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52. Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103).

Author

Garralda, Elena, Oh, Do Youn, Italiano, Antoine, Bedard, Philippe L., Delord, Jean‐Pierre, Calvo, Emiliano, LoRusso, Patricia, Wainberg, Zev, Cervantes, Andres, Rodriguez‐Vida, Alejo, Shemesh, Colby S., Sane, Rucha, Mendus, Diana, Ding, Hao, Hendricks, Robert, Meng, Ray, Cho, Byoung Chul, Kim, Tae Won, and Wu, Benjamin

Subjects
PATIENT safety, RESEARCH funding, ANTINEOPLASTIC agents, CLINICAL trials, DESCRIPTIVE statistics, MONOCLONAL antibodies, INTRAVENOUS therapy, CANCER cells, DRUG tolerance
Abstract

Tiragolumab is a first‐in‐class, fully human IgG1/kappa anti‐TIGIT monoclonal antibody that blocks the binding of TIGIT to CD155 (the poliovirus receptor). We summarize the pharmacokinetics (PK) data from the phase 1a/1b GO30103 study of Q3W (every 3 weeks) sequential dosing of tiragolumab (2, 8, 30, 100, 400, 600, or 1200 mg) followed by atezolizumab (1200 mg), Q4W (every 4 weeks) sequential dosing (tiragolumab 840 mg followed by atezolizumab 1680 mg), and Q4W co‐infusion (tiragolumab 840 mg plus atezolizumab 1680 mg). Serum samples were collected at multiple time points following tiragolumab and atezolizumab intravenous infusion in patients with solid tumors for PK and immunogenicity assessment. The serum PK profile of tiragolumab appeared to be biphasic, with a rapid distribution phase followed by a slower elimination phase when administered alone or in combination with atezolizumab. In phase 1a, across doses of tiragolumab ranging from 2 to 1200 mg (cycle 1), the geometric mean (GM), coefficient of variation (CV%), serum tiragolumab Cmax ranged from 0.682 to 270 µg/mL (18.6% to 36.5%) and Cmin ranged from 0.0125 to 75.3 µg/mL (0.0% to 24.2%). The GM systemic exposure (area under the plasma drug concentration‐time curve, AUC0‐21) ranged from 310 to 2670 µg day/mL (20.5% to 27.0%); interindividual variability in AUC0‐21 ranged from 20.5% to 43.9%. Tiragolumab exposure increased in an approximately dose‐proportional manner when administered alone or with atezolizumab at doses ≥100 mg. Postbaseline, 4/207 patients (1.9%) were positive for treatment‐emergent antidrug antibodies (ADA) against tiragolumab, each at a single time point. Tiragolumab combined with atezolizumab demonstrated desirable PK properties, with no drug‐drug interactions or immunogenicity liability. There were no meaningful differences in tiragolumab or atezolizumab exposure between the Q4W co‐infusion and sequential dosing cohorts. ClinicalTrials.gov: NCT02794571 (date of registration June 6, 2016). [ABSTRACT FROM AUTHOR]

Published
2024
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53. Supplementary Table S3 from Safety, Immunologic, and Clinical Activity of Durvalumab in Combination with Olaparib or Cediranib in Advanced Leiomyosarcoma: Results of the DAPPER Clinical Trial.

Author

Salawu, Abdulazeez, primary, Wang, Ben X., primary, Han, Ming, primary, Geady, Caryn, primary, Heirali, Alya, primary, Berman, Hal K., primary, Pfister, Thomas D., primary, Hernando-Calvo, Alberto, primary, Al-Ezzi, Esmail Mutahar, primary, Stayner, Lee-Anne, primary, Gupta, Abha A., primary, Ayodele, Olubukola, primary, Lam, Bernard, primary, Hansen, Aaron R., primary, Spreafico, Anna, primary, Bedard, Philippe L., primary, Butler, Marcus O., primary, Avery, Lisa, primary, Coburn, Bryan, primary, Haibe-Kains, Benjamin, primary, Siu, Lillian L., primary, and Abdul Razak, Albiruni R., primary

Published
2023
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54. Data from Safety, Immunologic, and Clinical Activity of Durvalumab in Combination with Olaparib or Cediranib in Advanced Leiomyosarcoma: Results of the DAPPER Clinical Trial.

Author

Salawu, Abdulazeez, primary, Wang, Ben X., primary, Han, Ming, primary, Geady, Caryn, primary, Heirali, Alya, primary, Berman, Hal K., primary, Pfister, Thomas D., primary, Hernando-Calvo, Alberto, primary, Al-Ezzi, Esmail Mutahar, primary, Stayner, Lee-Anne, primary, Gupta, Abha A., primary, Ayodele, Olubukola, primary, Lam, Bernard, primary, Hansen, Aaron R., primary, Spreafico, Anna, primary, Bedard, Philippe L., primary, Butler, Marcus O., primary, Avery, Lisa, primary, Coburn, Bryan, primary, Haibe-Kains, Benjamin, primary, Siu, Lillian L., primary, and Abdul Razak, Albiruni R., primary

Published
2023
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55. Supplementary Figure S1 from Safety, Immunologic, and Clinical Activity of Durvalumab in Combination with Olaparib or Cediranib in Advanced Leiomyosarcoma: Results of the DAPPER Clinical Trial.

