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116 results on '"A. Martinez-Marti"'

1. 120MO Adjuvant pembrolizumab versus placebo for early-stage NSCLC after resection and optional chemotherapy: Updated results from PEARLS/KEYNOTE-091

Author

Besse, B., primary, Havel, L., additional, Peters, S., additional, Marreaud, S.I., additional, Jha, N., additional, Oselin, K., additional, Esteban Gonzalez, E., additional, Isla Casado, M.D., additional, Martinez-Marti, A., additional, Faehling, M., additional, Lee, J-S., additional, Luo, Y., additional, Keller, S.M., additional, Dafni, U., additional, Mauer, M.E., additional, Stahel, R.A., additional, O'Brien, M.E.R., additional, Tsuboi, M., additional, and Paz-Ares, L., additional

Published
2023
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2. EP08.03-01 Copy Number Variants and Late Somatic Mutations Underlying Tumor Progression in NADIM Clinical Trials

Author

Serna Blasco, R., primary, García Campelo, M.R., additional, Nadal, E., additional, Mediavilla, P., additional, Calvo, V., additional, Gonzalez-Larriba, J.L., additional, Robado de Lope, L., additional, Massutí, B., additional, Martinez-Marti, A., additional, Casal, J., additional, Dómine, M., additional, Cobo, M., additional, Cruz, A., additional, Romero, A., additional, and Provencio, M., additional

Published
2023
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3. EP07.04-01 Free Circulating and Extracellular Vesicles-Derived microRNA as Prognostic Biomarkers in Resected Early-Stage NSCLC: RESTING Study Results

Author

Pasini, L., primary, Petracci, E., additional, Urbini, M., additional, Felip, E., additional, Stella, F., additional, Tebaldi, M., additional, Azzali, I., additional, Martinez-Marti, A., additional, Pancreach, E., additional, Davoli, F., additional, Salvi, M., additional, Beau, M., additional, Solli, P., additional, Lai, G., additional, Amat, R., additional, Carbonell, C., additional, Delmonte, A., additional, Crinò, L., additional, and Ulivi, P., additional

Published
2023
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4. P1.27-07 BRAF Mutations Identify Non-small-Cell Lung Cancer Patients Who Benefit from Neoadjuvant Chemo-Immunotherapy

Author

Robado de Lope, L., primary, Nadal, E., additional, Calvo, V., additional, González-Larriba, J.L., additional, Insa, A., additional, Martinez-Marti, A., additional, Massutí, B., additional, González, C., additional, Serna Blasco, R., additional, Bosch-Barrera, J., additional, Garcia-Campelo, M.R., additional, Ponce, S., additional, Reguart, N., additional, Bernabé, R., additional, Cobo, M., additional, De Castro, J., additional, Dómine, M., additional, Camps, C., additional, Barneto, I., additional, López-Vivanco, G., additional, Majem, M., additional, Rodríguez-Abreu, D., additional, Palmero, R., additional, Cruz-Bermudez, A., additional, Romero, A., additional, and Provencio, M., additional

Published
2023
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5. EP14.04-02 Expression of TILs and Patterns of Gene Expression from Paired Samples of Malignant Pleural Mesothelioma (MPM) Patients (p)

Author

Cedres, S., primary, Serna, G., additional, Valdivia, A., additional, Assaf, J.D., additional, Iranzo, P., additional, Callejo, A., additional, Pardo, N., additional, Navarro, A., additional, Martinez-Marti, A., additional, Priano, I., additional, Gonzalez-Medina, A., additional, Fasani, R., additional, Guardia, X., additional, Gonzalo, J., additional, Carbonell, C., additional, Frigola, J., additional, Amat, R., additional, Vivancos, A., additional, Nuciforo, P., additional, and Felip, E., additional

Published
2023
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6. Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB–IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial

Author

Mary O’Brien, Luis Paz-Ares, Sandrine Marreaud, Urania Dafni, Kersti Oselin, Libor Havel, Emilio Esteban, Dolores Isla, Alex Martinez-Marti, Martin Faehling, Masahiro Tsuboi, Jong-Seok Lee, Kazuhiko Nakagawa, Jing Yang, Ayman Samkari, Steven M Keller, Murielle Mauer, Nitish Jha, Rolf Stahel, Benjamin Besse, and Solange Peters

Subjects
Myocarditis, Lung Neoplasms, Oncology, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Hypertension, Humans, Antibodies, Monoclonal, Humanized, B7-H1 Antigen
Abstract

