, Danielli Matias, Fabio Chaves, Fabio Franke, Carlos Teixeira, Jacques Tabacof, Luiza Faria, Igor Morbeck, Eduardo Henrique Cronemberger, Iane Lima, Rodrigo Sardenberg, Tadeu de Paiva Junior, Carolina Dutra, Jose Luiz Guimaraes, Paul Begin, Adrian Langleben, Geoffrey Liu, Moishe Liberman, Jonathan Spicer, Shugeng Gao, Guofang Zhao, Tao Jiang, Xiaolong Yan, Jian Hu, Jun Chen, Lijie Tan, Qun Wang, Shanqing Li, Keneng Chen, Yue Yang, Jie Bai, Shaohua Ma, Haiquan Chen, Qixun Chen, Wenxiang Wang, Lanjun Zhang, Yuming Zhu, Tonu Vanakesa, Xavier Zasadny, Boris Duchemann, Nicolas Girard, Olivier Bylicki, Henri Berard, Luc Thiberville, Bertrand Mennecier, Julien Mazieres, Ekkehard Eigendorff, Reiner Bonnet, Peter Fix, Martin Reck, Achim Rittmeyer, Anke Reinacher-Schick, Thomas Wehler, Markus Lehmann, Monika Serke, Claas Wesseler, Dagmar Täuscher, Susanne Lang, Martin Wermke, Christian Grohe, Hubert Wirtz, Jens Kollmeier, Mathias Ritgen, Annette Mueller, Klaus-Peter Frohling, Gunther Vogel, Martin Faehling, Sinead Cuffe, Dearbhaile Collins, Angelo Delmonte, Marina Gilli, Francovito Piantedosi, Francesca Ogliari, Alessandra Bulotta, Vanesa Gregorc, Luca Gianni, Salvatore Grisanti, Salvatore Intagliata, Elisa Roca, Vittorio Ferrari, Alfredo Berruti, Diego Cortinovis, Giuseppe Lo Russo, Roberto Ferrara, Marina Garassino, Maria Rita Migliorino, Silvia Novello, Armando Santoro, Diego Signorelli, Masahiro Tsuboi, Morihito Okada, Terufumi Kato, Wataru Nishio, Hiroaki Kuroda, Junichi Shimizu, Yukinori Sakao, Kenji Sugio, Hidehito Horinouchi, Kazuya Takamochi, Hisashi Saji, Fumihiro Tanaka, Norihiko Ikeda, Satoshi Muto, Yutaka Shio, Hiroyuki Suzuki, Alinta Hegmane, Saulius Cicenas, Marius Zemaitis, Yong Kek Pang, Fook Yew Heng, Kong Leong Yu, Anna Lowczak, Krytsyna Makles, Maciej Bryl, Bogdan Zurawski, Ireneusz Pawlak, Ji-Youn Han, Se-Hoon Lee, Jhingook Kim, Byoung Yong Shim, Cristina Cebotaru, Doina Ganea, Roxana Scheusan, Ioana Ciurescu, Laura Mazilu, Andrei Ungureanu, Cristian Gal, Elena Ciubotaru, Ingrid Iordan, Radu Berceanu-Ion, Tudor Ciuleanu, Konstantin Laktionov, Nina Karaseva, Maria Smagina, Alexander Luft, Sergey Afanasyev, Alfiya Nesterova, Evgeny Levchenko, Alexander Arkhipov, Alexander Fedenko, Paul Ruff, Conrad Jacobs, Samuel Fourie, Enric Carcereny, Antonio Calles Blanco, Delvys Rodriguez Abreu, Margarita Majem Tarruella, Joaquim Bosch Barrera, Reyes Bernabe Caro, Ernest Nadal Alforja, Alex Martnez Marti, Bin-Chi Liao, Hsu-Ching Huang, Chao-Hua Chiu, Chin-Chou Wang, Chen-Liang Tsai, Nataliia Voitko, Anna Kryzhanivska, Olena Kolesnik, Oleh Levenko, Oleksii Kolesnik, Igor Bondarenko, Dmytro Trukhin, Grygorii Ursol, Viktor Paramonov, Iryna Sokur, Sarah Khan, Arvind Arora, Bojidar Goranov, Alastair Greystoke, Samreen Ahmed, Tony Pope, Mary O'Brien, Veena Charu, Patrick Cobb, Dan Costin, Benny Weksler, Lana Schumacher, Gene Finley, Muhammad Furqan, Ryan Gentzler, Jamal Misleh, Michael Guarino, Balazs Halmos, Roger Keresztes, Kirti Jain, Yan Yan Lou, Julian Molina, Theresa Liu-Dumlao, Qing Zhao, Jiaxin Niu, Zane Taysir Hammoud, Igor Rybkin, Raymund Cuevo, Hiran Fernando, Joan Schiller, Gordan Srkalovic, Michael Koontz, Laura Stampleman, Ian Anderson, Liza Villaruz, Sarah Wang, Takefumi Komiya, Sushil Jain, Alexander Starodub, Heather Wakelee, Apar Kishor Ganti, Vinicius Ernani, Timothy Kristedja, Steven O'Day, Saba Radhi, Ashish Sangal, Herbert Duvivier, Patricia Rich, Shayma Kazmi, Theodore Pollock, Jamie Chaft, Chenthilmurugan Rathnasabapathy, Panayiotis Savvides, Kimberly Costas, Paul Kaywin, Miguel Villalona-Calero, Todd Alekshun, Kevin Chen, Suman Rao, and Robert Siegel

