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4. Long-term avelumab in advanced non-small-cell lung cancer: summaries and post hoc analyses from JAVELIN Solid Tumor

Author

Hrinczenko, Borys, Iannotti, Nicholas, Goel, Sanjay, Spigel, David, Safran, Howard, Taylor, Matthew H, Bennouna, Jaafar, Wong, Deborah J, Kelly, Karen, Verschraegen, Claire, Bajars, Marcis, Manitz, Juliane, Ruisi, Mary, and Gulley, James L

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Research, Lung, Clinical Trials and Supportive Activities, Lung Cancer, Cancer, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Antibodies, Monoclonal, Humanized, B7-H1 Antigen, Carcinoma, Non-Small-Cell Lung, Disease Progression, Humans, Lung Neoplasms, clinical trials, immunotherapy, lung, metastasis, solid tumors, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

Background: This study examined patients with advanced non-small-cell lung cancer who received long-term avelumab (anti-PD-L1) in a large phase Ib trial (JAVELIN Solid Tumor). Methods: Patients receiving >2 years of avelumab were reviewed and exploratory descriptive analyses were conducted. Results: Individuals with varying baseline characteristics who had received up to 6 years of avelumab were reviewed. Overall, 37/340 (10.9%) had received ≥2 years of treatment; in this subgroup, best response was complete response in 5.4%, partial response in 59.5% and stable disease in 29.7%; 51.4% had continued treatment beyond disease progression. Conclusions: In this study, 11% of patients with advanced non-small-cell lung cancer received ≥2 years of avelumab treatment and experienced prolonged response or continued clinical benefit. Clinical Trial Registration: NCT02395172 (ClinicalTrials.gov).

Published
2022

5. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100

Author

Moehler, Markus, Dvorkin, Mikhail, Boku, Narikazu, Özgüroğlu, Mustafa, Ryu, Min-Hee, Muntean, Alina S, Lonardi, Sara, Nechaeva, Marina, Bragagnoli, Arinilda C, Coşkun, Hasan S, Gracian, Antonio Cubillo, Takano, Toshimi, Wong, Rachel, Safran, Howard, Vaccaro, Gina M, Wainberg, Zev A, Silver, Matthew R, Xiong, Huiling, Hong, Janet, Taieb, Julien, and Bang, Yung-Jue

Subjects
Rare Diseases, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Capecitabine, Female, Fluorouracil, Follow-Up Studies, Humans, Induction Chemotherapy, Maintenance Chemotherapy, Male, Middle Aged, Oxaliplatin, Prognosis, Stomach Neoplasms, Survival Rate, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe role of maintenance therapy for gastric (GC) or gastroesophageal junction cancer (GEJC) is unclear. We investigated avelumab (anti-programmed death ligand-1 [PD-L1]) maintenance after first-line induction chemotherapy for GC/GEJC.Patients and methodsJAVELIN Gastric 100 was a global, open-label, phase III trial. Eligible patients had untreated, unresectable, human epidermal growth factor receptor 2-negative, locally advanced or metastatic GC or GEJC. Patients without progressive disease after 12 weeks of first-line chemotherapy with oxaliplatin plus a fluoropyrimidine were randomly assigned 1:1 to avelumab 10 mg/kg every 2 weeks or continued chemotherapy, stratified by region (Asia v non-Asia). The primary end point was overall survival (OS) after induction chemotherapy in all randomly assigned patients or the PD-L1-positive randomly assigned population (≥ 1% of tumor cells; 73-10 assay).ResultsA total of 805 patients received induction; 499 were randomly assigned to avelumab (n = 249) or continued chemotherapy (n = 250). Median OS was 10.4 months (95% CI, 9.1 to 12.0 months) versus 10.9 months (95% CI, 9.6 to 12.4 months) and 24-month OS rate was 22.1% versus 15.5% with avelumab versus chemotherapy, respectively (hazard ratio [HR], 0.91; 95% CI, 0.74 to 1.11; P = .1779). In the PD-L1-positive population (n = 54), the HR for OS was 1.13 (95% CI, 0.57 to 2.23; P = .6352). In an exploratory analysis of the PD-L1-positive population, defined as combined positive score ≥ 1 (22C3 assay; n = 137), median OS was 14.9 months (95% CI, 8.7 to 17.3 months) with avelumab versus 11.6 months (95% CI, 8.4 to 12.6 months) with chemotherapy (unstratified HR, 0.72; 95% CI, 0.49 to 1.05). With avelumab and chemotherapy, treatment-related adverse events (TRAEs) occurred in 149 (61.3%) and 184 (77.3%) patients, including grade ≥ 3 TRAEs in 31 (12.8%) and 78 (32.8%) patients, respectively.ConclusionJAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1-positive population.

