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1. Clinical outcomes and ctDNA correlates for CAPOX BETR: a phase II trial of capecitabine, oxaliplatin, bevacizumab, trastuzumab in previously untreated advanced HER2+ gastroesophageal adenocarcinoma

Author

Singh, Harshabad, Lowder, Kristen E., Kapner, Kevin, Kelly, Ronan J., Zheng, Hui, McCleary, Nadine Jackson, Abrams, Thomas A., Chan, Jennifer A., Regan, Eileen M., Klempner, Samuel J., Hannigan, Alison M., Remland, Joshua, Brais, Lauren K., Andrews, Elizabeth, Yurgelun, Matthew, Cleary, James M., Rubinson, Douglas A., Ritterhouse, Lauren L., Maron, Garrett, Aguirre, Andrew J., Meyerhardt, Jeffrey A., Gardecki, Emma, Lennerz, Jochen K., Wolpin, Brian M., and Enzinger, Peter C.

Published
2024
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2. Neoadjuvant nivolumab or nivolumab plus LAG-3 inhibitor relatlimab in resectable esophageal/gastroesophageal junction cancer: a phase Ib trial and ctDNA analyses

Author

Kelly, Ronan J., Landon, Blair V., Zaidi, Ali H., Singh, Dipika, Canzoniero, Jenna V., Balan, Archana, Hales, Russell K., Voong, K. Ranh, Battafarano, Richard J., Jobe, Blair A., Yang, Stephen C., Broderick, Stephen, Ha, Jinny, Marrone, Kristen A., Pereira, Gavin, Rao, Nisha, Borole, Aryan, Karaindrou, Katerina, Belcaid, Zineb, White, James R., Ke, Suqi, Amjad, Ali I., Weksler, Benny, Shin, Eun Ji, Thompson, Elizabeth, Smith, Kellie N., Pardoll, Drew M., Hu, Chen, Feliciano, Josephine L., Anagnostou, Valsamo, and Lam, Vincent K.

Published
2024
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5. Circulating Tumor DNA as a Predictive Biomarker for Clinical Outcomes With Margetuximab and Pembrolizumab in Pretreated HER2-Positive Gastric/Gastroesophageal Adenocarcinoma

Author

Catenacci, Daniel V.T., Kang, Yoon-Koo, Uronis, Hope E., Lee, Keun-Wook, Ng, Matthew C.H., Enzinger, Peter C., Park, Se Hoon, Gold, Philip J., Lacy, Jill, Hochster, Howard S., Oh, Sang Cheul, Kim, Yeul Hong, Marrone, Kristen A., Kelly, Ronan J., Juergens, Rosalyn A., Kim, Jong Gwang, Alcindor, Thierry, Sym, Sun Jin, Song, Eun-Kee, Chee, Cheng Ean, Chao, Yee, Kim, Sunnie, Oh, Do-Youn, Yen, Jennifer, Odegaard, Justin I., Lagow, Errin, Li, Daner, Sun, Jichao, Kaminker, Patrick, Moore, Paul A., Rosales, Minori Koshiji, and Park, Haeseong

Subjects
Merck KGaA, MacroGenics Inc., Bayer AG, AstraZeneca PLC, Medical research, Medicine, Experimental, Immunohistochemistry, Tumors -- Patient outcomes, DNA, Adenocarcinoma -- Patient outcomes, Pharmaceutical industry, Health
Abstract

PURPOSE. To assess the ability of circulating tumor DNA (ctDNA)-based testing to identify patients with HER2 (encoded by ERBB2)-positive gastric/gastroesophageal adenocarcinoma (GEA) who progressed on or after trastuzumab-containing treatments were treated with combination therapy of anti-HER2 and anti-PD-1 agents. METHODS. ctDNA analysis was performed retrospectively using plasma samples collected at study entry from 86 patients participating in the phase 1/2 CP-MGAH22-05 study (NCT02689284). RESULTS. Objective response rate (ORR) was significantly higher in evaluable ERBB2 amplification-positive vs negative patients based on ctDNA analysis at study entry (37% vs 6%, respectively; P = .00094). ORR was 23% across all patients who were evaluable for response. ERBB2 amplification was detected at study entry in 57% of patients (all HER2 positive at diagnosis), and detection was higher (88%) when HER2 status was determined by immunohistochemistry fewer than 6 months before study entry. ctDNA was detected in 98% (84/86) of patients tested at study entry. Codetected ERBB2-activating mutations were not associated with response. CONCLUSIONS. Current ERBB2 status may be more effective than archival status at predicting clinical benefit from margetuximab plus pembrolizumab therapy. ctDNA testing for ERBB2 status prior to treatment will spare patients from repeat tissue biopsies, which may be reserved for reflex testing when ctDNA is not detected. KEYWORDS. gastric/gastroesophageal adenocarcinoma; HER2; ctDNA; and margetuximab plus pembrolizumab, BACKGROUND The human epidermal growth factor receptor 2 (HER2) protein is a receptor tyrosine-protein kinase, encoded by erythroblastic oncogene B2 (ERBB2), normally involved in the proliferation and division of cells. [...]