Pembrolizumab is a standard-of-care for advanced non-small-cell lung cancer (NSCLC). We assessed pembrolizumab as adjuvant therapy for completely resected stage IB-IIIA NSCLC.In this randomised, triple-blind, phase 3 trial (PEARLS/KEYNOTE-091), patients were recruited from 196 medical centres in 29 countries. Eligible patients were aged 18 years or older, with completely resected, pathologically confirmed stage IB (tumours of ≥4 cm in diameter), II, or IIIA NSCLC per the American Joint Committee on Cancer staging system (7th edition) of any histology or PD-L1 expression level, and an Eastern Cooperative Oncology Group performance status of 0 or 1; adjuvant chemotherapy was to be considered for stage IB disease and was strongly recommended for stage II and IIIA disease, according to national and local guidelines. Using a central interactive voice-response system, eligible participants were randomly assigned (1:1), using a minimisation technique and stratified by disease stage, previous adjuvant chemotherapy, PD-L1 expression, and geographical region, to pembrolizumab 200 mg or placebo, both administered intravenously every 3 weeks for up to 18 cycles. Participants, investigators, and analysts were masked to treatment assignment. Dual primary endpoints were disease-free survival in the overall population and in the population with PD-L1 tumour proportion score (TPS) of 50% or greater. Efficacy was assessed in the intention-to-treat (ITT) population (ie, all participants randomly assigned to a treatment group). Safety was assessed in all participants randomly assigned to treatment who received at least one dose of study treatment. Here we report results of the second interim analysis, prespecified to occur when approximately 118 disease-free survival events had occurred in the PD-L1 TPS of 50% or greater population. This study is registered with ClinicalTrials.gov, NCT02504372, and is active but not recruiting.Between Jan 20, 2016, and May 6, 2020, 1177 (60%) of 1955 screened participants were randomly assigned to pembrolizumab (n=590, including n=168 with PD-L1 TPS of ≥50%) or placebo (n=587; including n=165 with PD-L1 TPS of ≥50%) and included in the ITT population. Median follow-up as of data cutoff (Sept 20, 2021) for this interim analysis was 35·6 months (IQR 27·1-45·5). In the overall population, median disease-free survival was 53·6 months (95% CI 39·2 to not reached) in the pembrolizumab group versus 42·0 months (31·3 to not reached) in the placebo group (HR 0·76 [95% CI 0·63-0·91], p=0·0014). In the PD-L1 TPS of 50% or greater population, median disease-free survival was not reached in either the pembrolizumab group (95% CI 44·3 to not reached) or the placebo group (95% CI 35·8 to not reached; HR 0·82 [95% CI 0·57-1·18]; p=0·14). Grade 3 or worse adverse events occurred in 198 (34%) of 580 participants who received pembrolizumab and 150 (26%) of 581 participants who received placebo. Grade 3 or worse events that occurred in at least ten participants in either treatment group were hypertension (35 [6%]) and pneumonia (12 [2%]) with pembrolizumab and hypertension (32 [6%]) with placebo. Serious adverse events occurred in 142 (24%) participants in the pembrolizumab group and 90 (15%) in the placebo group; serious adverse events that occurred in more than 1% of participants were pneumonia (13 [2%]), pneumonitis (12 [2%]), and diarrhoea (seven [1%]) with pembrolizumab and pneumonia (nine [2%]) with placebo. Treatment-related adverse events led to death in four (1%) participants treated with pembrolizumab (one due to both cardiogenic shock and myocarditis, one due to both septic shock and myocarditis, one due to pneumonia, and one due to sudden death) and in no participants treated with placebo.Pembrolizumab significantly improved disease-free survival compared with placebo and was not associated with new safety signals in completely resected, PD-L1-unselected, stage IB-IIIA NSCLC. Pembrolizumab is potentially a new treatment option for stage IB-IIIA NSCLC after complete resection and, when recommended, adjuvant chemotherapy, regardless of PD-L1 expression.Merck Sharpamp; Dohme, a subsidiary of Merckamp; Co.

Published
2022
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7. Systemic and intracranial outcomes with first-line nivolumab plus ipilimumab in patients with metastatic non–small cell lung cancer and baseline brain metastases from CheckMate 227 Part 1

Author

Reck, Martin, primary, Ciuleanu, Tudor-Eliade, additional, Lee, Jong-Seok, additional, Schenker, Michael, additional, Zurawski, Bogdan, additional, Kim, Sang-We, additional, Mahave, Mauricio, additional, Alexandru, Aurelia, additional, Peters, Solange, additional, Pluzanski, Adam, additional, Caro, Reyes Bernabe, additional, Linardou, Helena, additional, Burgers, Jacobus A., additional, Nishio, Makoto, additional, Martinez-Marti, Alex, additional, Azuma, Koichi, additional, Axelrod, Rita, additional, Paz-Ares, Luis G., additional, Ramalingam, Suresh S., additional, Borghaei, Hossein, additional, O’Byrne, Kenneth J., additional, Li, Li, additional, Bushong, Judith, additional, Gupta, Ravi G., additional, Grootendorst, Diederik J., additional, Eccles, Laura J., additional, and Brahmer, Julie R., additional

Published
2023
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8. Systemic and intracranial outcomes with first-line nivolumab plus ipilimumab in patients with metastatic non–small cell lung cancer and baseline brain metastases from CheckMate 227 Part 1

Author

Martin Reck, Tudor-Eliade Ciuleanu, Jong-Seok Lee, Michael Schenker, Bogdan Zurawski, Sang-We Kim, Mauricio Mahave, Aurelia Alexandru, Solange Peters, Adam Pluzanski, Reyes Bernabe Caro, Helena Linardou, Jacobus A. Burgers, Makoto Nishio, Alex Martinez-Marti, Koichi Azuma, Rita Axelrod, Luis G. Paz-Ares, Suresh S. Ramalingam, Hossein Borghaei, Kenneth J. O’Byrne, Li Li, Judith Bushong, Ravi G. Gupta, Diederik J. Grootendorst, Laura J. Eccles, and Julie R. Brahmer