Published
2021

6. Trastuzumab with trimodality treatment for oesophageal adenocarcinoma with HER2 overexpression (NRG Oncology/RTOG 1010): a multicentre, randomised, phase 3 trial

Author

Safran, Howard P, Winter, Kathryn, Ilson, David H, Wigle, Dennis, DiPetrillo, Thomas, Haddock, Michael G, Hong, Theodore S, Leichman, Lawrence P, Rajdev, Lakshmi, Resnick, Murray, Kachnic, Lisa A, Seaward, Samantha, Mamon, Harvey, Diaz Pardo, Dayssy Alexandra, Anderson, Carryn M, Shen, Xinglei, Sharma, Anand K, Katz, Alan W, Salo, Jonathan, Leonard, Kara L, Moughan, Jennifer, and Crane, Christopher H

Published
2022
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7. Therapeutic insights for the aggressive subset of high-grade gliomas (HGG) driven by chromosome 1q32 MDM4-containing amplicon and unmethylated MGMT.

Author

El-Deiry, Wafik S., primary, Horowitch, Brooke, additional, Lou, Emil, additional, Subbiah, Vivek, additional, Carneiro, Benedito A., additional, Safran, Howard, additional, Gokaslan, Ziya L., additional, Sobol, Robert W., additional, Mani, Sendurai A., additional, Lawler, Sean E., additional, Chen, Clark C, additional, Wong, Eric T., additional, Kurzrock, Razelle, additional, Xiu, Joanne, additional, Elliott, Andrew, additional, Capelletti, Marzia, additional, Ressler, Steven, additional, Vanderwalde, Ari M., additional, Nabhan, Chadi, additional, and Spetzler, David, additional

Published
2024
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9. Evaluation of a summer program for minority high school students in the clinical cancer center: The Future Gen Cancer Scholars program.

Author

Ollila, Thomas, primary, Mega, Anthony E., additional, Martinez, Boris, additional, Salisbry, Paula, additional, Neville, Annabelle, additional, Johnson, Janell, additional, Dickens, Brett, additional, Tarantino, John, additional, Omoaregba, Luckson, additional, Oakes, Alissa, additional, and Safran, Howard, additional

Published
2024
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11. Avelumab, an Anti–Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study

Author

Apolo, Andrea B, Infante, Jeffrey R, Balmanoukian, Ani, Patel, Manish R, Wang, Ding, Kelly, Karen, Mega, Anthony E, Britten, Carolyn D, Ravaud, Alain, Mita, Alain C, Safran, Howard, Stinchcombe, Thomas E, Srdanov, Marko, Gelb, Arnold B, Schlichting, Michael, Chin, Kevin, and Gulley, James L

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Cancer, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Cohort Studies, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Treatment Outcome, Urologic Neoplasms, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

Purpose We assessed the safety and antitumor activity of avelumab, a fully human anti-programmed death-ligand 1 (PD-L1) IgG1 antibody, in patients with refractory metastatic urothelial carcinoma. Methods In this phase Ib, multicenter, expansion cohort, patients with urothelial carcinoma progressing after platinum-based chemotherapy and unselected for PD-L1 expression received avelumab 10 mg/kg intravenously every 2 weeks. The primary objectives were safety and tolerability. Secondary objectives included confirmed objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1), progression-free survival, overall survival (OS), and PD-L1-associated clinical activity. PD-L1 positivity was defined as expression by immunohistochemistry on ≥ 5% of tumor cells. Results Forty-four patients were treated with avelumab and followed for a median of 16.5 months (interquartile range, 15.8 to 16.7 months). The data cutoff was March 19, 2016. The most frequent treatment-related adverse events of any grade were fatigue/asthenia (31.8%), infusion-related reaction (20.5%), and nausea (11.4%). Grades 3 to 4 treatment-related adverse events occurred in three patients (6.8%) and included asthenia, AST elevation, creatine phosphokinase elevation, and decreased appetite. The confirmed objective response rate by independent central review was 18.2% (95% CI, 8.2% to 32.7%; five complete responses and three partial responses). The median duration of response was not reached (95% CI, 12.1 weeks to not estimable), and responses were ongoing in six patients (75.0%), including four of five complete responses. Seven of eight responding patients had PD-L1-positive tumors. The median progression-free survival was 11.6 weeks (95% CI, 6.1 to 17.4 weeks); the median OS was 13.7 months (95% CI, 8.5 months to not estimable), with a 12-month OS rate of 54.3% (95% CI, 37.9% to 68.1%). Conclusion Avelumab was well tolerated and associated with durable responses and prolonged survival in patients with refractory metastatic UC.