Published
2023

6. Safety and Efficacy of Durvalumab and Tremelimumab Alone or in Combination in Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

Author

Kelly, Ronan J, Lee, Jeeyun, Bang, Yung-Jue, Almhanna, Khaldoun, Blum-Murphy, Mariela, Catenacci, Daniel VT, Chung, Hyun Cheol, Wainberg, Zev A, Gibson, Michael K, Lee, Keun-Wook, Bendell, Johanna C, Denlinger, Crystal S, Chee, Cheng Ean, Omori, Takeshi, Leidner, Rom, Lenz, Heinz-Josef, Chao, Yee, Rebelatto, Marlon C, Brohawn, Philip Z, He, Peng, McDevitt, Jennifer, Sheth, Siddharth, Englert, Judson M, and Ku, Geoffrey Y

Subjects
Clinical Research, Cancer, Rare Diseases, Clinical Trials and Supportive Activities, Digestive Diseases, Patient Safety, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, B7-H1 Antigen, CTLA-4 Antigen, Circulating Tumor DNA, Esophagogastric Junction, Female, Humans, Interferon-gamma, Male, Middle Aged, Prospective Studies, Stomach Neoplasms, Transcriptome, Young Adult, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThis randomized, multicenter, open-label, phase Ib/II study assessed durvalumab and tremelimumab in combination or as monotherapy for chemotherapy-refractory gastric cancer or gastroesophageal junction (GEJ) cancer.Patients and methodsSecond-line patients were randomized 2:2:1 to receive durvalumab plus tremelimumab (arm A), or durvalumab (arm B) or tremelimumab monotherapy (arm C), and third-line patients received durvalumab plus tremelimumab (arm D). A tumor-based IFNγ gene signature was prospectively evaluated as a potential predictive biomarker in second- and third-line patients receiving the combination (arm E). The coprimary endpoints were objective response rate and progression-free survival (PFS) rate at 6 months.ResultsA total of 113 patients were treated: 6 in phase Ib and 107 (arm A, 27; arm B, 24; arm C, 12; arm D, 25; arm E, 19) in phase II. Overall response rates were 7.4%, 0%, 8.3%, 4.0%, and 15.8% in the five arms, respectively. PFS rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 4%, 42%, 16%, and 11% of patients, respectively.ConclusionsResponse rates were low regardless of monotherapy or combination strategies. No new safety signals were identified. Including use of a tumor-based IFNγ signature and change in baseline and on-treatment circulating tumor DNA are clinically feasible and may be novel strategies to improve treatment response in this difficult-to-treat population.

Published
2020

8. First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study

Author

Hegewisch-Becker, Susanna, primary, Mendez, Guillermo, additional, Chao, Joseph, additional, Nemecek, Radim, additional, Feeney, Kynan, additional, Van Cutsem, Eric, additional, Al-Batran, Salah-Eddin, additional, Mansoor, Wasat, additional, Maisey, Nicholas, additional, Pazo Cid, Roberto, additional, Burge, Matthew, additional, Perez-Callejo, David, additional, Hipkin, R. William, additional, Mukherjee, Sourav, additional, Lei, Ming, additional, Tang, Hao, additional, Suryawanshi, Satyendra, additional, Kelly, Ronan J., additional, and Tebbutt, Niall C., additional

Published
2024
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10. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis

Author

Planchard, David, Besse, Benjamin, Groen, Harry J.M., Hashemi, Sayed M.S., Mazieres, Julien, Kim, Tae Min, Quoix, Elisabeth, Souquet, Pierre-Jean, Barlesi, Fabrice, Baik, Christina, Villaruz, Liza C., Kelly, Ronan J., Zhang, Shirong, Tan, Monique, Gasal, Eduard, Santarpia, Libero, and Johnson, Bruce E.

Published
2022
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11. Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection

Author

McCullough, Peter A., Kelly, Ronan J., Ruocco, Gaetano, Lerma, Edgar, Tumlin, James, Wheelan, Kevin R., Katz, Nevin, Lepor, Norman E., Vijay, Kris, Carter, Harvey, Singh, Bhupinder, McCullough, Sean P., Bhambi, Brijesh K., Palazzuoli, Alberto, De Ferrari, Gaetano M., Milligan, Gregory P., Safder, Taimur, Tecson, Kristen M., Wang, Dee Dee, McKinnon, John E., O'Neill, William W., Zervos, Marcus, and Risch, Harvey A.