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2023
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9. 123P IMpower010: Exploratory overall survival (OS) with adjuvant atezolizumab (atezo) vs best supportive care (BSC) in stage II-IIIA NSCLC with high PD-L1 expression

Author

Rittmeyer, A., primary, Felip, E., additional, Altorki, N.K., additional, Vallieres, E., additional, Zhou, C., additional, Martinez-Marti, A., additional, Csoszi, T., additional, Reck, M., additional, Teixeira, M.E., additional, Deng, Y., additional, Huang, M., additional, McNally, V.A., additional, Bennett, E., additional, Gitlitz, B.J., additional, Srivastava, M., additional, and Wakelee, H., additional

Published
2022
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10. VP3-2022: Pembrolizumab (pembro) versus placebo for early-stage non-small cell lung cancer (NSCLC) following complete resection and adjuvant chemotherapy (chemo) when indicated: Randomized, triple-blind, phase III EORTC-1416-LCG/ETOP 8-15 – PEARLS/KEYNOTE-091 study

Author

L. Paz-Ares, M.E.R. O'Brien, M. Mauer, U. Dafni, K. Oselin, L. Havel, E. Esteban Gonzalez, D. Isla, A. Martinez-Marti, M. Faehling, M. Tsuboi, J-S. Lee, K. Nakagawa, J. Yang, S.M. Keller, N. Jha, S.I. Marreaud, R.A. Stahel, S. Peters, and B. Besse

Subjects
Oncology, Hematology
Published
2022
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11. 187P Tissue B-cell receptor repertoire as biomarker of complete pathological response in NSCLC patients treated with neoadjuvant chemoimmunotherapy (NADIM trials)

Author

B. Sierra-Rodero, C. Martínez-Toledo, M. Molina-Alejandre, V. Calvo, E. Nadal, B. Massuti Sureda, R. García Campelo, C. Gonzalez Ojea, A. Martinez-Marti, M. Domine Gomez, S. Ponce Aix, M.A. Insa Molla, J. De Castro Carpeno, M. Majem, I.C. Barneto Aranda, D. Rodriguez-Abreu, E. del Barco, M. Cobo Dols, M. Provencio Pulla, and A. Cruz-Bermudez

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2023
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12. Pembrolizumab plus Concurrent Chemoradiation Therapy (cCRT) for Unresectable, Locally Advanced, Stage III NSCLC: KEYNOTE-799 2-Year Update

Author

Jabbour, S.K., primary, Lee, K.H., additional, Frost, N., additional, Breder, V., additional, Kowalski, D., additional, Levchenko, E., additional, Reguart, N., additional, Martinez-Marti, A., additional, Houghton, B., additional, Paoli, J.B., additional, Safina, S., additional, Komiya, T., additional, Sanford, A., additional, Liu, H., additional, Song, A.J., additional, Keller, S., additional, and Reck, M., additional

Published
2022
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13. Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB–IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial

Author

O’Brien, Mary, primary, Paz-Ares, Luis, additional, Marreaud, Sandrine, additional, Dafni, Urania, additional, Oselin, Kersti, additional, Havel, Libor, additional, Esteban, Emilio, additional, Isla, Dolores, additional, Martinez-Marti, Alex, additional, Faehling, Martin, additional, Tsuboi, Masahiro, additional, Lee, Jong-Seok, additional, Nakagawa, Kazuhiko, additional, Yang, Jing, additional, Samkari, Ayman, additional, Keller, Steven M, additional, Mauer, Murielle, additional, Jha, Nitish, additional, Stahel, Rolf, additional, Besse, Benjamin, additional, and Peters, Solange, additional

Published
2022
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14. EP07.01-023 Family History of Cancer in a Series of Malignant Pleural Mesothelioma (MPM) Patients (P)

Author

Cedres, S., primary, Cruellas, M., additional, Assaf, J.D., additional, Iranzo, P., additional, Callejo, A., additional, Pardo, N., additional, Navarro, A., additional, Martinez-Marti, A., additional, Carbonell, C., additional, Frigola, J., additional, Amat, R., additional, Gonzalo, J., additional, Navarro, V., additional, Dienstmann, R., additional, Balmaña, J., additional, and Felip, E., additional

Published
2022
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15. 21P Circulating free and extracellular vesicles-derived microRNA as prognostic biomarkers in resected early-stage non-small cell lung cancer

Author

Ulivi, P., primary, Pasini, L., additional, Petracci, E., additional, Urbini, M., additional, Felip, E., additional, Stella, F., additional, Davoli, F., additional, Salvi, M., additional, Beau-Faller, M., additional, Tebaldi, M., additional, Azzali, I., additional, Solli, P., additional, Lai, G., additional, Amat, R., additional, Carbonell, C., additional, Martinez-Marti, A., additional, Pencreach, E., additional, Delmonte, A., additional, and Crinò, L., additional