Published
2017

12. ONC201 and imipridones: Anti-cancer compounds with clinical efficacy

Author

Prabhu, Varun Vijay, Morrow, Sara, Rahman Kawakibi, Abed, Zhou, Lanlan, Ralff, Marie, Ray, Jocelyn, Jhaveri, Aakash, Ferrarini, Isacco, Lee, Young, Parker, Cassandra, Zhang, Yiqun, Borsuk, Robyn, Chang, Wen-I, Honeyman, Joshua N., Tavora, Fabio, Carneiro, Benedito, Raufi, Alexander, Huntington, Kelsey, Carlsen, Lindsey, Louie, Anna, Safran, Howard, Seyhan, Attila A., Tarapore, Rohinton S., Schalop, Lee, Stogniew, Martin, Allen, Joshua E., Oster, Wolfgang, and El-Deiry, Wafik S.

Published
2020
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15. Supplementary Figure S9 from Phase I Study of Elraglusib (9-ING-41), a Glycogen Synthase Kinase-3β Inhibitor, as Monotherapy or Combined with Chemotherapy in Patients with Advanced Malignancies

Author

Carneiro, Benedito A., primary, Cavalcante, Ludimila, primary, Mahalingam, Devalingam, primary, Saeed, Anwaar, primary, Safran, Howard, primary, Ma, Wen Wee, primary, Coveler, Andrew L., primary, Powell, Steven, primary, Bastos, Bruno, primary, Davis, Elizabeth, primary, Sahai, Vaibhav, primary, Mikrut, William, primary, Longstreth, James, primary, Smith, Sheri, primary, Weisskittel, Taylor, primary, Li, Hu, primary, Borden, Brittany A., primary, Harvey, R. Donald, primary, Sahebjam, Solmaz, primary, Cervantes, Andrés, primary, Koukol, Austin, primary, Mazar, Andrew P., primary, Steeghs, Neeltje, primary, Kurzrock, Razelle, primary, Giles, Francis J., primary, and Munster, Pamela, primary

Published
2024
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16. Supplementary Table S8 from Phase I Study of Elraglusib (9-ING-41), a Glycogen Synthase Kinase-3β Inhibitor, as Monotherapy or Combined with Chemotherapy in Patients with Advanced Malignancies

Author

Carneiro, Benedito A., primary, Cavalcante, Ludimila, primary, Mahalingam, Devalingam, primary, Saeed, Anwaar, primary, Safran, Howard, primary, Ma, Wen Wee, primary, Coveler, Andrew L., primary, Powell, Steven, primary, Bastos, Bruno, primary, Davis, Elizabeth, primary, Sahai, Vaibhav, primary, Mikrut, William, primary, Longstreth, James, primary, Smith, Sheri, primary, Weisskittel, Taylor, primary, Li, Hu, primary, Borden, Brittany A., primary, Harvey, R. Donald, primary, Sahebjam, Solmaz, primary, Cervantes, Andrés, primary, Koukol, Austin, primary, Mazar, Andrew P., primary, Steeghs, Neeltje, primary, Kurzrock, Razelle, primary, Giles, Francis J., primary, and Munster, Pamela, primary

Published
2024
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17. Data from Phase I Study of Elraglusib (9-ING-41), a Glycogen Synthase Kinase-3β Inhibitor, as Monotherapy or Combined with Chemotherapy in Patients with Advanced Malignancies

Author

Carneiro, Benedito A., primary, Cavalcante, Ludimila, primary, Mahalingam, Devalingam, primary, Saeed, Anwaar, primary, Safran, Howard, primary, Ma, Wen Wee, primary, Coveler, Andrew L., primary, Powell, Steven, primary, Bastos, Bruno, primary, Davis, Elizabeth, primary, Sahai, Vaibhav, primary, Mikrut, William, primary, Longstreth, James, primary, Smith, Sheri, primary, Weisskittel, Taylor, primary, Li, Hu, primary, Borden, Brittany A., primary, Harvey, R. Donald, primary, Sahebjam, Solmaz, primary, Cervantes, Andrés, primary, Koukol, Austin, primary, Mazar, Andrew P., primary, Steeghs, Neeltje, primary, Kurzrock, Razelle, primary, Giles, Francis J., primary, and Munster, Pamela, primary