Published
2021
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12. Margetuximab plus pembrolizumab in patients with previously treated, HER2-positive gastro-oesophageal adenocarcinoma (CP-MGAH22–05): a single-arm, phase 1b–2 trial

Author

Catenacci, Daniel V T, Kang, Yoon-Koo, Park, Haeseong, Uronis, Hope E, Lee, Keun-Wook, Ng, Matthew C H, Enzinger, Peter C, Park, Se Hoon, Gold, Philip J, Lacy, Jill, Hochster, Howard S, Oh, Sang Cheul, Kim, Yeul Hong, Marrone, Kristen A, Kelly, Ronan J, Juergens, Rosalyn A, Kim, Jong Gwang, Bendell, Johanna C, Alcindor, Thierry, Sym, Sun Jin, Song, Eun-Kee, Chee, Cheng Ean, Chao, Yee, Kim, Sunnie, Lockhart, A Craig, Knutson, Keith L, Yen, Jennifer, Franovic, Aleksandra, Nordstrom, Jeffrey L, Li, Daner, Wigginton, Jon, Davidson-Moncada, Jan K, Rosales, Minori Koshiji, and Bang, Yung-Jue

Published
2020
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13. Sitravatinib combined with PD1 blockade enhances cytotoxic T-Cell infiltration by M2 to M1 tumor macrophage repolarization in esophageal adenocarcinoma

Author

Sweeney, Ryan, primary, Omstead, Ashten N, additional, Fitzpatrick, John T, additional, Zheng, Ping, additional, Gorbunova, Anastasia, additional, Grayhack, Erin E, additional, Goel, Arul, additional, Khan, Alisha F, additional, Kosovec, Juliann E, additional, Wagner, Patrick L, additional, Jobe, Blair A, additional, Kelly, Ronan J, additional, and Zaidi, Ali H, additional

Published
2023
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15. Relationship Between Prior Radiotherapy and Checkpoint-Inhibitor Pneumonitis in Patients With Advanced Non–Small-Cell Lung Cancer

Author

Voong, Khinh Ranh, Hazell, Sarah Z., Fu, Wei, Hu, Chen, Lin, Cheng Ting, Ding, Kai, Suresh, Karthik, Hayman, Jonathan, Hales, Russell K., Alfaifi, Salem, Marrone, Kristen A., Levy, Benjamin, Hann, Christine L., Ettinger, David S., Feliciano, Josephine L., Peterson, Valerie, Kelly, Ronan J., Brahmer, Julie R., Forde, Patrick M., and Naidoo, Jarushka

Published
2019
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16. Impact of Checkpoint Inhibitor Pneumonitis on Survival in NSCLC Patients Receiving Immune Checkpoint Immunotherapy

Author

Suresh, Karthik, Psoter, Kevin J., Voong, Khinh Ranh, Shankar, Bairavi, Forde, Patrick M., Ettinger, David S., Marrone, Kristen A., Kelly, Ronan J., Hann, Christine L., Levy, Benjamin, Feliciano, Josephine L., Brahmer, Julie R., Feller-Kopman, David, Lerner, Andrew D., Lee, Hans, Yarmus, Lonny, Hales, Russell K., D’Alessio, Franco, Danoff, Sonye K., and Naidoo, Jarushka

Published
2019
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17. Pneumonitis in Non–Small Cell Lung Cancer Patients Receiving Immune Checkpoint Immunotherapy: Incidence and Risk Factors

Author

Suresh, Karthik, Voong, Khinh Ranh, Shankar, Bairavi, Forde, Patrick M., Ettinger, David S., Marrone, Kristen A., Kelly, Ronan J., Hann, Christine L., Levy, Benjamin, Feliciano, Josephine L., Brahmer, Julie R., Feller-Kopman, David, Lerner, Andrew D., Lee, Hans, Yarmus, Lonny, D’Alessio, Franco, Hales, Russell K., Lin, Cheng Ting, Psoter, Kevin J., Danoff, Sonye K., and Naidoo, Jarushka

Published
2018
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18. Sitravatinib combined with PD-1 blockade enhances cytotoxic T-cell infiltration by M2 to M1 tumor macrophage repolarization in esophageal adenocarcinoma.

Author

Sweeney, Ryan, Omstead, Ashten N, Fitzpatrick, John T, Zheng, Ping, Gorbunova, Anastasia, Grayhack, Erin E, Goel, Arul, Khan, Alisha F, Kosovec, Juliann E, Wagner, Patrick L, Jobe, Blair A, Kelly, Ronan J, and Zaidi, Ali H

Abstract

Esophageal adenocarcinoma (EAC) is a leading cause of cancer-related mortality. Sitravatinib is a novel multi-gene tyrosine kinase inhibitor (TKI) that targets tumor-associated macrophage (TAM) receptors, VEGF, PDGF and c-Kit. Currently, sitravatinib is actively being studied in clinical trials across solid tumors and other TKIs have shown efficacy in combination with immune checkpoint inhibitors (ICI) in cancer models. In this study, we investigated the anti-tumor activity of sitravatinib alone and in combination with PD-1 blockade in an EAC rat model. Treatment response was evaluated by mortality, pre- and post-treatment MRI, gene expression, immunofluorescence and immunohistochemistry. Our results demonstrated adequate safety and significant tumor shrinkage in animals treated with sitravatinib, and more profoundly, sitravatinib and PD-1 inhibitor, AUNP-12 (P  < 0.01). Suppression of TAM receptors resulted in increased gene expression of pro-inflammatory cytokines and decreased expression of anti-inflammatory cytokines, enhanced infiltration of CD8+ T cells, and M2 to M1 macrophage phenotype repolarization in the tumor microenvironment of treated animals (P  < 0.01). Moreover, endpoint immunohistochemistry staining corroborated the anti-tumor activity by downregulation of Ki67 and upregulation of Caspase-3 in the treated animals. Additionally, pretreatment gene expression of TAM receptors and PD-L1 were significantly higher in major responders compared with the non-responders, in animals that received sitravatinib and AUNP-12 (P  < 0.02), confirming that TAM suppression enhances the efficacy of PD-1 blockade. In conclusion, this study proposes a promising immunomodulatory strategy using a multi-gene TKI to overcome developed resistance to an ICI in EAC, establishing rationale for future clinical development. [ABSTRACT FROM AUTHOR]

