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4. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial

Author

Rischin, Danny, Hughes, Brett GM, Gao, Bo, McGrath, Margaret, Greil, Richard, Thurnher, Dietmar, Fuereder, Thorsten, Burian, Martin, Rottey, Sylvie, Machiels, Jean-Pascal, Clement, Paul M, Henry, Stéphanie, Deheneffe, Stéphanie, Vasconcelos Alves, Gustavo, Lima, Iane Pinto Figueiredo, Mourão Dias, Josiane, De Marchi, Pedro Rafael Martins, Mak, Milena Perez, Pereira de Santana Gomes, Andrea Juliana, Oliveira de Castro Junior, Dalvaro, Motta, Tatiane Cardoso, Agostinho Padoan, Monica Luciana, Victorina, Ana Paula, de Azevedo, Sergio Jobim, Siu, Lillian L, Brule, Stephanie, Hilton, John, Wang, Chang Shu, Bouganim, Nathaniel, Webster, Marc, Walker, John, Chua, Neil, Zambrano, Angela Regina, Quiroga Echeverri, Alicia, Niño Gomez, Oscar Mauricio, Ortiz, Carlos Alberto, Rojas, Luis, Cardona Zorilla, Andrés, Urrego Meléndez, Olga Marcela, Holečková, Petra Beran, Melichar, Bohuslav, Cvek, Jakub, Prausová, Jana, Vošmik, Milan, Delord, Jean-Pierre, Zasadny, Xavier, Geoffrois, Lionnel, Tao, Yungan, Pointreau, Yoann, Fietkau, Rainer, Haderlein, Marlen, Mueller, Andreas H, Schroeder, Ursula, Wollenberg, Barbara, Laban, Simon, Ivanyi, Philipp, Gruenwald, Viktor, Schafhausen, Philippe, Gutfeld, Orit, Gluck, Iris, Popovtzer, Aron, Meirovitz, Amichay, Billan, Salem, Brenner, Baruch, Limon, Dror, Licitra, Lisa, Perri, Francesco, Caponigro, Francesco, Violati, Martina, Ferrari, Daris, Nole, Franco, Bertolini, Federica, Livi, Lorenzo, Ghi, Maria Grazia, Imarisio, Ilaria, Tahara, Makoto, Homma, Akihiro, Ueda, Tsutomu, Asada, Yukinori, Yamazaki, Tomoko, Matsumoto, Koji, Fujii, Takashi, Ikeda, Sadakatsu, Takahashi, Shunji, Kinoshita, Takashi, Sasaki, Keita, Tsuji, Akihito, Ahn, Myung-Ju, Cho, Byoung Chul, Lee, Keun-Wook, Lee, Ki Hyeong, Choi, Moon Ki, Yun, Hwan Jung, Hendriks, Mathijs P, Oosting, Sjoukje F, Buter, Jan, Van Meerten, Esther, Graham, Jonathan, Kawecki, Andrzej, Debicka, Izabella, Maciejczyk, Adam, Pysz, Maciej, Filarska, Dorota, Hetnał, Marcin, Koralewski, Piotr, Wygoda, Andrzej, Składowski, Krzysztof, Talerczyk, Małgorzata, Berrocal Jaime, Alfonso, Pérez Segura, Pedro, Braña García, Irene, Basté Rotllan, Neus, Mesía Nin, Ricard, Taberna Sanz, Miren, Iglesias Docampo, Lara, Soria Rivas, Ainara, Rueda Domínguez, Antonio, Trigo Pérez, José Manuel, Hong, Ruey-Long, Li, Shau-Hsuan, Wang, Hung-Ming, Yen, Chia-Jui, Yang, Muh-Hwa, Chang, Yi-Fang, Liu, Yi-Chun, Lin, Jin-Ching, Ekenel, Meltem, Harputluoğlu, Hakan, Aksoy, Sercan, Özyilkan, Özgür, Bılıcı, Ahmet, Şendur, Mehmet Alı Nahıt, Arslan, Cagatay, Harrington, Kevin, Ramkumar, Shanmugasundaram, Gujral, Dorothy, Stewart, Simon, Powell, Melanie, Sibtain, Amen, Roques, Tom, Yip, Kent, Mirza, Arafat, Sivaramalingam, Muthiah, Belman, Neil D, Agarwala, Sanjiv, Anderson, Ian, Patel, Arpan, Maggiore, Ronald, Baumgart, Megan, Burtness, Barbara, Fidler, Mary Jo, Kaur, Varinder, Gaughan, Elizabeth, Worden, Francis, Rodriguez, Cristina P, Sukari, Ammar, Wong, Deborah, Yom, Sue, Walsh, William V, Fiorillo, Joseph A, Yorio, Jeffrey T, Obara, Grzegorz S, Alves, Gustavo, Hughes, Brett G M, Mesía, Ricard, Taberna, Miren, Waldron, John N, Simon, Christian, Grégoire, Vincent, Harrington, Kevin J, Swaby, Ramona F, Zhang, Yayan, Gumuscu, Burak, and Bidadi, Behzad

Published
2024
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6. Coupling of response biomarkers between tumor and peripheral blood in patients undergoing chemoimmunotherapy

Author

Chin, Wee Loong, Cook, Alistair M., Chee, Jonathan, Principe, Nicola, Hoang, Tracy S., Kidman, Joel, Hmon, Khaing P.W., Yeow, Yen, Jones, Matthew E., Hou, Rui, Denisenko, Elena, McDonnell, Alison M., Hon, Chung-Chau, Moody, Jonathan, Anderson, Denise, Yip, Sonia, Cummins, Michelle M., Stockler, Martin R., Kok, Peey-Sei, Brown, Chris, John, Thomas, Kao, Steven C.-H., Karikios, Deme J., O’Byrne, Kenneth J., Hughes, Brett G.M., Lake, Richard A., Forrest, Alistair R.R., Nowak, Anna K., Lassmann, Timo, and Lesterhuis, W. Joost