Author

Salawu, Abdulazeez, primary, Wang, Ben X., primary, Han, Ming, primary, Geady, Caryn, primary, Heirali, Alya, primary, Berman, Hal K., primary, Pfister, Thomas D., primary, Hernando-Calvo, Alberto, primary, Al-Ezzi, Esmail Mutahar, primary, Stayner, Lee-Anne, primary, Gupta, Abha A., primary, Ayodele, Olubukola, primary, Lam, Bernard, primary, Hansen, Aaron R., primary, Spreafico, Anna, primary, Bedard, Philippe L., primary, Butler, Marcus O., primary, Avery, Lisa, primary, Coburn, Bryan, primary, Haibe-Kains, Benjamin, primary, Siu, Lillian L., primary, and Abdul Razak, Albiruni R., primary

Published
2023
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56. Supplementary Methods S1 from Safety, Immunologic, and Clinical Activity of Durvalumab in Combination with Olaparib or Cediranib in Advanced Leiomyosarcoma: Results of the DAPPER Clinical Trial.

Author

Salawu, Abdulazeez, primary, Wang, Ben X., primary, Han, Ming, primary, Geady, Caryn, primary, Heirali, Alya, primary, Berman, Hal K., primary, Pfister, Thomas D., primary, Hernando-Calvo, Alberto, primary, Al-Ezzi, Esmail Mutahar, primary, Stayner, Lee-Anne, primary, Gupta, Abha A., primary, Ayodele, Olubukola, primary, Lam, Bernard, primary, Hansen, Aaron R., primary, Spreafico, Anna, primary, Bedard, Philippe L., primary, Butler, Marcus O., primary, Avery, Lisa, primary, Coburn, Bryan, primary, Haibe-Kains, Benjamin, primary, Siu, Lillian L., primary, and Abdul Razak, Albiruni R., primary

Published
2023
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57. Anti-TIGIT Antibody Tiragolumab Alone or With Atezolizumab in Patients With Advanced Solid Tumors

Author

Kim, Tae Won, primary, Bedard, Philippe L., additional, LoRusso, Patricia, additional, Gordon, Michael S., additional, Bendell, Johanna, additional, Oh, Do-Youn, additional, Ahn, Myung-Ju, additional, Garralda, Elena, additional, D’Angelo, Sandra P., additional, Desai, Jayesh, additional, Hodi, F. Stephen, additional, Wainberg, Zev, additional, Delord, Jean-Pierre, additional, Cassier, Phillippe A., additional, Cervantes, Andrés, additional, Gil-Martin, Marta, additional, Wu, Benjamin, additional, Patil, Namrata S., additional, Jin, Yanling, additional, Hoang, Tien, additional, Mendus, Diana, additional, Wen, Xiaohui, additional, Meng, Raymond, additional, and Cho, Byoung Chul, additional

Published
2023
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58. Safety, Immunologic, and Clinical Activity of Durvalumab in Combination with Olaparib or Cediranib in Advanced Leiomyosarcoma. Results of the DAPPER Clinical Trial.

Author

Salawu, Abdulazeez, primary, Wang, Ben X., additional, Han, Ming, additional, Geady, Caryn, additional, Heirali, Alya, additional, Berman, Hal K., additional, Pfister, Thomas D., additional, Hernando-Calvo, Alberto, additional, Al-Ezzi, Esmail Mutahar, additional, Stayner, Lee-Anne, additional, Gupta, Abha A., additional, Ayodele, Olubukola, additional, Lam, Bernard, additional, Hansen, Aaron R., additional, Spreafico, Anna, additional, Bedard, Philippe L., additional, Butler, Marcus O., additional, Avery, Lisa, additional, Coburn, Bryan, additional, Haibe-Kains, Benjamin, additional, Siu, Lillian L., additional, and Abdul Razak, Albiruni R., additional

Published
2023
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59. Supplemental Fig. 3 from The GENIE BPC NSCLC Cohort: A Real-World Repository Integrating Standardized Clinical and Genomic Data for 1,846 Patients with Non–Small Cell Lung Cancer

Author

Choudhury, Noura J., primary, Lavery, Jessica A., primary, Brown, Samantha, primary, de Bruijn, Ino, primary, Jee, Justin, primary, Tran, Thinh Ngoc, primary, Rizvi, Hira, primary, Arbour, Kathryn C., primary, Whiting, Karissa, primary, Shen, Ronglai, primary, Hellmann, Matthew, primary, Bedard, Philippe L., primary, Yu, Celeste, primary, Leighl, Natasha, primary, LeNoue-Newton, Michele, primary, Micheel, Christine, primary, Warner, Jeremy L., primary, Ginsberg, Michelle S., primary, Plodkowski, Andrew, primary, Girshman, Jeffrey, primary, Sawan, Peter, primary, Pillai, Shirin, primary, Sweeney, Shawn M., primary, Kehl, Kenneth L., primary, Panageas, Katherine S., primary, Schultz, Nikolaus, primary, Schrag, Deborah, primary, and Riely, Gregory J., primary

Published
2023
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60. Data from The GENIE BPC NSCLC Cohort: A Real-World Repository Integrating Standardized Clinical and Genomic Data for 1,846 Patients with Non–Small Cell Lung Cancer

Author

Choudhury, Noura J., primary, Lavery, Jessica A., primary, Brown, Samantha, primary, de Bruijn, Ino, primary, Jee, Justin, primary, Tran, Thinh Ngoc, primary, Rizvi, Hira, primary, Arbour, Kathryn C., primary, Whiting, Karissa, primary, Shen, Ronglai, primary, Hellmann, Matthew, primary, Bedard, Philippe L., primary, Yu, Celeste, primary, Leighl, Natasha, primary, LeNoue-Newton, Michele, primary, Micheel, Christine, primary, Warner, Jeremy L., primary, Ginsberg, Michelle S., primary, Plodkowski, Andrew, primary, Girshman, Jeffrey, primary, Sawan, Peter, primary, Pillai, Shirin, primary, Sweeney, Shawn M., primary, Kehl, Kenneth L., primary, Panageas, Katherine S., primary, Schultz, Nikolaus, primary, Schrag, Deborah, primary, and Riely, Gregory J., primary

