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1. Dynamic Spectral fluorescence microscopy via Event-based & CMOS image-sensor fusion

Author

Baird, Richard G., Majumder, Apratim, and Menon, Rajesh

Subjects
Physics - Optics
Abstract

We present a widefield fluorescence microscope that integrates an event-based image sensor (EBIS) with a CMOS image sensor (CIS) for ultra-fast microscopy with spectral distinction capabilities. The EBIS achieves temporal resolution of $\sim10\thinspace\mu$s ($\sim\thinspace$50,000 frames/s), while the CIS provides diffraction-limited spatial resolution. A diffractive optical element encodes spectral information into a diffractogram, which is recorded by the CIS. The diffractogram is processed using a deep neural network to resolve the fluorescence of two beads, whose emission peaks are separated by only 7 nm and exhibit an 88\% spectral overlap. We validate our microscope by imaging the capillary flow of fluorescent beads, demonstrating a significant advancement in ultra-fast spectral microscopy. This technique holds broad potential for elucidating foundational dynamic biological processes.

Published
2024

2. Next generation clinical trials: Seamless designs and master protocols

Author

Burdon, Abigail, Jaki, Thomas, Chen, Xijin, Mozgunov, Pavel, Zheng, Haiyan, and Baird, Richard

Subjects
Statistics - Methodology
Abstract

Background: Drug development is often inefficient, costly and lengthy, yet it is essential for evaluating the safety and efficacy of new interventions. Compared with other disease areas, this is particularly true for Phase II / III cancer clinical trials where high attrition rates and reduced regulatory approvals are being seen. In response to these challenges, seamless clinical trials and master protocols have emerged to streamline the drug development process. Methods: Seamless clinical trials, characterized by their ability to transition seamlessly from one phase to another, can lead to accelerating the development of promising therapies while Master protocols provide a framework for investigating multiple treatment options and patient subgroups within a single trial. Results: We discuss the advantages of these methods through real trial examples and the principals that lead to their success while also acknowledging the associated regulatory considerations and challenges. Conclusion: Seamless designs and Master protocols have the potential to improve confirmatory clinical trials. In the disease area of cancer, this ultimately means that patients can receive life-saving treatments sooner., Comment: 12 manuscript pages, 2 figures and 2 tables

Published
2024

3. PI3K/AKT/mTOR signaling transduction pathway and targeted therapies in cancer.

Author

Glaviano, Antonino, Foo, Aaron, Lam, Hiu, Yap, Kenneth, Jacot, William, Jones, Robert, Eng, Huiyan, Nair, Madhumathy, Makvandi, Pooyan, Geoerger, Birgit, Kulke, Matthew, Baird, Richard, Prabhu, Jyothi, Carbone, Daniela, Pecoraro, Camilla, Teh, Daniel, Sethi, Gautam, Cavalieri, Vincenzo, Lin, Kevin, Javidi-Sharifi, Nathalie, Toska, Eneda, Davids, Matthew, Brown, Jennifer, Diana, Patrizia, Stebbing, Justin, Kumar, Alan, and Fruman, David

Subjects
AKT inhibitors, ATP-competitive mTOR inhibitors, Allosteric mTOR inhibitors, Bi-steric mTOR inhibitors, Cancer, Dual PI3K/mTOR inhibitors, Isoform-specific PI3K inhibitors, PDK1 inhibitors, PI3K/AKT/mTORC pathway, Pan PI3K inhibitors, Humans, Phosphatidylinositol 3-Kinases, Proto-Oncogene Proteins c-akt, Signal Transduction, TOR Serine-Threonine Kinases, Neoplasms
Abstract

The PI3K/AKT/mTOR (PAM) signaling pathway is a highly conserved signal transduction network in eukaryotic cells that promotes cell survival, cell growth, and cell cycle progression. Growth factor signalling to transcription factors in the PAM axis is highly regulated by multiple cross-interactions with several other signaling pathways, and dysregulation of signal transduction can predispose to cancer development. The PAM axis is the most frequently activated signaling pathway in human cancer and is often implicated in resistance to anticancer therapies. Dysfunction of components of this pathway such as hyperactivity of PI3K, loss of function of PTEN, and gain-of-function of AKT, are notorious drivers of treatment resistance and disease progression in cancer. In this review we highlight the major dysregulations in the PAM signaling pathway in cancer, and discuss the results of PI3K, AKT and mTOR inhibitors as monotherapy and in co-administation with other antineoplastic agents in clinical trials as a strategy for overcoming treatment resistance. Finally, the major mechanisms of resistance to PAM signaling targeted therapies, including PAM signaling in immunology and immunotherapies are also discussed.

Published
2023

4. Adaptive enrichment trial designs using joint modeling of longitudinal and time-to-event data

Author

Burdon, Abigail J., Baird, Richard D., and Jaki, Thomas

Subjects
Statistics - Methodology
Abstract

Adaptive enrichment allows for pre-defined patient subgroups of interest to be investigated throughout the course of a clinical trial. Many trials which measure a long-term time-to-event endpoint often also routinely collect repeated measures on biomarkers which may be predictive of the primary endpoint. Although these data may not be leveraged directly to support subgroup selection decisions and early stopping decisions, we aim to make greater use of these data to increase efficiency and improve interim decision making. In this work, we present a joint model for longitudinal and time-to-event data and two methods for creating standardised statistics based on this joint model. We can use the estimates to define enrichment rules and efficacy and futility early stopping rules for a flexible efficient clinical trial with possible enrichment. Under this framework, we show asymptotically that the familywise error rate is protected in the strong sense. To assess the results, we consider a trial for the treatment of metastatic breast cancer where repeated ctDNA measurements are available and the subgroup criteria is defined by patients' ER and HER2 status. Using simulation, we show that incorporating biomarker information leads to accurate subgroup identification and increases in power., Comment: Main paper consists of 14 pages (inclusive of 3 figures and 2 tables). Supplementary materials consist of 14 pages