Published
2025
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7. A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6

Author

Hughes, Brett G.M., Guminski, Alexander, Bowyer, Samantha, Migden, Michael R., Schmults, Chrysalyne D., Khushalani, Nikhil I., Chang, Anne Lynn S., Grob, Jean-Jacques, Lewis, Karl D., Ansstas, George, Day, Fiona, Ladwa, Rahul, Stein, Brian N., Muñoz Couselo, Eva, Meier, Friedegund, Hauschild, Axel, Schadendorf, Dirk, Basset-Seguin, Nicole, Modi, Badri, Dalac-Rat, Sophie, Dunn, Lara A., Flatz, Lukas, Mortier, Laurent, Guégan, Sarah, Heinzerling, Lucie M., Mehnert, Janice M., Trabelsi, Sabiha, Soria-Rivas, Ainara, Stratigos, Alexander J., Ulrich, Claas, Wong, Deborah J., Beylot-Barry, Marie, Bossi, Paolo, Bugés Sánchez, Cristina, Chandra, Sunandana, Robert, Caroline, Russell, Jeffery S., Silk, Ann W., Booth, Jocelyn, Yoo, Suk-Young, Seebach, Frank, Lowy, Israel, Fury, Matthew G., and Rischin, Danny

Published
2025
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8. Durvalumab, Tremelimumab, and Platinum Chemotherapy in EGFR Mutation–Positive NSCLC: An Open-Label Phase 2 Trial (ILLUMINATE)

Author

Lee, Chee Khoon, Liao, Bin-Chi, Subramaniam, Shalini, Chiu, Chao-Hua, Mersiades, Antony J., Ho, Chao-Chi, Brown, Chris, Lai, Chun-Liang, Hughes, Brett G.M., Yang, Tsung-Ying, O’Byrne, Ken, Luo, Yung-Hung, Yip, Sonia, Ho, Ching-Liang, Bray, Victoria, Su, Wu-Chou, Moore, Melissa, Feng, Wei-Lien, Bai, Ya-Ying, Ford, Kate, Cummins, Michelle M., Stockler, Martin R., Solomon, Benjamin J., John, Thomas, and Chih-Hsin Yang, James

Published
2025
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9. Health-Related Quality of Life with Pembrolizumab in Patients with Locally Advanced or Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: KEYNOTE-629

Author

Bratland, Åse, Munoz-Couselo, Eva, Mortier, Laurent, Roshdy, Osama, González, Rene, Schachter, Jacob, Arance, Ana M., Grange, Florent, Meyer, Nicolas, Joshi, Abhishek Jagdish, Billan, Salem, Hughes, Brett G. M., Grob, Jean-Jacques, Ramakrishnan, Karthik, Ge, Joy, Gumuscu, Burak, Swaby, Ramona F., and Gutzmer, Ralf

Published
2023
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11. Avelumab in Combination With Lorlatinib or Crizotinib in Patients With Previously Treated Advanced NSCLC: Phase 1b/2 Results From the JAVELIN Lung 101 Trial

Author

Solomon, Benjamin J., Dagogo-Jack, Ibiayi, Lee, Se-Hoon, Boyer, Michael J., Ramalingam, Suresh S., Carcereny, Enric, Felip, Enriqueta, Han, Ji-Youn, Hida, Toyoaki, Hughes, Brett G.M., Kim, Sang-We, Nishio, Makoto, Seto, Takashi, Okamoto, Tatsuro, Zhang, Xiaoxi, Martini, Jean-Francois, Wang, Erjian, De Beukelaer, Steven, and Bauer, Todd M.

Published
2024
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14. A tailored approach to horizon scanning for cancer medicines

Author

Soon, Jennifer A., To, Yat Hang, Alexander, Marliese, Trapani, Karen, Ascierto, Paolo A., Athan, Sophy, Brown, Michael P., Burge, Matthew, Haydon, Andrew, Hughes, Brett, Itchins, Malinda, John, Thomas, Kao, Steven, Koopman, Miriam, Li, Bob T., Long, Georgina V., Loree, Jonathan M., Markman, Ben, Meniawy, Tarek M., Menzies, Alexander M., Nott, Louise, Pavlakis, Nick, Petrella, Teresa M., Popat, Sanjay, Tie, Jeanne, Xu, Wen, Yip, Desmond, Zalcberg, John, Solomon, Benjamin J., Gibbs, Peter, McArthur, Grant A., Franchini, Fanny, and IJzerman, Maarten

Published
2023
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15. Neoadjuvant cemiplimab and surgery for stage II–IV cutaneous squamous-cell carcinoma: follow-up and survival outcomes of a single-arm, multicentre, phase 2 study

Author

Gross, Neil D, Miller, David M, Khushalani, Nikhil I, Divi, Vasu, Ruiz, Emily S, Lipson, Evan J, Meier, Friedegund, Su, Yungpo Bernard, Swiecicki, Paul L, Atlas, Jennifer, Geiger, Jessica L, Hauschild, Axel, Choe, Jennifer H, Hughes, Brett G M, Schadendorf, Dirk, Patel, Vishal A, Homsi, Jade, Taube, Janis M, Lim, Annette M, Ferrarotto, Renata, Yoo, Suk-Young, Mathias, Melissa, Han, Hyunsil, Seebach, Frank, Lowy, Israel, Fury, Matthew G, and Rischin, Danny

