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1,032 results on '"Awad, Mark M."'

1. RAS-ON inhibition overcomes clinical resistance to KRAS G12C-OFF covalent blockade

Author

Nokin, Marie-Julie, Mira, Alessia, Patrucco, Enrico, Ricciuti, Biagio, Cousin, Sophie, Soubeyran, Isabelle, San José, Sonia, Peirone, Serena, Caizzi, Livia, Vietti Michelina, Sandra, Bourdon, Aurelien, Wang, Xinan, Alvarez-Villanueva, Daniel, Martínez-Iniesta, María, Vidal, August, Rodrigues, Telmo, García-Macías, Carmen, Awad, Mark M., Nadal, Ernest, Villanueva, Alberto, Italiano, Antoine, Cereda, Matteo, Santamaría, David, and Ambrogio, Chiara

Published
2024
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3. Biomarker-directed targeted therapy plus durvalumab in advanced non-small-cell lung cancer: a phase 2 umbrella trial

Author

Besse, Benjamin, Pons-Tostivint, Elvire, Park, Keunchil, Hartl, Sylvia, Forde, Patrick M., Hochmair, Maximilian J., Awad, Mark M., Thomas, Michael, Goss, Glenwood, Wheatley-Price, Paul, Shepherd, Frances A., Florescu, Marie, Cheema, Parneet, Chu, Quincy S. C., Kim, Sang-We, Morgensztern, Daniel, Johnson, Melissa L., Cousin, Sophie, Kim, Dong-Wan, Moskovitz, Mor T., Vicente, David, Aronson, Boaz, Hobson, Rosalind, Ambrose, Helen J., Khosla, Sajan, Reddy, Avinash, Russell, Deanna L., Keddar, Mohamed Reda, Conway, James P., Barrett, J. Carl, Dean, Emma, Kumar, Rakesh, Dressman, Marlene, Jewsbury, Philip J., Iyer, Sonia, Barry, Simon T., Cosaert, Jan, and Heymach, John V.

Published
2024
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4. Three-Year Overall Survival Outcomes and Correlative Analyses in Patients With NSCLC and High (50%–89%) Versus Very High (≥90%) Programmed Death-Ligand 1 Expression Treated With First-Line Pembrolizumab or Cemiplimab

Author

Ricciuti, Biagio, Elkrief, Arielle, Lin, Jessica, Zhang, Jianjun, Alessi, Joao V., Lamberti, Giuseppe, Gandhi, Malini, Di Federico, Alessandro, Pecci, Federica, Wang, Xinan, Makarem, Maisam, Murilo Hidalgo Filho, Cassio, Gorria, Teresa, Saini, Arushi, Pabon, Cindy, Lindsay, James, Pfaff, Kathleen L., Welsh, Emma L., Nishino, Mizuki, Sholl, Lynette M., Rodig, Scott, Kilickap, Saadettin, Rietschel, Petra, McIntyre, Debra AG., Pouliot, Jean-Francois, Altan, Mehmet, Gainor, Justin F., Heymach, John V., Schoenfeld, Adam J., and Awad, Mark M.

Published
2024
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5. In vivo vulnerabilities to GPX4 and HDAC inhibitors in drug-persistent versus drug-resistant BRAFV600E lung adenocarcinoma

Author

Nokin, Marie-Julie, Darbo, Elodie, Richard, Elodie, San José, Sonia, de Hita, Sergio, Prouzet-Mauleon, Valérie, Turcq, Béatrice, Gerardelli, Laura, Crake, Rebekah, Velasco, Valérie, Koopmansch, Benjamin, Lambert, Frederic, Xue, Jenny Y., Sang, Ben, Horne, Julie, Ziemons, Eric, Villanueva, Alberto, Blomme, Arnaud, Herfs, Michael, Cataldo, Didier, Calvayrac, Olivier, Porporato, Paolo, Nadal, Ernest, Lito, Piro, Jänne, Pasi A., Ricciuti, Biagio, Awad, Mark M., Ambrogio, Chiara, and Santamaría, David

Published
2024
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9. Durvalumab plus tremelimumab alone or in combination with low-dose or hypofractionated radiotherapy in metastatic non-small-cell lung cancer refractory to previous PD(L)-1 therapy: an open-label, multicentre, randomised, phase 2 trial

Author

Schoenfeld, Jonathan D, Giobbie-Hurder, Anita, Ranasinghe, Srinika, Kao, Katrina Z, Lako, Ana, Tsuji, Junko, Liu, Yang, Brennick, Ryan C, Gentzler, Ryan D, Lee, Carrie, Hubbard, Joleen, Arnold, Susanne M, Abbruzzese, James L, Jabbour, Salma K, Uboha, Nataliya V, Stephans, Kevin L, Johnson, Jennifer M, Park, Haeseong, Villaruz, Liza C, Sharon, Elad, Streicher, Howard, Ahmed, Mansoor M, Lyon, Hayley, Cibuskis, Carrie, Lennon, Niall, Jhaveri, Aashna, Yang, Lin, Altreuter, Jennifer, Gunasti, Lauren, Weirather, Jason L, Mak, Raymond H, Awad, Mark M, Rodig, Scott J, Chen, Helen X, Wu, Catherine J, Monjazeb, Arta M, and Hodi, F Stephen