Published
2024
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20. The alveolar immune cell landscape is dysregulated in checkpoint inhibitor pneumonitis

Author

Suresh, Karthik, Naidoo, Jarushka, Zhong, Qiong, Xiong, Ye, Mammen, Jennifer, de Flores, Marcia Villegas, Cappelli, Laura, Balaji, Aanika, Palmer, Tsvi, Forde, Patrick M., Anagnostou, Valsamo, Ettinger, David S., Marrone, Kristen A., Kelly, Ronan J., Hann, Christine L., Levy, Benjamin, Feliciano, Josephine L., Lin, Cheng- Ting, Feller-Kopman, David, Lerner, Andrew D., Lee, Hans, Shafiq, Majid, Yarmus, Lonny, Lipson, Evan J., Soloski, Mark, Brahmer, Julie R., Danoff, Sonye K., and D'Alessio, Franco

Subjects
Interleukins -- Analysis, Pneumonia -- Care and treatment -- Analysis, Cell death -- Analysis, Immunotherapy -- Analysis, T cells -- Analysis, Cytokines, Therapeutics, Lymphocytes, Lung diseases, Corticosteroid drugs, Health care industry
Abstract

BACKGROUND. Checkpoint inhibitor pneumonitis (CIP) is a highly morbid complication of immune checkpoint immunotherapy (ICI), one which precludes the continuation of ICI. Yet, the mechanistic underpinnings of CIP are unknown. METHODS. To better understand the mechanism of lung injury in CIP, we prospectively collected bronchoalveolar lavage (BAL) samples in ICI-treated patients with (n = 12) and without CIP (n = 6), prior to initiating first-line therapy for CIP (high-dose corticosteroids). We analyzed BAL immune cell populations using a combination of traditional multicolor flow cytometry gating, unsupervised clustering analysis, and BAL supernatant cytokine measurements. RESULTS. We found increased BAL lymphocytosis, predominantly [CD4.sup.+] T cells, in patients with CIP. Specifically, we observed increased numbers of BAL central memory T cells, evidence of type I polarization, and decreased expression of cytotoxic T lymphocyte-associated protein 4 and programmed cell death protein 1 in BAL Tregs, suggesting both activation of proinflammatory subsets and an attenuated suppressive phenotype. CIP BAL myeloid immune populations displayed enhanced expression of IL-1[beta] and decreased expression of counterregulatory interleukin-1 receptor antagonist. We observed increased levels of T-cell chemoattractants in the BAL supernatant, consistent with our proinflammatory, lymphocytic cellular landscape. CONCLUSION. We observe several immune cell subpopulations that are dysregulated in CIP, which may represent possible targets that could lead to therapeutics for this morbid immune-related adverse event. FUNDING. NIH, Department of Defense, and the Bloomberg~Kimmel Institute for Cancer Immunotherapy., Introduction With recent clinical trials demonstrating clear efficacy for immunotherapy in patients with locally advanced and advanced-stage non-small-cell lung cancer (NSCLC) as well as other tumors, the use of immune [...]

Published
2019
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21. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of gastrointestinal cancer

Author

Kelly, Ronan J, primary, Bever, Katherine, additional, Chao, Joseph, additional, Ciombor, Kristen K, additional, Eng, Cathy, additional, Fakih, Marwan, additional, Goyal, Lipika, additional, Hubbard, Joleen, additional, Iyer, Renuka, additional, Kemberling, Holly T, additional, Krishnamurthi, Smitha, additional, Ku, Geoffrey, additional, Mordecai, Mindy Mintz, additional, Morris, Van K, additional, Paulson, Andrew Scott, additional, Peterson, Valerie, additional, Shah, Manish A, additional, and Le, Dung T, additional

Published
2023
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22. Scientific Advances in Thoracic Oncology 2016

Author

Soo, Ross A., Stone, Emily C.A., Cummings, K. Michael, Jett, James R., Field, John K., Groen, Harry J.M., Mulshine, James L., Yatabe, Yasushi, Bubendorf, Lukas, Dacic, Sanja, Rami-Porta, Ramon, Detterbeck, Frank C., Lim, Eric, Asamura, Hisao, Donington, Jessica, Wakelee, Heather A., Wu, Yi-Long, Higgins, Kristin, Senan, Suresh, Solomon, Benjamin, Kim, Dong-Wan, Johnson, Melissa, Yang, James C.H., Sequist, Lecia V., Shaw, Alice T., Ahn, Myung-Ju, Costa, Daniel B., Patel, Jyoti D., Horn, Leora, Gettinger, Scott, Peters, Solange, Wynes, Murry W., Faivre-Finn, Corinne, Rudin, Charles M., Tsao, Anne, Baas, Paul, Kelly, Ronan J., Leighl, Natasha B., Scagliotti, Giorgio V., Gandara, David R., Hirsch, Fred R., and Spigel, David R.

