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231 results on '"Koczywas, M."'

3. PP01.48 Efficacy and Safety of Patritumab Deruxtecan (HER3-DXd) in Locally Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) without EGFR-Activating Mutations

Author

Johnson, M.L., primary, Steuer, C.E., additional, Hayashi, H., additional, Su, W.-C., additional, Nishio, M., additional, Kim, D.-W., additional, Koczywas, M., additional, Felip, E., additional, Gold, K.A., additional, Murakami, H., additional, Baik, C.S., additional, Kim, S.-W., additional, Smit, E.F., additional, Gigantone, M., additional, Kim, B., additional, Fan, P.-D., additional, Qi, Z., additional, Wu, E.Y., additional, Sternberg, D., additional, and Jänne, P.A., additional

Published
2023
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4. MA13.08 A Phase 1 Trial of Sapanisertib and Telaglenastat (CB-839) in Patients with Advanced NSCLC (NCI 10327): Results from Dose Escalation

Author

Riess, J., primary, Frankel, P., additional, Massarelli, E., additional, Nieva, J., additional, Lai, W.-C.V., additional, Koczywas, M., additional, Shackelford, D., additional, Lanza, I., additional, Reid, J.M., additional, Gonsalves, W.I., additional, Remick, A.J., additional, Gandara, D.R., additional, Piekarz, R., additional, Lara, P.N., additional, Newman, E., additional, Villalona-Calero, M., additional, and Paik, P., additional

Published
2022
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5. MA13.07 TROPION-Lung02: Initial Results for Datopotamab Deruxtecan Plus Pembrolizumab and Platinum Chemotherapy in Advanced NSCLC

Author

Levy, B., primary, Paz-Ares, L., additional, Rixe, O., additional, Su, W.-C., additional, Yang, T.-Y., additional, Tolcher, A., additional, Lou, Y., additional, Zenke, Y., additional, Savvides, P., additional, Felip, E., additional, Domine, M., additional, Leventakos, K., additional, Pulla, M.P., additional, Koczywas, M., additional, Horiike, A., additional, Rawat, S., additional, Wu, X., additional, Basak, P., additional, Chisamore, M., additional, and Goto, Y., additional

Published
2022
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6. A phase 1 dose-escalation study to investigate the safety, efficacy, pharmacokinetics, and pharmacodynamic activity of CLN-619 (anti-MICA/MICB antibody) alone and in combination with pembrolizumab in patients with advanced solid tumors.

Author

Powderly J.D., Gutierrez M., Wang J.S., Hamilton E.P., Sharma M., Spira A.I., Millward M., Shackleton M.J., Frentzas S., Koczywas M., Mehta N., Christensen A.M., Shapiro I., Whalen K., Michaelson J., Baeuerle P., Janik J.E., Rasco D.W., Powderly J.D., Gutierrez M., Wang J.S., Hamilton E.P., Sharma M., Spira A.I., Millward M., Shackleton M.J., Frentzas S., Koczywas M., Mehta N., Christensen A.M., Shapiro I., Whalen K., Michaelson J., Baeuerle P., Janik J.E., and Rasco D.W.