Published
2023

6. Mechanisms of sensitivity and resistance to CDK4/CDK6 inhibitors in hormone receptor-positive breast cancer treatment

Author

Glaviano, Antonino, Wander, Seth A., Baird, Richard D., Yap, Kenneth C.-H., Lam, Hiu Yan, Toi, Masakazu, Carbone, Daniela, Geoerger, Birgit, Serra, Violeta, Jones, Robert H., Ngeow, Joanne, Toska, Eneda, Stebbing, Justin, Crasta, Karen, Finn, Richard S., Diana, Patrizia, Vuina, Karla, de Bruin, Robertus A.M., Surana, Uttam, Bardia, Aditya, and Kumar, Alan Prem

Published
2024
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7. Author Correction: Dose escalation and expansion cohorts in patients with advanced breast cancer in a Phase I study of the CDK7-inhibitor samuraciclib

Author

Coombes, R. C., Howell, Sacha, Lord, Simon R., Kenny, Laura, Mansi, Janine, Mitri, Zahi, Palmieri, Carlo, Chap, Linnea I., Richards, Paul, Gradishar, William, Sardesai, Sagar, Melear, Jason, O’Shaughnessy, Joyce, Ward, Patrick, Chalasani, Pavani, Arkenau, Tobias, Baird, Richard D., Jeselsohn, Rinath, Ali, Simak, Clack, Glen, Bahl, Ashwani, McIntosh, Stuart, and Krebs, Matthew G.

Published
2023
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8. Dose escalation and expansion cohorts in patients with advanced breast cancer in a Phase I study of the CDK7-inhibitor samuraciclib

Author

Coombes, R. C., Howell, Sacha, Lord, Simon R., Kenny, Laura, Mansi, Janine, Mitri, Zahi, Palmieri, Carlo, Chap, Linnea I., Richards, Paul, Gradishar, William, Sardesai, Sagar, Melear, Jason, O’Shaughnessy, Joyce, Ward, Patrick, Chalasani, Pavani, Arkenau, Tobias, Baird, Richard D., Jeselsohn, Rinath, Ali, Simak, Clack, Glen, Bahl, Ashwani, McIntosh, Stuart, and Krebs, Matthew G.

Published
2023
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11. Adaptive enrichment trial designs using joint modelling of longitudinal and time-to-event data.

Author

Burdon, Abigail J, Baird, Richard D, and Jaki, Thomas

Subjects
*METASTATIC breast cancer, *ERROR rates, *BIOMARKERS, *CLINICAL trials, *DATA modeling
Abstract

Adaptive enrichment allows for pre-defined patient subgroups of interest to be investigated throughout the course of a clinical trial. These designs have gained attention in recent years because of their potential to shorten the trial's duration and identify effective therapies tailored to specific patient groups. We describe enrichment trials which consider long-term time-to-event outcomes but also incorporate additional short-term information from routinely collected longitudinal biomarkers. These methods are suitable for use in the setting where the trajectory of the biomarker may differ between subgroups and it is believed that the long-term endpoint is influenced by treatment, subgroup and biomarker. Methods are most promising when the majority of patients have biomarker measurements for at least two time points. We implement joint modelling of longitudinal and time-to-event data to define subgroup selection and stopping criteria and we show that the familywise error rate is protected in the strong sense. To assess the results, we perform a simulation study and find that, compared to the study where longitudinal biomarker observations are ignored, incorporating biomarker information leads to increases in power and the (sub)population which truly benefits from the experimental treatment being enriched with higher probability at the interim analysis. The investigations are motivated by a trial for the treatment of metastatic breast cancer and the parameter values for the simulation study are informed using real-world data where repeated circulating tumour DNA measurements and HER2 statuses are available for each patient and are used as our longitudinal data and subgroup identifiers, respectively. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Using Least-Significant Bit and Random Pixel Encoding with Encryption for Image Steganography

Author

Soni, Tapan, Baird, Richard, Lobo, Andrea, Heydari, Vahid, Kacprzyk, Janusz, Series Editor, Pal, Nikhil R., Advisory Editor, Bello Perez, Rafael, Advisory Editor, Corchado, Emilio S., Advisory Editor, Hagras, Hani, Advisory Editor, Kóczy, László T., Advisory Editor, Kreinovich, Vladik, Advisory Editor, Lin, Chin-Teng, Advisory Editor, Lu, Jie, Advisory Editor, Melin, Patricia, Advisory Editor, Nedjah, Nadia, Advisory Editor, Nguyen, Ngoc Thanh, Advisory Editor, Wang, Jun, Advisory Editor, Choo, Kim-Kwang Raymond, editor, Morris, Tommy, editor, Peterson, Gilbert L., editor, and Imsand, Eric, editor

Published
2021
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14. The Molecular Tumor Board Portal supports clinical decisions and automated reporting for precision oncology

Author

Tamborero, David, Dienstmann, Rodrigo, Rachid, Maan Haj, Boekel, Jorrit, Lopez-Fernandez, Adria, Jonsson, Markus, Razzak, Ali, Braña, Irene, De Petris, Luigi, Yachnin, Jeffrey, Baird, Richard D., Loriot, Yohann, Massard, Christophe, Martin-Romano, Patricia, Opdam, Frans, Schlenk, Richard F., Vernieri, Claudio, Masucci, Michele, Villalobos, Xenia, Chavarria, Elena, Balmaña, Judith, Apolone, Giovanni, Caldas, Carlos, Bergh, Jonas, Ernberg, Ingemar, Fröhling, Stefan, Garralda, Elena, Karlsson, Claes, Tabernero, Josep, Voest, Emile, Rodon, Jordi, and Lehtiö, Janne

Published
2022
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15. Discriminating subtypes in advanced breast cancer with ctDNA methylation profiling.