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Research, Lung, Lung Cancer, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 6.5 Radiotherapy and other non-invasive therapies, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Combined Modality Therapy, Female, Humans, Immune Checkpoint Inhibitors, Lung Neoplasms, Male, Middle Aged, Neoplasm Metastasis, Radiation Dose Hypofractionation, Radiotherapy Dosage, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundPatients with non-small-cell lung cancer (NSCLC) that is resistant to PD-1 and PD-L1 (PD[L]-1)-targeted therapy have poor outcomes. Studies suggest that radiotherapy could enhance antitumour immunity. Therefore, we investigated the potential benefit of PD-L1 (durvalumab) and CTLA-4 (tremelimumab) inhibition alone or combined with radiotherapy.MethodsThis open-label, multicentre, randomised, phase 2 trial was done by the National Cancer Institute Experimental Therapeutics Clinical Trials Network at 18 US sites. Patients aged 18 years or older with metastatic NSCLC, an Eastern Cooperative Oncology Group performance status of 0 or 1, and progression during previous PD(L)-1 therapy were eligible. They were randomly assigned (1:1:1) in a web-based system by the study statistician using a permuted block scheme (block sizes of three or six) without stratification to receive either durvalumab (1500 mg intravenously every 4 weeks for a maximum of 13 cycles) plus tremelimumab (75 mg intravenously every 4 weeks for a maximum of four cycles) alone or with low-dose (0·5 Gy delivered twice per day, repeated for 2 days during each of the first four cycles of therapy) or hypofractionated radiotherapy (24 Gy total delivered over three 8-Gy fractions during the first cycle only), 1 week after initial durvalumab-tremelimumab administration. Study treatment was continued until 1 year or until progression. The primary endpoint was overall response rate (best locally assessed confirmed response of a partial or complete response) and, along with safety, was analysed in patients who received at least one dose of study therapy. The trial is registered with ClinicalTrials.gov, NCT02888743, and is now complete.FindingsBetween Aug 24, 2017, and March 29, 2019, 90 patients were enrolled and randomly assigned, of whom 78 (26 per group) were treated. This trial was stopped due to futility assessed in an interim analysis. At a median follow-up of 12·4 months (IQR 7·8-15·1), there were no differences in overall response rates between the durvalumab-tremelimumab alone group (three [11·5%, 90% CI 1·2-21·8] of 26 patients) and the low-dose radiotherapy group (two [7·7%, 0·0-16·3] of 26 patients; p=0·64) or the hypofractionated radiotherapy group (three [11·5%, 1·2-21·8] of 26 patients; p=0·99). The most common grade 3-4 adverse events were dyspnoea (two [8%] in the durvalumab-tremelimumab alone group; three [12%] in the low-dose radiotherapy group; and three [12%] in the hypofractionated radiotherapy group) and hyponatraemia (one [4%] in the durvalumab-tremelimumab alone group vs two [8%] in the low-dose radiotherapy group vs three [12%] in the hypofractionated radiotherapy group). Treatment-related serious adverse events occurred in one (4%) patient in the durvalumab-tremelimumab alone group (maculopapular rash), five (19%) patients in the low-dose radiotherapy group (abdominal pain, diarrhoea, dyspnoea, hypokalemia, and respiratory failure), and four (15%) patients in the hypofractionated group (adrenal insufficiency, colitis, diarrhoea, and hyponatremia). In the low-dose radiotherapy group, there was one death from respiratory failure potentially related to study therapy.InterpretationRadiotherapy did not increase responses to combined PD-L1 plus CTLA-4 inhibition in patients with NSCLC resistant to PD(L)-1 therapy. However, PD-L1 plus CTLA-4 therapy could be a treatment option for some patients. Future studies should refine predictive biomarkers in this setting.FundingThe US National Institutes of Health and the Dana-Farber Cancer Institute.

Published
2022

10. ALK peptide vaccination restores the immunogenicity of ALK-rearranged non-small cell lung cancer

Author

Mota, Ines, Patrucco, Enrico, Mastini, Cristina, Mahadevan, Navin R., Thai, Tran C., Bergaggio, Elisa, Cheong, Taek-Chin, Leonardi, Giulia, Karaca-Atabay, Elif, Campisi, Marco, Poggio, Teresa, Menotti, Matteo, Ambrogio, Chiara, Longo, Dario L., Klaeger, Susan, Keshishian, Hasmik, Sztupinszki, Zsófia M., Szallasi, Zoltan, Keskin, Derin B., Duke-Cohan, Jonathan S., Reinhold, Bruce, Carr, Steven A., Wu, Catherine J., Moynihan, Kelly D., Irvine, Darrell J., Barbie, David A., Reinherz, Ellis L., Voena, Claudia, Awad, Mark M., Blasco, Rafael B., and Chiarle, Roberto

Published
2023
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11. Federated benchmarking of medical artificial intelligence with MedPerf

Author

Karargyris, Alexandros, Umeton, Renato, Sheller, Micah J., Aristizabal, Alejandro, George, Johnu, Wuest, Anna, Pati, Sarthak, Kassem, Hasan, Zenk, Maximilian, Baid, Ujjwal, Narayana Moorthy, Prakash, Chowdhury, Alexander, Guo, Junyi, Nalawade, Sahil, Rosenthal, Jacob, Kanter, David, Xenochristou, Maria, Beutel, Daniel J., Chung, Verena, Bergquist, Timothy, Eddy, James, Abid, Abubakar, Tunstall, Lewis, Sanseviero, Omar, Dimitriadis, Dimitrios, Qian, Yiming, Xu, Xinxing, Liu, Yong, Goh, Rick Siow Mong, Bala, Srini, Bittorf, Victor, Puchala, Sreekar Reddy, Ricciuti, Biagio, Samineni, Soujanya, Sengupta, Eshna, Chaudhari, Akshay, Coleman, Cody, Desinghu, Bala, Diamos, Gregory, Dutta, Debo, Feddema, Diane, Fursin, Grigori, Huang, Xinyuan, Kashyap, Satyananda, Lane, Nicholas, Mallick, Indranil, Mascagni, Pietro, Mehta, Virendra, Moraes, Cassiano Ferro, Natarajan, Vivek, Nikolov, Nikola, Padoy, Nicolas, Pekhimenko, Gennady, Reddi, Vijay Janapa, Reina, G. Anthony, Ribalta, Pablo, Singh, Abhishek, Thiagarajan, Jayaraman J., Albrecht, Jacob, Wolf, Thomas, Miller, Geralyn, Fu, Huazhu, Shah, Prashant, Xu, Daguang, Yadav, Poonam, Talby, David, Awad, Mark M., Howard, Jeremy P., Rosenthal, Michael, Marchionni, Luigi, Loda, Massimo, Johnson, Jason M., Bakas, Spyridon, and Mattson, Peter

Published
2023
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12. Genomic and transcriptomic analysis of checkpoint blockade response in advanced non-small cell lung cancer

Author

Ravi, Arvind, Hellmann, Matthew D., Arniella, Monica B., Holton, Mark, Freeman, Samuel S., Naranbhai, Vivek, Stewart, Chip, Leshchiner, Ignaty, Kim, Jaegil, Akiyama, Yo, Griffin, Aaron T., Vokes, Natalie I., Sakhi, Mustafa, Kamesan, Vashine, Rizvi, Hira, Ricciuti, Biagio, Forde, Patrick M., Anagnostou, Valsamo, Riess, Jonathan W., Gibbons, Don L., Pennell, Nathan A., Velcheti, Vamsidhar, Digumarthy, Subba R., Mino-Kenudson, Mari, Califano, Andrea, Heymach, John V., Herbst, Roy S., Brahmer, Julie R., Schalper, Kurt A., Velculescu, Victor E., Henick, Brian S., Rizvi, Naiyer, Jänne, Pasi A., Awad, Mark M., Chow, Andrew, Greenbaum, Benjamin D., Luksza, Marta, Shaw, Alice T., Wolchok, Jedd, Hacohen, Nir, Getz, Gad, and Gainor, Justin F.