Abstract

BACKGROUND Among patients with resectable early-stage non-small-cell lung cancer (NSCLC), a perioperative approach that includes both neoadjuvant and adjuvant immune checkpoint inhibition may provide benefit beyond either approach alone. METHODS We conducted a randomized, double-blind, phase 3 trial to evaluate perioperative pembrolizumab in patients with early-stage NSCLC. Participants with resectable stage II, IIIA, or IIIB (N2 stage) NSCLC were assigned in a 1:1 ratio to receive neoadjuvant pembrolizumab (200 mg) or placebo once every 3 weeks, each of which was given with cisplatin-based chemotherapy for 4 cycles, followed by surgery and adjuvant pembrolizumab (200 mg) or placebo once every 3 weeks for up to 13 cycles. The dual primary end points were event-free survival (the time from randomization to the first occurrence of local progression that precluded the planned surgery, unresectable tumor, progression or recurrence, or death) and overall survival. Secondary end points included major pathological response, pathological complete response, and safety. RESULTS A total of 397 participants were assigned to the pembrolizumab group, and 400 to the placebo group. At the prespecified first interim analysis, the median follow-up was 25.2 months. Event-free survival at 24 months was 62.4% in the pembrolizumab group and 40.6% in the placebo group (hazard ratio for progression, recurrence, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.72; P<0.001). The estimated 24-month overall survival was 80.9% in the pembrolizumab group and 77.6% in the placebo group (P = 0.02, which did not meet the significance criterion). A major pathological response occurred in 30.2% of the participants in the pembrolizumab group and in 11.0% of those in the placebo group (difference, 19.2 percentage points; 95% CI, 13.9 to 24.7; P<0.0001; threshold, P = 0.0001), and a pathological complete response occurred in 18.1% and 4.0%, respectively (difference, 14.2 percentage points

Published
2023

8. 35MO Number of IL-2 doses and clinical outcomes of tumor-infiltrating lymphocyte (TIL) cell therapy: Post hoc analysis of the C-144-01 trial of lifileucel in patients with advanced melanoma

Author

Hassel, J.C., primary, Sarnaik, A., additional, Chesney, J., additional, Medina, T., additional, Hamid, O., additional, Thomas, S., additional, Wermke, M., additional, Domingo-Musibay, E., additional, Kirkwood, J.M., additional, Larkin, J., additional, Weber, J.S., additional, Arance Fernandez, A.M., additional, Rodriguez, J.F., additional, Thomas, I., additional, Corrie, P.G., additional, Gontcharova, V., additional, Wu, X., additional, Shi, W., additional, and Kluger, H., additional

Published
2022
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10. 1001MO Initial safety, pharmacokinetics, and anti-tumor activity data of TCER IMA401, a MAGEA4/8-directed half-life extended TCR bispecific, in phase I dose escalation.