Author

Pasha, Nida, primary, Cutts, Ros, additional, Amenssag, Aya, additional, Hrebien, Sarah, additional, Gulati, Aditi, additional, Gao, Qiong, additional, Haider, Syed, additional, Roylance, Rebecca, additional, Tutt, Andrew N. J., additional, Baird, Richard D., additional, MacPherson, Iain R., additional, Ring, Alistair E., additional, Johnston, Stephen R. D., additional, Okines, Alicia Frances Clare, additional, Garcia-Murillas, Isaac, additional, Filippi, Sarah, additional, and Turner, Nicholas C., additional

Published
2024
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17. Imaging breast cancer using hyperpolarized carbon-13 MRI

Author

Gallagher, Ferdia A., Woitek, Ramona, McLean, Mary A., Gill, Andrew B., Garcia, Raquel Manzano, Provenzano, Elena, Riemer, Frank, Kaggie, Joshua, Chhabra, Anita, Ursprung, Stephan, Grist, James T., Daniels, Charlie J., Zaccagna, Fulvio, Laurent, Marie-Christine, Locke, Matthew, Hilborne, Sarah, Frary, Amy, Torheim, Turid, Boursnell, Chris, Schiller, Amy, Patterson, Ilse, Slough, Rhys, Carmo, Bruno, Kane, Justine, Biggs, Heather, Harrison, Emma, Deen, Surrin S., Patterson, Andrew, Lanz, Titus, Kingsbury, Zoya, Ross, Mark, Basu, Bristi, Baird, Richard, Lomas, David J., Sala, Evis, Wason, James, Rueda, Oscar M., Chin, Suet-Feung, Wilkinson, Ian B., Graves, Martin J., Abraham, Jean E., Gilbert, Fiona J., Caldas, Carlos, and Brindle, Kevin M.

Published
2020

18. Metabolic Imaging Detects Resistance to PI3Kα Inhibition Mediated by Persistent FOXM1 Expression in ER+ Breast Cancer

Author

Ros, Susana, Wright, Alan J., D'Santos, Paula, Hu, De-en, Hesketh, Richard L., Lubling, Yaniv, Georgopoulou, Dimitra, Lerda, Giulia, Couturier, Dominique-Laurent, Razavi, Pedram, Pelossof, Rapahel, Batra, Ankita S., Mannion, Elizabeth, Lewis, David Y., Martin, Alistair, Baird, Richard D., Oliveira, Mafalda, de Boo, Leonora W., Linn, Sabine C., Scaltriti, Maurizio, Rueda, Oscar M., Bruna, Alejandra, Caldas, Carlos, and Brindle, Kevin M.

Published
2020
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19. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): a multicentre, multicohort, phase 2a, platform trial

Author

Turner, Nicholas C, Kingston, Belinda, Kilburn, Lucy S, Kernaghan, Sarah, Wardley, Andrew M, Macpherson, Iain R, Baird, Richard D, Roylance, Rebecca, Stephens, Peter, Oikonomidou, Olga, Braybrooke, Jeremy P, Tuthill, Mark, Abraham, Jacinta, Winter, Matthew C, Bye, Hannah, Hubank, Michael, Gevensleben, Heidrun, Cutts, Ros, Snowdon, Claire, Rea, Daniel, Cameron, David, Shaaban, Abeer, Randle, Katrina, Martin, Sue, Wilkinson, Katie, Moretti, Laura, Bliss, Judith M, and Ring, Alistair

Published
2020
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20. A phase 1 trial of human telomerase reverse transcriptase (hTERT) vaccination combined with therapeutic strategies to control immune-suppressor mechanisms

Author

Zareian, Nahid, primary, Eremin, Oleg, additional, Pandha, Hardev, additional, Baird, Richard, additional, Kwatra, Vineet, additional, Funingana, Gabriel, additional, Verma, Chandan, additional, Choy, Desmond, additional, Hargreaves, Steven, additional, Moghimi, Pejvak, additional, Shepherd, Adrian, additional, Lobo, Dileep N., additional, Eremin, Jennifer, additional, Farzaneh, Farzin, additional, Kordasti, Shahram, additional, and Spicer, James, additional

Published
2024
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21. Genomic profile of advanced breast cancer in circulating tumour DNA

Author

Kingston, Belinda, Cutts, Rosalind J., Bye, Hannah, Beaney, Matthew, Walsh-Crestani, Giselle, Hrebien, Sarah, Swift, Claire, Kilburn, Lucy S., Kernaghan, Sarah, Moretti, Laura, Wilkinson, Katie, Wardley, Andrew M., Macpherson, Iain R., Baird, Richard D., Roylance, Rebecca, Reis-Filho, Jorge S., Hubank, Michael, Faull, Iris, Banks, Kimberly C., Lanman, Richard B., Garcia-Murillas, Isaac, Bliss, Judith M., Ring, Alistair, and Turner, Nicholas C.

Published
2021
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22. Author Correction: Genomic profile of advanced breast cancer in circulating tumor DNA

Author

Kingston, Belinda, Cutts, Rosalind J., Bye, Hannah, Beaney, Matthew, Walsh-Crestani, Giselle, Hrebien, Sarah, Swift, Claire, Kilburn, Lucy S., Kernaghan, Sarah, Moretti, Laura, Wilkinson, Katie, Wardley, Andrew M., Macpherson, Iain R., Baird, Richard D., Roylance, Rebecca, Reis-Filho, Jorge S., Hubank, Michael, Faull, Iris, Banks, Kimberly C., Lanman, Richard B., Garcia-Murillas, Isaac, Bliss, Judith M., Ring, Alistair, and Turner, Nicholas C.

Published
2021
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23. A Case of Sustained Tumor Regression With MP0274, a Novel DARPin Therapeutic Targeting Human Epidermal Growth Factor Receptor 2 Signaling, in Metastatic Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer After Prior Trastuzumab and Pertuzumab

Author

Fischer, Stefanie, Götze, Thorsten O., Omlin, Aurelius, Baird, Richard D., Dawson, Keith M., Zitt, Christof, Arany, Zita, Tresch, Gaby, Fiedler, Ulrike, Jeger, Simone, Fung, Samson, Legenne, Philippe, Leupin, Nicolas, Schneeweiss, Andreas, and Fremd, Carlo

Published
2022
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24. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)