Published
2017
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23. Targeting the Hedgehog Pathway Using Itraconazole to Prevent Progression of Barrettʼs Esophagus to Invasive Esophageal Adenocarcinoma

Author

Kelly, Ronan J., Ansari, Amir M., Miyashita, Tomoharu, Zahurak, Marianna, Lay, Frank, Ahmed, A. Karim, Born, Louis J., Pezhouh, Maryam K., Salimian, Kevan J., Ng, Christopher, Matsangos, Aerielle E., Stricker-Krongrad, Anne-Heloise, Mukaisho, Ken-ichi, Marti, Guy P., Chung, Christine H., Canto, Marcia I., Rudek, Michelle A., Meltzer, Stephen J., and Harmon, John W.

Published
2019
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24. Abstract CT155: Long term results and ctDNA correlatives for CAPOX BETR: A multi-center phase II trial of capecitabine, oxaliplatin, bevacizumab and trastuzumab for previously untreated HER2 positive metastatic gastroesophageal adenocarcinoma

Author

Singh, Harshabad, primary, Lowder, Kristen E., additional, Kapner, Kevin, additional, Kelly, Ronan J., additional, Zheng, Hui, additional, McCleary, Nadine J., additional, Abrams, Thomas A., additional, Chan, Jennifer A., additional, Regan, Eileen M., additional, Klempner, Samuel J., additional, Hannigan, Alison M., additional, Brais, Lauren K., additional, Andrews, Elizabeth A., additional, Yurgelun, Matthew B., additional, Cleary, James M., additional, Rubinson, Douglas A., additional, Ritterhouse, Lauren L., additional, Maron, Garrett E., additional, Aguirre, Andrew J., additional, Tan, Lu, additional, Du, Pan, additional, Meyerhardt, Jeffrey A., additional, Gardecki, Emma, additional, Lennerz, Jochen K., additional, Jia, Shidong, additional, Wolpin, Brian M., additional, and Enzinger, Peter C., additional

Published
2023
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25. Abstract 3374: Circulating cell-free tumor DNA dynamics capture minimal residual disease with neoadjuvant immune checkpoint blockade plus chemoradiotherapy for patients with operable esophageal/gastroesophageal junction cancer

Author

Landon, Blair V., primary, Kelly, Ronan J., additional, Zaidi, Ali H., additional, Balan, Archana, additional, Canzoniero, Jenna V., additional, Pereira, Gavin, additional, Belcaid, Zineb, additional, Hales, Russell K., additional, Voong, K Ranh, additional, Battafarano, Richard J., additional, Jobe, Blair A., additional, Yang, Stephen C., additional, Broderick, Stephen, additional, Ha, Jinny, additional, Smith, Kellie N., additional, Thompson, Elizabeth, additional, Shaikh, Fyza Y., additional, White, James R., additional, Sears, Cynthia L., additional, Shin, Eun J., additional, Amjad, Ali I., additional, Weksler, Benny, additional, Feliciano, Josephine L., additional, Hu, Chen, additional, Lam, Vincent K., additional, and Anagnostou, Valsamo, additional

Published
2023
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26. Abstract 3366: A machine learning approach to determine the cellular origin of variants in liquid biopsies

Author

Canzoniero, Jenna V., primary, Balan, Archana, additional, Phallen, Jillian, additional, Landon, Blair V., additional, Sivapalan, Lavanya, additional, Green, Benjamin, additional, Belcaid, Zineb, additional, Scott, Susan C., additional, Pereira, Gavin, additional, Lam, Vincent K., additional, Zaidi, Ali H., additional, Kelly, Ronan J., additional, Hann, Christine L., additional, Iams, Wade T., additional, Lovly, Christine M., additional, Forde, Patrick M., additional, Meijer, Gerrit A., additional, Vink, Geraldine R., additional, Fijneman, Remond J., additional, Group, The MEDOCC, additional, Velculescu, Victor E., additional, Scharpf, Robert B., additional, and Anagnostou, Valsamo, additional

Published
2023
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27. Supplementary Data from Evaluation of KRAS Mutations, Angiogenic Biomarkers, and DCE-MRI in Patients with Advanced Non–Small-Cell Lung Cancer Receiving Sorafenib

Author

Kelly, Ronan J., primary, Rajan, Arun, primary, Force, Jeremy, primary, Lopez-Chavez, Ariel, primary, Keen, Corrine, primary, Cao, Liang, primary, Yu, Yunkai, primary, Choyke, Peter, primary, Turkbey, Baris, primary, Raffeld, Mark, primary, Xi, Liqiang, primary, Steinberg, Seth M., primary, Wright, John J., primary, Kummar, Shivaani, primary, Gutierrez, Martin, primary, and Giaccone, Giuseppe, primary

