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3. Updates in the Treatment of Peripheral T-Cell Lymphomas

Author

Saleh K, Michot JM, and Ribrag V

Subjects
peripheral t-cell lymphomas, brentuximab vedotin, hdac inhibitors, immune checkpoint inhibitors, chop, stem cell transplantation, Therapeutics. Pharmacology, RM1-950
Abstract

Khalil Saleh,1 Jean-Marie Michot,1,2 Vincent Ribrag1,2 1Department of Hematology, Gustave Roussy Cancer Campus, Villejuif, 94800, France; 2Département d’Innovation Thérapeutique et d’Essais Précoces (DITEP), Gustave Roussy Cancer Campus, Villejuif, 94800, FranceCorrespondence: Vincent RibragDepartment of Hematology, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, Villejuif, 94800, FranceTel +33 1 42 11 59 54Fax +33 1 42 11 52 70Email vincent.ribrag@gustaveroussy.frAbstract: Peripheral T-cell lymphomas (PTCLs) represent a heterogeneous group of rare hematologic malignancies accounting for less than 10% of non-Hodgkin lymphomas. The 2016 classification of World Health Organization recognized 29 different entities of PTCLs. These subgroups are characterized by different molecular and genetic patterns. For nearly 30 years, little improvement in the treatment of PTCLs has been noticed due to the paucity of randomized trials and anthracycline-based chemotherapy remains the mainstay of first-line treatment. In front-line setting, ECHELON-2, the first randomized controlled Phase III clinical trial, recently met its primary endpoint of PFS demonstrating the superiority of BV containing regimen when compared to standard CHOP in patients with CD30 positive PTCLs. The role of therapeutic intensifications such as autologous or allogenic stem cell transplantations remains controversial in first-line setting and in relapsed/refractory disease due to the lack of studies clearly addressing this question and the recently published negative studies. PTCLs are often refractory to first-line chemotherapy and tend to relapse after an initial response. New agents have been approved for relapsed/refractory disease such as Histone deacetylase inhibitors, folate analogue metabolic inhibitor or CD30 antibody drug conjugated. Despite an acceptable response to these agents, progression-free survival remains very poor. New strategies such as combinations of different agents have been evaluated in order to improve outcomes. Innovative drugs in the fields of epigenetics, immunomodulation within the tumor microenvironment, and direct targeting of tumor cells to CD30 and T-cell receptor abnormalities open new perspectives to improve the treatment of PTCLs.Keywords: peripheral T-cell lymphomas, brentuximab vedotin, HDAC inhibitors, immune checkpoint inhibitors, CHOP, stem cell transplantation

Published
2021

4. A randomized study of pomalidomide vs placebo in persons with myeloproliferative neoplasm-associated myelofibrosis and RBC-transfusion dependence.

Author

Tefferi, A, Al-Ali, H, Barosi, G, Devos, T, Gisslinger, H, Jiang, Q, Kiladjian, J-J, Mesa, R, Passamonti, F, McMullin, M, Ribrag, V, Schiller, G, Vannucchi, A, Zhou, D, Reiser, D, Zhong, J, and Gale, R

Subjects
Adult, Aged, Aged, 80 and over, Biomarkers, Erythrocyte Transfusion, Female, Humans, Immunologic Factors, Male, Middle Aged, Myeloproliferative Disorders, Phenotype, Primary Myelofibrosis, Thalidomide, Treatment Outcome, Workflow
Abstract

RBC-transfusion dependence is common in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis. The objective of this study was to determine the rates of RBC-transfusion independence after therapy with pomalidomide vs placebo in persons with MPN-associated myelofibrosis and RBC-transfusion dependence. Two hundred and fifty-two subjects (intent-to-treat (ITT) population) including 229 subjects confirmed by central review (modified ITT population) were randomly assigned (2:1) to pomalidomide or placebo. Trialists and subjects were blinded to treatment allocation. Primary end point was proportion of subjects achieving RBC-transfusion independence within 6 months. One hundred and fifty-two subjects received pomalidomide and 77 placebo. Response rates were 16% (95% confidence interval (CI), 11, 23%) vs 16% (8, 26%; P=0.87). Response in the pomalidomide cohort was associated with ⩽4 U RBC/28 days (odds ratio (OR)=3.1; 0.9, 11.1), age ⩽65 (OR=2.3; 0.9, 5.5) and type of MPN-associated myelofibrosis (OR=2.6; 0.7, 9.5). Responses in the placebo cohort were associated with ⩽4 U RBC/28 days (OR=8.6; 0.9, 82.3), white blood cell at randomization >25 × 109/l (OR=4.9; 0.8, 28.9) and interval from diagnosis to randomization >2 years (OR=4.9; 1.1, 21.9). Pomalidomide was associated with increased rates of oedema and neutropenia but these adverse effects were manageable. Pomalidomide and placebo had similar RBC-transfusion-independence response rates in persons with MPN-associated RBC-transfusion dependence.