Published
2023
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19. Adenosine 2A Receptor Blockade as an Immunotherapy for Treatment-Refractory Renal Cell Cancer

Author

Fong, Lawrence, Hotson, Andrew, Powderly, John D, Sznol, Mario, Heist, Rebecca S, Choueiri, Toni K, George, Saby, Hughes, Brett GM, Hellmann, Matthew D, Shepard, Dale R, Rini, Brian I, Kummar, Shivaani, Weise, Amy M, Riese, Matthew J, Markman, Ben, Emens, Leisha A, Mahadevan, Daruka, Luke, Jason J, Laport, Ginna, Brody, Joshua D, Hernandez-Aya, Leonel, Bonomi, Philip, Goldman, Jonathan W, Berim, Lyudmyla, Renouf, Daniel J, Goodwin, Rachel A, Munneke, Brian, Ho, Po Y, Hsieh, Jessica, McCaffery, Ian, Kwei, Long, Willingham, Stephen B, and Miller, Richard A

Subjects
Kidney Disease, Rare Diseases, Immunization, Cancer, Vaccine Related, Biotechnology, Clinical Research, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, 2.1 Biological and endogenous factors, Aetiology, Adult, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Renal Cell, Drug Resistance, Neoplasm, Female, Follow-Up Studies, Furans, Humans, Kidney Neoplasms, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Pyridines, Pyrimidines, Receptor, Adenosine A2A, Salvage Therapy, Survival Rate, Oncology and Carcinogenesis
Abstract

Adenosine mediates immunosuppression within the tumor microenvironment through triggering adenosine 2A receptors (A2AR) on immune cells. To determine whether this pathway could be targeted as an immunotherapy, we performed a phase I clinical trial with a small-molecule A2AR antagonist. We find that this molecule can safely block adenosine signaling in vivo. In a cohort of 68 patients with renal cell cancer (RCC), we also observe clinical responses alone and in combination with an anti-PD-L1 antibody, including subjects who had progressed on PD-1/PD-L1 inhibitors. Durable clinical benefit is associated with increased recruitment of CD8+ T cells into the tumor. Treatment can also broaden the circulating T-cell repertoire. Clinical responses are associated with an adenosine-regulated gene-expression signature in pretreatment tumor biopsies. A2AR signaling, therefore, represents a targetable immune checkpoint distinct from PD-1/PD-L1 that restricts antitumor immunity. SIGNIFICANCE: This first-in-human study of an A2AR antagonist for cancer treatment establishes the safety and feasibility of targeting this pathway by demonstrating antitumor activity with single-agent and anti-PD-L1 combination therapy in patients with refractory RCC. Responding patients possess an adenosine-regulated gene-expression signature in pretreatment tumor biopsies.See related commentary by Sitkovsky, p. 16.This article is highlighted in the In This Issue feature, p. 1.

Published
2020

22. Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048

Author

Rischin, Danny, Harrington, Kevin J., Greil, Richard, Soulières, Denis, Tahara, Makoto, de Castro Jr, Gilberto, Psyrri, Amanda, Braña, Irene, Neupane, Prakash, Bratland, Åse, Fuereder, Thorsten, Hughes, Brett G.M., Mesía, Ricard, Ngamphaiboon, Nuttapong, Rordorf, Tamara, Ishak, Wan Zamaniah Wan, Hong, Ruey-Long, Mendoza, René Gonzalez, Jia, Liyi, Chirovsky, Diana, Norquist, Josephine, Jin, Fan, and Burtness, Barbara

Published
2022
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23. Real‐world outcomes for patients with pleural mesothelioma: A multisite retrospective cohort study.

Author

Chow, Kar Ven Cavan, Turner, Cassie, Hughes, Brett, Lwin, Zarnie, and Chan, Bryan

Subjects
OVERALL survival, IMMUNOTHERAPY, DESCRIPTIVE statistics, PROGNOSIS, CONFIDENCE intervals
Abstract

Aim: To evaluate the real‐world treatment patterns and outcomes for patients with pleural mesothelioma (PM) in the era of immunotherapy. Methods: This retrospective audit included patients with PM diagnosed within three tertiary referral centers in Queensland, Australia from January 2017 to July 2023. Patient and treatment characteristics and outcomes were recorded. Data was analyzed using descriptive statistics and the Kaplan‐Meier survival method. Results: A total of 90 patients were included: 84% were male, the median age was 75 years (range 70–79) and 85% had baseline Eastern Group Cooperative Group of 0–1. Subtypes included 54% epithelioid, 17% biphasic, 12% sarcomatoid, and 17% unspecified/unknown. First‐line treatment was received by 57/90 patients (63%) and 33/90 patients (37%) received the best supportive care (BSC). Chemotherapy was most used (63%) overall, but first‐line immunotherapy was more commonly used since ipilimumab/nivolumab was reimbursed by the Australian Pharmaceutical Benefits Scheme in July 2021. After first‐line treatment, only 40% received second‐line treatment and 60% received BSC. 12‐month overall survival (OS) and progression‐free survival for all patients were 53% (95% confidence interval [CI]: 43–65) and 25% (95% CI 15–40) respectively. 12‐month OS was 72%, 64%, and 29% for immunotherapy, chemotherapy, and BSC, respectively. There was no significant difference in survival between chemotherapy and immunotherapy (hazard ratio 1.28, 95% CI: 0.65–2.5, p = 0.5). Conclusion: In our unselected real‐world cohort, both chemotherapy and immunotherapy are active against PM, but the prognosis remains guarded. There remains a need for better treatment options, especially in the first‐line setting. Enrolment in clinical trials is crucial to improving outcomes in this debilitating disease. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Revalidation of Proactive Gastrostomy Tube Placement Guidelines for Head and Neck Cancer Patients Receiving Helical Intensity-Modulated Radiotherapy †.