Published
2023
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28. Supplementary Data from A Pharmacodynamic Study of Docetaxel in Combination with the P-glycoprotein Antagonist Tariquidar (XR9576) in Patients with Lung, Ovarian, and Cervical Cancer

Author

Kelly, Ronan J., primary, Draper, Deborah, primary, Chen, Clara C., primary, Robey, Robert W., primary, Figg, William D., primary, Piekarz, Richard L., primary, Chen, Xiaohong, primary, Gardner, Erin R., primary, Balis, Frank M., primary, Venkatesan, Aradhana M., primary, Steinberg, Seth M., primary, Fojo, Tito, primary, and Bates, Susan E., primary

Published
2023
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29. Supplementary Table 1, Supplementary Figures 1-4 from A Phase I, Dose Escalation Study of Oral ASP8273 in Patients with Non–small Cell Lung Cancers with Epidermal Growth Factor Receptor Mutations

Author

Yu, Helena A., primary, Spira, Alexander, primary, Horn, Leora, primary, Weiss, Jared, primary, West, Howard, primary, Giaccone, Giuseppe, primary, Evans, Tracey, primary, Kelly, Ronan J., primary, Desai, Bhardwaj, primary, Krivoshik, Andrew, primary, Moran, Diarmuid, primary, Poondru, Srinivasu, primary, Jie, Fei, primary, Aoyama, Kouji, primary, Keating, Anne, primary, and Oxnard, Geoffrey R., primary

Published
2023
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30. Supplementary Methods, Figures 1-2 from A Phase I Combination Study of Olaparib with Cisplatin and Gemcitabine in Adults with Solid Tumors

Author

Rajan, Arun, primary, Carter, Corey A., primary, Kelly, Ronan J., primary, Gutierrez, Martin, primary, Kummar, Shivaani, primary, Szabo, Eva, primary, Yancey, Mary Ann, primary, Ji, Jiuping, primary, Mannargudi, Baskar, primary, Woo, Sukyung, primary, Spencer, Shawn, primary, Figg, William Douglas, primary, and Giaccone, Giuseppe, primary

Published
2023
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31. Supplementary Methods, Figures 1-3, Tables 1-5 from A Phase I Study of PF-04929113 (SNX-5422), an Orally Bioavailable Heat Shock Protein 90 Inhibitor, in Patients with Refractory Solid Tumor Malignancies and Lymphomas

Author

Rajan, Arun, primary, Kelly, Ronan J., primary, Trepel, Jane B., primary, Kim, Yeong Sang, primary, Alarcon, Sylvia V., primary, Kummar, Shivaani, primary, Gutierrez, Martin, primary, Crandon, Sonja, primary, Zein, Wadih M., primary, Jain, Lokesh, primary, Mannargudi, Baskar, primary, Figg, William D., primary, Houk, Brett E., primary, Shnaidman, Michael, primary, Brega, Nicoletta, primary, and Giaccone, Giuseppe, primary

Published
2023
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32. Dabrafenib in patients with BRAFV600E-positive advanced non-small-cell lung cancer: a single-arm, multicentre, open-label, phase 2 trial

Author

Planchard, David, Kim, Tae Min, Mazieres, Julien, Quoix, Elisabeth, Riely, Gregory, Barlesi, Fabrice, Souquet, Pierre-Jean, Smit, Egbert F, Groen, Harry J M, Kelly, Ronan J, Cho, B C, Socinski, Mark A, Pandite, Lini, Nase, Christine, Ma, Bo, D'Amelio, Anthony, Jr, Mookerjee, Bijoyesh, Curtis, C Martin, Jr, and Johnson, Bruce E

Published
2016
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37. The Texas Immuno-Oncology Biorepository, a statewide biospecimen collection and clinical informatics system to enable longitudinal tumor and immune profiling

Author

Kelly, Ronan J., primary, Whitsett, Timothy G., additional, Snipes, G. Jackson, additional, Dobin, Sheila M., additional, Finholt, Jennifer, additional, Settele, Natalie, additional, Priest, Elisa L., additional, Youens, Kenneth, additional, Wallace, Lucy B., additional, Schwartz, Gary, additional, Wong, Lucas, additional, Henderson, Sherronda M., additional, Gowan, Alan C., additional, Fonkem, Ekokobe, additional, Juarez, Maria I., additional, Murray, Christal E., additional, Wu, Jeffrey, additional, Van Keuren-Jensen, Kendall, additional, Pirrotte, Patrick, additional, Highlander, Sarah, additional, Contente, Tania, additional, Baker, Angela, additional, Victorino, Jose, additional, and Berens, Michael E., additional

Published
2022
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38. Multi-center matched cohort study of convalescent plasma for hospitalized patients with COVID-19

Author

Zhou, Cindy Ke, primary, Bennett, Monica M., additional, Villa, Carlos H., additional, Hammonds, Kendall P., additional, Lu, Yun, additional, Ettlinger, Jason, additional, Priest, Elisa L., additional, Gottlieb, Robert L., additional, Davis, Steven, additional, Mays, Edward, additional, Clarke, Tainya C., additional, Shoaibi, Azadeh, additional, Wong, Hui-Lee, additional, Anderson, Steven A., additional, and Kelly, Ronan J., additional

