Search Results - "Theoret, Marc Robert"

FDA analysis of pembrolizumab trials in multiple myeloma: Immune related adverse events (irAEs) and response by Krauss, Aviva C, Mulkey, Flora, Shen, Yuan-Li, Rosenberg, Amy, Miller, Barry, Carioti, Theresa, Scott, Kimberly, Gormley, Nicole, Theoret, Marc Robert, Sridhara, Rajeshwari, Farrell, Ann T., Pazdur, Richard

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Analysis of early mortality in randomized clinical trials evaluating anti-PD-1/PD-L1 antibodies: A systematic analysis by the United States Food and Drug Administration (FDA) by Mulkey, Flora, By, Kunthel, Theoret, Marc Robert, Maher, Virginia Ellen, Pazdur, Richard, Sridhara, Rajeshwari

“…Abstract only 2516 Background: Many studies exhibit what seems to be dis-proportionately higher early mortality (EM) in anti-PD-1/PD-L1 containing arms (IO)…”
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FDA analysis: Impact of BMI on efficacy outcomes in multiple myeloma trials by Ershler, Rachel, Fernandes, Laura L, Kanapuru, Bindu, Gwise, Thomas, Kluetz, Paul Gustav, Theoret, Marc Robert, Gormley, Nicole, Pazdur, Richard

“…Abstract only 8543 Background: Obesity has been implicated as a risk factor for the development of certain types of cancers, including multiple myeloma…”
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Antibiotic therapy and association with oncological outcomes from targeted and immune-based therapy in hepatocellular carcinoma (HCC) by Pinato, David J. James, Li, Xiaoxue, Mishra-Kalyani, Pallavi Shruti, D'Alessio, Antonio, Fulgenzi, Claudia A.M., Wei, Guo, Schneider, Julie A., Rivera, Donna, Pazdur, Richard, Theoret, Marc Robert, Casak, Sandra J., Lemery, Steven, Fashoyin, Ibilola, Cortellini, Alessio, Pelosof, Lorraine Cheryl

“…4089 Background: Immune checkpoint inhibitors (ICI) alone or in combination with tyrosine kinase (TKI) or VEGF pathway inhibitors (VEGFi) are therapeutic…”
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Time to treatment failure (TTF) as a potential clinical endpoint in real-world evidence (RWE) studies of melanoma by Sridhara, Rajeshwari, Zhou, Jiaxi, Theoret, Marc Robert, Mishra-Kalyani, Pallavi Shruti

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An FDA analysis of the association of tumor growth rate and overall and progression-free survival in metastatic non-small cell lung cancer (NSCLC) patients by Gong, Yutao, Mason, Jeremy, Shen, Yuan-Li, Chang, Elaine, Kazandjian, Dickran, Blumenthal, Gideon Michael, Singh, Harpreet, Theoret, Marc Robert, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A.

“…Abstract only 9541 Background: Previous studies have suggested that tumor growth rate (g), estimated using prostate-specific antigen values, is associated with…”
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FDA analysis of depth of response (DpR) and survival across 10 randomized controlled trials in patients with previously untreated unresectable or metastatic melanoma (UMM) by therapy type by Osgood, Christy, Mulkey, Flora, Mishra-Kalyani, Pallavi Shruti, Lemery, Steven, Ward, Ashley, Keegan, Patricia, Sridhara, Rajeshwari, Theoret, Marc Robert, Pazdur, Richard

“…Abstract only 9508 Background: Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 may not capture the full spectrum of benefit that patients with…”
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Patient-reported outcomes in PD-1/PD-L1 inhibitor registration trials: FDA analysis of data submitted and future directions by Howie, Lynn Jackson, Singh, Harpreet, King-Kallimanis, Bellinda, Roydhouse, Jessica, Theoret, Marc Robert, Blumenthal, Gideon Michael, Kluetz, Paul Gustav

“…Abstract only 134 Background: Patient-reported outcome measures (PROs) can capture the patient’s experience with disease and treatment. Anti-PD-1/PD-L1…”
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Impact of radiotherapy on risk of adverse events in patients receiving immunotherapy: A U.S. Food and Drug Administration pooled analysis by Anscher, Mitchell Steven, Arora, Shaily, Weinstock, Chana, Lubitz, Rachael, Amatya, Anup, Fiero, Mallorie, Tang, Shenghui, Bandaru, Pradeep, Sanchez, Jacquelyn, Girvin, Andrew, Tang, Chad, Amiri-Kordestani, Laleh, Theoret, Marc Robert, Pazdur, Richard, Beaver, Julia A.