Published
2023
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61. Supplemental Table 1 from The GENIE BPC NSCLC Cohort: A Real-World Repository Integrating Standardized Clinical and Genomic Data for 1,846 Patients with Non–Small Cell Lung Cancer

Author

Choudhury, Noura J., primary, Lavery, Jessica A., primary, Brown, Samantha, primary, de Bruijn, Ino, primary, Jee, Justin, primary, Tran, Thinh Ngoc, primary, Rizvi, Hira, primary, Arbour, Kathryn C., primary, Whiting, Karissa, primary, Shen, Ronglai, primary, Hellmann, Matthew, primary, Bedard, Philippe L., primary, Yu, Celeste, primary, Leighl, Natasha, primary, LeNoue-Newton, Michele, primary, Micheel, Christine, primary, Warner, Jeremy L., primary, Ginsberg, Michelle S., primary, Plodkowski, Andrew, primary, Girshman, Jeffrey, primary, Sawan, Peter, primary, Pillai, Shirin, primary, Sweeney, Shawn M., primary, Kehl, Kenneth L., primary, Panageas, Katherine S., primary, Schultz, Nikolaus, primary, Schrag, Deborah, primary, and Riely, Gregory J., primary

Published
2023
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62. Supplemental Fig. 2 from The GENIE BPC NSCLC Cohort: A Real-World Repository Integrating Standardized Clinical and Genomic Data for 1,846 Patients with Non–Small Cell Lung Cancer

Author

Choudhury, Noura J., primary, Lavery, Jessica A., primary, Brown, Samantha, primary, de Bruijn, Ino, primary, Jee, Justin, primary, Tran, Thinh Ngoc, primary, Rizvi, Hira, primary, Arbour, Kathryn C., primary, Whiting, Karissa, primary, Shen, Ronglai, primary, Hellmann, Matthew, primary, Bedard, Philippe L., primary, Yu, Celeste, primary, Leighl, Natasha, primary, LeNoue-Newton, Michele, primary, Micheel, Christine, primary, Warner, Jeremy L., primary, Ginsberg, Michelle S., primary, Plodkowski, Andrew, primary, Girshman, Jeffrey, primary, Sawan, Peter, primary, Pillai, Shirin, primary, Sweeney, Shawn M., primary, Kehl, Kenneth L., primary, Panageas, Katherine S., primary, Schultz, Nikolaus, primary, Schrag, Deborah, primary, and Riely, Gregory J., primary

Published
2023
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63. Supplemental Table 2 from The GENIE BPC NSCLC Cohort: A Real-World Repository Integrating Standardized Clinical and Genomic Data for 1,846 Patients with Non–Small Cell Lung Cancer

Author

Choudhury, Noura J., primary, Lavery, Jessica A., primary, Brown, Samantha, primary, de Bruijn, Ino, primary, Jee, Justin, primary, Tran, Thinh Ngoc, primary, Rizvi, Hira, primary, Arbour, Kathryn C., primary, Whiting, Karissa, primary, Shen, Ronglai, primary, Hellmann, Matthew, primary, Bedard, Philippe L., primary, Yu, Celeste, primary, Leighl, Natasha, primary, LeNoue-Newton, Michele, primary, Micheel, Christine, primary, Warner, Jeremy L., primary, Ginsberg, Michelle S., primary, Plodkowski, Andrew, primary, Girshman, Jeffrey, primary, Sawan, Peter, primary, Pillai, Shirin, primary, Sweeney, Shawn M., primary, Kehl, Kenneth L., primary, Panageas, Katherine S., primary, Schultz, Nikolaus, primary, Schrag, Deborah, primary, and Riely, Gregory J., primary

Published
2023
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64. Supplemental Table 4 from The GENIE BPC NSCLC Cohort: A Real-World Repository Integrating Standardized Clinical and Genomic Data for 1,846 Patients with Non–Small Cell Lung Cancer

Author

Choudhury, Noura J., primary, Lavery, Jessica A., primary, Brown, Samantha, primary, de Bruijn, Ino, primary, Jee, Justin, primary, Tran, Thinh Ngoc, primary, Rizvi, Hira, primary, Arbour, Kathryn C., primary, Whiting, Karissa, primary, Shen, Ronglai, primary, Hellmann, Matthew, primary, Bedard, Philippe L., primary, Yu, Celeste, primary, Leighl, Natasha, primary, LeNoue-Newton, Michele, primary, Micheel, Christine, primary, Warner, Jeremy L., primary, Ginsberg, Michelle S., primary, Plodkowski, Andrew, primary, Girshman, Jeffrey, primary, Sawan, Peter, primary, Pillai, Shirin, primary, Sweeney, Shawn M., primary, Kehl, Kenneth L., primary, Panageas, Katherine S., primary, Schultz, Nikolaus, primary, Schrag, Deborah, primary, and Riely, Gregory J., primary

Published
2023
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65. Supplemental Fig. 1 from The GENIE BPC NSCLC Cohort: A Real-World Repository Integrating Standardized Clinical and Genomic Data for 1,846 Patients with Non–Small Cell Lung Cancer