Published
2022
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41. Cixutumumab for patients with recurrent or refractory advanced thymic epithelial tumours: a multicentre, open-label, phase 2 trial

Author

Rajan, Arun, Carter, Corey A, Berman, Arlene, Cao, Liang, Kelly, Ronan J, Thomas, Anish, Khozin, Sean, Chavez, Ariel Lopez, Bergagnini, Isabella, Scepura, Barbara, Szabo, Eva, Lee, Min-Jung, Trepel, Jane B, Browne, Sarah K, Rosen, Lindsey B, Yu, Yunkai, Steinberg, Seth M, Chen, Helen X, Riely, Gregory J, and Giaccone, Giuseppe

Published
2014
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44. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer

Author

Kelly, Ronan J, Ajani, Jaffer A, Kuzdzal, Jaroslaw, Zander, Thomas, Van Cutsem, Eric, Piessen, Guillaume, Mendez, Guillermo, Feliciano, Josephine, Motoyama, Satoru, Lièvre, Astrid, Uronis, Hope, Elimova, Elena, Grootscholten, Cecile, Geboes, Karen, Zafar, Syed, Snow, Stephanie, Ko, Andrew H, Feeney, Kynan, Schenker, Michael, Kocon, Piotr, Zhang, Jenny, Zhu, Lili, Lei, Ming, Singh, Prianka, Kondo, Kaoru, Cleary, James M, Moehler, Markus, CheckMate 577 Investigators, Van den Eynde, Marc, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'hépato-gastro-entérologie, UCL - (SLuc) Service d'hématologie, Baylor University, MD Anderson Cancer Center [Houston], The University of Texas Health Science Center at Houston (UTHealth), Uniwersytet Jagielloński w Krakowie = Jagiellonian University (UJ), Universitätsklinikum Köln (Uniklinik Köln), Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), CHU Lille, Favaloro Foundation, Johns Hopkins University (JHU), Akita University, Chemistry, Oncogenesis, Stress and Signaling (COSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Duke Cancer Institute Durham, Duke University Medical Center, Princess Margaret Hospital, University of Toronto, Netherlands Cancer Institute (NKI), Antoni van Leeuwenhoek Hospital, Ghent University Hospital, Florida Hospital Cancer Institute, University of California [San Francisco] (UC San Francisco), University of California (UC), Bristol-Myers Squibb Company, Dana-Farber Cancer Institute [Boston], Johannes Gutenberg - Universität Mainz = Johannes Gutenberg University (JGU), Bristol Myers Squibb Bristol-Myers Squibb, Ono Pharmaceutical, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of California [San Francisco] (UCSF), University of California, and Johannes Gutenberg - Universität Mainz (JGU)

Subjects
Adult, Male, medicine.medical_specialty, Esophageal Neoplasms, medicine.medical_treatment, [SDV.CAN]Life Sciences [q-bio]/Cancer, Kaplan-Meier Estimate, Adenocarcinoma, 030204 cardiovascular system & hematology, Gastroenterology, B7-H1 Antigen, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Stomach Neoplasms, Internal medicine, Medicine and Health Sciences, medicine, Carcinoma, Humans, 030212 general & internal medicine, Esophagus, Immune Checkpoint Inhibitors, Neoadjuvant therapy, Aged, Aged, 80 and over, Chemotherapy, business.industry, Cancer, Chemoradiotherapy, Adjuvant, General Medicine, Middle Aged, medicine.disease, Neoadjuvant Therapy, Intention to Treat Analysis, 3. Good health, Nivolumab, medicine.anatomical_structure, Chemotherapy, Adjuvant, Carcinoma, Squamous Cell, Female, Esophagogastric Junction, business, Adjuvant, Chemoradiotherapy
Abstract

BackgroundNo adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer. MethodsWe conducted CheckMate 577, a global, randomized, double-blind, placebo-controlled phase 3 trial to evaluate a checkpoint inhibitor as adjuvant therapy in patients with esophageal or gastroesophageal junction cancer. Adults with resected (R0) stage II or III esophageal or gastroesophageal junction cancer who had received neoadjuvant chemoradiotherapy and had residual pathological disease were randomly assigned in a 2:1 ratio to receive nivolumab (at a dose of 240 mg every 2 weeks for 16 weeks, followed by nivolumab at a dose of 480 mg every 4 weeks) or matching placebo. The maximum duration of the trial intervention period was 1 year. The primary end point was disease-free survival. ResultsThe median follow-up was 24.4 months. Among the 532 patients who received nivolumab, the median disease-free survival was 22.4 months (95% confidence interval [CI], 16.6 to 34.0), as compared with 11.0 months (95% CI, 8.3 to 14.3) among the 262 patients who received placebo (hazard ratio for disease recurrence or death, 0.69; 96.4% CI, 0.56 to 0.86; P

Published
2021

45. Abstract 1973: Patients with operable esophageal cancer and improved responses to combined chemoradiotherapy and immunotherapy display distinct microbiome profiles enriched in multiple Bacteroides species