“…Abstract only 3018 Background: Immune checkpoint inhibitors (ICIs) are widely used in the treatment of multiple advanced malignancies. Radiotherapy (RT) has…”
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Outcomes in patients with advanced non-small cell lung cancer (aNSCLC) and high PD-L1 expression treated with immune checkpoint inhibitor monotherapy: An FDA-pooled analysis by Shah, Sujay Yogesh, Vallejo, Jonathon Joseph, Gong, Yutao, Brown, Thomas D., Zhang, Chenan, Hirsch, Jonathan, Tang, Shenghui, Blumenthal, Gideon Michael, Singh, Harpreet, Kluetz, Paul Gustav, Theoret, Marc Robert, Beaver, Julia A., Pazdur, Richard

“…Abstract only 9606 Background: Higher PD-L1 score ≥ 50% predicts for greater benefit to immune checkpoint inhibitor (ICI) therapy in first line (1L) treatment…”
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Impact of timing of antibiotic use on clinical outcomes in patients with urothelial cancer treated with immune checkpoint inhibitors (ICIs) by Weinstock, Chana, Bandaru, Pradeep, Fernandes, Laura L, Chang, Elaine, Girvin, Andrew, Tang, Shenghui, Agrawal, Sundeep, Suzman, Daniel L., Singh, Harpreet, Brave, Michael Holman, Xu, James, Goldberg, Kirsten B., Ibrahim, Amna, Theoret, Marc Robert, Pazdur, Richard, Beaver, Julia A.

“…Abstract only 5045 Background: Although recent evidence has suggested that patients who receive antibiotics (ABX) during the course of ICI treatment might…”
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FDA’s Oncology Center for Excellence Pilots Project Orbis: A framework for concurrent submission and review of oncology products among international partners by Spillman, Dianne, Arora, Shaily, Venugopal, Rajesh, Scott, Bradley, Golding, Sarah, Richardson, Nicholas, Kasamon, Yvette L., Ethier, Jean-Francois, Gurd, Kate, Singh, Harpreet, DeClaro, R. Angelo, Beaver, Julia A., Kim, Tamy, Goldberg, Kirsten B., Kluetz, Paul Gustav, Theoret, Marc Robert, Pazdur, Richard

“…Abstract only e14125 Background: Cancer therapeutics often receive FDA approval months to years before regulatory submission to other countries. [i]…”
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Treatment-related toxicity and improved outcomes with immune checkpoint inhibitors in patients with hepatocellular carcinoma by Cortellini, Alessio, Marron, Thomas Urban, Mishra-Kalyani, Pallavi Shruti, Gong, Yutao, Saeed, Anwaar, Jun, Tomi, Dharmapuri, Sirish, Naqash, Abdul Rafeh, Khan, Uqba, Kaseb, Ahmed Omar, Huang, Yi-Hsiang, Ang, Celina, Schneider, Julie A., Pillai, Anjana, Rimassa, Lorenza, Pazdur, Richard, Theoret, Marc Robert, Lemery, Steven, Pelosof, Lorraine Cheryl, Pinato, David James

“…Abstract only 4085 Background: The development of treatment-related adverse events (trAE) correlates favorably with clinical outcomes in multiple studies of…”
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Clinical efficacy of abiraterone and enzalutamide metastatic castration sensitive prostate cancer patients who progressed rapidly on docetaxel with a genomic analysis by Chen, Gang, VanderWeele, David James, Karzai, Fatima, Bilusic, Marijo, Al Harthy, Munjid, Arlen, Philip M., Theoret, Marc Robert, Rosner, Inger L., Chun, Guinevere, Owens, Helen, Couvillon, Anna, Hankin, Amy, Williams, Monique, Gulley, James L., Dahut, William L., Madan, Ravi Amrit