Author

Brown, Teresa E., Byrnes, Angela, Chan, Aaron C., Dwyer, Kathleen, Edwards, Anna, Blake, Claire L., Banks, Merrilyn D., Hughes, Brett G. M., Lin, Charles Y., Kenny, Lizbeth M., Spurgin, Ann-Louise, and Bauer, Judith D.

Subjects
HEAD & neck cancer, WOMEN'S hospitals, INTENSITY modulated radiotherapy, ENTERAL feeding, RISERS (Founding)
Abstract

The Royal Brisbane and Women's Hospital (RBWH) Swallowing and Nutrition Management Guidelines for Patients with Head and Neck Cancer were developed to enable evidence-based decision-making by the Head and Neck Multidisciplinary Team (H&N MDT) regarding enteral nutrition support options. The purpose of this study was to revalidate these guidelines in a cohort of patients receiving helical intensity-modulated radiotherapy (H-IMRT) compared to a historical cohort who received primarily 3D-conformal radiotherapy. Eligible patients attending the RBWH H&N MDT between 2013 and 2014 (n = 315) were assessed by the guidelines, with high-risk patients being recommended proactive gastrostomy tube placement. Data were collected on guideline adherence, gastrostomy tube insertions, the duration of enteral tube use and weight change. Sensitivity, specificity and positive predictive and negative predictive values were calculated and compared with the historical cohort. Overall guideline adherence was 84%, with 60% and 96% adherence to the high-risk and low-risk pathways, respectively. Seventy patients underwent proactive gastrostomy tube placement (n = 62 high-risk; n = 8 low-risk). Validation outcomes were sensitivity 73% (compared to 72%) and specificity 86% (compared to 96%). The guidelines yielded a high sensitivity and specificity, remaining valid in a cohort of patients treated with H-IMRT. Further studies are recommended to improve the sensitivity and understand the decrease in specificity in order to make ongoing guideline improvements. [ABSTRACT FROM AUTHOR]

Published
2024
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25. CCTG BR34: A Randomized Phase 2 Trial of Durvalumab and Tremelimumab With or Without Platinum-Based Chemotherapy in Patients With Metastatic NSCLC

Author

Leighl, Natasha B., Laurie, Scott A., Goss, Glenwood D., Hughes, Brett G.M., Stockler, Martin, Tsao, Ming-Sound, Hwang, David M., Joubert, Phillipe, Kulkarni, Swati, Blais, Normand, Joy, Anil A., Mates, Mihaela, Rana, Punam, Yadav, Sunil K., Underhill, Craig, Lee, Christopher, Bradbury, Penelope A., Hiltz, Andrea, Dancey, Janet, Ding, Keyue, and Vera-Badillo, Francisco

Published
2022
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26. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study