Abstract

Background: The major histocompatibility complex (MHC) class I-related proteins MICA and MICB are stress-inducible, surface glycoproteins that are up-regulated on human tumors. MICA/MICB are ligands for the activating receptor, Natural Killer Group 2 member D (NKG2D) expressed on Natural Killer (NK) cells, CD8+ T cells, gammadelta T cells and iNKT cells. Proteases in the tumor microenvironment cleave MICA/MICB from the cell surface which enables tumor cells to evade immune cell recognition and destruction by NKG2D-expressing cells. Increased concentrations of shed MICA have been observed in serum from patients across multiple tumor types and correlate with poor survival. CLN-619 is a humanized, clinical-stage, MICA/MICB-specific IgG1 monoclonal antibody that prevents the proteolytic release of MICA/MICB thereby exposing tumor cells for immune destruction through both NKG2D-mediated and antibody-dependent cell-mediated cytotoxicity (ADCC). The antibody has been shown to restore the MICA/MICB-NKG2D axis to promote NK-mediated tumor cell lysis (AACR Annual Meeting abstract 3506, April 2022). In mice bearing MICA/MICB-expressing human tumor xenografts, CLN-619 treatment yielded robust anti-tumor activity at low doses. MICA/MICB is expressed in a wide range of solid tumors. Therefore, CLN-619 is expected to have broad anti-tumor activity. Method(s): CLN-619 is being evaluated in an open-label, non-randomized, dose-escalation (phase 1) study as monotherapy, and in combination with pembrolizumab, in patients with advanced solid tumors. Cohort expansion in patients with specific indications as monotherapy and in combination with pembrolizumab will be conducted. The phase 1 study explores ascending intravenous doses of CLN-619 as monotherapy (0.1, 0.3, 1.0, 3.0, 6.0 and 10.0 mg/kg) and in combination with pembrolizumab (200 mg) in 21-day cycles to identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Key eligibility criteria include 1) histological o

Published
2022

9. OA13.01 S1619 A Trial of Neoadjuvant Cisplatin-Pemetrexed With Atezolizumab in Combination and Maintenance for Resectable Pleural Mesothelioma

Author

Tsao, A., primary, Qian, L., additional, Cetnar, J., additional, Sepesi, B., additional, Gomez, D., additional, Wrangle, J., additional, Simon, G., additional, Mott, F., additional, Hall, R., additional, Santana-Davila, R., additional, Koczywas, M., additional, Redman, M., additional, and Kelly, K., additional

Published
2021
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11. OA03.04 Efficacy and Safety of the Novel HER3 Directed Antibody Drug Conjugate Patritumab Deruxtecan (HER3-DXd; U3-1402) in EGFR-mutated NSCLC

Author

Yu, H., primary, Baik, C., additional, Gold, K., additional, Hayashi, H., additional, Johnson, M., additional, Koczywas, M., additional, Murakami, H., additional, Nishio, M., additional, Steuer, C., additional, Su, W., additional, Yang, J.C., additional, Karam, S., additional, Qi, Z., additional, Qiu, Y., additional, Chen, S., additional, Yu, C., additional, and Janne, P., additional

Published
2021
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12. Intermittent dosing of RMC-4630, a potent, selective inhibitor of SHP2, combined with the MEK inhibitor cobimetinib, in a phase 1b/2 clinical trial for advanced solid tumors with activating mutations of RAS signaling

Author

Bendell, J., primary, Ulahannan, S., additional, Koczywas, M., additional, Brahmer, J., additional, Capasso, A., additional, Eckhardt, S.G., additional, Gordon, M., additional, McCoach, C., additional, Nagasaka, M., additional, Ng, K., additional, Pacheco, J., additional, Riess, J., additional, Spira, A., additional, Steuer, C., additional, Dua, R., additional, Chittivelu, S., additional, Masciari, S., additional, Wang, Z., additional, Wang, X., additional, and Ou, S.H., additional

Published
2020
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13. LBA62 Efficacy and safety of patritumab deruxtecan (U3-1402), a novel HER3 directed antibody drug conjugate, in patients (pts) with EGFR-mutated (EGFRm) NSCLC

Author

Yu, H.A., primary, Baik, C.S., additional, Gold, K., additional, Hayashi, H., additional, Johnson, M., additional, Koczywas, M., additional, Murakami, H., additional, Nishio, M., additional, Steuer, C., additional, Su, W-C., additional, Yang, J., additional, Karam, S., additional, Qi, Z., additional, Qiu, Y., additional, Chen, S., additional, Yu, C., additional, and Jänne, P.A., additional

Published
2020
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15. A12 The SHP2 Inhibitor RMC-4630 in Patients with KRAS-Mutant Non-Small Cell Lung Cancer: Preliminary Evaluation of a First-in-Man Phase 1 Clinical Trial