Published
2023
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13. Twists and Turns from 'Tumor in Tumor' Profiling: Surveillance of CLL leads to detection of a lung adenocarcinoma, whose genomic characterization alters the original hematologic diagnosis

Author

Terraf, Panieh, Sholl, Lynette M, Davids, Matthew S, Awad, Mark M, Garcia, Elizabeth P, MacConaill, Laura E, Dal Cin, Paola, Kim, Annette, Lindeman, Neal I, Stachler, Matthew, Hwang, David H, and Dubuc, Adrian M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Lymphoma, Lung, Cancer, Genetics, Lung Cancer, Hematology, Good Health and Well Being, Adenocarcinoma of Lung, Aged, Biomarkers, Tumor, Diagnostic Errors, Female, Gene Expression Profiling, Gene Rearrangement, High-Throughput Nucleotide Sequencing, Humans, In Situ Hybridization, Fluorescence, Leukemia, Lymphocytic, Chronic, B-Cell, Lung Neoplasms, Lymphoma, Mantle-Cell, Neoplasms, Multiple Primary, Positron Emission Tomography Computed Tomography, chronic lymphatic leukemia, hematological neoplasm, lung adenocarcinoma, Pharmacology and pharmaceutical sciences
Abstract

Comprehensive characterization of somatic genomic alterations has led to fundamental shifts in our understanding of tumor biology. In clinical practice, these studies can lead to modifications of diagnosis and/or specific treatment implications, fulfilling the promise of personalized medicine. Herein, we describe a 78-yr-old woman under surveillance for long-standing untreated chronic lymphocytic leukemia (CLL). Molecular studies from a peripheral blood specimen revealed a TP53 p.V157F mutation, whereas karyotype and fluorescence in situ hybridization (FISH) identified a 17p deletion, trisomy 12, and no evidence of IGH-CCND1 rearrangement. Positron emission tomography-computed tomography scan identified multistation intra-abdominal lymphadenopathy and a pulmonary nodule, and subsequent pulmonary wedge resection confirmed the presence of a concurrent lung adenocarcinoma. Targeted next-generation sequencing of the lung tumor identified an EGFR in-frame exon 19 deletion, two TP53 mutations (p.P152Q, p.V157F), and, unexpectedly, a IGH-CCND1 rearrangement. Follow-up immunohistochemistry (IHC) studies demonstrated a cyclin D1-positive lymphoid aggregate within the lung adenocarcinoma. The presence of the TP53 p.V157F mutation in the lung resection, detection of an IGH-CCND1 rearrangement, and cyclin D1 positivity by IHC led to revision of the patient's hematologic diagnosis and confirmed the extranodal presence of mantle cell lymphoma within the lung mass, thus representing a "tumor in tumor." Manual review of the sequencing data suggested the IGH-CCND1 rearrangement occurred via an insertional event, whose size precluded detection by original FISH studies. Thus, routine imaging for this patient's known hematologic malignancy led to detection of an unexpected solid tumor, whose subsequent precision medicine studies in the solid tumor redefined the original hematological diagnosis.

Published
2021

14. Patient-Reported Health-Related Quality of Life in KEYNOTE-604: Pembrolizumab or Placebo Added to Etoposide and Platinum as First-Line Therapy for Extensive-Stage SCLC

Author

Kim, Hye Ryun, Awad, Mark M., Navarro, Alejandro, Gottfried, Maya, Peters, Solange, Csőszi, Tibor, Cheema, Parneet K., Rodriguez-Abreu, Delvys, Wollner, Mirjana, Yang, James Chih-Hsin, Mazieres, Julien, Orlandi, Francisco J., Luft, Alexander, Gümüş, Mahmut, Kato, Terufumi, Kalemkerian, Gregory P., Luo, Yiwen, Santorelli, Melissa L., Pietanza, M. Catherine, and Rudin, Charles M.

Published
2023
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15. Impact of Aneuploidy and Chromosome 9p Loss on Tumor Immune Microenvironment and Immune Checkpoint Inhibitor Efficacy in NSCLC

Author

Alessi, Joao V., Wang, Xinan, Elkrief, Arielle, Ricciuti, Biagio, Li, Yvonne Y., Gupta, Hersh, Spurr, Liam F., Rizvi, Hira, Luo, Jia, Pecci, Federica, Lamberti, Giuseppe, Recondo, Gonzalo, Venkatraman, Deepti, Di Federico, Alessandro, Gandhi, Malini M., Vaz, Victor R., Nishino, Mizuki, Sholl, Lynette M., Cherniack, Andrew D., Ladanyi, Marc, Price, Adam, Richards, Allison L., Donoghue, Mark, Lindsay, James, Sharma, Bijaya, Turner, Madison M., Pfaff, Kathleen L., Felt, Kristen D., Rodig, Scott J., Lin, Xihong, Meyerson, Matthew L., Johnson, Bruce E., Christiani, David C., Schoenfeld, Adam J., and Awad, Mark M.