Published
2017

5. Sensitivity, specificity, and accuracy of molecular profiling on circulating cell-free DNA in refractory or relapsed multiple myeloma patients, results of MM-EP1 study.

Author

Quivoron, C., Michot, J.-M., Danu, A., Lecourt, H., Saada, V., Saleh, K., Vergé, V., Cotteret, S., Bernard, O. A., and Ribrag, V.

Subjects
CIRCULATING tumor DNA, CELL-free DNA, MULTIPLE myeloma, BONE marrow, OVERALL survival
Abstract

As a promising alternative to bone marrow aspiration (BMA), mutational profiling on blood-derived circulating cell-free tumor DNA (cfDNA) is a harmless and simple technique to monitor molecular response and treatment resistance of patients with refractory/relapsed multiple myeloma (R/R MM). We evaluated the sensitivity and specificity of cfDNA compared to BMA CD138 positive myeloma plasma cells (PCs) in a series of 45 R/R MM patients using the 29-gene targeted panel (AmpliSeq) NGS. KRAS, NRAS, FAM46C, DIS3, and TP53 were the most frequently mutated genes. The average sensitivity and specificity of cfDNA detection were 65% and 97%, respectively. The concordance per gene between the two samples was good to excellent according to Cohen's κ coefficients interpretation. An increased number of mutations detected in cfDNA were associated with a decreased overall survival. In conclusion, we demonstrated cfDNA NGS analysis feasibility and accuracy in R/R MM patients who may benefit from early phase clinical trial. [ABSTRACT FROM AUTHOR]

Published
2024
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6. ANTIBODY DRUG CONJUGATES IN OLDER PATIENTS: STATE OF THE ART

Author

Rached, L, primary, Geraud, A, additional, Frelaut, M, additional, Thomas, Z ap, additional, Goldschmidt, V, additional, Beraud-Chaulet, G, additional, Nagera-Lazarovici, C, additional, Danlos, FX, additional, Henon, C, additional, Parisi, C, additional, Gazzah, A, additional, Bahleda, R, additional, Postel Vinay, S, additional, Smolenschi, C, additional, Hollebecque, A, additional, Michot, JM, additional, Ribrag, V, additional, Loriot, Y, additional, Champiat, S, additional, Ouali, K, additional, Massard, C, additional, Ponce Aix, S, additional, Bringuier, M, additional, and Baldini, C, additional

Published
2023
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9. LISOCABTAGENE MARALEUCEL (LISO‐CEL) VERSUS STANDARD OF CARE (SOC) AS SECOND‐LINE THERAPY IN LARGE B‐CELL LYMPHOMA (TRANSFORM STUDY): SUBGROUP ANALYSES BY PRIOR THERAPY RESPONSE

Author

Nastoupil, L. J., primary, Kamdar, M., additional, Chavez, J. C., additional, Ghesquieres, H., additional, Ghosh, M., additional, Holmes, H., additional, López‐Guillermo, A., additional, Martínez‐López, J., additional, Novak, U., additional, Ribrag, V., additional, Roddie, C., additional, Waller, E. K., additional, Feldman, T., additional, Rosenthal, A. C., additional, Sauter, C., additional, von Bonin, M., additional, Karmali, R., additional, Montheard, S., additional, Previtali, A., additional, and Abramson, J., additional

Published
2023
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10. PHASE 1 STUDY OF JNJ‐67856633, A FIRST‐IN‐HUMAN MALT1 INHIBITOR, IN RELAPSED/REFRACTORY (R/R) B‐CELL NON‐HODGKIN LYMPHOMA (B‐NHL) AND CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