Published
2022
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16. EP08.01-078 Clinical Outcomes in Metastatic Non-small Cell Lung Cancer Harboring BRAF Mutations Treated With Immune Checkpoint Inhibitors

Author

Garcia-Illescas, D., primary, Callejo, A., additional, Iranzo, P., additional, Assaf, J.D., additional, Molina, G., additional, Priano, I., additional, Valdivia, A., additional, Pardo, N., additional, Navarro, A., additional, Martinez-Marti, A., additional, Cedres, S., additional, Carbonell, C., additional, Frigola, J., additional, Amat, R., additional, and Felip, E., additional

Published
2022
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17. EP07.01-022 Analysis of Second Surgery for Recurrence in Malignant Pleural Mesothelioma (MPM) Patients (P)

Author

Cedres, S., primary, Romero, L., additional, Assaf, J.D., additional, Iranzo, P., additional, Callejo, A., additional, Pardo, N., additional, Navarro, A., additional, Martinez-Marti, A., additional, Molina, G., additional, Garcia-Illescas, D., additional, Sanchez, L., additional, Rosado, J., additional, Carbonell, C., additional, Frigola, J., additional, Amat, R., additional, Gonzalo, J., additional, Navarro, V., additional, Dienstmann, R., additional, and Felip, E., additional

Published
2022
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18. 939P Changes in immune gene signatures after neoadjuvant chemoimmunotherapy treatment in NSCLC patients from NADIM trial

Author

Casarrubios, M., primary, Cruz-Bermudez, A., additional, Sierra-Rodero, B., additional, Martinez, C., additional, Nadal, E., additional, Insa Molla, M.A., additional, Martinez, J. Mosquera, additional, Ojea, C. Gonzalez, additional, Gomez, M. Domine, additional, Tarruella, M. Majem, additional, Abreu, D. Rodriguez, additional, Martinez-Marti, A., additional, De Castro Carpeno, J., additional, Dols, M. Cobo, additional, Vivanco, G. Lopez, additional, Caro, R. Bernabe, additional, Segarra, N. Vinolas, additional, Aranda, I.C. Barneto, additional, Sureda, B. Massuti, additional, and Pulla, M. Provencio, additional

Published
2022
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19. 930MO PD-L1 expression and outcomes of pembrolizumab and placebo in completely resected stage IB-IIIA NSCLC: Subgroup analysis of PEARLS/KEYNOTE-091

Author

Peters, S., primary, Besse, B., additional, Marreaud, S., additional, Dafni, U., additional, Oselin, K., additional, Havel, L., additional, Esteban Gonzalez, E., additional, Isla, D., additional, Martinez-Marti, A., additional, Faehling, M., additional, Tsuboi, M., additional, Lee, J-S., additional, Nakagawa, K., additional, Yang, J., additional, Keller, S.M., additional, Mauer, M.E., additional, Jha, N., additional, Stahel, R.A., additional, Paz-Ares, L., additional, and O'Brien, M.E.R., additional

Published
2022
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20. PL03.09 IMpower010:Overall Survival Interim Analysis of a Phase III Study of Atezolizumab vs Best Supportive Care in Resected NSCLC

Author

Wakelee, H., primary, Altorki, N., additional, Felip, E., additional, Vallieres, E., additional, Vynnychenko, I.O., additional, Akopov, A., additional, Martinez-Marti, A., additional, Chella, A., additional, Bondarenko, I., additional, Sugawara, S., additional, Fan, Y., additional, Kenmotsu, H., additional, Chen, Y.-M., additional, Deng, Y., additional, Wu, F., additional, McNally, V., additional, Bennett, E., additional, Gitlitz, B.J., additional, and Zhou, C., additional

Published
2022
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21. 1637P Impact of immune-related adverse events (irAEs) and survival (OS) in a cohort of MPM patients (p) treated with immunotherapy (IT)

Author

Cedres Perez, S.M., primary, Valdivia, A., additional, Assaf, J.D., additional, Iranzo Gomez, P., additional, Callejo, A., additional, Pardo Aranda, N., additional, Navarro Mendivil, A.F., additional, Martinez-Marti, A., additional, Molina, G., additional, Navarro, V., additional, Gonzalo, J., additional, Soleda, M., additional, Frigola, J., additional, Carbonell, C., additional, Amat, R., additional, Dienstmann, R., additional, and Felip, E., additional

Published
2022
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25. 939P Changes in immune gene signatures after neoadjuvant chemoimmunotherapy treatment in NSCLC patients from NADIM trial

Author

M. Casarrubios, A. Cruz-Bermudez, B. Sierra-Rodero, C. Martinez, E. Nadal, M.A. Insa Molla, J. Mosquera Martinez, C. Gonzalez Ojea, M. Domine Gomez, M. Majem Tarruella, D. Rodriguez Abreu, A. Martinez-Marti, J. De Castro Carpeno, M. Cobo Dols, G. Lopez Vivanco, R. Bernabe Caro, N. Vinolas Segarra, I.C. Barneto Aranda, B. Massuti Sureda, and M. Provencio Pulla