Author

Choudhury, Noura J., primary, Lavery, Jessica A., primary, Brown, Samantha, primary, de Bruijn, Ino, primary, Jee, Justin, primary, Tran, Thinh Ngoc, primary, Rizvi, Hira, primary, Arbour, Kathryn C., primary, Whiting, Karissa, primary, Shen, Ronglai, primary, Hellmann, Matthew, primary, Bedard, Philippe L., primary, Yu, Celeste, primary, Leighl, Natasha, primary, LeNoue-Newton, Michele, primary, Micheel, Christine, primary, Warner, Jeremy L., primary, Ginsberg, Michelle S., primary, Plodkowski, Andrew, primary, Girshman, Jeffrey, primary, Sawan, Peter, primary, Pillai, Shirin, primary, Sweeney, Shawn M., primary, Kehl, Kenneth L., primary, Panageas, Katherine S., primary, Schultz, Nikolaus, primary, Schrag, Deborah, primary, and Riely, Gregory J., primary

Published
2023
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66. Supplemental Table 3 from The GENIE BPC NSCLC Cohort: A Real-World Repository Integrating Standardized Clinical and Genomic Data for 1,846 Patients with Non–Small Cell Lung Cancer

Author

Choudhury, Noura J., primary, Lavery, Jessica A., primary, Brown, Samantha, primary, de Bruijn, Ino, primary, Jee, Justin, primary, Tran, Thinh Ngoc, primary, Rizvi, Hira, primary, Arbour, Kathryn C., primary, Whiting, Karissa, primary, Shen, Ronglai, primary, Hellmann, Matthew, primary, Bedard, Philippe L., primary, Yu, Celeste, primary, Leighl, Natasha, primary, LeNoue-Newton, Michele, primary, Micheel, Christine, primary, Warner, Jeremy L., primary, Ginsberg, Michelle S., primary, Plodkowski, Andrew, primary, Girshman, Jeffrey, primary, Sawan, Peter, primary, Pillai, Shirin, primary, Sweeney, Shawn M., primary, Kehl, Kenneth L., primary, Panageas, Katherine S., primary, Schultz, Nikolaus, primary, Schrag, Deborah, primary, and Riely, Gregory J., primary

Published
2023
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70. A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancer

Author

Abramson, Vandana G., Oliveira, Mafalda, Cervantes, Andrés, Wildiers, Hans, Patel, Manish R., Bauer, Todd M., Bedard, Philippe L., Becerra, Carlos, Richey, Stephen, Wei, Michael C., Reyner, Eric, Bond, John, Cui, Na, Wilson, Timothy R., Moore, Heather M., Saura, Cristina, and Krop, Ian E.

Published
2019
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73. Supplemental Table S1 from Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens

Author

Tabernero, Josep, primary, Bedard, Philippe L., primary, Bang, Yung-Jue, primary, Vieito, Maria, primary, Ryu, Min-Hee, primary, Fagniez, Nathalie, primary, Chadjaa, Mustapha, primary, Soufflet, Christine, primary, Masson, Nina, primary, and Gazzah, Anas, primary

Published
2023
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76. Supplemental Figure S2 from Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens

Author

Tabernero, Josep, primary, Bedard, Philippe L., primary, Bang, Yung-Jue, primary, Vieito, Maria, primary, Ryu, Min-Hee, primary, Fagniez, Nathalie, primary, Chadjaa, Mustapha, primary, Soufflet, Christine, primary, Masson, Nina, primary, and Gazzah, Anas, primary

Published
2023
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80. Data from Heterogeneity of Circulating Tumor Cell–Associated Genomic Gains in Breast Cancer and Its Association with the Host Immune Response

Author

Kanwar, Nisha, primary, Balde, Zaldy, primary, Nair, Ranju, primary, Dawe, Melanie, primary, Chen, Shiyi, primary, Maganti, Manjula, primary, Atenafu, Eshetu G., primary, Manolescu, Sabrina, primary, Wei, Carrie, primary, Mao, Amanda, primary, Fu, Fred, primary, Wang, Dan, primary, Cheung, Alison, primary, Yerofeyeva, Yulia, primary, Peters, Rachel, primary, Liu, Kela, primary, Desmedt, Christine, primary, Sotiriou, Christos, primary, Szekely, Borbala, primary, Kulka, Janina, primary, McKee, Trevor D., primary, Hirano, Naoto, primary, Bartlett, John M.S., primary, Yaffe, Martin J., primary, Bedard, Philippe L., primary, McCready, David, primary, and Done, Susan J., primary

Published
2023
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81. Supplementary File from Heterogeneity of Circulating Tumor Cell–Associated Genomic Gains in Breast Cancer and Its Association with the Host Immune Response

Author

Kanwar, Nisha, primary, Balde, Zaldy, primary, Nair, Ranju, primary, Dawe, Melanie, primary, Chen, Shiyi, primary, Maganti, Manjula, primary, Atenafu, Eshetu G., primary, Manolescu, Sabrina, primary, Wei, Carrie, primary, Mao, Amanda, primary, Fu, Fred, primary, Wang, Dan, primary, Cheung, Alison, primary, Yerofeyeva, Yulia, primary, Peters, Rachel, primary, Liu, Kela, primary, Desmedt, Christine, primary, Sotiriou, Christos, primary, Szekely, Borbala, primary, Kulka, Janina, primary, McKee, Trevor D., primary, Hirano, Naoto, primary, Bartlett, John M.S., primary, Yaffe, Martin J., primary, Bedard, Philippe L., primary, McCready, David, primary, and Done, Susan J., primary

Published
2023
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82. Supplementary Information from Heterogeneity of Circulating Tumor Cell–Associated Genomic Gains in Breast Cancer and Its Association with the Host Immune Response