Published
2023
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17. Germline variants associated with toxicity to immune checkpoint blockade

Author

Groha, Stefan, Alaiwi, Sarah Abou, Xu, Wenxin, Naranbhai, Vivek, Nassar, Amin H., Bakouny, Ziad, El Zarif, Talal, Saliby, Renee Maria, Wan, Guihong, Rajeh, Ahmad, Adib, Elio, Nuzzo, Pier V., Schmidt, Andrew L., Labaki, Chris, Ricciuti, Biagio, Alessi, Joao Victor, Braun, David A., Shukla, Sachet A., Keenan, Tanya E., Van Allen, Eliezer, Awad, Mark M., Manos, Michael, Rahma, Osama, Zubiri, Leyre, Villani, Alexandra-Chloe, Fairfax, Benjamin, Hammer, Christian, Khan, Zia, Reynolds, Kerry, Semenov, Yevgeniy, Schrag, Deborah, Kehl, Kenneth L., Freedman, Matthew L., Choueiri, Toni K., and Gusev, Alexander

Published
2022
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18. Clinicopathologic and Genomic Factors Impacting Efficacy of First-Line Chemoimmunotherapy in Advanced NSCLC

Author

Alessi, Joao V., Elkrief, Arielle, Ricciuti, Biagio, Wang, Xinan, Cortellini, Alessio, Vaz, Victor R., Lamberti, Giuseppe, Frias, Rosa L., Venkatraman, Deepti, Fulgenzi, Claudia A.M., Pecci, Federica, Recondo, Gonzalo, Di Federico, Alessandro, Barrichello, Adriana, Park, Hyesun, Nishino, Mizuki, Hambelton, Grace M., Egger, Jacklynn V., Ladanyi, Marc, Digumarthy, Subba, Johnson, Bruce E., Christiani, David C., Lin, Xihong, Gainor, Justin F., Lin, Jessica J., Pinato, David J., Schoenfeld, Adam J., and Awad, Mark M.

Published
2023
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19. Clinical outcomes with perioperative nivolumab (NIVO) by nodal status among patients (pts) with stage III resectable NSCLC: Results from the phase 3 CheckMate 77T study.

Author

Provencio, Mariano, primary, Awad, Mark M., additional, Spicer, Jonathan, additional, Janssens, Annelies, additional, Moiseenko, Fedor Vladimirovich, additional, Gao, Yang, additional, Watanabe, Yasutaka, additional, Alexandru, Aurelia, additional, Guisier, Florian, additional, Frost, Nikolaj, additional, Franke, Fabio A., additional, Hiltermann, T.Jeroen Jeroen Nicolaas, additional, He, Jie, additional, Tanaka, Fumihiro, additional, Lu, Shun, additional, Coronado Erdmann, Cinthya, additional, Sathyanarayana, Padma, additional, Tran, Phuong, additional, Devas, Vipul, additional, and Cascone, Tina, additional

Published
2024
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20. Neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) vs chemo in patients (pts) with resectable NSCLC: 4-year update from CheckMate 816.

Author

Spicer, Jonathan, primary, Girard, Nicolas, additional, Provencio, Mariano, additional, Wang, Changli, additional, Mitsudomi, Tetsuya, additional, Awad, Mark M., additional, Vokes, Everett E., additional, Taube, Janis M., additional, Lupinacci, Lorena, additional, Saylors, Gene B., additional, Tanaka, Fumihiro, additional, Liberman, Moishe, additional, Lee, Sung Yong, additional, Alexandru, Aurelia, additional, D’Arcangelo, Manolo, additional, Tran, Phuong, additional, Mahmood, Javed, additional, Gharpure, Vishwanath Suresh, additional, Bhingare, Apurva, additional, and Forde, Patrick M., additional

Published
2024
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21. Open-label, phase 1, multicenter study to evaluate the safety and preliminary anti-tumor activity of NT-175 in human leukocyte antigen-a*02:01-positive adult subjects with unresectable, advanced and/or metastatic solid tumors that are positive for the TP53 R175H mutation.

Author

Becerra, Carlos Roberto, primary, Awad, Mark M., additional, Hecht, J. Randolph, additional, Paulson, Andrew Scott, additional, Lee, Jennifer, additional, Palluconi, Gabi, additional, Dalton, Jaquelin, additional, Patel, Anuradha, additional, Yan, Ying, additional, Perez, Arianne, additional, Xie, Sunny, additional, Cohen, Sarah, additional, and Fakih, Marwan, additional

Published
2024
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22. Body Composition in Advanced Non-Small Cell Lung Cancer Treated With Immunotherapy

Author

Chaunzwa, Tafadzwa L., primary, Qian, Jack M., additional, Li, Qin, additional, Ricciuti, Biagio, additional, Nuernberg, Leonard, additional, Johnson, Justin W., additional, Weiss, Jakob, additional, Zhang, Zhongyi, additional, MacKay, Jamie, additional, Kagiampakis, Ioannis, additional, Bikiel, Damian, additional, Di Federico, Alessandro, additional, Alessi, Joao V., additional, Mak, Raymond H., additional, Jacob, Etai, additional, Awad, Mark M., additional, and Aerts, Hugo J. W. L., additional

Published
2024
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25. Diminished Efficacy of Programmed Death-(Ligand)1 Inhibition in STK11- and KEAP1-Mutant Lung Adenocarcinoma Is Affected by KRAS Mutation Status

Author

Ricciuti, Biagio, Arbour, Kathryn C., Lin, Jessica J., Vajdi, Amir, Vokes, Natalie, Hong, Lingzhi, Zhang, Jianjun, Tolstorukov, Michael Y., Li, Yvonne Y., Spurr, Liam F., Cherniack, Andrew D., Recondo, Gonzalo, Lamberti, Giuseppe, Wang, Xinan, Venkatraman, Deepti, Alessi, Joao V., Vaz, Victor R., Rizvi, Hira, Egger, Jacklynn, Plodkowski, Andrew J., Khosrowjerdi, Sara, Digumarthy, Subba, Park, Hyesun, Vaz, Nuno, Nishino, Mizuki, Sholl, Lynette M., Barbie, David, Altan, Mehmet, Heymach, John V., Skoulidis, Ferdinandos, Gainor, Justin F., Hellmann, Matthew D., and Awad, Mark M.