Subjects
Oncology, Hematology
Published
2022
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28. VP3-2022: Pembrolizumab (pembro) versus placebo for early-stage non-small cell lung cancer (NSCLC) following complete resection and adjuvant chemotherapy (chemo) when indicated: Randomized, triple-blind, phase III EORTC-1416-LCG/ETOP 8-15 – PEARLS/KEYNOTE-091 study

Author

Paz-Ares, L., primary, O'Brien, M.E.R., additional, Mauer, M., additional, Dafni, U., additional, Oselin, K., additional, Havel, L., additional, Esteban Gonzalez, E., additional, Isla, D., additional, Martinez-Marti, A., additional, Faehling, M., additional, Tsuboi, M., additional, Lee, J-S., additional, Nakagawa, K., additional, Yang, J., additional, Keller, S.M., additional, Jha, N., additional, Marreaud, S.I., additional, Stahel, R.A., additional, Peters, S., additional, and Besse, B., additional

Published
2022
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29. 80O Atezolizumab (atezo) vs best supportive care (BSC) in stage II-IIIA NSCLC with high PD-L1 expression: Sub-analysis from the pivotal phase III IMpower010 study

Author

Felip, E., primary, Altorki, N.K., additional, Zhou, C., additional, Vallieres, E., additional, Vynnychenko, I.O., additional, Akopov, A., additional, Martinez-Marti, A., additional, Chella, A., additional, Bondarenko, I., additional, Ursol, G., additional, Levchenko, E., additional, Kislov, N., additional, Liersch, R., additional, Belleli, R., additional, McNally, V.A., additional, Bennett, E., additional, Gitlitz, B.J., additional, and Wakelee, H., additional

Published
2022
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34. Pembrolizumab Plus Platinum Chemotherapy and Radiotherapy for Unresectable, Locally Advanced, Stage 3 NSCLC: KEYNOTE-799

Author

Jabbour, S.K., primary, Lee, K.H., additional, Frost, N., additional, Breder, V., additional, Kowalski, D., additional, Alawin, I., additional, Levchenko, E., additional, Reguart, N., additional, Martinez-Marti, A., additional, Houghton, B., additional, Paoli, J.B., additional, Safina, S., additional, Park, K., additional, Komiya, T., additional, Sanford, A., additional, Boolell, V., additional, Liu, H., additional, Samkari, A., additional, Keller, S., additional, and Reck, M., additional

Published
2021
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35. OA20.02 Pre-Treatment Levels of ctDNA for Long-Term Survival Prediction in Stage IIIA NSCLC Treated With Neoadjuvant Chemo-Immunotherapy

Author

Romero, A., primary, Nadal, E., additional, Serna, R., additional, Insa, A., additional, Campelo, M.R. García, additional, Benito, C., additional, Domine, M., additional, Majem, M., additional, Abreu, D. Rodriguez, additional, Martinez-Marti, A., additional, De Castro, J., additional, Cobo, M., additional, Vivanco, G. López, additional, Del Barco, E., additional, Bernabé, R., additional, Viñolas, N., additional, Barneto, I., additional, Viteri, S., additional, Pereira, E., additional, Royuela, A., additional, Casarrubios, M., additional, Calvo, V., additional, Laza - Briviesca, R., additional, Massuti, B., additional, Cruz, A., additional, Sánchez-Herrero, E., additional, and Provencio, M., additional

Published
2021
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36. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB–IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial

Author

Felip, Enriqueta, primary, Altorki, Nasser, additional, Zhou, Caicun, additional, Csőszi, Tibor, additional, Vynnychenko, Ihor, additional, Goloborodko, Oleksandr, additional, Luft, Alexander, additional, Akopov, Andrey, additional, Martinez-Marti, Alex, additional, Kenmotsu, Hirotsugu, additional, Chen, Yuh-Min, additional, Chella, Antonio, additional, Sugawara, Shunichi, additional, Voong, David, additional, Wu, Fan, additional, Yi, Jing, additional, Deng, Yu, additional, McCleland, Mark, additional, Bennett, Elizabeth, additional, Gitlitz, Barbara, additional, and Wakelee, Heather, additional

Published
2021
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37. MA04.07 Clinical Characteristics and Outcomes in Patients With Malignant Pleural Mesothelioma (MPM) with COVID-19 Infection

Author

Cedres, S., primary, Assaf, J.D., additional, Iranzo, P., additional, Pardo, N., additional, Martinez-Marti, A., additional, Navarro, A., additional, Marmolejo, D., additional, Rezqallah, A., additional, Gonzalo, J., additional, Carbonell, C., additional, Frigola, J., additional, Amat, R., additional, Viaplana, C., additional, Dienstmann, R., additional, and Felip, E., additional

Published
2021
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38. OA20.01 Long Term Survival in Operable Stage Iiia Nsclc Patients Treated With Neoadjuvant Nivolumab Plus Chemotherapy - Nadim Study