Author

Kanwar, Nisha, primary, Balde, Zaldy, primary, Nair, Ranju, primary, Dawe, Melanie, primary, Chen, Shiyi, primary, Maganti, Manjula, primary, Atenafu, Eshetu G., primary, Manolescu, Sabrina, primary, Wei, Carrie, primary, Mao, Amanda, primary, Fu, Fred, primary, Wang, Dan, primary, Cheung, Alison, primary, Yerofeyeva, Yulia, primary, Peters, Rachel, primary, Liu, Kela, primary, Desmedt, Christine, primary, Sotiriou, Christos, primary, Szekely, Borbala, primary, Kulka, Janina, primary, McKee, Trevor D., primary, Hirano, Naoto, primary, Bartlett, John M.S., primary, Yaffe, Martin J., primary, Bedard, Philippe L., primary, McCready, David, primary, and Done, Susan J., primary

Published
2023
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83. Supplemental Table S3 from Tusamitamab ravtansine in patients with advanced solid tumors: Phase 1 study of safety, pharmacokinetics, and antitumor activity using alternative dosing regimens

Author

Tabernero, Josep, primary, Bedard, Philippe L., primary, Bang, Yung-Jue, primary, Vieito, Maria, primary, Ryu, Min-Hee, primary, Fagniez, Nathalie, primary, Chadjaa, Mustapha, primary, Soufflet, Christine, primary, Masson, Nina, primary, and Gazzah, Anas, primary

Published
2023
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84. Tusamitamab ravtansine in patients with advanced solid tumors: Phase 1 study of safety, pharmacokinetics, and antitumor activity using alternative dosing regimens

Author

Tabernero, Josep, primary, Bedard, Philippe L., additional, Bang, Yung-Jue, additional, Vieito, Maria, additional, Ryu, Min-Hee, additional, Fagniez, Nathalie, additional, Chadjaa, Mustapha, additional, Soufflet, Christine, additional, Masson, Nina, additional, and Gazzah, Anas, additional

Published
2023
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85. Supplemental Figure S1 from Tusamitamab ravtansine in patients with advanced solid tumors: Phase 1 study of safety, pharmacokinetics, and antitumor activity using alternative dosing regimens

Author

Tabernero, Josep, primary, Bedard, Philippe L., primary, Bang, Yung-Jue, primary, Vieito, Maria, primary, Ryu, Min-Hee, primary, Fagniez, Nathalie, primary, Chadjaa, Mustapha, primary, Soufflet, Christine, primary, Masson, Nina, primary, and Gazzah, Anas, primary

Published
2023
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87. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors

Author

Garralda, Elena, primary, Schram, Alison M, additional, Bedard, Philippe L, additional, Schwartz, Gary K, additional, Yuen, Eunice, additional, McNeely, Samuel C, additional, Ribeiro, Silvia, additional, Cunningham, Jason, additional, Wang, Yi, additional, Urunuela, Arantxa, additional, Xu, Xiaojian, additional, and LoRusso, Patricia, additional

Published
2023
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88. Identification of intratumoral and peripheral T-cell receptor (TCR) repertoire features associated with acquired (Ar) and primary (Pr) resistance to immune checkpoint inhibitors (ICI).

Author

Genta, Sofia, primary, Soleimani, Shirin, additional, Li, Xuan, additional, Pedersen, Stephanie, additional, Nguyen, Alisa, additional, Abdul Razak, Albiruni Ryan, additional, Saibil, Samuel, additional, Butler, Marcus O., additional, Bedard, Philippe L., additional, Zhang, Tong, additional, Tsao, Ming Sound, additional, Wang, Ben X, additional, Singaravelan, Nittusha, additional, Covelli, Andrea, additional, de Almeida, John R., additional, Hansen, Aaron Richard, additional, Eng, Lawson, additional, Pugh, Trevor J., additional, Siu, Lillian L., additional, and Spreafico, Anna, additional

Published
2023
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89. Deciphering the tumor microenvironment (TME) dynamics in advanced colorectal (CRC) and pancreatic cancers (PDAC) treated with durvalumab (D) with olaparib (O) or cediranib (C): Results from a phase 2 randomized trial.

Author

Hernando-Calvo, Alberto, primary, Han, Ming, additional, Ayodele, Olubukola, additional, Wang, Ben X, additional, Vila-Casadesús, Maria, additional, Yang, S Y Cindy, additional, Berman, Hal, additional, Vivancos, Ana, additional, Lam, Bernard, additional, Lungu, Ilinca, additional, Salawu, Abdulazeez, additional, Stayner, Lee-Anne, additional, Haibe-Kains, Benjamin, additional, Bedard, Philippe L., additional, Avery, Lisa, additional, Abdul Razak, Albiruni Ryan, additional, Pugh, Trevor John, additional, Spreafico, Anna, additional, Siu, Lillian L., additional, and Hansen, Aaron Richard, additional

Published
2023
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90. Deciphering primary and acquired immunotherapy resistance with whole genome and transcriptome analysis (WGTA).