Published
2022
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27. Activating point mutations in the MET kinase domain represent a unique molecular subset of lung cancer and other malignancies targetable with MET inhibitors

Author

Pecci, Federica, primary, Nakazawa, Seshiru, additional, Ricciuti, Biagio, additional, Harada, Guilherme, additional, Lee, Jessica K., additional, Alessi, Joao V., additional, Barrichello, Adriana, additional, Vaz, Victor R., additional, Lamberti, Giuseppe, additional, Di Federico, Alessandro, additional, Gandhi, Malini M., additional, Gazgalis, Dimitris, additional, Feng, William W., additional, Jiang, Jie, additional, Baldacci, Simon, additional, Locquet, Marie-Anais, additional, Gottlieb, Felix H., additional, Chen, Monica F., additional, Lee, Elinton, additional, Haradon, Danielle, additional, Smokovich, Anna, additional, Voligny, Emma, additional, Nguyen, Tom, additional, Goel, Vikas K., additional, Zimmerman, Zachary, additional, Atwal, Sumandeep, additional, Wang, Xinan, additional, Bahcall, Magda, additional, Heist, Rebecca S., additional, Iqbal, Sumaiya, additional, Gandhi, Nishant, additional, Elliott, Andrew, additional, Vanderwalde, Ari M., additional, Ma, Patrick C., additional, Halmos, Balazs, additional, Liu, Stephen V., additional, Che, Jianwei, additional, Schrock, Alexa B., additional, Drilon, Alexander, additional, Janne, Pasi A., additional, and Awad, Mark M., additional

Published
2024
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28. Three-year overall survival outcomes and correlative analyses in patients with non–small-cell lung cancer and high (50-89%) versus very high (≥90%) PD-L1 expression treated with first-line pembrolizumab or cemiplimab

Author

Ricciuti, Biagio, primary, Elkrief, Arielle, additional, Lin, Jessica, additional, Zhang, Jianjun, additional, Alessi, Joao V., additional, Lamberti, Giuseppe, additional, Gandhi, Malini, additional, Di Federico, Alessandro, additional, Pecci, Federica, additional, Wang, Xinan, additional, Makarem, Maisam, additional, Hidalgo Filho, Cassio Murilo, additional, Gorria, Teresa, additional, Pabon, Cindy, additional, Lindsay, James, additional, Pfaff, Kathleen L., additional, Welsh, Emma L., additional, Nishino, Mizuki, additional, Sholl, Lynette M., additional, Rodig, Scott, additional, Kilickap, Saadettin, additional, Rietschel, Petra, additional, McIntyre, Debra AG., additional, Pouliot, Jean-Francois, additional, Altan, Mehmet, additional, Gainor, Justin F., additional, Heymach, John V., additional, Schoenfeld, Adam J., additional, and Awad, Mark M., additional

Published
2024
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29. Association of Baseline Tumor-Specific Neoantigens and CD8+ T-Cell Infiltration With Immune-Related Adverse Events Secondary to Immune Checkpoint Inhibitors

Author

Kerepesi, Csaba, primary, Abushukair, Hassan Mohammed, additional, Ricciuti, Biagio, additional, Nassar, Amin H., additional, Adib, Elio, additional, Alessi, Joao V., additional, Pecci, Federica, additional, Rakaee, Mehrdad, additional, Fadlullah, Muhammad Zaki Hidayatullah, additional, Tőkés, Anna-Mária, additional, Rodig, Scott J., additional, Awad, Mark M., additional, Tan, Aik Choon, additional, Bakacs, Tibor, additional, and Naqash, Abdul Rafeh, additional

Published
2024
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31. Outcomes With Pembrolizumab Plus Platinum-Based Chemotherapy for Patients With NSCLC and Stable Brain Metastases: Pooled Analysis of KEYNOTE-021, -189, and -407

Author

Powell, Steven F., Rodríguez-Abreu, Delvys, Langer, Corey J., Tafreshi, Ali, Paz-Ares, Luis, Kopp, Hans-Georg, Rodríguez-Cid, Jeronimo, Kowalski, Dariusz M., Cheng, Ying, Kurata, Takayasu, Awad, Mark M., Lin, Jinaxin, Zhao, Bin, Pietanza, M. Catherine, Piperdi, Bilal, and Garassino, Marina C.

Published
2021
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34. Association between immune-related adverse events and clinical outcomes to PD-1/PD-L1 blockade in small cell lung cancer

Author

Ricciuti, Biagio, Naqash, Abdul Rafeh, Naidoo, Jarushka, Sehgal, Kartik, Miller, Adam, Kehl, Kenneth, Venkatraman, Deepti, Sands, Jacob, Lamberti, Giuseppe, Recondo, Gonzalo, Zhang, Jiajia, Macherla, Shravanti, Baig, Sameer, Walker, Paul, Rangachari, Deepa, Gainor, Justin F., Costa, Daniel B., Rizvi, Naiyer, Sholl, Lynette M., Nishino, Mizuki, Henick, Brian, Farago, Anna F., and Awad, Mark M.

Published
2020
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37. The Effect of Gene Alterations and Tyrosine Kinase Inhibition on Survival and Cause of Death in Patients With Adenocarcinoma of the Lung and Brain Metastases

Author

Sperduto, Paul W, Yang, T Jonathan, Beal, Kathryn, Pan, Hubert, Brown, Paul D, Bangdiwala, Ananta, Shanley, Ryan, Yeh, Norman, Gaspar, Laurie E, Braunstein, Steve, Sneed, Penny, Boyle, John, Kirkpatrick, John P, Mak, Kimberley S, Shih, Helen A, Engelman, Alex, Roberge, David, Arvold, Nils D, Alexander, Brian, Awad, Mark M, Contessa, Joseph, Chiang, Veronica, Hardie, John, Ma, Daniel, Lou, Emil, Sperduto, William, and Mehta, Minesh P

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Lung Cancer, Rare Diseases, Lung, Clinical Research, Adenocarcinoma, Aged, Aged, 80 and over, Anaplastic Lymphoma Kinase, Antineoplastic Agents, Brain Neoplasms, ErbB Receptors, Female, Genetic Markers, Genetic Predisposition to Disease, Humans, Incidence, Lung Neoplasms, Male, Middle Aged, Mutation, Polymorphism, Single Nucleotide, Prevalence, Protein-Tyrosine Kinases, Receptor Protein-Tyrosine Kinases, Retrospective Studies, Risk Factors, Survival Rate, United States, Other Physical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis, Theoretical and computational chemistry, Medical and biological physics
Abstract