Author

Provencio, M., primary, Nadal, E., additional, Insa, A., additional, Campelo, M.R. García, additional, Pereiro, D., additional, Domine, M., additional, Majem, M., additional, Abreu, D. Rodriguez, additional, Martinez-Marti, A., additional, De Castro, J., additional, Cobo, M., additional, Vivanco, G. López, additional, Del Barco, E., additional, Bernabé, R., additional, Viñolas, N., additional, Barneto, I., additional, Viteri, S., additional, Pereira, E., additional, Royuela, A., additional, Casarrubios, M., additional, Salas, C., additional, Parra, E.R., additional, Wistuba, I., additional, Calvo, V., additional, Laza - Briviesca, R., additional, Romero, A., additional, Massuti, B., additional, and Cruz, A., additional

Published
2021
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39. 1733P Analysis of chemotherapy (Ct) efficacy according to histology in malignant pleural mesothelioma (MPM) patients (p)

Author

Cedres, S., primary, Assaf, J.D., additional, Gomez, P. Iranzo, additional, Perez, A. Callejo, additional, Aranda, N. Pardo, additional, Navarro, A., additional, Martinez-Marti, A., additional, Castaneda, D.H. Marmolejo, additional, Aron, M.A. Rezqallah, additional, Pedrola, A., additional, Gonzalo, J., additional, Frigola, J., additional, Carbonell, C., additional, Amat, R., additional, Dienstmann, R., additional, and Felip, E., additional

Published
2021
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40. LBA42 COAST: An open-label, randomised, phase II platform study of durvalumab alone or in combination with novel agents in patients with locally advanced, unresectable, stage III NSCLC

Author

Martinez-Marti, A., primary, Majem, M., additional, Barlesi, F., additional, Carcereny Costa, E., additional, Chu, Q., additional, Monnet, I., additional, Sanchez, A., additional, Dahkil, S., additional, Camidge, D.R., additional, He, P., additional, Soo-Hoo, Y., additional, Cooper, Z., additional, Kumar, R., additional, Bothos, J., additional, Aggarwal, C., additional, and Herbst, R.S., additional

Published
2021
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41. Pembrolizumab Plus Platinum Chemotherapy and Radiotherapy for Unresectable, Locally Advanced, Stage 3 NSCLC: KEYNOTE-799

Author

Amy Sanford, A. Samkari, B. Houghton, M. Reck, K.H. Lee, Hong Liu, Salma K. Jabbour, I. Alawin, V. Breder, S. Safina, A. Martinez-Marti, Noemí Reguart, Steven M. Keller, K. Park, V. Boolell, D. Kowalski, E. Levchenko, J.B. Paoli, T. Komiya, and Nicolaj Frost

Subjects
Cancer Research, medicine.medical_specialty, Radiation, business.industry, medicine.medical_treatment, Phases of clinical research, Pembrolizumab, Neutropenia, medicine.disease, Gastroenterology, Carboplatin, Radiation therapy, chemistry.chemical_compound, Oncology, chemistry, Internal medicine, Cohort, medicine, Radiology, Nuclear Medicine and imaging, Stage (cooking), business, Pneumonitis
Abstract

Purpose/Objective(s) KEYNOTE-799 (NCT03631784), a phase 2 study of the anti‒PD-1 antibody pembrolizumab (pembro) plus concurrent chemoradiation therapy (cCRT) in patients (pts) with unresectable, locally advanced stage III NSCLC, completed accrual and follow up is ongoing. Results in a subset of pts from this study showed an ORR of 69.6% in cohort A (squamous [sq]/nonsquamous [nonsq], n = 112) and 70.5% in cohort B (nonsq, n = 61), and grade ≥3 pneumonitis in 8.0% and 7.9% of pts, respectively. We assessed safety and efficacy of pembro + cCRT in all pts from KEYNOTE-799. Materials/Methods This nonrandomized, multisite, open-label trial enrolled pts aged ≥18 y with previously untreated, unresectable, pathologically confirmed, stage IIIA‒C NSCLC with measurable disease per RECIST v1.1. Pts in cohort A (sq and nonsq) received 1 cycle of carboplatin AUC 6 and paclitaxel 200 mg/m2 and pembro 200 mg. After 3 weeks, pts received carboplatin AUC 2 and paclitaxel 45 mg/m2 QW for 6 weeks and 2 cycles of pembro 200 mg Q3W + standard thoracic radiotherapy (TRT; using a standardized 3D conformal radiotherapy technique on a linear accelerator operating at ≥6 MV beam energy for a total target dose of 60 Gy in 30 daily fractions of 2 Gy). Pts in cohort B (nonsq) received 3 cycles of cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and pembro 200 mg Q3W, and TRT in cycles 2 and 3. All pts received up to 14 additional cycles of pembro 200 mg Q3W. Primary endpoints were ORR per RECIST v1.1 by BICR and incidence of grade ≥3 pneumonitis (per NCI CTCAE v4.0); assessed in all pts as-treated. Results Of 216 pts enrolled (cohort A, n = 112; cohort B, n = 104), 112 in cohort A and 102 in cohort B were treated. As of October 28, 2020, the median (range) time from first dose to database cutoff was 18.5 (13.6–23.8) months in cohort A and 13.7 (2.9–23.5) months in cohort B. ORR (95% CI) was 70.5% (61.2%‒78.8%) and 70.6% (60.7%‒79.2%), respectively. Median DOR, OS, and PFS were not reached in either cohort. Twelve-month OS and PFS rates were 81.3% and 67.1% in cohort A; and 87.0% and 71.6% in cohort B. Grade ≥3 pneumonitis occurred in 9 pts (8.0%) in cohort A and 7 (6.9%) in cohort B. Median (range) time to onset of any pneumonitis was 4.3 (1.4–10.4) months in cohort A, and 4.4 (0.1–12.3) months in cohort B. Grade 3–5 treatment-related AEs occurring in ≥10% pts were neutropenia (cohort A, 16.1%; cohort B, 9.8%) and anemia (10.7% and 4.9%). See Table for additional safety data. Conclusion Pembro + cCRT continues to demonstrate promising antitumor activity, and manageable toxicity in pts with previously untreated, locally advanced, stage III NSCLC with longer follow-up.