Author

Bouzid, Kamel, Campone, Mario, Coudert, Bruno, Nowecki, Zbigniew, Errihani, Hassan, Dalenc, Florence, Ferreira, Ana, Mano, Max, Ricci, Francesco, Kalofonos, Haralabos, Andreetta, Claudia, Montemurro, Filippo, Barrett, Sophie, Zhang, Qingyuan, Mavroudis, Dimitris, Matus, Juan, Beato, Carlos, Hu, Xichun, Gaafar, Rabab, Abdel Azeem, Hamdy, Perrin, Christophe, Ettl, Johannes, Lang, Istvan, Verma, Sunil, Li, Huiping, Brain, Etienne, Hoffmann, Oliver, Cariello, Anna, Tondini, Carlo, Altwegeiri, Taher, Loman, Niklas, Lux, Michael, Frassoldati, Antonio, Aziz, Zeba, Salas, Fernando, Streb, Joanna, Wronski, Andrzej, Menjón Beltrán, Salomón, Cicin, Irfan, Schmid, Peter, Laing, Robert, Tong, Zhongsheng, Boer, Katalin, Juhasz, Balazs, Gianni, Luca, Curigliano, Giuseppe, Juarez, Alejandro, Susnjar, Snezana, Matos, Erika, Uslu, Ruchan, Wildiers, Hans, Cruz, Marcelo, Bourgeois, Hugues, von Schumann, Raquel, Stemmer, Salomón, Vásquez, Flavia Morales, Dominguez, Adriana, Wojtukiewicz, Marek, Trifunovic, Jasna, Illarramendi, Jose Juan, Garcia, Laura, Peron, Yann Izarzugaza, Echarri, Maria Jose, Voitko, Natliia, Wheatley, Duncan, Waters, Simon, De Boer, Richard, Jerusalem, Guy, Cocquyt, Véronique, Barrios, Carlos, Panasci, Lawrence, Mattson, Johanna, Tanner, Minna, Gozy, Michel, Vasilopoulos, Georgios, Revesz, Janos, Latini, Luciano, Gridelli, Cesare, Lazaro, Jesus, Gonzalez, Antonio, Barnadas Molins, Agusti, Martinez, Eduardo, Alarcón, Jesús, Arance, Ana, Klint, Leif, Kovalyov, Oleksiy, Baird, Richard, Yeo, Belinda, McCarthy, Nicole, Greil, Richard, Wang, Shusen, Artignan, Xavier, Augereau, Paule, Juhasz-Boess, Ingolf, Ngan, Roger, Goldberg, Hadassah, Di Costanzo, Francesco, Ferraù, Francesco, Aleknavicius, Eduardas, Rashid, Kamran, Costa, Luís, Angel Garcia, Jose, de la Cruz, Luis Ruiz, López López, Rafael, Del Val, Olga, Ozyilkan, Ozgur, Azribi, Fathi, Verrill, Mark, Turner, Nicholas, Beith, Jane, Petzer, Andreas, Andrade, Jurandyr, Bernstein, Vanessa, Rayson, Daniel, Saad Eldin, Ibtessam, Achille, Mihaëla, Mueller, Volkmar, Gennari, Alessandra, Cascinu, Stefano, Ghosn, Marwan, El-Saghir, Nagi, Van den Bosch, Joan, Oosterkamp, Rianne, Kukulska, Monika, Pelaez, Ignacio, Hernandez, Carolina, del Mar Gordon, Maria, Dalmau, Elsa, Alonso, Jose Luis, Aksoy, Sercan, Coskun, Hasan Senol, Shparyk, Yaroslav, Varughese, Mohini, Panwar, Udaiveer, Barraclough, Lisa, Levitt, Nicola, Hicks, Jonathan, Rigg, Anna, Allen, Mark, Castillo, Cecila, Fein, Luis Enrique, Stuart-Harris, Robin, Singer, Christian, Stoeger, Herbert, Smiljanic, Sasha, Feng, Jifeng, Cedeño, Miguel, Berdah, Jean Francois, Orfeuvre, Hubert, Goncalves, Anthony, Grischke, Eva-Maria, Simon, Eike, Wagner, Steffen, Efremidou, Anna, Papazisis, Konstantinos, Evron, Ella, Inbar, Moshe, Baruch, Noa Ben, Geffen, David, Karminsky, Natalya, Ruggeri, Enzo Maria, Luigi, Cavanna, Grasso, Donatella, Juozaityte, Elona, Rafael Rodriguez Cid, Jeronimo, Roerdink, Henk, Siddiqi, Neelum, Passos Coelho, José Luís, Garre, Elisa Garcia, Garcia, Andres, Martínez Jañez, Noelia, Lopez Ceballos, Maria Helena, Mele, Mireia, García, María, Arcediano, Alberto, McAdam, Karen, Perren, Timothy, Taylor, Wendy, Humphreys, Alison, Vera, Raul, Kaen, Luis Alberto, Steger, Günther, Andel, Johannes, de Grève, Jacques, Huizing, Manon, Hegg, Roberto, Joy, Anil, Sehdev, Sandeep, Kütner, Riina, Ruohola, Johanna, Dohollou, Nadine, Grosjean, Jessica, Laplaige, Philippe, Largillier, Rémy, Martin, Philippe, Pottier, Virginie, Alexandre, Jerome, Christensen, Bernd, Zahm, Dirk-Michael, Khandan, Fariba, Lueck, Hans-Joachim, Fountzilas, Georgios, Fried, Georgeta, Giacobino, Alice, Bonetti, Andrea, Guerra, Yanin Chavarri, Van Warmerdam, Laurens, Van der Velden, Annette, Vrijaldenhoven, Suzan, de Jongh, Felix, Cavero, Milagros, Andres Conejero, Raquel, Murias, Adolfo, Saura, Salvador, Oltra, Amparo, Redondo, Andres, Ribelles, Nuria, Bachmeier, Kilian, Joffe, Johnathan, Chakraborti, Prabir, Beresford, Mark, Butt, Mohammad, Poole, Christopher, Yordi, Gassan, Woodward, Natasha, Amorim, Gilberto, Califaretti, Nadia, Fox, Susan, Robidoux, Andre, Li, NanLi, Li, Nenxiao, Jiang, Jun, Soria, Tannia, Padrik, Peeter, Saarni, Outi, Genet, Dominique, Catala, Stéphanie, Barletta, Hugues, Teixeira, Luis, Facchini, Thomas, Hesse, Tobias, Kühn, Thorsten, Ober, Angelika, Repp, Roland, Schroeder, Willibald, Pectasides, Dimitrios, Bodoky, Gyorgy, Kahan, Zsuzsanna, Jiveliouk, Irina, Rosengarten, Ora, Alabiso, Oscar, Perez, Mario, Van de Wouw, Yes, Smok-Kalwat, Jolanta, Damasceno, Margarida, Sousa, Gabriela, Abulkhair, Omalkhair, Antón Torres, Antonio, Martinez, Maria Purificación, Garcia Mata, Jesús, Jesús Florián Jerico, Marta Santisteban, Llombart, Antonio, Sanchez, Rosa, Torrego, Juan Carlos, Garate, Clara Olier, Rodriguez, Cesar, Llorente, Rosa, de Prado, Diego Soto, Cortés, Javier, Llorca, Cristina, Galán, Antonio, Viñas Villaro, Gemma, Narbe, Ulrik, Bjömeklett, Helena Granstam, Westwell, Sarah, Newby, Jackie, Jafri, Mariam, Rodríguez, Robinson, Alonso, Isabel, Bachelot, T., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Bondarenko, I., Paluch-Shimon, S., Wardley, A., Merot, J.-L., du Toit, Y., Easton, V., Lindegger, N., and Miles, D.