Author

Wermke, M., Ochsenreither, S., Chatterjee, M., Gröpper, S., Häring, M-F., Heudobler, D., Jäger, D., Bleckmann, A., Spoerl, S., Knop, S., Hecker, J.S., Bunk, S., Hilf, N., Hutt, M., Mayer-Mokler, A., Missel, S., Veremchuk, O., Britten, C., and Reinhardt, C.

Subjects
*ANTINEOPLASTIC agents, *PHARMACOKINETICS, *SAFETY
Published
2024
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12. 732MO The combination of ICT01, a γ9δ2 T cell-activating mAb, plus pembrolizumab induces a broad antitumor immune response and disease control in patients with CPI-failure melanoma, NSCLC and bladder cancer: EVICTION trial

Author

Champiat, S., primary, Wermke, M., additional, Vicier, C., additional, de Bono, J.S., additional, Jungels, C., additional, Vey, N., additional, Kotecki, N., additional, Wetzko, K., additional, Ruhnke, L., additional, Garralda, E., additional, Galvao de Aguiar, V., additional, Lorusso, P., additional, de Gassart, A., additional, Valentin, E., additional, Brune, P., additional, Iche, M., additional, Leparquier, C., additional, Olive, D., additional, Marabelle, A., additional, and Frohna, P.A., additional

Published
2022
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16. Treatment outcome of atypical EGFR mutations in the German National Network Genomic Medicine Lung Cancer (nNGM)

Author

Janning, M., primary, Süptitz, J., additional, Albers-Leischner, C., additional, Delpy, P., additional, Tufman, A., additional, Velthaus-Rusik, J.-L., additional, Reck, M., additional, Jung, A., additional, Kauffmann-Guerrero, D., additional, Bonzheim, I., additional, Brändlein, S., additional, Hummel, H.-D., additional, Wiesweg, M., additional, Schildhaus, H.-U., additional, Stratmann, J.A., additional, Sebastian, M., additional, Alt, J., additional, Buth, J., additional, Esposito, I., additional, Berger, J., additional, Tögel, L., additional, Saalfeld, F.C., additional, Wermke, M., additional, Merkelbach-Bruse, S., additional, Hillmer, A.M., additional, Klauschen, F., additional, Bokemeyer, C., additional, Buettner, R., additional, Wolf, J., additional, Loges, S., additional, Simon, Ronald, additional, Sauter, Guido, additional, Volk, Alexander, additional, Neumann, Jens, additional, Klauschen, Frederick, additional, Weichert, Wilko, additional, Kalhori, Naser, additional, Lüthen, Reinhard, additional, Stöhr, Robert, additional, Schubart, Chistoph, additional, Wacker, Heidemarie, additional, Fuchs, Florian, additional, Hartmann, Nils, additional, Graf, Stefanie, additional, Brandts, Christian, additional, Wild, Peter, additional, Demes, Melanie, additional, Reis, Henning, additional, and Rohde, Gernot, additional

Published
2022
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17. P937: PRECLINICAL DISCOVERY AND EARLY FINDINGS FROM THE PHASE 1, DOSE-ESCALATION STUDY OF WVT078, A BCMA-CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH R/R MULTIPLE MYELOMA

Author

Raab, M. S., primary, Cohen, Y. C., additional, Schjesvold, F., additional, Aardalen, K., additional, Oka, A., additional, Spencer, A., additional, Wermke, M., additional, Hari, P., additional, Kaufman, J. L., additional, Cafro, A. M., additional, Ocio, E. M., additional, Doki, N., additional, Henson, K., additional, Trabucco, G., additional, Juif, P.-E., additional, Chawla, R., additional, Cotton, J., additional, Fessehatsion, A., additional, Fan, L., additional, Blankenship, J., additional, Granda, B., additional, Lu, H., additional, and De Vita, S., additional

Published
2022
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18. Treatment outcome of atypical EGFR mutations in the German National Network Genomic Medicine Lung Cancer (nNuM)