Author

Ou, S.I., primary, Koczywas, M., additional, Ulahannan, S., additional, Janne, P., additional, Pacheco, J., additional, Burris, H., additional, McCoach, C., additional, Wang, J.S., additional, Gordon, M., additional, Haura, E., additional, Riess, J.W., additional, Zhu, V., additional, Ng, K., additional, Eckhardt, S.G., additional, Capasso, A., additional, Dua, R., additional, Chen, A., additional, Wang, Z., additional, Hayes, J., additional, Nichols, R., additional, and Bivona, T., additional

Published
2020
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16. MA09.02 In Vivo, Ex Vivo and Early Clinical Activity of EGFR Monoclonal Antibody and Osimertinib in EGFR Exon 20 Insertion NSCLC

Author

Riess, J., primary, Floch, N., additional, Mack, P., additional, Martin, M., additional, Vang, D., additional, Smith, P., additional, Cross, D., additional, Cheng, M., additional, Keck, J., additional, Groshen, S., additional, Rabin, M., additional, Padda, S., additional, Oxnard, G., additional, Sands, J., additional, Ramchandran, K., additional, Koczywas, M., additional, Moscow, J., additional, Jänne, P., additional, Lara, P., additional, Newman, E., additional, and Gandara, D., additional

Published
2019
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17. P1.18-05 ChemoXRT W/ Consolidation Pembrolizumab in Unresectable Stage III NSCLC: Long-Term Survival Update and Analysis of Post-Progression Therapy

Author

Durm, G., primary, Althouse, S., additional, Sadiq, A., additional, Jalal, S., additional, Jabbour, S., additional, Zon, R., additional, Kloecker, G., additional, Williamson, M., additional, Reckamp, K., additional, Kio, E., additional, Langdon, R., additional, Adesunloye, B., additional, Gentzler, R., additional, Harb, W., additional, Walling, R., additional, Yeon, C., additional, Koczywas, M., additional, and Hanna, N., additional

Published
2019
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20. Factors Predicting for Early Mortality in Non-Small Cell Lung Cancer

Author

Amini, A., primary, Glaser, S.M., additional, Akhavan, D., additional, Li, R., additional, Nelson, R., additional, Stokes, W.A., additional, Koczywas, M., additional, Reckamp, K.L., additional, Salgia, R., additional, Gaspar, L.E., additional, Kavanagh, B.D., additional, Rusthoven, C.G., additional, and Liu, A.K., additional

Published
2018
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22. Phase IV, open-label, multicentre trial of afatinib in patients (pts) aged ≥70 yrs with NSCLC harbouring common (Del19/L858R) EGFR mutations: Preliminary results

Author

Reckamp, K.L., primary, Gilman, P., additional, Halmos, B., additional, Jahanzeb, M., additional, McCann, J., additional, Paripati, H., additional, Seneviratne, L.C., additional, Wallace, J.A., additional, Rueter, B., additional, Esler, A., additional, Dowling, E., additional, and Koczywas, M., additional

Published
2018
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25. Phase II Trial of Atezolizumab As First-Line or Subsequent Therapy for Patients With Programmed Death-Ligand 1-Selected Advanced Non-Small-Cell Lung Cancer (BIRCH)

Author

Peters, S., Gettinger, S., Johnson, M.L., Janne, P.A., Garassino, M.C., Christoph, D., Toh, C.K., Rizvi, N.A., Chaft, J.E., Costa, E., Patel, J.D., Chow, L.Q.M., Koczywas, M., Ho, C., Fruh, M., Heuvel, M. van den, Rothenstein, J., Reck, M., Paz-Ares, L., Shepherd, F.A., Kurata, T., Li, Z., Qiu, J., Kowanetz, M., Mocci, S., Shankar, G., Sandler, A., Felip, E., Peters, S., Gettinger, S., Johnson, M.L., Janne, P.A., Garassino, M.C., Christoph, D., Toh, C.K., Rizvi, N.A., Chaft, J.E., Costa, E., Patel, J.D., Chow, L.Q.M., Koczywas, M., Ho, C., Fruh, M., Heuvel, M. van den, Rothenstein, J., Reck, M., Paz-Ares, L., Shepherd, F.A., Kurata, T., Li, Z., Qiu, J., Kowanetz, M., Mocci, S., Shankar, G., Sandler, A., and Felip, E.