Published
2021
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42. OA20.02 Pre-Treatment Levels of ctDNA for Long-Term Survival Prediction in Stage IIIA NSCLC Treated With Neoadjuvant Chemo-Immunotherapy

Author

R. Laza Briviesca, Maria Rosario Garcia Campelo, Delvys Rodriguez Abreu, Margarita Majem, Roberto Serna, A. Insa, Manuel Domine, Guillermo López Vivanco, Ana Royuela, V. Calvo, B. Massuti, C. Benito, Isidoro Barneto, E. Pereira, R. Bernabé, Amândio Cruz, Estela Sánchez-Herrero, E. Del Barco, M. Casarrubios, Alex Martinez-Marti, E. Nadal, M. Cobo, M. Provencio, Nuria Viñolas, Amalia Pérez Romero, J. de Castro, and Santiago Viteri

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Multivariate analysis, business.industry, medicine.disease, Clinical trial, Chemoimmunotherapy, Internal medicine, Stage IIIA NSCLC, Long term survival, medicine, Nivolumab, Lung cancer, business, Chemo immunotherapy
Abstract

Introduction: There are currently no predictive biomarkers for long-term survival after neoadjuvant chemoimmunotherapy. However, the identification of non-small lung cancer (NSCLC) patients who obtain long-term benefit from chemoimmunotherapy is essential to optimize therapies. Methods: Using samples from NADIM clinical trial (NCT03081689), in which resectable stage IIIA NSCLC patients were treated with neoadjuvant chemo-immunotherapy with nivolumab, we have evaluated the capacity of ctDNA levels before treatment initiation to predict overall survival (OS) and progression-free survival (PFS) by calculating Harrell’s C-statistic and we compare its predictive value with classical survival surrogates as the pathological response and clinical response assessed according to RECIST criteria v.1.1. The ctDNA was analyzed by NGS, using the Oncomine Pan-Cancer Cell-Free Assay™ (Thermo Fisher Scientific®). To explore the prognostic value of the amount of ctDNA at baseline, for each positive plasma sample, we calculated the sum of the mutant allele frequency (MAF) for all detected mutations. Patients who died from COVID19 were excluded from this analysis. Results: In our study, clinical responses based on RECIST criteria were not predictive for OS or PFS. On the contrary, in the multivariate analysis, patients with low ctDNA levels (

Published
2021
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43. 1733P Analysis of chemotherapy (Ct) efficacy according to histology in malignant pleural mesothelioma (MPM) patients (p)

Author

M.A. Rezqallah Aron, D.H. Marmolejo Castaneda, Caterina Carbonell, A. Pedrola, Jaime Frigola, Susana Cedres, Rodrigo Dienstmann, Ramon Amat, J. Gonzalo, N. Pardo Aranda, Atilio Navarro, A. Callejo Perez, P. Iranzo Gomez, Enriqueta Felip, Alex Martinez-Marti, and J.D. Assaf

Subjects
medicine.medical_specialty, Chemotherapy, Oncology, Pleural mesothelioma, business.industry, medicine.medical_treatment, medicine, Histology, Hematology, Radiology, business
Published
2021
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45. A Placebo-Controlled Phase II Study of Ruxolitinib in Combination With Pemetrexed and Cisplatin for First-Line Treatment of Patients With Advanced Nonsquamous Non–Small-Cell Lung Cancer and Systemic Inflammation

Author

Saiama N. Waqar, Huiling Zhen, Giuseppe Giaccone, Rachel E. Sanborn, Santiago Ponce, Gerard Kennealey, Eric Schaefer, Susan Erickson-Viitanen, and Alex Martinez-Marti

Subjects
Adult, Male, 0301 basic medicine, Pulmonary and Respiratory Medicine, Oncology, Cancer Research, medicine.medical_specialty, Ruxolitinib, Lung Neoplasms, Phases of clinical research, Pemetrexed, Systemic inflammation, Placebo, Maintenance Chemotherapy, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Nitriles, medicine, Humans, Lung cancer, Aged, Inflammation, Cisplatin, business.industry, Induction Chemotherapy, Middle Aged, Prognosis, medicine.disease, Survival Rate, Pyrimidines, 030104 developmental biology, 030220 oncology & carcinogenesis, Pyrazoles, Female, Non small cell, medicine.symptom, business, Follow-Up Studies, medicine.drug
Abstract