“…Abstract only e16536 Background: Docetaxel has become a standard of care for mCSPC. Enzalutamide and abiraterone have been proven to improve survival in…”
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Impact of antibiotic use on clinical outcomes in patients with urothelial cancer receiving a programmed death protein 1 or programmed death ligand 1 (anti-PD-1/L1) antibody by Weinstock, Chana, Maher, Virginia Ellen, Fernandes, Laura L, Tang, Shenghui, Agrawal, Sundeep, Brave, Michael Holman, Ning, Yang-Min, Singh, Harpreet, Suzman, Daniel L., Xu, James, Goldberg, Kirsten B., Sridhara, Rajeshwari, Ibrahim, Amna, Theoret, Marc Robert, Beaver, Julia A., Pazdur, Richard

“…Abstract only 4557 Background: Previous data has suggested that patients treated with anti-PD-1/L1 antibodies who receive antibiotics during their therapy…”
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An FDA analysis of the association between adverse events and outcome in patients with urothelial cancer receiving a programmed death protein 1 or programmed death ligand 1 (anti-PD-1/L1) antibody by Weinstock, Chana, Maher, Virginia Ellen, Fernandes, Laura L., Tang, Shenghui, Agrawal, Sundeep, Brave, Michael Holman, Ning, Yang-Min, Singh, Harpreet, Suzman, Daniel L., Xu, James, Goldberg, Kirsten B., Sridhara, Rajeshwari, Ibrahim, Amna, Theoret, Marc Robert, Beaver, Julia A., Pazdur, Richard

“…Abstract only 4549 Background: To assess the relationship between tumor response rate, overall survival, and the development of related adverse events of…”
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FDA pooled analysis of time to treatment discontinuation (TTD) in frontline advanced renal cell carcinoma trials by Chang, Elaine, Gong, Yutao, Weinstock, Chana, Fernandes, Laura L, Hawley, Jessica, Gwise, Thomas, Regan, Meredith M., Choueiri, Toni K., Rini, Brian I., McDermott, David F., Atkins, Michael B., Suzman, Daniel L., Ibrahim, Amna, Tang, Shenghui, Theoret, Marc Robert, Kluetz, Paul Gustav, Pazdur, Richard, Beaver, Julia A.

“…Abstract only 5081 Background: Time to treatment discontinuation (TTD) has been proposed as a potential pragmatic real-world data (RWD) endpoint, and was…”
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Metastasis free survival in older men with nonmetastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: An FDA-pooled analysis by Singh, Harpreet, Zhang, Lijun, Amatya, Anup, Gong, Yutao, Suzman, Daniel L., Weinstock, Chana, Chang, Elaine, Anscher, Mitchell Steven, Chi, Dow-Chung, Xu, James, Brewer, Jamie Renee, Agrawal, Sundeep, Brave, Michael Holman, Hadadi, Mehrnoosh, Theoret, Marc Robert, Kluetz, Paul Gustav, Ibrahim, Amna, Pazdur, Richard, Beaver, Julia A.

“…Abstract only 12038 Background: The FDA has approved three androgen receptor (AR) inhibitors for nonmetastatic castration-resistant prostate cancer (nmCRPC)…”
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Combination of a therapeutic cancer vaccine and immune checkpoint inhibitors in prostate cancer by Madan, Ravi Amrit, Bilusic, Marijo, Strauss, Julius, Karzai, Fatima, Cordes, Lisa M., Arlen, Philip M., Theoret, Marc Robert, Rauckhorst, Myrna, Pritchard, Colin, Abdul Sater, Houssein, Couvillon, Anna, Hankin, Amy, Williams, Monique, Dahut, William L., Schlom, Jeffrey, Gulley, James L.

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Immunotherapy for biochemically recurrent prostate cancer by Madan, Ravi Amrit, Karzai, Fatima, Bilusic, Marijo, Strauss, Julius, Slovin, Susan F., Harshman, Lauren Christine, Theoret, Marc Robert, Arlen, Philip M., Rauckhorst, Myrna, Couvillon, Anna, Hankin, Amy, Williams, Monique, Kantoff, Philip W., Dahut, William L., Schlom, Jeffrey, Gulley, James L.

“…Abstract only 215 Background: Annually about 30-50,000 men are diagnosed with biochemically recurrent prostate cancer (BCRpc), defined by a rising PSA after…”
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