Author

Genta, Sofia, primary, Bruce, Jeff, additional, Li, Xuan, additional, Felicen, Sam, additional, Abdul Razak, Albiruni Ryan, additional, Saibil, Samuel, additional, Butler, Marcus O., additional, Bedard, Philippe L., additional, Lam, Bernard, additional, Tsao, Ming Sound, additional, Leong, Wey Liang, additional, Easson, Alexandra, additional, Wang, Ben X, additional, Lungu, Ilinca, additional, Goldstein, David Paul, additional, Hansen, Aaron Richard, additional, Eng, Lawson, additional, Pugh, Trevor John, additional, Siu, Lillian L., additional, and Spreafico, Anna, additional

Published
2023
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91. Latency and interval therapy affect the evolution in metastatic colorectal cancer

Author

Nikbakht, Hamid, Jessa, Selin, Sukhai, Mahadeo A., Arseneault, Madeleine, Zhang, Tong, Letourneau, Louis, Thomas, Mariam, Bourgey, Mathieu, Roehrl, Michael H. A., Eveleigh, Robert, Chen, Eric X., Krzyzanowska, Monika, Moore, Malcolm J., Giesler, Amanda, Yu, Celeste, Bedard, Philippe L., Kamel-Reid, Suzanne, Majewski, Jacek, Siu, Lillian L., Riazalhosseini, Yasser, and Graham, Donna M.

Published
2020
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92. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors.

Author

Garralda, Elena, Schram, Alison M, Bedard, Philippe L, Schwartz, Gary K, Yuen, Eunice, McNeely, Samuel C, Ribeiro, Silvia, Cunningham, Jason, Wang, Yi, Urunuela, Arantxa, Xu, Xiaojian, and LoRusso, Patricia

Subjects
THERAPEUTIC use of antineoplastic agents, DRUG efficacy, DRUG dosage, DRUG tolerance, CLINICAL trials, DIARRHEA, NAUSEA, PROTEIN kinase inhibitors, ANTINEOPLASTIC agents, GASTROINTESTINAL diseases, CANCER patients, VOMITING, ASTHENIA, CELL cycle, RESEARCH funding, DESCRIPTIVE statistics, ANEMIA, PLATELET count, GENE expression profiling, TUMORS, FATIGUE (Physiology), ABDOMINAL pain, PATIENT safety, DRUG toxicity
Abstract

Background This study aimed to evaluate the safety, pharmacokinetics (PKs), and preliminary activity of LY3405105, a covalent inhibitor of cyclin-dependent kinase 7 (CDK7), in patients with advanced solid tumors. Materials and Methods LY3405105 monotherapy was given once daily (QD; part A1) or thrice weekly (TIW; part A2) starting at 1 and 2 mg orally, respectively, and escalated per a Bayesian design in adult patients. The primary endpoint was safety, and secondary endpoints included PKs and antitumor activity. Results Fifty-four patients were enrolled: 43 in part A1 and 11 in part A2. Seven patients had dose-limiting toxicities, all in part A1 (45 mg: n  = 3; 35 mg: n  = 3; 25 mg: n  = 1). Thirty-five patients (64.8%) reported at least one treatment-related adverse event (TRAE). TRAEs (≥10%) were diarrhea, nausea, fatigue, vomiting, abdominal pain, anemia, asthenia, and decreased platelet count. QD dosing showed sustained exposure with less peak-trough fluctuation compared to TIW dosing. Median time to maximum concentration was 1-2 hours and half-life was 15-19 hours. CDK7-target occupancy in skin and peripheral blood on day 15 was dose-dependent and reached near maximal occupancy of 75% at ≥15 mg QD. The maximum tolerated dose (MTD) was 20 mg QD. Twelve patients in part A1 (27.9%) and 5 patients in part A2 (45.5%) had a best overall response of stable disease. No complete response or partial response was observed. Conclusion The MTD of LY3405105 monotherapy was 20 mg QD. The most common toxicities were gastrointestinal adverse events, myelosuppression, fatigue, and asthenia. Limited clinical activity was observed in this phase I trial, and there are no plans for further development. ClinicalTrials.gov Identifier NCT03770494. [ABSTRACT FROM AUTHOR]

Published
2024
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93. Sensitive tumour detection and classification using plasma cell-free DNA methylomes

Author

Shen, Shu Yi, Singhania, Rajat, Fehringer, Gordon, Chakravarthy, Ankur, Roehrl, Michael H. A., Chadwick, Dianne, Zuzarte, Philip C., Borgida, Ayelet, Wang, Ting Ting, Li, Tiantian, Kis, Olena, Zhao, Zhen, Spreafico, Anna, Medina, Tiago da Silva, Wang, Yadon, Roulois, David, Ettayebi, Ilias, Chen, Zhuo, Chow, Signy, Murphy, Tracy, Arruda, Andrea, O’Kane, Grainne M., Liu, Jessica, Mansour, Mark, McPherson, John D., O’Brien, Catherine, Leighl, Natasha, Bedard, Philippe L., Fleshner, Neil, Liu, Geoffrey, Minden, Mark D., Gallinger, Steven, Goldenberg, Anna, Pugh, Trevor J., Hoffman, Michael M., Bratman, Scott V., Hung, Rayjean J., and De Carvalho, Daniel D.

Published
2018
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95. The GENIE BPC NSCLC cohort: a real-world repository integrating standardized clinical and genomic data for 1,846 patients with non-small cell lung cancer

Author

Choudhury, Noura J., primary, Lavery, Jessica A., additional, Brown, Samantha, additional, de Bruijn, Ino, additional, Jee, Justin, additional, Tran, Thinh Ngoc., additional, Rizvi, Hira, additional, Arbour, Kathryn C., additional, Whiting, Karissa, additional, Shen, Ronglai, additional, Hellmann, Matthew, additional, Bedard, Philippe L., additional, Yu, Celeste, additional, Leighl, Natasha, additional, LeNoue-Newton, Michele, additional, Micheel, Christine, additional, Warner, Jeremy L., additional, Ginsberg, Michelle S., additional, Plodkowski, Andrew, additional, Girshman, Jeffrey, additional, Sawan, Peter, additional, Pillai, Shirin, additional, Sweeney, Shawn M., additional, Kehl, Kenneth L., additional, Panageas, Katherine S., additional, Schultz, Nikolaus, additional, Schrag, Deb, additional, and Riely, Gregory J., additional