Published
2024
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18. Phase I Study of Elraglusib (9-ING-41), a Glycogen Synthase Kinase-3β Inhibitor, as Monotherapy or Combined with Chemotherapy in Patients with Advanced Malignancies

Author

Carneiro, Benedito A., primary, Cavalcante, Ludimila, additional, Mahalingam, Devalingam, additional, Saeed, Anwaar, additional, Safran, Howard, additional, Ma, Wen Wee, additional, Coveler, Andrew L., additional, Powell, Steven, additional, Bastos, Bruno, additional, Davis, Elizabeth, additional, Sahai, Vaibhav, additional, Mikrut, William, additional, Longstreth, James, additional, Smith, Sheri, additional, Weisskittel, Taylor, additional, Li, Hu, additional, Borden, Brittany A., additional, Harvey, R. Donald, additional, Sahebjam, Solmaz, additional, Cervantes, Andrés, additional, Koukol, Austin, additional, Mazar, Andrew P., additional, Steeghs, Neeltje, additional, Kurzrock, Razelle, additional, Giles, Francis J., additional, and Munster, Pamela, additional

Published
2023
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19. Postresection CA19-9 and margin status as predictors of recurrence after adjuvant treatment for pancreatic carcinoma: Analysis of NRG oncology RTOG trial 9704

Author

Regine, William F., Winter, Kathryn, Abrams, Ross A., Safran, Howard, Kessel, Ivan L., Chen, Yuhchyau, Fugazzi, James A., Donnelly, Eric D., DiPetrillo, Thomas A., Narayan, Samir, Plastaras, John P., Gaur, Rakesh, Delouya, Guila, Suh, John H., Meyer, Joshua E., Haddock, Michael G., Didolkar, Mukund S., Padula, Gilbert D.A., Johnson, David, Hoffman, John P., and Crane, Christopher H.

Published
2018
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22. Analysis of Radiation Therapy Quality Assurance in NRG Oncology RTOG 0848

Author

Tchelebi, Leila T., primary, Winter, Kathryn A., additional, Abrams, Ross A., additional, Safran, Howard P., additional, Regine, William F., additional, McNulty, Susan, additional, Wu, Abraham, additional, Du, Kevin L., additional, Seaward, Samantha A., additional, Bian, Shelly X., additional, Aljumaily, Raid, additional, Shivnani, Anand, additional, Knoble, Jeanna L., additional, Crocenzi, Todd S., additional, DiPetrillo, Thomas A., additional, Roof, Kevin S., additional, Crane, Christopher H., additional, and Goodman, Karyn A., additional

Published
2023
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29. Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question—Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head: A Phase II Randomized Clinical Trial

Author

Abrams, Ross A., Winter, Kathryn A., Safran, Howard, Goodman, Karyn A., Regine, William F., Berger, Adam C., Gillin, Michael T., Philip, Philip A., Lowy, Andrew M., Wu, Abraham, DiPetrillo, Thomas A., Corn, Benjamin W., Seaward, Samantha A., Haddock, Michael G., Song, Suisui, Jiang, Yixing, Fisher, Barbara J., Katz, Alan W., Mehta, Sharmila, Willett, Christopher G., and Crane, Christopher H.

Published
2020
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31. Avelumab (anti–PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial

Author

Chung, Hyun Cheol, Arkenau, Hendrik-Tobias, Lee, Jeeyun, Rha, Sun Young, Oh, Do-Youn, Wyrwicz, Lucjan, Kang, Yoon-Koo, Lee, Keun-Wook, Infante, Jeffrey R., Lee, Sung Sook, Kemeny, Margaret, Keilholz, Ulrich, Melichar, Bohuslav, Mita, Alain, Plummer, Ruth, Smith, Denis, Gelb, Arnold B., Xiong, Huiling, Hong, Janet, Chand, Vikram, and Safran, Howard

Published
2019
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32. Abstract 4185: Inclusive basic and advanced translational laboratory research competencies for research in cancer biology and therapeutics