PurposeLung cancer remains the most common cause of both cancer mortality and brain metastases (BM). The purpose of this study was to assess the effect of gene alterations and tyrosine kinase inhibition (TKI) on median survival (MS) and cause of death (CoD) in patients with BM from lung adenocarcinoma (L-adeno).MethodsA multi-institutional retrospective database of patients with L-adeno and newly diagnosed BM between 2006 and 2014 was created. Demographics, gene alterations, treatment, MS, and CoD were analyzed. The treatment patterns and outcomes were compared with those in prior trials.ResultsOf 1521 L-adeno patients, 816 (54%) had known alteration status. The gene alteration rates were 29%, 10%, and 26% for EGFR, ALK, and KRAS, respectively. The time from primary diagnosis to BM for EGFR-/+ was 10/15 months (P=.02) and for ALK-/+ was 10/20 months (P

Published
2016

38. STK11/LKB1 Deficiency Promotes Neutrophil Recruitment and Proinflammatory Cytokine Production to Suppress T-cell Activity in the Lung Tumor Microenvironment

Author

Koyama, Shohei, Akbay, Esra A, Li, Yvonne Y, Aref, Amir R, Skoulidis, Ferdinandos, Herter-Sprie, Grit S, Buczkowski, Kevin A, Liu, Yan, Awad, Mark M, Denning, Warren L, Diao, Lixia, Wang, Jing, Parra-Cuentas, Edwin R, Wistuba, Ignacio I, Soucheray, Margaret, Thai, Tran, Asahina, Hajime, Kitajima, Shunsuke, Altabef, Abigail, Cavanaugh, Jillian D, Rhee, Kevin, Gao, Peng, Zhang, Haikuo, Fecci, Peter E, Shimamura, Takeshi, Hellmann, Matthew D, Heymach, John V, Hodi, F Stephen, Freeman, Gordon J, Barbie, David A, Dranoff, Glenn, Hammerman, Peter S, and Wong, Kwok-Kin

Subjects
Clinical Research, Lung, Cancer, Lung Cancer, 5.1 Pharmaceuticals, 2.1 Biological and endogenous factors, Aetiology, Development of treatments and therapeutic interventions, AMP-Activated Protein Kinase Kinases, AMP-Activated Protein Kinases, Animals, B7-H1 Antigen, Cytokines, Humans, Lung Neoplasms, Lymphocytes, Tumor-Infiltrating, Mice, Mutation, Neutrophil Infiltration, Protein Serine-Threonine Kinases, T-Lymphocytes, Tumor Microenvironment, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

STK11/LKB1 is among the most commonly inactivated tumor suppressors in non-small cell lung cancer (NSCLC), especially in tumors harboring KRAS mutations. Many oncogenes promote immune escape, undermining the effectiveness of immunotherapies, but it is unclear whether the inactivation of tumor suppressor genes, such as STK11/LKB1, exerts similar effects. In this study, we investigated the consequences of STK11/LKB1 loss on the immune microenvironment in a mouse model of KRAS-driven NSCLC. Genetic ablation of STK11/LKB1 resulted in accumulation of neutrophils with T-cell-suppressive effects, along with a corresponding increase in the expression of T-cell exhaustion markers and tumor-promoting cytokines. The number of tumor-infiltrating lymphocytes was also reduced in LKB1-deficient mouse and human tumors. Furthermore, STK11/LKB1-inactivating mutations were associated with reduced expression of PD-1 ligand PD-L1 in mouse and patient tumors as well as in tumor-derived cell lines. Consistent with these results, PD-1-targeting antibodies were ineffective against Lkb1-deficient tumors. In contrast, treating Lkb1-deficient mice with an IL6-neutralizing antibody or a neutrophil-depleting antibody yielded therapeutic benefits associated with reduced neutrophil accumulation and proinflammatory cytokine expression. Our findings illustrate how tumor suppressor mutations can modulate the immune milieu of the tumor microenvironment, and they offer specific implications for addressing STK11/LKB1-mutated tumors with PD-1-targeting antibody therapies.

Published
2016

39. Supplementary Figure S6 from Clinical and Molecular Features of Long-term Response to Immune Checkpoint Inhibitors in Patients with Advanced Non–Small Cell Lung Cancer

Author

Thummalapalli, Rohit, primary, Ricciuti, Biagio, primary, Bandlamudi, Chaitanya, primary, Muldoon, Daniel, primary, Rizvi, Hira, primary, Elkrief, Arielle, primary, Luo, Jia, primary, Alessi, Joao V., primary, Pecci, Federica, primary, Lamberti, Giuseppe, primary, Di Federico, Alessandro, primary, Hong, Lingzhi, primary, Zhang, Jianjun, primary, Heymach, John V., primary, Gibbons, Don L., primary, Plodkowski, Andrew J., primary, Ravichandran, Vignesh, primary, Donoghue, Mark T.A., primary, Vanderbilt, Chad, primary, Ladanyi, Marc, primary, Rudin, Charles M., primary, Kris, Mark G., primary, Riely, Gregory J., primary, Chaft, Jamie E., primary, Hellmann, Matthew D., primary, Vokes, Natalie I., primary, Awad, Mark M., primary, and Schoenfeld, Adam J., primary

Published
2023
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40. Supplementary Table S1 from Clinical and Molecular Features of Long-term Response to Immune Checkpoint Inhibitors in Patients with Advanced Non–Small Cell Lung Cancer

Author

Thummalapalli, Rohit, primary, Ricciuti, Biagio, primary, Bandlamudi, Chaitanya, primary, Muldoon, Daniel, primary, Rizvi, Hira, primary, Elkrief, Arielle, primary, Luo, Jia, primary, Alessi, Joao V., primary, Pecci, Federica, primary, Lamberti, Giuseppe, primary, Di Federico, Alessandro, primary, Hong, Lingzhi, primary, Zhang, Jianjun, primary, Heymach, John V., primary, Gibbons, Don L., primary, Plodkowski, Andrew J., primary, Ravichandran, Vignesh, primary, Donoghue, Mark T.A., primary, Vanderbilt, Chad, primary, Ladanyi, Marc, primary, Rudin, Charles M., primary, Kris, Mark G., primary, Riely, Gregory J., primary, Chaft, Jamie E., primary, Hellmann, Matthew D., primary, Vokes, Natalie I., primary, Awad, Mark M., primary, and Schoenfeld, Adam J., primary