Published
2023
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96. Data from Characteristics and Outcome of AKT1E17K-Mutant Breast Cancer Defined through AACR Project GENIE, a Clinicogenomic Registry

Author

Smyth, Lillian M., primary, Zhou, Qin, primary, Nguyen, Bastien, primary, Yu, Celeste, primary, Lepisto, Eva M., primary, Arnedos, Monica, primary, Hasset, Michael J., primary, Lenoue-Newton, Michele L., primary, Blauvelt, Natalie, primary, Dogan, Semih, primary, Micheel, Christine M., primary, Wathoo, Chetna, primary, Horlings, Hugo, primary, Hudecek, Jan, primary, Gross, Benjamin E., primary, Kundra, Ritika, primary, Sweeney, Shawn M., primary, Gao, JianJiong, primary, Schultz, Nikolaus, primary, Zarski, Andrew, primary, Gardos, Stuart M., primary, Lee, Jocelyn, primary, Sheffler-Collins, Seth, primary, Park, Ben H., primary, Sawyers, Charles L., primary, André, Fabrice, primary, Levy, Mia, primary, Meric-Bernstam, Funda, primary, Bedard, Philippe L., primary, Iasonos, Alexia, primary, Schrag, Deborah, primary, and Hyman, David M., primary

Published
2023
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97. Data from AACR Project GENIE: Powering Precision Medicine through an International Consortium

Author

André, Fabrice, primary, Arnedos, Monica, primary, Baras, Alexander S., primary, Baselga, José, primary, Bedard, Philippe L., primary, Berger, Michael F., primary, Bierkens, Mariska, primary, Calvo, Fabien, primary, Cerami, Ethan, primary, Chakravarty, Debyani, primary, Dang, Kristen K., primary, Davidson, Nancy E., primary, Del Vecchio Fitz, Catherine, primary, Dogan, Semih, primary, DuBois, Raymond N., primary, Ducar, Matthew D., primary, Futreal, P. Andrew, primary, Gao, Jianjiong, primary, Garcia, Francisco, primary, Gardos, Stu, primary, Gocke, Christopher D., primary, Gross, Benjamin E., primary, Guinney, Justin, primary, Heins, Zachary J., primary, Hintzen, Stephanie, primary, Horlings, Hugo, primary, Hudeček, Jan, primary, Hyman, David M., primary, Kamel-Reid, Suzanne, primary, Kandoth, Cyriac, primary, Kinyua, Walter, primary, Kumari, Priti, primary, Kundra, Ritika, primary, Ladanyi, Marc, primary, Lefebvre, Céline, primary, LeNoue-Newton, Michele L., primary, Lepisto, Eva M., primary, Levy, Mia A., primary, Lindeman, Neal I., primary, Lindsay, James, primary, Liu, David, primary, Lu, Zhibin, primary, MacConaill, Laura E., primary, Maurer, Ian, primary, Maxwell, David S., primary, Meijer, Gerrit A., primary, Meric-Bernstam, Funda, primary, Micheel, Christine M., primary, Miller, Clinton, primary, Mills, Gordon, primary, Moore, Nathanael D., primary, Nederlof, Petra M., primary, Omberg, Larsson, primary, Orechia, John A., primary, Park, Ben Ho, primary, Pugh, Trevor J., primary, Reardon, Brendan, primary, Rollins, Barrett J., primary, Routbort, Mark J., primary, Sawyers, Charles L., primary, Schrag, Deborah, primary, Schultz, Nikolaus, primary, Shaw, Kenna R Mills, primary, Shivdasani, Priyanka, primary, Siu, Lillian L., primary, Solit, David B., primary, Sonke, Gabe S., primary, Soria, Jean Charles, primary, Sripakdeevong, Parin, primary, Stickle, Natalie H., primary, Stricker, Thomas P., primary, Sweeney, Shawn M., primary, Taylor, Barry S., primary, ten Hoeve, Jelle J., primary, Thomas, Stacy B., primary, Van Allen, Eliezer M., primary, Van 'T Veer, Laura J., primary, van de Velde, Tony, primary, van Tinteren, Harm, primary, Velculescu, Victor E., primary, Virtanen, Carl, primary, Voest, Emile E., primary, Wang, Lucy L., primary, Wathoo, Chetna, primary, Watt, Stuart, primary, Yu, Celeste, primary, Yu, Thomas V., primary, Yu, Emily, primary, Zehir, Ahmet, primary, and Zhang, Hongxin, primary

Published
2023
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98. Table S3 from AACR Project GENIE: Powering Precision Medicine through an International Consortium