Author

El-Deiry, Wafik S., primary, George, Andrew, additional, Cristofano, Francesca Di, additional, Srinivasan, Praveen, additional, Carlsen, Lindsey, additional, Huntington, Kelsey E., additional, Cruz, Arielle De La, additional, Zhang, Leiqing, additional, Hahn, Marina, additional, Zhao, Shuai, additional, Seyhan, Attila, additional, DeNardo, Bradley D., additional, Maxwell, Aaron W., additional, Kim, Dae Hee, additional, Raufi, Alex, additional, Khan, Hina, additional, Graff, Stephanie L., additional, Dizon, Don S., additional, Azzoli, Christopher, additional, Abbas, Abbas E., additional, Wood, Roxanne, additional, Lulla, Rishi R., additional, Safran, Howard P., additional, Carneiro, Benedito A., additional, Navaraj, Arunasalam, additional, Tian, Xiaobing, additional, Zhang, Shengliang, additional, and Zhou, Lanlan, additional

Published
2023
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33. Abstract 1822: IFN-γ and TRAIL involvement in androgen signaling-mediated NK cell killing of prostate cancer cells and further enhancement by NKG2A checkpoint inhibition with monalizumab

Author

Schwermann, Maximilian, primary, Carlsen, Lindsey, additional, Huntington, Kelsey E., additional, Zhou, Lanlan, additional, George, Andrew, additional, Srinivasan, Praveen, additional, Tajiknia, Vida, additional, Cruz, Arielle De La, additional, De Souza, Andre, additional, Mega, Anthony E., additional, Safran, Howard P., additional, Carneiro, Benedito A., additional, and El-Deiry, Wafik S., additional

Published
2023
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34. Data from The Landscape of Glycogen Synthase Kinase-3 Beta Genomic Alterations in Cancer

Author

Borden, Brittany A., primary, Baca, Yasmine, primary, Xiu, Joanne, primary, Tavora, Fabio, primary, Winer, Ira, primary, Weinberg, Benjamin A., primary, Vanderwalde, Ari M., primary, Darabi, Sourat, primary, Korn, W. Michael, primary, Mazar, Andrew P., primary, Giles, Francis J., primary, Crawford, Lorin, primary, Safran, Howard, primary, El-Deiry, Wafik S., primary, and Carneiro, Benedito A., primary

Published
2023
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35. Supplemental File 1 from The Landscape of Glycogen Synthase Kinase-3 Beta Genomic Alterations in Cancer

Author

Borden, Brittany A., primary, Baca, Yasmine, primary, Xiu, Joanne, primary, Tavora, Fabio, primary, Winer, Ira, primary, Weinberg, Benjamin A., primary, Vanderwalde, Ari M., primary, Darabi, Sourat, primary, Korn, W. Michael, primary, Mazar, Andrew P., primary, Giles, Francis J., primary, Crawford, Lorin, primary, Safran, Howard, primary, El-Deiry, Wafik S., primary, and Carneiro, Benedito A., primary

Published
2023
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36. Data from Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer

Author

Tabernero, Josep, primary, Ohtsu, Atsushi, primary, Muro, Kei, primary, Van Cutsem, Eric, primary, Oh, Sang Cheul, primary, Bodoky, György, primary, Shimada, Yasuhiro, primary, Hironaka, Shuichi, primary, Ajani, Jaffer A., primary, Tomasek, Jiri, primary, Safran, Howard, primary, Chandrawansa, Kumari, primary, Hsu, Yanzhi, primary, Heathman, Michael, primary, Khan, Azhar, primary, Ni, Lan, primary, Melemed, Allen S., primary, Gao, Ling, primary, Ferry, David, primary, and Fuchs, Charles S., primary

Published
2023
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37. Supplemental Table 1 from The Landscape of Glycogen Synthase Kinase-3 Beta Genomic Alterations in Cancer

Author

Borden, Brittany A., primary, Baca, Yasmine, primary, Xiu, Joanne, primary, Tavora, Fabio, primary, Winer, Ira, primary, Weinberg, Benjamin A., primary, Vanderwalde, Ari M., primary, Darabi, Sourat, primary, Korn, W. Michael, primary, Mazar, Andrew P., primary, Giles, Francis J., primary, Crawford, Lorin, primary, Safran, Howard, primary, El-Deiry, Wafik S., primary, and Carneiro, Benedito A., primary

Published
2023
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38. Table S1 from Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer

Author

Tabernero, Josep, primary, Ohtsu, Atsushi, primary, Muro, Kei, primary, Van Cutsem, Eric, primary, Oh, Sang Cheul, primary, Bodoky, György, primary, Shimada, Yasuhiro, primary, Hironaka, Shuichi, primary, Ajani, Jaffer A., primary, Tomasek, Jiri, primary, Safran, Howard, primary, Chandrawansa, Kumari, primary, Hsu, Yanzhi, primary, Heathman, Michael, primary, Khan, Azhar, primary, Ni, Lan, primary, Melemed, Allen S., primary, Gao, Ling, primary, Ferry, David, primary, and Fuchs, Charles S., primary

Published
2023
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39. Supplemental Table 2 from The Landscape of Glycogen Synthase Kinase-3 Beta Genomic Alterations in Cancer

Author

Borden, Brittany A., primary, Baca, Yasmine, primary, Xiu, Joanne, primary, Tavora, Fabio, primary, Winer, Ira, primary, Weinberg, Benjamin A., primary, Vanderwalde, Ari M., primary, Darabi, Sourat, primary, Korn, W. Michael, primary, Mazar, Andrew P., primary, Giles, Francis J., primary, Crawford, Lorin, primary, Safran, Howard, primary, El-Deiry, Wafik S., primary, and Carneiro, Benedito A., primary

Published
2023
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40. Figure S1 from Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer

Author

Tabernero, Josep, primary, Ohtsu, Atsushi, primary, Muro, Kei, primary, Van Cutsem, Eric, primary, Oh, Sang Cheul, primary, Bodoky, György, primary, Shimada, Yasuhiro, primary, Hironaka, Shuichi, primary, Ajani, Jaffer A., primary, Tomasek, Jiri, primary, Safran, Howard, primary, Chandrawansa, Kumari, primary, Hsu, Yanzhi, primary, Heathman, Michael, primary, Khan, Azhar, primary, Ni, Lan, primary, Melemed, Allen S., primary, Gao, Ling, primary, Ferry, David, primary, and Fuchs, Charles S., primary

Published
2023
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41. Supplementary Data from Phase I and Pharmacology Study of Ropidoxuridine (IPdR) as Prodrug for Iododeoxyuridine-Mediated Tumor Radiosensitization in Advanced GI Cancer Undergoing Radiation

Author

Kinsella, Timothy, primary, Safran, Howard, primary, Wiersma, Susan, primary, DiPetrillo, Thomas, primary, Schumacher, Andrew, primary, Rosati, Kayla, primary, Vatkevich, John, primary, Anderson, Lawrence W., primary, Hill, Kimberly D., primary, Kunos, Charles, primary, and Collins, Jerry M., primary

Published
2023
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44. Clinical features of patients with MTAP-deleted bladder cancer

Author

De Souza, Andre L, Mega, Anthony E, Douglass, John, Olszewski, Adam J, Gamsiz Uzun, Ece D, Uzun, Alper, Chou, Charissa, Duan, Fenghai, Wang, Jinyu, Ali, Amin, Golijanin, Dragan J, Holder, Sheldon L, Lagos, Galina G, Safran, Howard, El-Deiry, Wafik S, and Carneiro, Benedito A