Published
2019
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25. Abstract PD11-09: PD11-09 Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): updated results from BEGONIA, a phase 1b/2 study

Author

Schmid, Peter, Wysocki, Piotr, Ma, Cynthia, Park, Yeon H, Fernandes, Ricardo, Lord, Simon, Baird, Richard D, Prady, Catherine, Jung, Kyung Hae, Asselah, Jamil, Huisden, Robert, Stewart, Ross, Vuković, Petra, Nunes, Ana T, Nowecki, Zbigniew, Baird, Richard [0000-0001-7071-6483], and Apollo - University of Cambridge Repository

Subjects
3204 Immunology, Cancer Research, Oncology, Clinical Research, 6.1 Pharmaceuticals, 32 Biomedical and Clinical Sciences, 3211 Oncology and Carcinogenesis, 6 Evaluation of treatments and therapeutic interventions, Cancer
Abstract

Background: Patients with a/mTNBC have limited treatment options and a poor prognosis (objective response rate [ORR] of 37%, median duration of response 6.5 months, median overall survival 15.5 months for 1L chemotherapy [Rugo, et al. Ann Oncol. 2021 LBA16]). Combining checkpoint inhibitors with 1L chemotherapy modestly improves outcomes but only in PD-L1–positive a/mTNBC, emphasizing a critical unmet need for patients with PD-L1–negative disease and for further improving outcomes in PD-L1–positive disease. BEGONIA (NCT03742102) is an ongoing 2-part, open-label platform study, evaluating safety and efficacy of D, an anti–PD-L1 antibody, combined with other novel therapies in 1L a/mTNBC, including Dato-DXd, an antibody-drug conjugate consisting of a humanized anti-TROP2 antibody covalently linked to a highly potent topoisomerase I inhibitor payload via a stable, tumor-selective, tetrapeptide-based cleavable linker. Early data from BEGONIA of D in combination with Dato-DXd showed promising responses. Here, we report updated results of Dato-DXd + D. Methods: Patients with unresectable a/mTNBC eligible for 1L treatment were enrolled, regardless of PD-L1 or TROP2 status, and received intravenous Dato-DXd 6 mg/kg + D 1120 mg every 3 weeks until progression or unacceptable toxicity. PD-L1, assessed using the VENTANA PD-L1 (SP263) Assay, was defined as high if ≥ 5% of the tumor area was populated by PD-L1–expressing tumor or immune cells. Primary endpoints were safety and tolerability. Secondary endpoints included investigator-assessed ORR (RECIST v1.1) and duration of response. Patients included in the efficacy analysis had ≥ 2 on-treatment disease assessments, progressed, died, or withdrew from the study. Results: As of April 8, 2022, 47 patients received Dato-DXd + D (39 ongoing) and 33 of those were included in the efficacy analysis. Median (range) follow-up was 7.5 (0–11) months. Patient age was a median of 51 years, 57% received prior treatment for early stage TNBC, and 60% had visceral metastases at baseline. Confirmed ORR was 26/33 (79%; 95% CI, 61–91); 2/33 patients (6%) had a complete response and 24/33 (73%) had a partial response. Confirmed response was irrespective of PD-L1 expression (PD-L1 high ORR, 4/5 [80%]; PD-L1 low, 16/21 [76%]; PD-L1 missing, 6/7 [86%] patients). Median duration of response was not reached; 100% of patients with a complete or partial response remained in response at 6 month follow-up, and 96% had an ongoing response at data cutoff. Adverse events (AEs) were manageable and consistent with the known safety profiles of each agent, with treatment-related AEs occurring in 41 patients (87%), any Grade 3/4 AEs in 17 patients (36%), and any serious AEs in 7 patients (15%). The most common all-Grade AEs were gastrointestinal (nausea in 26 patients [55%] and stomatitis in 24 patients [51%]). A low rate of diarrhea was reported (6 patients [13%], all Grade 1 or 2); 4 patients had anemia and 1 had neutropenia. There were no cases of interstitial lung disease/pneumonitis or thrombocytopenia. Nine patients (19%) and 11 patients (23%) underwent Dato-DXd dose reduction and delay, respectively; 14 (30%) had D dose delay. Treatment was discontinued due to an AE for 3 patients (6%). There were no deaths due to treatment-related AEs. Conclusions: In this updated analysis with additional patients and longer follow-up, the combination of Dato-DXd + D in 1L a/mTNBC demonstrated a manageable safety profile and compelling high response rates with promising durability. Although subgroups were small, responses occurred irrespective of PD-L1 expression. Further investigation of this treatment combination is warranted. Analysis of translational data is ongoing. Funding: AstraZeneca/Daiichi Sankyo Citation Format: Peter Schmid, Piotr Wysocki, Cynthia Ma, Yeon H. Park, Ricardo Fernandes, Simon Lord, Richard D. Baird, Catherine Prady, Kyung Hae Jung, Jamil Asselah, Robert Huisden, Ross Stewart, Petra Vuković, Ana T. Nunes, Zbigniew Nowecki. PD11-09 Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): updated results from BEGONIA, a phase 1b/2 study [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD11-09.