Author

André, Fabrice, primary, Arnedos, Monica, primary, Baras, Alexander S., primary, Baselga, José, primary, Bedard, Philippe L., primary, Berger, Michael F., primary, Bierkens, Mariska, primary, Calvo, Fabien, primary, Cerami, Ethan, primary, Chakravarty, Debyani, primary, Dang, Kristen K., primary, Davidson, Nancy E., primary, Del Vecchio Fitz, Catherine, primary, Dogan, Semih, primary, DuBois, Raymond N., primary, Ducar, Matthew D., primary, Futreal, P. Andrew, primary, Gao, Jianjiong, primary, Garcia, Francisco, primary, Gardos, Stu, primary, Gocke, Christopher D., primary, Gross, Benjamin E., primary, Guinney, Justin, primary, Heins, Zachary J., primary, Hintzen, Stephanie, primary, Horlings, Hugo, primary, Hudeček, Jan, primary, Hyman, David M., primary, Kamel-Reid, Suzanne, primary, Kandoth, Cyriac, primary, Kinyua, Walter, primary, Kumari, Priti, primary, Kundra, Ritika, primary, Ladanyi, Marc, primary, Lefebvre, Céline, primary, LeNoue-Newton, Michele L., primary, Lepisto, Eva M., primary, Levy, Mia A., primary, Lindeman, Neal I., primary, Lindsay, James, primary, Liu, David, primary, Lu, Zhibin, primary, MacConaill, Laura E., primary, Maurer, Ian, primary, Maxwell, David S., primary, Meijer, Gerrit A., primary, Meric-Bernstam, Funda, primary, Micheel, Christine M., primary, Miller, Clinton, primary, Mills, Gordon, primary, Moore, Nathanael D., primary, Nederlof, Petra M., primary, Omberg, Larsson, primary, Orechia, John A., primary, Park, Ben Ho, primary, Pugh, Trevor J., primary, Reardon, Brendan, primary, Rollins, Barrett J., primary, Routbort, Mark J., primary, Sawyers, Charles L., primary, Schrag, Deborah, primary, Schultz, Nikolaus, primary, Shaw, Kenna R Mills, primary, Shivdasani, Priyanka, primary, Siu, Lillian L., primary, Solit, David B., primary, Sonke, Gabe S., primary, Soria, Jean Charles, primary, Sripakdeevong, Parin, primary, Stickle, Natalie H., primary, Stricker, Thomas P., primary, Sweeney, Shawn M., primary, Taylor, Barry S., primary, ten Hoeve, Jelle J., primary, Thomas, Stacy B., primary, Van Allen, Eliezer M., primary, Van 'T Veer, Laura J., primary, van de Velde, Tony, primary, van Tinteren, Harm, primary, Velculescu, Victor E., primary, Virtanen, Carl, primary, Voest, Emile E., primary, Wang, Lucy L., primary, Wathoo, Chetna, primary, Watt, Stuart, primary, Yu, Celeste, primary, Yu, Thomas V., primary, Yu, Emily, primary, Zehir, Ahmet, primary, and Zhang, Hongxin, primary

Published
2023
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99. Supplementary file - liver genes from Genomic and Transcriptomic Analyses of Breast Cancer Primaries and Matched Metastases in AURORA, the Breast International Group (BIG) Molecular Screening Initiative

Author

Aftimos, Philippe, primary, Oliveira, Mafalda, primary, Irrthum, Alexandre, primary, Fumagalli, Debora, primary, Sotiriou, Christos, primary, Gal-Yam, Einav Nili, primary, Robson, Mark E., primary, Ndozeng, Justin, primary, Di Leo, Angelo, primary, Ciruelos, Eva M., primary, de Azambuja, Evandro, primary, Viale, Giuseppe, primary, Scheepers, Elsemieke D., primary, Curigliano, Giuseppe, primary, Bliss, Judith M., primary, Reis-Filho, Jorge S., primary, Colleoni, Marco, primary, Balic, Marija, primary, Cardoso, Fatima, primary, Albanell, Joan, primary, Duhem, Caroline, primary, Marreaud, Sandrine, primary, Romagnoli, Dario, primary, Rojas, Beatriz, primary, Gombos, Andrea, primary, Wildiers, Hans, primary, Guerrero-Zotano, Angel, primary, Hall, Peter, primary, Bonetti, Andrea, primary, Larsson, Karolina Fs, primary, Degiorgis, Martina, primary, Khodaverdi, Silvia, primary, Greil, Richard, primary, Sverrisdóttir, Ásgerdur, primary, Paoli, Marta, primary, Seyll, Ethel, primary, Loibl, Sibylle, primary, Linderholm, Barbro, primary, Zoppoli, Gabriele, primary, Davidson, Nancy E., primary, Johannsson, Oskar Th, primary, Bedard, Philippe L., primary, Loi, Sherene, primary, Knox, Susan, primary, Cameron, David A., primary, Harbeck, Nadia, primary, Montoya, Maite Lasa, primary, Brandão, Mariana, primary, Vingiani, Andrea, primary, Caballero, Carmela, primary, Hilbers, Florentine S., primary, Yates, Lucy R., primary, Benelli, Matteo, primary, Venet, David, primary, and Piccart, Martine J., primary

Published
2023
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100. Supplementary Data from Characteristics and Outcome of AKT1E17K-Mutant Breast Cancer Defined through AACR Project GENIE, a Clinicogenomic Registry

Author

Smyth, Lillian M., primary, Zhou, Qin, primary, Nguyen, Bastien, primary, Yu, Celeste, primary, Lepisto, Eva M., primary, Arnedos, Monica, primary, Hasset, Michael J., primary, Lenoue-Newton, Michele L., primary, Blauvelt, Natalie, primary, Dogan, Semih, primary, Micheel, Christine M., primary, Wathoo, Chetna, primary, Horlings, Hugo, primary, Hudecek, Jan, primary, Gross, Benjamin E., primary, Kundra, Ritika, primary, Sweeney, Shawn M., primary, Gao, JianJiong, primary, Schultz, Nikolaus, primary, Zarski, Andrew, primary, Gardos, Stuart M., primary, Lee, Jocelyn, primary, Sheffler-Collins, Seth, primary, Park, Ben H., primary, Sawyers, Charles L., primary, André, Fabrice, primary, Levy, Mia, primary, Meric-Bernstam, Funda, primary, Bedard, Philippe L., primary, Iasonos, Alexia, primary, Schrag, Deborah, primary, and Hyman, David M., primary

Published
2023
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