Subjects
Original Article
Abstract

Advanced urothelial carcinoma continues to have a dismal prognosis despite several new therapies in the last 5 years. FGFR2 and FGFR3 mutations and fusions, PD-L1 expression, tumor mutational burden, and microsatellite instability are established predictive biomarkers in advanced urothelial carcinoma. Novel biomarkers can optimize the sequencing of available treatments and improve outcomes. We describe herein the clinical and pathologic features of patients with an emerging subtype of bladder cancer characterized by deletion of the gene MTAP encoding the enzyme S-Methyl-5’-thioadenosine phosphatase, a potential biomarker of response to pemetrexed. We performed a retrospective analysis of 61 patients with advanced urothelial carcinoma for whom demographics, pathologic specimens, next generation sequencing, and clinical outcomes were available. We compared the frequency of histology variants, upper tract location, pathogenic gene variants, tumor response, progression free survival (PFS) and overall survival (OS) between patients with tumors harboring MTAP deletion (MTAP-del) and wild type tumors (MTAP-WT). A propensity score matching of 5 covariates (age, gender, presence of variant histology, prior surgery, and prior non-muscle invasive bladder cancer) was calculated to compensate for disparity when comparing survival in these subgroups. Non-supervised clustering analysis of differentially expressed genes between MTAP-del and MTAP-WT urothelial carcinomas was performed. MTAP-del occurred in 19 patients (31%). Tumors with MTAP-del were characterized by higher prevalence of squamous differentiation (47.4 vs 11.9%), bone metastases (52.6 vs 23.5%) and lower frequency of upper urinary tract location (5.2% vs 26.1%). Pathway gene set enrichment analysis showed that among the genes upregulated in the MTAP-del cohort, at least 5 were linked to keratinization (FOXN1, KRT33A/B, KRT84, RPTN) possibly contributing to the higher prevalence of squamous differentiation. Alterations in the PIK3 and MAPK pathways were more frequent when MTAP was deleted. There was a trend to inferior response to chemotherapy among MTAP-del tumors, but no difference in the response to immune checkpoint inhibitors or enfortumab. Median progression free survival after first line therapy (PFS1) was 5.5 months for patients with MTAP-WT and 4.5 months for patients with MTAP-del (HR = 1.30; 95% CI, 0.64-2.63; P = 0.471). There was no difference in the time from metastatic diagnosis to death (P = 0.6346). Median OS from diagnosis of localized or de novo metastatic disease was 16 months (range 1.5-60, IQR 8-26) for patients with MTAP-del and 24.5 months (range 3-156, IQR 16-48) for patients with MTAP-WT (P = 0.0218), suggesting that time to progression to metastatic disease is shorter in MTAP-del patients. Covariates did not impact significantly overall survival on propensity score matching. In conclusion, MTAP -del occurs in approximately 30% of patients with advanced urothelial carcinoma and defines a subgroup of patients with aggressive features, such as squamous differentiation, frequent bone metastases, poor response to chemotherapy, and shorter time to progression to metastatic disease.

Published
2023

46. PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study: BrUOG 244

Author

Elinzano, Heinrich, Glantz, Michael, Mrugala, Maciej, Kesari, Santosh, Piccioni, David E., Kim, Lyndon, Pan, Edward, Yunus, Shakeeb, Coyle, Thomas, Timothy, Kinsella, Evans, Devon, Mantripragada, Kalyan, Boxerman, Jerrold, DiPetrillo, Thomas, Donahue, John E., Hebda, Nicholas, Mitchell, Kristen M., Rosati, Kayla L., and Safran, Howard

Published
2018
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47. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial

Author

Fuchs, Charles S, Tomasek, Jiri, Yong, Cho Jae, Dumitru, Filip, Passalacqua, Rodolfo, Goswami, Chanchal, Safran, Howard, dos Santos, Lucas Vieira, Aprile, Giuseppe, Ferry, David R, Melichar, Bohuslav, Tehfe, Mustapha, Topuzov, Eldar, Zalcberg, John Raymond, Chau, Ian, Campbell, William, Sivanandan, Choondal, Pikiel, Joanna, Koshiji, Minori, Hsu, Yanzhi, Liepa, Astra M, Gao, Ling, Schwartz, Jonathan D, and Tabernero, Josep

Published
2014
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48. Effect of the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation Therapy for Patients With Esophageal Cancer: The NRG Oncology RTOG 0436 Phase 3 Randomized Clinical Trial

Author

Suntharalingam, Mohan, Winter, Kathryn, Ilson, David, Dicker, Adam P., Kachnic, Lisa, Konski, André, Chakravarthy, A. Bapsi, Anker, Christopher J., Thakrar, Harish, Horiba, Naomi, Dubey, Ajay, Greenberger, Joel S., Raben, Adam, Giguere, Jeffrey, Roof, Kevin, Videtic, Gregory, Pollock, Jondavid, Safran, Howard, and Crane, Christopher H.

Published
2017
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50. Clinical activity of 9-ING-41, a small molecule selective glycogen synthase kinase-3 beta (GSK-3β) inhibitor, in refractory adult T-Cell leukemia/lymphoma

Author

Hsu, Andrew, primary, Huntington, Kelsey E., additional, De Souza, Andre, additional, Zhou, Lanlan, additional, Olszewski, Adam J., additional, Makwana, Nirav P., additional, Treaba, Diana O., additional, Cavalcante, Ludimila, additional, Giles, Francis J., additional, Safran, Howard, additional, El-Deiry, Wafik S., additional, and Carneiro, Benedito A., additional

Published
2022
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