Published
2023
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41. Multi-institutional analysis of aneuploidy and outcomes to chemoradiation and durvalumab in stage III non-small cell lung cancer

Author

Alessi, Joao V, primary, Price, Adam, additional, Richards, Allison L, additional, Ricciuti, Biagio, additional, Wang, Xinan, additional, Elkrief, Arielle, additional, Pecci, Federica, additional, Di Federico, Alessandro, additional, Gandhi, Malini M, additional, Lebow, Emily S, additional, Santos, Patricia Mae G, additional, Thor, Maria, additional, Rimner, Andreas, additional, Schoenfeld, Adam J, additional, Chaft, Jamie E, additional, Johnson, Bruce E, additional, Gomez, Daniel R, additional, Awad, Mark M, additional, and Shaverdian, Narek, additional

Published
2023
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42. 218 Prospective spatial immune cell profiling identifies features of the tumor-immune microenvironment associated with genomic alterations and patient survival in a 2,023 patient pan-cancer cohort

Author

Alessi, Joao V, primary, Lindsay, James, additional, Lotter, William, additional, Giobbie-Hurder, Anita, additional, Sharma, Bijaya, additional, Pfaff, Kathleen, additional, Manos, Michael, additional, Welsh, Emma L, additional, Felt, Kristen D, additional, Jones, Stephanie M, additional, Turner, Madison, additional, Adib, Elio, additional, Weirather, Jason, additional, Altreuter, Jennifer O, additional, Dryg, Ian D, additional, Federico, Alessandro Di, additional, Ricciuti, Biagio, additional, Wang, Xinan, additional, Pecci, Federica, additional, Gandhi, Malini M, additional, Chan, Sabrina J, additional, Holovatska, Marta, additional, Hughes, Melissa E, additional, Tess A, O’Meara, additional, Lindeman, Neal I, additional, Johnson, Bruce E, additional, Konstantinopoulos, Panagiotis, additional, Curtis, Jennifer, additional, Santagata, Sandro, additional, Sorger, Peter K, additional, Hanna, Glenn J, additional, Tolaney, Sara M, additional, Cerami, Ethan, additional, Sholl, Lynette M, additional, Novak, Jonathan A, additional, Awad, Mark M, additional, and Rodig, Scott J, additional

Published
2023
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43. Data from Clinical and Molecular Features of Long-term Response to Immune Checkpoint Inhibitors in Patients with Advanced Non–Small Cell Lung Cancer

Author

Thummalapalli, Rohit, primary, Ricciuti, Biagio, primary, Bandlamudi, Chaitanya, primary, Muldoon, Daniel, primary, Rizvi, Hira, primary, Elkrief, Arielle, primary, Luo, Jia, primary, Alessi, Joao V., primary, Pecci, Federica, primary, Lamberti, Giuseppe, primary, Di Federico, Alessandro, primary, Hong, Lingzhi, primary, Zhang, Jianjun, primary, Heymach, John V., primary, Gibbons, Don L., primary, Plodkowski, Andrew J., primary, Ravichandran, Vignesh, primary, Donoghue, Mark T.A., primary, Vanderbilt, Chad, primary, Ladanyi, Marc, primary, Rudin, Charles M., primary, Kris, Mark G., primary, Riely, Gregory J., primary, Chaft, Jamie E., primary, Hellmann, Matthew D., primary, Vokes, Natalie I., primary, Awad, Mark M., primary, and Schoenfeld, Adam J., primary

Published
2023
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45. Antitumor activity of crizotinib in lung cancers harboring a MET exon 14 alteration

Author

Drilon, Alexander, Clark, Jeffrey W., Weiss, Jared, Ou, Sai-Hong Ignatius, Camidge, D. Ross, Solomon, Benjamin J., Otterson, Gregory A., Villaruz, Liza C., Riely, Gregory J., Heist, Rebecca S., Awad, Mark M., Shapiro, Geoffrey I., Satouchi, Miyako, Hida, Toyoaki, Hayashi, Hidetoshi, Murphy, Danielle A., Wang, Sherry C., Li, Sherry, Usari, Tiziana, Wilner, Keith D., and Paik, Paul K.

Published
2020
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47. Association of Baseline Tumor-Specific Neoantigens and CD8 + T-Cell Infiltration With Immune-Related Adverse Events Secondary to Immune Checkpoint Inhibitors.

Author

Kerepesi, Csaba, Abushukair, Hassan Mohammed, Ricciuti, Biagio, Nassar, Amin H., Adib, Elio, Alessi, Joao V., Pecci, Federica, Rakaee, Mehrdad, Fadlullah, Muhammad Zaki Hidayatullah, Tőkés, Anna-Mária, Rodig, Scott J., Awad, Mark M., Tan, Aik Choon, Bakacs, Tibor, and Naqash, Abdul Rafeh

Subjects
DRUG side effects, IMMUNE checkpoint inhibitors, T cells, CD8 antigen, NON-small-cell lung carcinoma, IPILIMUMAB
Abstract