Author

Janning, M., Sueptitz, J., Albers-Leischner, C., Delpy, P., Tufman, A., Velthaus-Rusik, J-L, Reck, M., Jung, A., Kauffmann-Guerrero, D., Bonzheim, I, Braendlein, S., Hummel, H-D, Wiesweg, M., Schildhaus, H-U, Stratmann, J. A., Sebastian, M., Alt, J., Buth, J., Esposito, I, Berger, J., Toegel, L., Saalfeld, F. C., Wermke, M., Merkelbach-Bruse, S., Hillmer, A. M., Klauschen, F., Bokemeyer, C., Buettner, R., Wolf, J., Loges, S., Janning, M., Sueptitz, J., Albers-Leischner, C., Delpy, P., Tufman, A., Velthaus-Rusik, J-L, Reck, M., Jung, A., Kauffmann-Guerrero, D., Bonzheim, I, Braendlein, S., Hummel, H-D, Wiesweg, M., Schildhaus, H-U, Stratmann, J. A., Sebastian, M., Alt, J., Buth, J., Esposito, I, Berger, J., Toegel, L., Saalfeld, F. C., Wermke, M., Merkelbach-Bruse, S., Hillmer, A. M., Klauschen, F., Bokemeyer, C., Buettner, R., Wolf, J., and Loges, S.

Abstract

Background: Atypical EGFR mutations occur in 10%-30% of non-small-cell lung cancer (NSCLC) patients with EGFR mutations and their sensitivity to classical epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKI) is highly heterogeneous. Patients harboring one group of uncommon, recurrent EGFR mutations (G719X, 57681, L861Q) respond to EGFR-TKI. Exon 20 insertions are mostly insensitive to EGFR-TKI but display sensitivity to exon 20 inhibitors. Clinical outcome data of patients with very rare point and compound mutations upon systemic treatments are still sparse to date. Patients and methods: In this retrospective, multicenter study of the national Network Genomic Medicine (nNGM) in Germany, 856 NSCLC cases with atypical EGFR mutations including co-occurring mutations were reported from 12 centers. Clinical follow-up data after treatment with different EGFR-TKIs, chemotherapy and immune checkpoint inhibitors were available from 260 patients. Response to treatment was analyzed in three major groups: (i) uncommon mutations (G719X, 57681, L861Q and combinations), (ii) exon 20 insertions and (iii) very rare EGFR mutations (very rare single point mutations, compound mutations, exon 18 deletions, exon 19 insertions). Results: Our study comprises the largest thus far reported real-world cohort of very rare EGFR single point and compound mutations treated with different systemic treatments. We validated higher efficacy of EGFR-TKI in comparison to chemotherapy in group 1 (uncommon), while most exon 20 insertions (group 2) were not EGFR-TKI responsive. In addition, we found TKI sensitivity of very rare point mutations (group 3) and of complex EGFR mutations containing exon 19 deletions or L858R mutations independent of the combination partner. Notably, treatment responses in group 3 (very rare) were highly heterogeneous. Co-occurring TP53 mutations exerted a non-significant trend for a detrimental effect on outcome in EGFR-TKI-treated patients in groups 2 and

Published
2022

19. 532P Phase Ib study evaluating BI 836880 (VEGF/Ang2 nanobody) in combination with ezabenlimab (BI 754091; anti-PD-1 antibody) in patients with solid tumours

Author

Girard, N., primary, Wermke, M., additional, Ledin, E., additional, Kim, D-W., additional, Ghiringhelli, F., additional, Bennouna, J., additional, Lesimple, T., additional, Felip, E., additional, Berz, D., additional, Lee, J-S., additional, Jeanson, A., additional, Mascaux, C., additional, Voskoboynik, M., additional, Serwatowski, P., additional, Burger, M.C., additional, Landsteiner, H.T., additional, Chen, V., additional, Jayadeva, G., additional, Alt, J., additional, and Hackanson, B., additional

Published
2021
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20. 1655P Real-world outcome of patients with relapsed or refractory small cell lung cancer treated with checkpoint inhibitors in Tertiary Care Centers across Germany

Author

Stratmann, J.A., primary, Timalsina, R., additional, Atmaca, A., additional, Rosery, V., additional, Frost, N., additional, Alt, J., additional, Waller, C.F., additional, Reinmuth, N., additional, Rohde, G., additional, Wermke, M., additional, Becker von Rose, A., additional, Moeller, M., additional, and Sebastian, M., additional

Published
2021
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26. 1988MO Recruitment discontinuation in TREASURE trial (thoracic radiotherapy with atezolizumab in small cell lung cancer extensive disease) due to unexpected safety data

Author

Bozorgmehr, F., Weykamp, F., Overbeck, T.R., Maguire, N., Buchmeier, E.L., Hammer-Hellmig, M., Gauler, T.C., Wermke, M., Troost, E.G.C., Ulmer, M., Mueller, A-C., Kokowski, K., Röper, B., Wehler, T., Hey-Koch, S., Consdorf, N-S., Behnisch, R., Christopoulos, P., Thomas, M., and Rieken, S.