Background Dysregulation of the Janus kinase (JAK)/signal transducers and activators of transcription pathway contributes to abnormal inflammatory responses and poor prognosis in non–small-cell lung cancer (NSCLC). We evaluated the JAK1/JAK2 inhibitor ruxolitinib plus pemetrexed/cisplatin first-line in patients with stage IIIB/IV or recurrent nonsquamous NSCLC with systemic inflammation (modified Glasgow prognostic score [mGPS] 1/2). Patients and Methods Part 1 was an open-label, safety run-in, in which we assessed ruxolitinib (15 mg twice daily [b.i.d.]) plus pemetrexed (500 mg/m2 intravenous, day 1) and cisplatin (75 mg/m2 intravenous, day 1). Ruxolitinib dose selection for part 2 required Results Fifteen patients enrolled in part 1 (median age, 64 years; 80% male, 80% mGPS 1) received ruxolitinib 15 mg b.i.d. plus pemetrexed/cisplatin. Median treatment duration was 140 days and no DLTs occurred in 11 evaluable patients. No new safety concerns arose when ruxolitinib was combined with pemetrexed/cisplatin. At study termination, 39 patients were randomized to ruxolitinib and 37 to placebo in part 2. Median treatment duration was 43 days. Response rate was 31% (12 of 39) with ruxolitinib and 35% (13 of 37) with placebo (all partial responses). Conclusion Ruxolitinib 15 mg b.i.d. had an acceptable safety profile in combination with pemetrexed/cisplatin asfirst-line treatment of patients with stage IIIB/IV or recurrent nonsquamous NSCLC and systemic inflammation. Early study termination limited the interpretation of efficacy data in the randomized phase II part of the study.

Published
2018
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46. 126P Clinical predictive factors in real world setting in advanced non-small cell lung cancer (NSCLC) patients (pts)treated with immune checkpoint inhibitors (ICI)

Author

Callejo, A., primary, Marmolejo, D., additional, Iranzo, P., additional, Assaf, J.D., additional, Pardo, N., additional, Navarro, A., additional, Martinez-Marti, A., additional, Cedres, S., additional, Mejia, N.M. Diaz, additional, Carbonell, C., additional, Amat, R., additional, Frigola, J., additional, and Felip, E., additional

Published
2021
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47. 127P Real-world evidence and clinical characteristics in patients (pts) with advanced non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors (ICI)

Author

Iranzo, P., primary, Callejo, A., additional, Marmolejo, D., additional, Assaf, J.D., additional, Pardo, N., additional, Navarro, A., additional, Martinez-Marti, A., additional, Cedres, S., additional, Mejia, N.M. Diaz, additional, Carbonell, C., additional, Amat, R., additional, Frigola, J., additional, and Felip, E., additional

Published
2021
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48. 198P Analysis of efficacy of immunotherapy according to histology in malignant pleural mesothelioma (MPM) patients

Author

Cedres, S., primary, Assaf, J.D., additional, Iranzo, P., additional, Callejo, A., additional, Pardo, N., additional, Navaro, A., additional, Martinez-Marti, A., additional, Bote, H., additional, Marmolejo, D., additional, Lostes, J., additional, Monton, V., additional, Gonzalo, J., additional, Pedrola, A., additional, and Felip, E., additional

Published
2021
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49. 81P Predictive molecular parameters of pneumonitis development in stage IIIa NSCLC patients treated with neo-adjuvant chemo-immunotherapy from NADIM clinical trial

Author

Sierra-Rodero, B., primary, Garitaonaindia, Y., additional, Martinez-Cutillas, M., additional, Nadal, E., additional, Insa, A., additional, Campelo, M.R. Garcia, additional, Rubio, J. Casal, additional, Gomez, M. Domine, additional, Tarruella, M. Majem, additional, Abreu, D. Rodriguez, additional, Martinez-Marti, A., additional, De Castro Carpeno, J., additional, del Barco, E., additional, Viñolas, N., additional, Aranda, I.C. Barneto, additional, Sureda, B. Massuti, additional, Casarrubios, M., additional, Laza-Briviesca, R., additional, Cruz-Bermudez, A., additional, and Provencio, M., additional

Published
2021
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50. P60.07 TMB and Selected Mutations in Resectable Stage IIIA NSCLC Patients Receiving Neo-Adjuvant Chemo-Immunotherapy from NADIM Trial

Author

Cruz-Bermudez, A., primary, Casarrubios, M., additional, Briviesca, R. Laza, additional, Nadal, E., additional, Insa, A., additional, Mosquera, J., additional, Huidobro, G., additional, Gómez, M. Dómine, additional, Massuti, B., additional, Tarruella, M. Majem, additional, Rodríguez-Abreu, D., additional, Martinez-Marti, A., additional, De Castro Campeño, J., additional, Dols, M. Cobo, additional, Vivanco, G. López, additional, Del Barco, E., additional, Caro, R. Bernabé, additional, Viñolas, N., additional, Barneto, I., additional, Viteri, S., additional, Jove, M., additional, Romero, A., additional, Franco, F., additional, and Provencio, M., additional

Published
2021
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