Author

Lerzo, Guillermo, Tatangelo, Marcelo, Varela, Mirta, Zarba, Juan Jose, Boyer, Michael, Gan, Hui, Gao, Bo, Hughes, Brett, Mallesara, Girish, Rischin, Danny, Taylor, Anne, Burian, Martin, Fuereder, Thorsten, Greil, Richard, Barrios, Carlos Henrique, de Castro Junior, Dalvaro Oliveira, Castro, Gilberto, Franke, Fabio Andre, Girotto, Gustavo, Lima, Iane Pinto Figueiredo, Nicolau, Ulisses Ribaldo, Pinto, Gustavo Dix Junqueira, Santos, Lucas, Victorino, Ana-Paula, Chua, Neil, Couture, Felix, Gregg, Richard, Hansen, Aaron, Hilton, John, McCarthy, Joy, Soulieres, Denis, Ascui, Rodrigo, Gonzalez, Pablo, Villanueva, Luis, Torregroza, Marco, Zambrano, Angela, Holeckova, Petra, Kral, Zdenek, Melichar, Bohuslav, Prausova, Jana, Vosmik, Milan, Andersen, Maria, Gyldenkerne, Niels, Jurgens, Hannes, Putnik, Kadri, Reinikainen, Petri, Gruenwald, Viktor, Laban, Simon, Aravantinos, Gerasimos, Boukovinas, Ioannis, Georgoulias, Vassilis, Psyrri, Amanda, Kwong, Dora, Al-Farhat, Yousuf, Csoszi, Tibor, Erfan, Jozsef, Horvai, Geza, Landherr, Laszlo, Remenar, Eva, Ruzsa, Agnes, Szota, Judit, Billan, Salem, Gluck, Iris, Gutfeld, Orit, Popovtzer, Aron, Benasso, Marco, Bui, Simona, Ferrari, Vittorio, Licitra, Lisa, Nole, Franco, Fujii, Takashi, Fujimoto, Yasushi, Hanai, Nobuhiro, Hara, Hiroki, Matsumoto, Koji, Mitsugi, Kenji, Monden, Nobuya, Nakayama, Masahiro, Okami, Kenji, Oridate, Nobuhiko, Shiga, Kiyoto, Shimizu, Yasushi, Sugasawa, Masashi, Tahara, Makoto, Takahashi, Masanobu, Takahashi, Shunji, Tanaka, Kaoru, Ueda, Tsutomu, Yamaguchi, Hironori, Yamazaki, Tomoko, Yasumatsu, Ryuji, Yokota, Tomoya, Yoshizaki, Tomokazu, Kudaba, Iveta, Stara, Zinaida, Wan Ishak, Wan Zamaniah, Cheah, Soon Keat, Aguilar Ponce, Jose, Gonzalez Mendoza, Rene, Hernandez Hernandez, Carlos, Medina Soto, Francisco, Buter, Jan, Hoeben, Ann, Oosting, S., Suijkerbuijk, Karijn, Bratland, Aase, Brydoey, Marianne, Alvarez, Renzo, Mas, Luis, Caguioa, Priscilla, Querol, John, Regala, Eugenio Emmanuel, Tamayo, Maria Belen, Villegas, Ellie May, Kawecki, Andrzej, Karpenko, Andrey, Klochikhin, Arkadiy, Smolin, Alexey, Zarubenkov, Oleg, Goh, Boon Cher, Cohen, Graham, du Toit, Johanna, Jordaan, Christa, Landers, Gregory, Ruff, Paul, Szpak, Waldemar, Tabane, Neonyana, Brana, Irene, Iglesias Docampo, Lara, Lavernia, Javier, Mesia, Ricard, Abel, Edvard, Muratidu, Valentina, Nielsen, Niels, Cristina, Valerie, Rordorf, Tamara, Rothschild, Sacha, Hong, Ruey-Long, Wang, Hung-Ming, Yang, Muh-Hwa, Yeh, Su-Peng, Yen, Chia-Jui, Ngamphaiboon, Nuttapong, Soparattanapaisarn, Nopadol, Sriuranpong, Virote, Aksoy, Sercan, Cicin, Irfan, Ekenel, Meltem, Harputluoglu, Hakan, Ozyilkan, Ozgur, Harrington, Kevin, Agarwala, Sanjiv, Ali, Haythem, Alter, Robert, Anderson, Daniel, Bruce, Justine, Burtness, Barbara, Campbell, Nicholas, Conde, Miguel, Deeken, John, Edenfield, William, Feldman, Lawrence, Gaughan, Elizabeth, Goueli, Basem, Halmos, Balazs, Hegde, Upendra, Hunis, Brian, Jotte, Robert, Karnad, Anand, Khan, Saad, Laudi, Noel, Laux, Douglas, Martincic, Danko, McCune, Steven, McGaughey, Dean, Misiukiewicz, Krzysztof, Mulford, Deborah, Nadler, Eric, Neupane, Prakash, Nunnink, Johannes, Ohr, James, O'Malley, Meaghan, Patson, Brian, Paul, Doru, Popa, Elizabeta, Powell, Steven, Redman, Rebecca, Rella, Vincent, Rocha Lima, Chaio, Sivapiragasam, Abirami, Su, Yungpo, Sukari, Ammar, Wong, Stuart, Yilmaz, Emrullah, Yorio, Jeffrey, Harrington, Kevin J, Soulières, Denis, de Castro, Gilberto, Jr, Basté, Neus, Bratland, Åse, Hughes, Brett G M, Mesía, Ricard, González Mendoza, René, Roy, Ananya, Zhang, Yayan, Gumuscu, Burak, Cheng, Jonathan D, and Jin, Fan

Published
2019
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27. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial

Author

Machiels, Jean-Pascal, primary, Tao, Yungan, additional, Licitra, Lisa, additional, Burtness, Barbara, additional, Tahara, Makoto, additional, Rischin, Danny, additional, Alves, Gustavo, additional, Lima, Iane Pinto Figueiredo, additional, Hughes, Brett G M, additional, Pointreau, Yoann, additional, Aksoy, Sercan, additional, Laban, Simon, additional, Greil, Richard, additional, Burian, Martin, additional, Hetnał, Marcin, additional, Delord, Jean-Pierre, additional, Mesía, Ricard, additional, Taberna, Miren, additional, Waldron, John N, additional, Simon, Christian, additional, Grégoire, Vincent, additional, Harrington, Kevin J, additional, Swaby, Ramona F, additional, Zhang, Yayan, additional, Gumuscu, Burak, additional, Bidadi, Behzad, additional, Siu, Lillian L, additional, Hughes, Brett GM, additional, Gao, Bo, additional, McGrath, Margaret, additional, Thurnher, Dietmar, additional, Fuereder, Thorsten, additional, Rottey, Sylvie, additional, Machiels, Jean-Pascal, additional, Clement, Paul M, additional, Henry, Stéphanie, additional, Deheneffe, Stéphanie, additional, Vasconcelos Alves, Gustavo, additional, Mourão Dias, Josiane, additional, De Marchi, Pedro Rafael Martins, additional, Mak, Milena Perez, additional, Pereira de Santana Gomes, Andrea Juliana, additional, Oliveira de Castro Junior, Dalvaro, additional, Motta, Tatiane Cardoso, additional, Agostinho Padoan, Monica Luciana, additional, Victorina, Ana Paula, additional, de Azevedo, Sergio Jobim, additional, Brule, Stephanie, additional, Hilton, John, additional, Wang, Chang Shu, additional, Bouganim, Nathaniel, additional, Webster, Marc, additional, Walker, John, additional, Chua, Neil, additional, Zambrano, Angela Regina, additional, Quiroga Echeverri, Alicia, additional, Niño Gomez, Oscar Mauricio, additional, Ortiz, Carlos Alberto, additional, Rojas, Luis, additional, Cardona Zorilla, Andrés, additional, Urrego Meléndez, Olga Marcela, additional, Holečková, Petra Beran, additional, Melichar, Bohuslav, additional, Cvek, Jakub, additional, Prausová, Jana, additional, Vošmik, Milan, additional, Zasadny, Xavier, additional, Geoffrois, Lionnel, additional, Fietkau, Rainer, additional, Haderlein, Marlen, additional, Mueller, Andreas H, additional, Schroeder, Ursula, additional, Wollenberg, Barbara, additional, Ivanyi, Philipp, additional, Gruenwald, Viktor, additional, Schafhausen, Philippe, additional, Gutfeld, Orit, additional, Gluck, Iris, additional, Popovtzer, Aron, additional, Meirovitz, Amichay, additional, Billan, Salem, additional, Brenner, Baruch, additional, Limon, Dror, additional, Perri, Francesco, additional, Caponigro, Francesco, additional, Violati, Martina, additional, Ferrari, Daris, additional, Nole, Franco, additional, Bertolini, Federica, additional, Livi, Lorenzo, additional, Ghi, Maria Grazia, additional, Imarisio, Ilaria, additional, Homma, Akihiro, additional, Ueda, Tsutomu, additional, Asada, Yukinori, additional, Yamazaki, Tomoko, additional, Matsumoto, Koji, additional, Fujii, Takashi, additional, Ikeda, Sadakatsu, additional, Takahashi, Shunji, additional, Kinoshita, Takashi, additional, Sasaki, Keita, additional, Tsuji, Akihito, additional, Ahn, Myung-Ju, additional, Cho, Byoung Chul, additional, Lee, Keun-Wook, additional, Lee, Ki Hyeong, additional, Choi, Moon Ki, additional, Yun, Hwan Jung, additional, Hendriks, Mathijs P, additional, Oosting, Sjoukje F, additional, Buter, Jan, additional, Van Meerten, Esther, additional, Graham, Jonathan, additional, Kawecki, Andrzej, additional, Debicka, Izabella, additional, Maciejczyk, Adam, additional, Pysz, Maciej, additional, Filarska, Dorota, additional, Koralewski, Piotr, additional, Wygoda, Andrzej, additional, Składowski, Krzysztof, additional, Talerczyk, Małgorzata, additional, Berrocal Jaime, Alfonso, additional, Pérez Segura, Pedro, additional, Braña García, Irene, additional, Basté Rotllan, Neus, additional, Mesía Nin, Ricard, additional, Taberna Sanz, Miren, additional, Iglesias Docampo, Lara, additional, Soria Rivas, Ainara, additional, Rueda Domínguez, Antonio, additional, Trigo Pérez, José Manuel, additional, Hong, Ruey-Long, additional, Li, Shau-Hsuan, additional, Wang, Hung-Ming, additional, Yen, Chia-Jui, additional, Yang, Muh-Hwa, additional, Chang, Yi-Fang, additional, Liu, Yi-Chun, additional, Lin, Jin-Ching, additional, Ekenel, Meltem, additional, Harputluoğlu, Hakan, additional, Özyilkan, Özgür, additional, Bılıcı, Ahmet, additional, Şendur, Mehmet Alı Nahıt, additional, Arslan, Cagatay, additional, Harrington, Kevin, additional, Ramkumar, Shanmugasundaram, additional, Gujral, Dorothy, additional, Stewart, Simon, additional, Powell, Melanie, additional, Sibtain, Amen, additional, Roques, Tom, additional, Yip, Kent, additional, Mirza, Arafat, additional, Sivaramalingam, Muthiah, additional, Belman, Neil D, additional, Agarwala, Sanjiv, additional, Anderson, Ian, additional, Patel, Arpan, additional, Maggiore, Ronald, additional, Baumgart, Megan, additional, Fidler, Mary Jo, additional, Kaur, Varinder, additional, Gaughan, Elizabeth, additional, Worden, Francis, additional, Rodriguez, Cristina P, additional, Sukari, Ammar, additional, Wong, Deborah, additional, Yom, Sue, additional, Walsh, William V, additional, Fiorillo, Joseph A, additional, Yorio, Jeffrey T, additional, and Obara, Grzegorz S, additional

Published
2024
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32. CD155 on Tumor Cells Drives Resistance to Immunotherapy by Inducing the Degradation of the Activating Receptor CD226 in CD8+ T Cells

Author

Braun, Matthias, Aguilera, Amelia Roman, Sundarrajan, Ashmitha, Corvino, Dillon, Stannard, Kimberley, Krumeich, Sophie, Das, Indrajit, Lima, Luize G., Meza Guzman, Lizeth G., Li, Kunlun, Li, Rui, Salim, Nazhifah, Jorge, Maria Villancanas, Ham, Sunyoung, Kelly, Gabrielle, Vari, Frank, Lepletier, Ailin, Raghavendra, Ashwini, Pearson, Sally, Madore, Jason, Jacquelin, Sebastien, Effern, Maike, Quine, Brodie, Koufariotis, Lambros T., Casey, Mika, Nakamura, Kyohei, Seo, Eun Y., Hölzel, Michael, Geyer, Matthias, Kristiansen, Glen, Taheri, Touraj, Ahern, Elizabeth, Hughes, Brett G.M., Wilmott, James S., Long, Georgina V., Scolyer, Richard A., Batstone, Martin D., Landsberg, Jennifer, Dietrich, Dimo, Pop, Oltin T., Flatz, Lukas, Dougall, William C., Veillette, André, Nicholson, Sandra E., Möller, Andreas, Johnston, Robert J., Martinet, Ludovic, Smyth, Mark J., and Bald, Tobias

Published
2020
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33. Durvalumab with first-line chemotherapy in previously untreated malignant pleural mesothelioma (DREAM): a multicentre, single-arm, phase 2 trial with a safety run-in

Author

Nowak, Anna K, Lesterhuis, W Joost, Kok, Peey-Sei, Brown, Chris, Hughes, Brett GM, Karikios, Deme J, John, Thomas, Kao, Steven C-H, Leslie, Connull, Cook, Alistair M, Pavlakis, Nick, Briscoe, Karen, O'Byrne, Kenneth J, Karapetis, Christos S, Lam, Wei-Sen, Langford, Ailsa, Yip, Sonia, and Stockler, Martin R