PURPOSE: Recent evidence has shown that higher tumor mutational burden strongly correlates with an increased risk of immune-related adverse events (irAEs). By using an integrated multiomics approach, we further studied the association between relevant tumor immune microenvironment (TIME) features and irAEs. METHODS: Leveraging the US Food and Drug Administration Adverse Event Reporting System, we extracted cases of suspected irAEs to calculate the reporting odds ratios (RORs) of irAEs for cancers treated with immune checkpoint inhibitors (ICIs). TIME features for 32 cancer types were calculated on the basis of the cancer genomic atlas cohorts and indirectly correlated with each cancer's ROR for irAEs. A separate ICI-treated cohort of non–small-cell lung cancer (NSCLC) was used to evaluate the correlation between tissue-based immune markers (CD8+, PD-1/L1+, FOXP3+, tumor-infiltrating lymphocytes [TILs]) and irAE occurrence. RESULTS: The analysis of 32 cancers and 33 TIME features demonstrated a significant association between irAE RORs and the median number of base insertions and deletions (INDEL), neoantigens (r = 0.72), single-nucleotide variant neoantigens (r = 0.67), and CD8+ T-cell fraction (r = 0.51). A bivariate model using the median number of INDEL neoantigens and CD8 T-cell fraction had the highest accuracy in predicting RORs (adjusted r2 = 0.52, P =.002). Immunoprofile assessment of 156 patients with NSCLC revealed a strong trend for higher baseline median CD8+ T cells within patients' tumors who experienced any grade irAEs. Using machine learning, an expanded ICI-treated NSCLC cohort (n = 378) further showed a treatment duration–independent association of an increased proportion of high TIL (>median) in patients with irAEs (59.7% v 44%, P =.005). This was confirmed by using the Fine-Gray competing risk approach, demonstrating higher baseline TIL density (>median) associated with a higher cumulative incidence of irAEs (P =.028). CONCLUSION: Our findings highlight a potential role for TIME features, specifically INDEL neoantigens and baseline-immune infiltration, in enabling optimal irAE risk stratification of patients. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Influence of TP53 Comutation on the Tumor Immune Microenvironment and Clinical Outcomes With Immune Checkpoint Inhibitors in STK11 -Mutant Non–Small-Cell Lung Cancer.

Author

Naqash, Abdul Rafeh, Floudas, Charalampos S., Aber, Etan, Maoz, Asaf, Nassar, Amin H., Adib, Elio, Choucair, Khalil, Xiu, Joanne, Baca, Yasmine, Ricciuti, Biagio, Alessi, Joao V., Awad, Mark M., Kim, Chul, Judd, Julia, Raez, Luis E., Lopes, Gilberto, Nieva, Jorge J., Borghaei, Hossein, Takebe, Naoko, and Ma, Patrick C.

Subjects
IMMUNE checkpoint inhibitors, NON-small-cell lung carcinoma, GLUTAMINE, TUMOR microenvironment, GLUTAMINE synthetase, KILLER cells, METABOLIC reprogramming
Abstract

PURPOSE: Non–small-cell lung cancer (NSCLC) with STK11 mut has inferior outcomes to immune checkpoint inhibitors (ICIs). Using multiomics, we evaluated whether a subtype of STK11 mut NSCLC with a uniquely inflamed tumor immune microenvironment (TIME) harboring TP53 comutations could have favorable outcomes to ICIs. PATIENTS AND METHODS: NSCLC tumors (N = 16,896) were analyzed by next-generation sequencing (DNA-Seq/592 genes). A subset (n = 5,034) underwent gene expression profiling (RNA-Seq/whole transcriptome). Exome-level neoantigen load for STK11 mut NSCLC was obtained from published pan-immune analysis. Tumor immune cell content was obtained from transcriptome profiles using the microenvironment cell population (MCP) counter. ICI data from POPLAR/OAK (n = 34) and the study by Rizvi et al (n = 49) were used to model progression-free survival (PFS), and a separate ICI-treated cohort (n = 53) from Dana-Farber Cancer Institute (DFCI) was used to assess time to treatment failure (TTF) and tumor RECIST response for STK11 mut TP53 mut versus STK11 mut TP53 wt NSCLC. RESULTS: Overall, 12.6% of NSCLC tumors had a STK11 mut with the proportions of tumor mutational burden (TMB)-high (≥10 mut/Mb), PD-L1 ≥50%, and microsatellite instability-high being 38.3%, 11.8%, and 0.72%, respectively. Unsupervised hierarchical clustering of STK11 mut (n = 463) for stimulator of interferon-gamma (STING) pathway genes identified a STING-high cluster, which was significantly enriched in TP53 mut NSCLC (P <.01). Compared with STK11 mut TP53 wt, tumors with STK11 mut TP53 mut had higher CD8+T cells and natural killer cells (P <.01), higher TMB (P <.001) and neoantigen load (P <.001), and increased expression of MYC and HIF-1A (P <.01), along with higher expression (P <.01) of glycolysis/glutamine metabolism genes. Meta-analysis of data from OAK/POPLAR and the study by Rizvi et al showed a trend toward improved PFS in patients with STK11 mut TP53 mut. In the DFCI cohort, compared with the STK11 mut TP53 wt cohort, the STK11 mut TP53 mut tumors had higher objective response rates (42.9% v 16.7%; P =.04) and also had longer TTF (14.5 v 4.5 months, P adj =.054) with ICI. CONCLUSION: STK11 mut NSCLC with TP53 comutation is a distinct subgroup with an immunologically active TIME and metabolic reprogramming. These properties should be exploited to guide patient selection for novel ICI-based combination approaches. [ABSTRACT FROM AUTHOR]

Published
2024
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49. Loss of p53 and mutational heterogeneity drives immune resistance in an autochthonous mouse lung cancer model with high tumor mutational burden

Author

Zhu, Mingrui, primary, Kim, Jiwoong, additional, Deng, Qing, additional, Ricciuti, Biagio, additional, Alessi, Joao V., additional, Eglenen-Polat, Buse, additional, Bender, Matthew E., additional, Huang, Hai-Cheng, additional, Kowash, Ryan R., additional, Cuevas, Ileana, additional, Bennett, Zachary T., additional, Gao, Jinming, additional, Minna, John D., additional, Castrillon, Diego H., additional, Awad, Mark M., additional, Xu, Lin, additional, and Akbay, Esra A., additional

Published
2023
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50. Outcomes of Combination Platinum-Doublet Chemotherapy and Anti-PD(L)-1 Blockade in KRASG12C-Mutant Non-Small Cell Lung Cancer

Author

Elkrief, Arielle, primary, Riccuiti, Biagio, additional, Alessi, Joao V, additional, Fei, Teng, additional, Kalvin, Hannah L, additional, Egger, Jacklynn V, additional, Rizvi, Hira, additional, Thummalapalli, Rohit, additional, Lamberti, Guiseppe, additional, Plodkowski, Andrew, additional, Hellmann, Matthew D, additional, Kris, Mark G, additional, Arcila, Maria E, additional, Baine, Marina K, additional, Rudin, Charles M, additional, Lito, Piro, additional, Ladanyi, Marc, additional, Schoenfeld, Adam J, additional, Riely, Gregory J, additional, Awad, Mark M, additional, and Arbour, Kathryn C, additional

Published
2023
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