Published
2023
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28. 1431P The nNGM Preclinical Platform: Preclinical research to generate evidence for patients with non-small cell lung cancer harboring variants of unknown significance

Author

Ziegler, M., Albers-Leischner, C., Salgueiro, L., Khoury, N., Sharapova, Y., Saalfeld, F.C., Wenzel, C., Scharpenseel, H., Schmidt, C., Naveja-Romero, J., Meemboor, S., Hillmer, A., Nogova, L., Wermke, M., Wolf, J., Diederichs, S., Brummer, T., Büttner, R., Janning, M., and Loges, S.

Published
2023
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29. 1336P Small cell transformation in EGFR-mutated non-small cell lung cancer (EGFR+ NSCLC): Efficacy of immune checkpoint inhibitors or tyrosine kinase inhibitors combined with platinum-based chemotherapy

Author

Saalfeld, F.C., Möller, J., Michels, S., Grohe, C., Wiesweg, M., Schubart, C., Alt, J., Griesinger, F., Kauffmann-Guerrero, D., Kulhavy, J., Overbeck, T.R., Pelusi, N., Rohde, G., Wesseler, C., Vathiotis, I., Veluswamy, R., Illini, O.M., Rothschild, S.I., Christopoulos, P., and Wermke, M.

Published
2023
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34. 153P Real-world study of NSCLC with EGFR exon 20 insertions

Author

Christopoulos, P., primary, Grohé, C., additional, Griesinger, F., additional, Falkenstern-Ge, R.F., additional, Krisam, J., additional, Brückner, L., additional, Wermke, M., additional, Misch, D., additional, Hackanson, B., additional, Faehling, M., additional, Tufman, A., additional, Janning, M., additional, Schulz, C., additional, Reck, M., additional, Hong, J-L., additional, Lin, H.M., additional, Stenzinger, A., additional, and Thomas, M., additional

Published
2021
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35. CANOPY-1: Safety run-in results from phase (ph) 3 study of canakinumab (CAN) or placebo (PBO) in combination (comb) with pembrolizumab (PEM) plus platinum-based doublet chemotherapy (Ctx) as 1st line therapy in patients (pts) with advanced or metastatic NSCLC

Author

Grohe, C., Johnson, B. E., Kim, T. M., Hiltermann, T. J. N., Barlesi, F., Goto, Y., Gunnarsson, O., Overbeck, T., Reguart, N., Wermke, M., de Castro, G., Felip, E., Greystoke, A., Solomon, B. J., Deudon, S., Louveau, A. -L., Passos, V., Tan, D. S. W., and Translational Immunology Groningen (TRIGR)

Published
2020

36. EATON: A phase I dose-escalation trial of nazartinib (EGF816) and trametinib in EGFR-mutant non-small cell lung cancer (NSCLC) - preliminary data

Author

Michels, S., Westphal, T., Nogova, L., Scheffler, M., Deschler-Baier, B., Sebastian, M., Schuler, M., Wermke, M., Abdulla, D. S. Y., Fischer, R. N., Koleczko, S., Kron, A., Pinto, A., Riedel, R., Weber, J. -P., Fassunke, J., Merkelbach-Bruse, S., Haverkamp, H., Hellmich, M., Buettner, R., Wolf, J., Michels, S., Westphal, T., Nogova, L., Scheffler, M., Deschler-Baier, B., Sebastian, M., Schuler, M., Wermke, M., Abdulla, D. S. Y., Fischer, R. N., Koleczko, S., Kron, A., Pinto, A., Riedel, R., Weber, J. -P., Fassunke, J., Merkelbach-Bruse, S., Haverkamp, H., Hellmich, M., Buettner, R., and Wolf, J.