Published
2023
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26. Abstract P3-07-13: The next generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) is active against wild type and mutant estrogen receptor α

Author

Morrow, Christopher, Carnevalli, Larissa, Baird, Richard D, Brier, Tim, Ciardullo, Carmela, Cureton, Natalie, Lawson, Mandy, McEwen, Robert, Nikolaou, Myria, Armstrong, Anne, Bermejo, Begoña, Calvo, Emiliano, Ciruelos, Eva, Garcia-Corbacho, Javier, Hamilton, Erika, Incorvati, Jason, Kabos, Peter, Oliveira, Mafalda, Patel, Manish R, Ruiz-Borregó, Manuel, Turner, Nicholas, Twelves, Chris, Vaklavas, Christos, Carroll, Danielle, Ching, Steven, Cvetesic, Nevena, DuPont, Michelle, Gibbons, Lisa, Mathewson, Alastair, Maudsley, Rhiannon, Gutierrez, Pablo Morentin, Reddy, Avinash, Rodriguez-Canales, Jaime, Ros, Susana, Sudhan, Dhivya, Sykes, Andy, Whitson, David, Klinowska, Teresa, Lindemann, Justin, Baird, Richard [0000-0001-7071-6483], and Apollo - University of Cambridge Repository

Subjects
Cancer Research, Oncology, Clinical Research, Breast Cancer, Clinical Trials and Supportive Activities, Genetics, 32 Biomedical and Clinical Sciences, 3211 Oncology and Carcinogenesis, 3202 Clinical Sciences, Estrogen, Cancer
Abstract

Endocrine therapy forms the backbone treatment for patients with estrogen receptor (ER) positive tumors in both the adjuvant and metastatic setting. Aromatase inhibitors (AI) are the most common endocrine treatment option. Mutation of ESR1, the gene encoding ERα, is a common mechanism of resistance to AIs which leads to ligand independent activity of ERα. Camizestrant (AZD9833) is a next generation SERD and pure ER antagonist that is in Phase 3 trials (SERENA-4: NCT04711252; SERENA-6: NCT04964934). Here we report the preclinical and clinical activity of camizestrant in patients with ESR1 wild-type (ESR1wt) and mutant (ESR1m) tumors. The binding affinities of camizestrant, fulvestrant, and estradiol to wt ERα and ERα variants with mutations in the ligand binding domain were assessed. All three compounds exhibited reduced binding to mutant forms of ERα compared with wt ERα; the Y537S mutation had the greatest impact on binding. This was reflected in requirement for greater concentrations of camizestrant and fulvestrant to degrade and antagonize mutated ERα and to impact cellular proliferation in MCF-7 cells that expressed Y537S ESR1m compared to ESR1wt MCF-7 cells. Furthermore, while a 3 mg/kg dose of camizestrant achieved a maximal anti-tumor effect in a ESR1wt patient derived xenograft model, a 10 mg/kg was required for maximal effect in a D538G ESR1m model. Considering this difference between ESR1m and ESR1wt, pharmacokinetic/pharmacodynamic modelling of preclinical data predicted that a camizestrant dose of 75 mg would be maximally efficacious in patients with ESR1m tumors. Indeed, analysis of ESR1m circulating tumor DNA levels in patients from the SERENA-1 (NCT03616587) Phase 1 trial showed a clear effect of 14 days treatment with 75 mg camizestrant resulting in a >2-fold reduction in ESR1m variant allele frequency in 12/13 (92%) cases with complete clearance of ESR1m ctDNA in 7/13 (54%) cases. Interestingly, the clinical activity of camizestrant was higher in heavily pretreated patients with metastatic breast cancer with ESR1m tumors compared to those with no detectable mutation (ESR1m not detected). At a camizestrant dose of 75 mg, median progression-free survival was 8.3 months (maturity 12/15) in patients with ESR1m tumors compared to 5.6 months (8/9) in those with ESR1m not detected (data cut-off 6 October 2021). Camizestrant-induced ERα degradation was seen in both groups (mean reduction in H-score 42% in ESR1m tumors (n= 12 evaluable pairs) and 46% in tumors with ESR1m not detected (n=7)). Whole transcriptome analysis revealed a trend towards higher ERα activity at baseline in ESR1m tumors compared to ESR1m not detected; ERα activity reduced on treatment in both groups. Consistent with the clinical activity data, camizestrant induced more profound reductions in cell proliferation in ESR1m tumors compared to ESR1m not detected tumors (as seen by greater reductions in Ki67-positive tumor cells). These data demonstrate the activity of camizestrant in patients with ESR1m tumors. Clinical activity along with degradation and antagonism of the ERα is also seen in patients with tumors in which ESR1 mutations are not detected. In this heavily pre-treated Phase 1 patient population from SERENA-1, ESR1m may be a predictive biomarker to enrich for patients with maintained endocrine sensitivity. The SERENA-6 trial is investigating the efficacy and safety of camizestrant plus a CDK4/6 inhibitor in patients with metastatic breast cancer and detectable ESR1m. We acknowledge Helen Heffron, PhD, from InterComm International who provided medical writing support funded by AstraZeneca. Citation Format: Christopher Morrow, Larissa Carnevalli, Richard D. Baird, Tim Brier, Carmela Ciardullo, Natalie Cureton, Mandy Lawson, Robert McEwen, Myria Nikolaou, Anne Armstrong, Begoña Bermejo, Emiliano Calvo, Eva Ciruelos, Javier Garcia-Corbacho, Erika Hamilton, Jason Incorvati, Peter Kabos, Mafalda Oliveira, Manish R Patel, Manuel Ruiz-Borregó, Nicholas Turner, Chris Twelves, Christos Vaklavas, Danielle Carroll, Steven Ching, Nevena Cvetesic, Michelle DuPont, Lisa Gibbons, Alastair Mathewson, Rhiannon Maudsley, Pablo Morentin Gutierrez, Avinash Reddy, Jaime Rodriguez-Canales, Susana Ros, Dhivya Sudhan, Andy Sykes, David Whitson, Teresa Klinowska, Justin Lindemann. The next generation oral selective estrogen receptor degrader (SERD) camizestrant (AZD9833) is active against wild type and mutant estrogen receptor α [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-07-13.