Abstract

Item does not contain fulltext, Purpose BIRCH was designed to examine the efficacy of atezolizumab, a humanized anti-programmed death-ligand 1 (PD-L1) monoclonal antibody, in advanced non-small-cell lung cancer (NSCLC) across lines of therapy. Patients were selected on the basis of PD-L1 expression on tumor cells (TC) or tumor-infiltrating immune cells (IC). Patients and Methods Eligible patients had advanced-stage NSCLC, no CNS metastases, and zero to two or more lines of prior chemotherapy. Patients whose tumors expressed PD-L1 using the SP142 immunohistochemistry assay on >/= 5% of TC or IC (TC2/3 or IC2/3 [TC or IC >/= 5% PD-L1-expressing cells, respectively]) were enrolled. Atezolizumab 1,200 mg was administered intravenously every 3 weeks. Efficacy-evaluable patients (N = 659) comprised three cohorts: first line (cohort 1; n = 139); second line (cohort 2; n = 268); and third line or higher (cohort 3; n = 252). The primary end point was independent review facility-assessed objective response rate (ORR; Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1). Secondary end points included median duration of response, progression-free survival, and overall survival (OS). Results BIRCH met its primary objective of demonstrating a significant ORR versus historical controls. With a minimum of 12 months of follow-up, the independent review facility-assessed ORR was 18% to 22% for the three cohorts, and 26% to 31% for the TC3 or IC3 subgroup; most responses are ongoing. Responses occurred regardless of EGFR or KRAS mutation status. The median OS from an updated survival analysis (minimum of 20 month follow up) for cohort 1 was 23.5 months (26.9 months for TC3 or IC3 patients); the median OS in cohorts 2 and 3 was 15.5 and 13.2 months, respectively. The safety profile was similar across cohorts and consistent with previous atezolizumab monotherapy trials. Conclusion BIRCH demonstrated responses with atezolizumab monotherapy in patients with PD-L1-selected advanced NSCLC, with good tolerabi

Published
2017

26. KRAS in non-small cell lung cancer

Author

Amanam, I., primary, Gupta, R., additional, Mambetsariev, I., additional, Koczywas, M., additional, Cristea, M., additional, Massarelli, E., additional, Reckamp, K.L., additional, and Salgia, R., additional

Published
2017
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28. Atezolizumab as first-line therapy (1L) for advanced PD-L1-selected NSCLC patients: updated ORR, PFS, OS and exploratory biomarker results from the BIRCH study

Author

Eberhardt, W, additional, Garassino, MC, additional, Rizvi, NA, additional, Besse, B, additional, Jänne, PA, additional, Peters, S, additional, Keong Toh, C, additional, Kurata, T, additional, Carcereny Costa, E, additional, Koczywas, M, additional, Felip Font, E, additional, Chaft, J, additional, Qiu, J, additional, Kowanetz, M, additional, Zou, W, additional, Coleman, S, additional, Mocci, S, additional, Sandler, A, additional, Gettinger, S, additional, and Johnson, ML, additional

Published
2017
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29. Randomized phase 2 trial of erlotinib in combination with high-dose celecoxib or placebo in patients with advanced non-small cell lung cancer

Author

Reckamp, KL, Koczywas, M, Cristea, MC, Dowell, JE, Wang, HJ, Gardner, BK, Milne, GL, Figlin, RA, Fishbein, MC, Elashoff, RM, and Dubinett, SM