Published
2020
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36. Human papillomavirus associated oropharyngeal cancer now the most common mucosal head and neck cancer in Queensland

Author

Porceddu, Sandro V, primary, Negrello, Theresa, additional, Rawson, Neal, additional, Dunn, Nathan, additional, Batstone, Martin, additional, Collins, Michael, additional, Dowthwaite, Sam, additional, Hughes, Brett GM, additional, Kenny, Liz, additional, Ladwa, Rahul, additional, Panizza, Ben, additional, and Cossio, Danica, additional

Published
2024
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37. Type I interferon drives a cellular state inert to TCR-stimulation and could impede effective T-cell differentiation in cancer

Author

Corvino, Dillon, primary, Batstone, Martin, additional, Hughes, Brett G.M., additional, Kempchen, Tim, additional, Ng, Susanna S, additional, Salim, Nazhifah, additional, Schneppenheim, Franziska, additional, Rommel, Denise, additional, Kumar, Ananthi, additional, Pearson, Sally, additional, Madore, Jason, additional, Koufariotis, Lambross T, additional, Steinheuer, Lisa Maria, additional, Pathirana, Dilan, additional, Thurley, Kevin, additional, Hoelzel, Michael, additional, Borcherding, Nicholas, additional, Braun, Matthias, additional, and Bald, Tobias, additional

Published
2024
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38. High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma

Author

Rischin, Danny, primary, Hughes, Brett G M, additional, Basset-Séguin, Nicole, additional, Schadendorf, Dirk, additional, Bowyer, Samantha, additional, Trabelsi Messai, Sabiha, additional, Meier, Friedegund, additional, Eigentler, Thomas K, additional, Casado Echarren, Victoria, additional, Stein, Brian, additional, Beylot-Barry, Marie, additional, Dalac, Sophie, additional, Dréno, Brigitte, additional, Migden, Michael R, additional, Hausschild, Axel, additional, Schmults, Chrysalyne D, additional, Lim, Annette M, additional, Yoo, Suk-Young, additional, Paccaly, Anne J, additional, Papachristos, Apostolos, additional, Nguyen, Jenny-Hoa, additional, Okoye, Emmanuel, additional, Seebach, Frank, additional, Booth, Jocelyn, additional, Lowy, Israel, additional, Fury, Matthew G, additional, and Guminski, Alexander, additional

Published
2024
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40. Lurbinectedin in small cell lung cancer: Real-world experience of a multicentre national early access programme

Author

Alexander, Marliese, Rogers, Jennifer, Parakh, Sagun, Mitchell, Paul, Clay, Timothy D., Kao, Steven, Hughes, Brett G.M., Itchins, Malinda, Kong, Benjamin Y., Pavlakis, Nick, Solomon, Benjamin J., John, Thomas, Alexander, Marliese, Rogers, Jennifer, Parakh, Sagun, Mitchell, Paul, Clay, Timothy D., Kao, Steven, Hughes, Brett G.M., Itchins, Malinda, Kong, Benjamin Y., Pavlakis, Nick, Solomon, Benjamin J., and John, Thomas

Abstract

Background and Aims: Lurbinectedin is a novel oncogenic transcription inhibitor active in several cancers, including small cell lung cancer (SCLC). We aimed to describe the first Australian experience of the clinical efficacy and tolerability of lurbinectedin for the treatment of SCLC after progression on platinum-containing therapy. Methods: Multicentre real-world study of individuals with SCLC initiating lurbinectedin monotherapy (3.2 mg/m2 three-weekly) on an early access programme between May 2020 and December 2021. Key outcomes were clinical utilisation, efficacy and tolerability. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan–Meier method. Outcome data were collected within the AUstralian Registry and biObank of thoRacic cAncers (AURORA). Results: Data were analysed for 46 individuals across seven sites. Lurbinectedin was given as second- (83%, 38/46) or subsequent- (17%, 8/46) line therapy, mostly with prior chemoimmunotherapy (87%, 40/46). We report dose modifications (17%, 8/46), interruptions/delays (24%, 11/46), high-grade toxicities (28%, 13/46) and hospitalisations (54%, 25/46) during active treatment. The overall response rate was 33% and the disease control rate was 50%. Six-month OS was 44% (95% confidence interval (CI): 29.0–57.1). Twelve-month OS was 15% (95% CI: 6.5–26.8). From lurbinectedin first dose, the median PFS was 2.5 months (95% CI: 1.8–2.9) and OS was 4.5 months (95% CI: 3.5–7.2). From SCLC diagnosis, the median OS was 12.9 months (95% CI: 11.0–17.2). Individuals with a longer chemotherapy-free interval prior to lurbinectedin had longer PFS and OS. Conclusion: This real-world national experience of lurbinectedin post-platinum chemotherapy and immunotherapy for individuals with SCLC was similar to that reported in clinical trials.