Published
2023
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28. Supplementary Figure S3 from Olaparib and Ceralasertib (AZD6738) in Patients with Triple-Negative Advanced Breast Cancer: Results from Cohort E of the plasmaMATCH Trial (CRUK/15/010)

Author

Ring, Alistair, primary, Kilburn, Lucy S., primary, Pearson, Alex, primary, Moretti, Laura, primary, Afshari-Mehr, Angelica, primary, Wardley, Andrew M., primary, Gurel, Bora, primary, Macpherson, Iain R., primary, Riisnaes, Ruth, primary, Baird, Richard D., primary, Martin, Sue, primary, Roylance, Rebecca, primary, Johnson, Hannah, primary, Ferreira, Ana, primary, Winter, Matthew C., primary, Dunne, Kathryn, primary, Copson, Ellen, primary, Hickish, Tamas, primary, Burcombe, Russell, primary, Randle, Kat, primary, Serra, Violeta, primary, Llop-Guevara, Alba, primary, Bliss, Judith M., primary, and Turner, Nicolas C., primary

Published
2023
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32. Author Correction: The Molecular Tumor Board Portal supports clinical decisions and automated reporting for precision oncology

Author

Tamborero, David, Dienstmann, Rodrigo, Rachid, Maan Haj, Boekel, Jorrit, Lopez-Fernandez, Adria, Jonsson, Markus, Razzak, Ali, Braña, Irene, De Petris, Luigi, Yachnin, Jeffrey, Baird, Richard D., Loriot, Yohann, Massard, Christophe, Martin-Romano, Patricia, Opdam, Frans, Schlenk, Richard F., Vernieri, Claudio, Masucci, Michele, Villalobos, Xenia, Chavarria, Elena, Balmaña, Judith, Apolone, Giovanni, Caldas, Carlos, Bergh, Jonas, Ernberg, Ingemar, Fröhling, Stefan, Garralda, Elena, Karlsson, Claes, Tabernero, Josep, Voest, Emile, Rodon, Jordi, and Lehtiö, Janne

Published
2022
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36. Olaparib and celarasertib (AZD6738) in patients with triple negative advanced breast cancer: results from Cohort E of the plasmaMATCH trial (CRUK/15/010)

Author

Ring, Alistair, primary, Kilburn, Lucy S., additional, Pearson, Alex, additional, Moretti, Laura, additional, Afshari-Mehr, Angelica, additional, Wardley, Andrew M., additional, Gurel, Bora, additional, Macpherson, Iain R., additional, Riisnaes, Ruth, additional, Baird, Richard D., additional, Martin, Sue, additional, Roylance, Rebecca, additional, Johnson, Hannah, additional, Ferreira, Ana, additional, Winter, Matthew C., additional, Dunne, Kathryn, additional, Copson, Ellen, additional, Hickish, Tamas, additional, Burcombe, Russell, additional, Randle, Kat, additional, Serra, Violeta, additional, Llop-Guevara, Alba, additional, Bliss, Judith M., additional, and Turner, Nicholas C., additional

Published
2023
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39. Support systems to guide clinical decision-making in precision oncology: The Cancer Core Europe Molecular Tumor Board Portal

Author

Tamborero, David, Dienstmann, Rodrigo, Rachid, Maan Haj, Boekel, Jorrit, Baird, Richard, Braña, Irene, and De Petris, Luigi

Subjects
Decision support systems -- Usage -- Health aspects, Cancer -- Care and treatment, Company business management, Decision support software, Biological sciences, Health
Abstract

Author(s): David Tamborero [sup.1] , Rodrigo Dienstmann [sup.2] , Maan Haj Rachid [sup.1] , Jorrit Boekel [sup.1] , Richard Baird [sup.4] , Irene Braña [sup.5] , Luigi De Petris [sup.6] [...]

Published
2020
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40. A Road Map for Designing Phase I Clinical Trials of Radiotherapy–Novel Agent Combinations

Author

Brown, Sarah R, Hinsley, Samantha, Hall, Emma, Hurt, Chris, Baird, Richard D, Forster, Martin, Scarsbrook, Andrew F, Adams, Richard A, Brown, Sarah R [0000-0002-7975-7537], Hinsley, Samantha [0000-0001-6903-4688], Hall, Emma [0000-0001-5999-5020], Hurt, Chris [0000-0003-1206-8355], Baird, Richard D [0000-0001-7071-6483], Scarsbrook, Andrew F [0000-0002-4243-032X], Adams, Richard A [0000-0003-3915-7243], and Apollo - University of Cambridge Repository

Subjects
Cancer Research, Clinical Trials, Phase I as Topic, Dose-Response Relationship, Drug, Maximum Tolerated Dose, Oncology, Research Design, Neoplasms, Antineoplastic Combined Chemotherapy Protocols, Humans, Software
Abstract

Radiotherapy has proven efficacy in a wide range of cancers. There is growing interest in evaluating radiotherapy–novel agent combinations and a drive to initiate this earlier in the clinical development of the novel agent, where the scientific rationale and preclinical evidence for a radiotherapy combination approach are high. Optimal design, delivery, and interpretation of studies are essential. In particular, the design of phase I studies to determine safety and dosing is critical to an efficient development strategy. There is significant interest in early-phase research among scientific and clinical communities over recent years, at a time when the scrutiny of the trial methodology has significantly increased. To enhance trial design, optimize safety, and promote efficient trial conduct, this position paper reviews the current phase I trial design landscape. Key design characteristics extracted from 37 methodology papers were used to define a road map and a design selection process for phase I radiotherapy–novel agent trials. Design selection is based on single- or dual-therapy dose escalation, dose-limiting toxicity categorization, maximum tolerated dose determination, subgroup evaluation, software availability, and design performance. Fifteen of the 37 designs were identified as being immediately accessible and relevant to radiotherapy–novel agent phase I trials. Applied examples of using the road map are presented. Developing these studies is intensive, highlighting the need for funding and statistical input early in the trial development to ensure appropriate design and implementation from the outset. The application of this road map will improve the design of phase I radiotherapy–novel agent combination trials, enabling a more efficient development pathway.