Author

Shaikh, Fyza Y., primary, White, James R., additional, Kelly, Ronan J., additional, Zaidi, Ali H., additional, Canzoniero, Jenna V., additional, Feliciano, Josephine L., additional, Hales, Russell K., additional, Voong, K Ranh, additional, Battafarano, Richard J., additional, Jobe, Blair A., additional, Yang, Stephen C., additional, Broderick, Stephen, additional, Ha, Jinny, additional, Smith, Kellie N., additional, Thompson, Elizabeth, additional, Shin, Eun J., additional, Amjad, Ali I., additional, Guerrieri, Patrizia, additional, Weksler, Benny, additional, Hu, Chen, additional, Anagnostou, Valsamo, additional, Lam, Vincent K., additional, and Sears, Cynthia L., additional

Published
2022
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46. CSF-1R inhibitor, pexidartinib, sensitizes esophageal adenocarcinoma to PD-1 immune checkpoint blockade in a rat model

Author

Omstead, Ashten N, primary, Paskewicz, Michael, additional, Gorbunova, Anastasia, additional, Zheng, Ping, additional, Salvitti, Madison S, additional, Mansoor, Rubab, additional, Reed, Payton, additional, Ballengee, Sydne, additional, Wagner, Patrick L, additional, Jobe, Blair A, additional, Kelly, Ronan J, additional, and Zaidi, Ali H, additional

Published
2022
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49. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC

Author

Planchard, David, Besse, Benjamin, Groen, Harry J. M., Hashemi, Sayed M. S., Mazieres, Julien, Kim, Tae Min, Quoix, Elisabeth, Souquet, Pierre-Jean, Barlesi, Fabrice, Baik, Christina, Villaruz, Liza C., Kelly, Ronan J., Zhang, Shirong, Tan, Monique, Gasal, Eduard, Santarpia, Libero, Johnson, Bruce E., Institut Gustave Roussy (IGR), Département de médecine oncologique [Gustave Roussy], Department of Pulmonary Medicine, University Medical Center Groningen [Groningen] (UMCG), Service de pneumologie [Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Strasbourg, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Baylor University

Subjects
[SDV]Life Sciences [q-bio]
Abstract

Introduction: Dabrafenib plus trametinib was found to have robust antitumor activity in patients with BRAF V600Emutant metastatic NSCLC (mNSCLC). We report updated survival analysis of a phase 2 study (NCT01336634) with a minimum of 5-year follow-up and updated genomic data. Methods: Pretreated (cohort B) and treatment-naive (cohort C) patients with BRAF V600E-mutant mNSCLC received dabrafenib 150 mg twice daily and trametinib 2 mg once daily. The primary end point was investigator-assessed overall response rate per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary end points were duration of response, progression-free survival, overall survival, and safety. Results: At data cutoff, for cohorts B (57 patients) and C (36 patients), the median follow-up was 16.6 (range: 0.5- 78.5) and 16.3 (range: 0.4-80) months, overall response rate (95% confidence interval [CI]) was 68.4% (54.8-80.1) and 63.9% (46.2-79.2), median progression-free survival (95% CI) was 10.2 (6.9-16.7) and 10.8 (7.0-14.5) months, and median overall survival (95% CI) was 18.2 (14.3-28.6) and 17.3 (12.3-40.2) months, respectively. The 4-and 5 year survival rates were 26% and 19% in pretreated patients and 34% and 22% in treatment-naive patients, respectively. A total of 17 patients (18%) were still alive. The most frequent adverse event was pyrexia (56%). Exploratory genomic analysis indicated that the presence of coexisting genomic alterations might influence clinical outcomes in these patients; however, these results require further investigation. Conclusions: Dabrafenib plus trametinib therapy was found to have substantial and durable clinical benefit, with a manageable safety profile, in patients with BRAF V600Emutant mNSCLC, regardless of previous treatment. (c) 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

Published
2022

50. Scientific Advances in Lung Cancer 2015

Author

Tsao, Anne S., Scagliotti, Giorgio V., Bunn, Paul A., Jr., Carbone, David P., Warren, Graham W., Bai, Chunxue, de Koning, Harry J., Yousaf-Khan, Uraujh A., McWilliams, Annette, Tsao, Ming Sound, Adusumilli, Prasad S., Rami-Porta, Ramón, Asamura, Hisao, Van Schil, Paul E., Darling, Gail E., Ramalingam, Suresh S., Gomez, Daniel R., Rosenzweig, Kenneth E., Zimmermann, Stefan, Peters, Solange, Ou, Sai-Hong Ignatius, Reungwetwattana, Thanyanan, Jänne, Pasi A., Mok, Tony S., Wakelee, Heather A., Pirker, Robert, Mazières, Julien, Brahmer, Julie R., Zhou, Yang, Herbst, Roy S., Papadimitrakopoulou, Vassiliki A., Redman, Mary W., Wynes, Murry W., Gandara, David R., Kelly, Ronan J., Hirsch, Fred R., and Pass, Harvey I.

Published
2016
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