Published
2024

41. Immune checkpoint inhibitor therapy for advanced cutaneous squamous cell carcinoma in Australia: A retrospective real world cohort study

Author

McLean, Luke S., Lim, Annette M., Bressel, Mathias, Lee, Jenny, Ladwa, Rahul, Guminski, Alexander D., Hughes, Brett, Bowyer, Samantha, Briscoe, Karen, Harris, Samuel, Kukard, Craig, Zielinski, Rob, Alamgeer, Muhammad, Carlino, Matteo, Mo, Jeremy, Park, John J., Khattak, Muhammad A., Day, Fiona, Rischin, Danny, McLean, Luke S., Lim, Annette M., Bressel, Mathias, Lee, Jenny, Ladwa, Rahul, Guminski, Alexander D., Hughes, Brett, Bowyer, Samantha, Briscoe, Karen, Harris, Samuel, Kukard, Craig, Zielinski, Rob, Alamgeer, Muhammad, Carlino, Matteo, Mo, Jeremy, Park, John J., Khattak, Muhammad A., Day, Fiona, and Rischin, Danny

Abstract

Objectives: To review the outcomes of immune checkpoint inhibitor (ICI) treatment of advanced cutaneous squamous cell carcinoma (CSCC) outside clinical trials. Study design: Retrospective observational study; review of patient records in fifteen Australian institutions. Setting, participants: All Australian adults with locally advanced or metastatic CSCC not amenable to curative surgery or radiotherapy treated with ICIs, 5 May 2017 – 23 May 2022, through a cemiplimab compassionate access scheme (Therapeutic Goods Administration Special Access Scheme) or who personally covered the cost of pembrolizumab prior to the start of the access scheme. Main outcome measures: Best overall response rate (ORR) according to standardised assessment criteria using the hierarchy: Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the modified World Health Organization clinical response criteria, and the Positron Emission Tomography Response Criteria (PERCIST 1.0); overall and progression-free survival. Results: A total of 286 people with advanced CSCC received ICI therapy during May 2017 – May 2022 (cemiplimab, 270; pembrolizumab, 16). Their median age was 75.2 years (range, 39.3–97.5 years) and 232 were men (81%); median follow-up time was 12.2 months (interquartile range, 5.5–20.5 months). Eighty-eight people (31%) were immunocompromised, 27 had autoimmune disease, and 59 of 277 (21%) had ECOG performance scores of 2 or 3. The ORR was 60% (166 of 278 evaluable patients): complete responses were recorded for 74 (27%) and partial responses for 92 patients (33%). Twelve-month overall survival was 78% (95% confidence interval [CI], 72–83%); progression-free survival was 65% (95% CI, 58–70%). Poorer ECOG performance status was associated with poorer overall survival (per unit: adjusted hazard ratio [aHR], 3.0; 95% CI, 2.0–4.3) and progression-free survival (aHR, 2.4; 95% CI, 1.8–3.3), as was being immunocompromised (overall: aHR, 1.8; 95% CI, 1.1–3.0; progression-free: aHR, 1.8

Published
2024

47. A phase Ib study to assess the safety of the human papillomavirus DNA vaccine (AMV002) in combination with durvalumab for HPV-associated oropharyngeal squamous cell carcinoma.

Author

Ladwa, Rahul, Chandra, Janin, Wai-Ping Woo, Finlayson, Neil, Liu, Howard, McGrath, Margaret, See, Adrienne, Hughes, Brett G., Cooper, Caroline L., Jackson, Jim E., Dzienis, Marcin, Yan Xu, Panizza, Benedict, Frazer, Ian, and Porceddu, Sandro V.

Subjects
HUMAN papillomavirus vaccines, SQUAMOUS cell carcinoma, HUMAN papillomavirus, GENITAL warts, DNA vaccines, VACCINE effectiveness
Abstract

Background: Programmed cell death ligand 1 (PD-L1) inhibitors have limited efficacy as monotherapy in patients with recurrent/metastatic (R/M) Human Papilloma Virus (HPV) oropharyngeal squamous cell carcinoma (OPSCC). A phase I study of the therapeutic HPV-16 DNA vaccine AMV002 in curatively treated patients with OPSCC demonstrated a measurable immune response against HPV while being associated with high safety and tolerability. This prospective phase Ib single centre pilot study aims to test the safety and tolerability of combined PD-L1 inhibitor, Durvalumab, with AMV002 in 12 patients with recurrent OPSCC. Methods: Participants had evidence of R/M HPV-associated OPSCC. They received three intradermal administrations of AMV002 with Durvalumab followed by Durvalumab maintenance. Safety and tolerability data was the primary endpoint. The study was conducted with ethical approval (HREC/2018/QMS/47293) in Brisbane, Australia. Findings: The most common adverse event (AE) related to vaccine administration was erythema at the injection site. There were no grade 3 or 4 vaccine related AEs. There was one presumed immune-related grade 3 elevation in lipase secondary to Durvalumab with no intervention required. No patient ceased study due to treatment-related AEs. At week 16, objective response rate was 8% (N=1) and disease control rate was 17% (N=2). At a median follow up of 25.6 (20.0-26.6) months there was one long term complete response while all other participants developed progressive disease. Of the 11 evaluated patients, 9, (82%) had E6 and/or E7-specific T cell responses to the vaccine. Conclusion: The combination of AMV002 therapeutic HPV-16 vaccine and Durvalumab was found to be safe and well tolerated with no increased safety signals generated. T cell responses to vaccine were observed but further work will be required to improve efficacy. [ABSTRACT FROM AUTHOR]

Published
2024
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48. PS3-3 Pembrolizumab + chemoradiation therapy for locally advanced head and neck squamous cell carcinoma (HNSCC): KEYNOTE-412

Author

Tahara, Makoto, primary, Machiels, Jean-Pascal, additional, Tao, Yungan, additional, Burtness, Barbara, additional, Rischin, Danny, additional, Alves, Gustavo V., additional, Figueiredo Lima, Iane Pinto, additional, Hughes, Brett G.M., additional, Pointreau, Yoann, additional, Aksoy, Sercan, additional, Laban, Simon, additional, Greil, Richard, additional, Burian, Martin, additional, Hetnal, Marcin, additional, Licitra, Lisa, additional, Swaby, Ramona, additional, Zhang, Yayan, additional, Bidadi, Behzad, additional, and Siu, Lillian L., additional

Published
2023
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