Published
2020

37. FIND: a phase II study to evaluate the efficacy of erdafitinib in FGFR-altered NSCLC

Author

Nogova, L., Malchers, F., Hillmer, A. M., Merkelbach-Bruse, S., Pinto, A., Scheel, A. H., Siemanowski, J., Ueckeroth, F., Scheffler, M., Hummel, H. -D., Kern, J., Wermke, M., Kolbe, M., Grohe, C., Stratmann, J., Sebastian, M., Trummer, A., Weber, J. -P., Westphal, T., Michels, S., Koleczko, S., Sueptitz, J., Keser, E., Kron, A., Riedel, R., Abdulla, D. S. Y., Zadoyan, G., Sweiti, H., Santiago-Walker, A., Rothe, A., Draube, A., Sandler, A., Rodermann, E., Linck, D., Thomas, R. K., Buettner, R., Wolf, J., Nogova, L., Malchers, F., Hillmer, A. M., Merkelbach-Bruse, S., Pinto, A., Scheel, A. H., Siemanowski, J., Ueckeroth, F., Scheffler, M., Hummel, H. -D., Kern, J., Wermke, M., Kolbe, M., Grohe, C., Stratmann, J., Sebastian, M., Trummer, A., Weber, J. -P., Westphal, T., Michels, S., Koleczko, S., Sueptitz, J., Keser, E., Kron, A., Riedel, R., Abdulla, D. S. Y., Zadoyan, G., Sweiti, H., Santiago-Walker, A., Rothe, A., Draube, A., Sandler, A., Rodermann, E., Linck, D., Thomas, R. K., Buettner, R., and Wolf, J.

Published
2020

43. Risk stratification of EGFR+ lung cancer diagnosed with panel-based next-generation sequencing

Author

Christopoulos, P., primary, Kirchner, M., additional, Roeper, J., additional, Saalfeld, F., additional, Janning, M., additional, Bozorgmehr, F., additional, Magios, N., additional, Kazdal, D., additional, Volckmar, A.L., additional, Brückner, L.M., additional, Bochtler, T., additional, Kriegsmann, M., additional, Endris, V., additional, Penzel, R., additional, Kriegsmann, K., additional, Eichhorn, M., additional, Herth, F.J.F., additional, Heussel, C.P., additional, El Shafie, R.A., additional, Schneider, M.A., additional, Muley, T., additional, Meister, M., additional, Faehling, M., additional, Fischer, J.R., additional, Heukamp, L., additional, Schirmacher, P., additional, Bischoff, H., additional, Wermke, M., additional, Loges, S., additional, Griesinger, F., additional, Stenzinger, A., additional, and Thomas, M., additional

Published
2020
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44. LBA58 ORR in patients receiving nivolumab plus radiotherapy in advanced non-small cell lung cancer: First results from the FORCE trial

Author

Bozorgmehr, F., primary, Fischer, J.R., additional, Bischof, M., additional, Atmaca, A., additional, Wetzel, S., additional, Faehling, M., additional, Bottke, D., additional, Wermke, M., additional, Troost, E.G.C., additional, Schmidtke-Schrezenmeier, G., additional, Wiegel, T., additional, van Laak, V., additional, Stupavsky, A., additional, Engel-Riedel, W., additional, Ingenhoff, E., additional, Reinmuth, N., additional, Krisam, J., additional, Stenzinger, A., additional, Thomas, M., additional, and Rieken, S., additional

Published
2020
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48. EATON: An open-label, multicenter, phase I dose-escalation trial of nazartinib (EGF816) and trametinib in patients with EGFR-mutant non-small cell lung cancer - preliminary data on safety and tolerability

Author

Michels, S, Nogova, L, Deschler-Baier, B, Sebastian, M, Schuler, M, Wermke, M, Felip, E, Rodriguez-Abreu, D, Rosell, R, Abdulla, DSY, Fischer, RN, Koleczko, S, Kron, A, Pinto, A, Riedel, R, Scheffler, M, Suptitz, J, Fassunke, J, Merkelbach-Bruse, S, Hellmich, M, Buttner, R, and Wolf, J

Published
2019

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