Subjects
Adult, Male, erlotinib, Lung Neoplasms, DNA Mutational Analysis, Clinical Trials and Supportive Activities, Oncology and Carcinogenesis, Kaplan-Meier Estimate, Dinoprostone, Disease-Free Survival, Erlotinib Hydrochloride, Double-Blind Method, Clinical Research, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Humans, Oncology & Carcinogenesis, cyclooxygenase 2, Non-Small-Cell Lung, neoplasms, Lung, erbB-1, non-small cell lung cancer, Proportional Hazards Models, Aged, Cancer, prostaglandin E2, celecoxib, Carcinoma, Lung Cancer, Evaluation of treatments and therapeutic interventions, Middle Aged, Immunohistochemistry, Genes, 6.1 Pharmaceuticals, Public Health and Health Services, Female, epidermal growth factor receptor
Abstract

© 2015 American Cancer Society. BACKGROUND: Cyclooxygenase 2 (COX-2)-dependent signaling represents a potential mechanism of resistance to therapy with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. This is mediated in part through an EGFR-independent activation of mitogen-activated protein kinase (MAPK)/extracellular signal-regulated kinase (Erk) by prostaglandin E2 (PGE2). PGE2 promotes downregulation of E cadherin and epithelial to mesenchymal transition. The current study investigated EGFR and COX-2 inhibition in patients with non-small cell lung cancer (NSCLC) and elevated baseline urinary metabolite of PGE2 (PGEM). METHODS: Patients with stage IIIB/IV (AJCC 6th edition) NSCLC who progressed after at least 1 line of therapy or refused standard chemotherapy were randomized to receive erlotinib and celecoxib versus erlotinib and placebo. The primary endpoint was progression-free survival (PFS) with 80% power to detect a 50% improvement with a 1-sided significance level of .2 in the intent-to-treat and elevated baseline PGEM populations. Secondary endpoints included response rate, overall survival, and evaluation of molecular markers to assess targeting COX-2-related pathways and evaluate EGFR tyrosine kinase inhibitor resistance. RESULTS: A total of 107 patients were enrolled with comparable baseline characteristics. Among the patients treated with celecoxib, those with wild-type EGFR were found to have an increased PFS (3.2 months vs 1.8 months; P=.03). PFS was numerically improved among patients in the intent-to-treat group who received erlotinib and celecoxib compared with those treated with erlotinib and placebo (5.4 months vs 3.5 months; P=.33) and was increased in patients in the erlotinib and celecoxib arm with elevated baseline PGEM (5.4 months vs 2.2 months; P=.15). Adverse events were similar in both treatment arms. CONCLUSIONS: The combination of erlotinib and celecoxib did not appear to improve outcomes in an unselected population, but selection by elevated baseline PGEM led to an increase in PFS with this combination. Patients with EGFR wild-type status may benefit from the combination of erlotinib and celecoxib.

Published
2015

31. Defining a Standard Set of Patient Centered Outcomes for Patients With Lung Cancer

Author

Mak, K.S., primary, Van Bommel, A.C.M., additional, Stowell, C., additional, Abrahm, J.L., additional, Baker, M., additional, Baldotto, C., additional, Baldwin, D.R., additional, Borthwick, D., additional, Carbone, D.P., additional, Chen, A.B., additional, Haswell, T., additional, Koczywas, M., additional, Kozower, B.D., additional, Mehran, R.J., additional, Schramel, F.M., additional, Senan, S., additional, Stirling, R.G., additional, van Meerbeeck, J.P., additional, Wouters, M.W.J.M., additional, and Peake, M.D., additional

Published
2015
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33. MODULATION OF THE CYCLOOXYGENASE PATHWAY IS ASSOCIATED WITH EFFICACY IN A RANDOMIZED PHASE II TRIAL OF ERLOTINIB AND CELECOXIB OR PLACEBO IN ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC)

Author

Fishbein, MC, Gardner, B, Milne, GL, Koczywas, M, Cristea, M, Dowell, JE, Wang, H, Figlin, RA, Elashoff, RM, Dubinett, SM, and Reckamp, KL

Subjects
Targeted therapy, Epidermal growth factor receptor, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis, Cardiorespiratory Medicine and Haematology, Biomarkers, Cyclooxygenase
Published
2013