Published
2022
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43. Abstract CT269: A highly sensitive and specific PARylation assay confirms significant and durable target engagement by AZD5305 in patients

Author

Lombardi, Benedetta, primary, Marco-Casanova, Paola, additional, Karapetsas, Athanasios, additional, Hornett, Mya, additional, Lukacs, Edit, additional, Sugibayashi, Ko, additional, Cosulich, Sabina, additional, Dowson, Adam, additional, Moorthy, Ganesh, additional, Brown, Jessica, additional, Yap, Timothy A., additional, Schram, Alison M., additional, Balmana, Judith, additional, Luen, Stephen J., additional, Im, Seock-Ah, additional, Sharp, Adam, additional, Baird, Richard, additional, Harrington, Elizabeth A., additional, and Linardopoulos, Spiros, additional

Published
2023
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44. Supplementary Figure 1 from Plasma Metabolomic Changes following PI3K Inhibition as Pharmacodynamic Biomarkers: Preclinical Discovery to Phase I Trial Evaluation

Author

Ang, Joo Ern, primary, Pandher, Rupinder, primary, Ang, Joo Chew, primary, Asad, Yasmin J., primary, Henley, Alan T., primary, Valenti, Melanie, primary, Box, Gary, primary, de Haven Brandon, Alexis, primary, Baird, Richard D., primary, Friedman, Lori, primary, Derynck, Mika, primary, Vanhaesebroeck, Bart, primary, Eccles, Suzanne A., primary, Kaye, Stan B., primary, Workman, Paul, primary, de Bono, Johann S., primary, and Raynaud, Florence I., primary

Published
2023
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45. Supplementary Table 3 from Plasma Metabolomic Changes following PI3K Inhibition as Pharmacodynamic Biomarkers: Preclinical Discovery to Phase I Trial Evaluation

Author

Ang, Joo Ern, primary, Pandher, Rupinder, primary, Ang, Joo Chew, primary, Asad, Yasmin J., primary, Henley, Alan T., primary, Valenti, Melanie, primary, Box, Gary, primary, de Haven Brandon, Alexis, primary, Baird, Richard D., primary, Friedman, Lori, primary, Derynck, Mika, primary, Vanhaesebroeck, Bart, primary, Eccles, Suzanne A., primary, Kaye, Stan B., primary, Workman, Paul, primary, de Bono, Johann S., primary, and Raynaud, Florence I., primary

Published
2023
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46. Supplementary Table 1 from Plasma Metabolomic Changes following PI3K Inhibition as Pharmacodynamic Biomarkers: Preclinical Discovery to Phase I Trial Evaluation

Author

Ang, Joo Ern, primary, Pandher, Rupinder, primary, Ang, Joo Chew, primary, Asad, Yasmin J., primary, Henley, Alan T., primary, Valenti, Melanie, primary, Box, Gary, primary, de Haven Brandon, Alexis, primary, Baird, Richard D., primary, Friedman, Lori, primary, Derynck, Mika, primary, Vanhaesebroeck, Bart, primary, Eccles, Suzanne A., primary, Kaye, Stan B., primary, Workman, Paul, primary, de Bono, Johann S., primary, and Raynaud, Florence I., primary

Published
2023
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47. Supplementary Table 5 from Plasma Metabolomic Changes following PI3K Inhibition as Pharmacodynamic Biomarkers: Preclinical Discovery to Phase I Trial Evaluation

Author

Ang, Joo Ern, primary, Pandher, Rupinder, primary, Ang, Joo Chew, primary, Asad, Yasmin J., primary, Henley, Alan T., primary, Valenti, Melanie, primary, Box, Gary, primary, de Haven Brandon, Alexis, primary, Baird, Richard D., primary, Friedman, Lori, primary, Derynck, Mika, primary, Vanhaesebroeck, Bart, primary, Eccles, Suzanne A., primary, Kaye, Stan B., primary, Workman, Paul, primary, de Bono, Johann S., primary, and Raynaud, Florence I., primary

Published
2023
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48. Data from Plasma Metabolomic Changes following PI3K Inhibition as Pharmacodynamic Biomarkers: Preclinical Discovery to Phase I Trial Evaluation

Author

Ang, Joo Ern, primary, Pandher, Rupinder, primary, Ang, Joo Chew, primary, Asad, Yasmin J., primary, Henley, Alan T., primary, Valenti, Melanie, primary, Box, Gary, primary, de Haven Brandon, Alexis, primary, Baird, Richard D., primary, Friedman, Lori, primary, Derynck, Mika, primary, Vanhaesebroeck, Bart, primary, Eccles, Suzanne A., primary, Kaye, Stan B., primary, Workman, Paul, primary, de Bono, Johann S., primary, and Raynaud, Florence I., primary

Published
2023
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49. Supplementary Table 4 from Plasma Metabolomic Changes following PI3K Inhibition as Pharmacodynamic Biomarkers: Preclinical Discovery to Phase I Trial Evaluation

Author

Ang, Joo Ern, primary, Pandher, Rupinder, primary, Ang, Joo Chew, primary, Asad, Yasmin J., primary, Henley, Alan T., primary, Valenti, Melanie, primary, Box, Gary, primary, de Haven Brandon, Alexis, primary, Baird, Richard D., primary, Friedman, Lori, primary, Derynck, Mika, primary, Vanhaesebroeck, Bart, primary, Eccles, Suzanne A., primary, Kaye, Stan B., primary, Workman, Paul, primary, de Bono, Johann S., primary, and Raynaud, Florence I., primary

Published
2023
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50. Supplementary Table 2 from Plasma Metabolomic Changes following PI3K Inhibition as Pharmacodynamic Biomarkers: Preclinical Discovery to Phase I Trial Evaluation

Author

Ang, Joo Ern, primary, Pandher, Rupinder, primary, Ang, Joo Chew, primary, Asad, Yasmin J., primary, Henley, Alan T., primary, Valenti, Melanie, primary, Box, Gary, primary, de Haven Brandon, Alexis, primary, Baird, Richard D., primary, Friedman, Lori, primary, Derynck, Mika, primary, Vanhaesebroeck, Bart, primary, Eccles, Suzanne A., primary, Kaye, Stan B., primary, Workman, Paul, primary, de Bono, Johann S., primary, and Raynaud, Florence I., primary

Published
2023
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