37. Phase I study of the halichondrin B analogue eribulin mesylate in combination with cisplatin in advanced solid tumors

Author

Koczywas, M, primary, Frankel, P H, additional, Synold, T W, additional, Lenz, H-J, additional, Mortimer, J E, additional, El-Khoueiry, A B, additional, Gandara, D R, additional, Cristea, M C, additional, Chung, V M, additional, Lim, D, additional, Reckamp, K L, additional, Lau, D H, additional, Doyle, L A, additional, Ruel, C, additional, Carroll, M I, additional, and Newman, E M, additional

Published
2014
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38. Randomized phase II trial of pemetrexed/cisplatin with or without CBP501 in patients with advanced malignant pleural mesothelioma

Author

Krug, L.M., primary, Wozniak, A.J., additional, Kindler, H.L., additional, Feld, R., additional, Koczywas, M., additional, Morero, J.L., additional, Rodriguez, C.P., additional, Ross, H.J., additional, Bauman, J.E., additional, Orlov, S.V., additional, Ruckdeschel, J.C., additional, Mita, A.C., additional, Fein, L., additional, He, X., additional, Hall, R., additional, Kawabe, T., additional, and Sharma, S., additional

Published
2014
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42. A phase I/II prospective, single arm trial of gefitinib, trastuzumab, and docetaxel in patients with stage IV HER-2 positive metastatic breast cancer

Author

Somlo, G., primary, Martel, C. L., additional, Lau, S. K., additional, Frankel, P., additional, Ruel, C., additional, Gu, L., additional, Hurria, A., additional, Chung, C., additional, Luu, T., additional, Morgan, R., additional, Leong, L., additional, Koczywas, M., additional, McNamara, M., additional, Russell, C. A., additional, and Kane, S. E., additional

Published
2011
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45. Cediranib (C) in patients (pts) with malignant mesothelioma (MM): A phase II trial of The University of Chicago Phase II Consortium.

Author

Campbell, N. P., primary, Kunnavakkam, R., additional, Leighl, N. B., additional, Vincent, M. D., additional, Gandara, D. R., additional, Koczywas, M., additional, Gitlitz, B. J., additional, Agamah, E. S., additional, Thomas, S. P., additional, Stadler, W. M., additional, Vokes, E. E., additional, and Kindler, H. L., additional

Published
2011
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48. Long-term survival after high-dose chemotherapy followed by peripheral stem cell rescue for high-risk locally advanced/inflammatory and metastatic breast cancer.

Author

Vanderwalde, A. M., primary, Ye, W., additional, Frankel, P. H., additional, Asuncion, D. G., additional, Pezner, R. D., additional, Luu, T. H., additional, Shibata, S., additional, Leong, L. A., additional, Margolin, K. A., additional, Morgan, R., additional, Koczywas, M., additional, Chow, W. A., additional, Twardowski, P., additional, Wong, J. Y., additional, Doroshow, J. H., additional, Forman, S. J., additional, and Somlo, G., additional

Published
2011
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49. PCN121 ONCOLOGY MEDICATION UTILIZATION BASED ON FEDERAL DRUG ADMINISTRATION (FDA) LABELING, NATIONAL COMPREHENSIVE CANCER NETWORK (NCCN) CLINICAL PRACTICE GUIDELINE (GL) RECOMMENDATIONS, AND EVIDENCE FOR PATIENTS WITH ADVANCED NON SMALL CELL LUNG CANCER (NSCLC): AN ANALYSIS FROM THE NCCN ONCOLOGY OUTCOMES DATABASE

Author

Lepisto, E.M., primary, Vandergrift, J.L., additional, Kalemkerian, G.P., additional, Pisters, K.M., additional, Zornosa, C., additional, Rabin, M.S., additional, Reid, M.E., additional, Koczywas, M., additional, Otterson, G.A., additional, and Ettinger, D.S., additional

Published
2011
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