Author

Hertzberg, M., primary, Kalac, M., additional, Cheah, C. Y., additional, Ribrag, V., additional, Abrisqueta, P., additional, Opat, S., additional, Bachy, E., additional, Ysebaert, L., additional, Qiu, L., additional, Yi, S., additional, Nishimura, N., additional, Lemech, C., additional, Bussolari, J., additional, Deng, C., additional, Lu, T., additional, Xiu, L., additional, Hemelryck, S. V., additional, Philippar, U., additional, Guo, Y., additional, Soete, V., additional, Paradinas, I. S., additional, Fourneau, N., additional, Gerecitano, J., additional, and Morschhauser, F., additional

Published
2023
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11. A phase II, open‐label, multicenter study of capivasertib, a potent, oral pan‐AKT inhibitor, in patients with relapsed or refractory B‐cell non‐Hodgkin lymphoma (CAPITAL)

Author

Hodson, D., primary, Shouse, G., additional, Shin, H., additional, Salar, A., additional, Bobillo, S., additional, Ribrag, V., additional, Macpherson, N., additional, Cordoba, R., additional, Kim, J. S., additional, Radford, J., additional, Guidez, S., additional, Herrera, A. F., additional, Morchhauser, F., additional, Johnson, D., additional, Izuzquiza, M., additional, Sambamurthy, N., additional, Forcina, A., additional, Gorgun, G., additional, Chen, R., additional, Younes, A., additional, Wang, M., additional, and Kim, W. S., additional

Published
2023
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12. VERY LONG‐TERM FOLLOW‐UP OF RITUXIMAB MAINTENANCE IN YOUNG PATIENTS WITH MANTLE CELL LYMPHOMA INCLUDED IN THE LYMA TRIAL, A LYSA STUDY.

Author

Sarkozy, C., primary, Thieblemont, C., additional, Oberic, L., additional, Moreau, A., additional, Bouabdallah, K., additional, Damaj, G., additional, Gastine, T., additional, Ribrag, V., additional, Casasnovas, O., additional, Haioun, C., additional, Houot, R., additional, Jardin, F., additional, Van Den Neste, E., additional, Cheminant, M., additional, Morschhauser, F., additional, Callana, M., additional, Ghesquieres, H., additional, Gressin, R., additional, Hermine, O., additional, and Le Gouill, S., additional

Published
2023
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14. 86P Validation of the Gustave Roussy Immune (GRIm) score in patients treated with bispecific CD3 T cell engagers in phase I clinical trials

Author

Herbel, N., primary, Goldschmidt, V., additional, Michot, J-M., additional, Laparra, A., additional, Géraud, A., additional, Ouali, K., additional, Danlos, F-X., additional, Martin Romano, P., additional, Vuagnat, P., additional, Bernard-Tessier, A., additional, Gazzah, A., additional, Bahleda, R., additional, Hollebecque, A., additional, Marabelle, A., additional, Postel-Vinay, S., additional, Massard, C., additional, Ribrag, V., additional, Ponce Aix, S., additional, Champiat, S., additional, and Baldini, C., additional

Published
2023
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15. Cobimetinib alone and plus venetoclax with/without atezolizumab in patients with relapsed/refractory multiple myeloma

Author

Schjesvold, F. (Fredrik), Lourenco-Paiva, B. (Bruno David), Ribrag, V. (Vincent), Rodríguez-Otero, P. (Paula), San-Miguel-Izquierdo, J. (Jesús Fernando), Robak, P. (Pawel), Hansson, M. (Markus), Onishi, M. (Maika), Hamidi, H. (Habib), Malhi, V. (Vikram), Dail, M., Dail, M. (Monique), Javery, A. (Apurva), Ku, G. (Grace), and Raab, M. S. (Marc S.)

Subjects
B-cell lymphoma-2, Mitogen-activated protein kinase pathway, Immunotherapy, Biomarker, Programmed death-ligand 1, Área de Medicina Clínica y Epidemiología
Abstract

This phase IB/II trial evaluated safety and efficacy of cobimetinib alone and in novel combinations with veneto-clax with/without atezolizumab in patients with relapsed/refractory multiple myeloma. Forty-nine patients were enrolled. Cobimetinib alone and in combination with venetoclax with/without atezolizumab was determined to be safe and tolerable; anti-tumor activity was moderate overall but higher in patients with translocation t(11;14). Introduction: Mitogen-activated protein kinase pathway mutations are present in > 50% of patients with relapsed/refractory (R/R) multiple myeloma (MM). MEK inhibitors show limited single-agent activity in R/R MM; combi-nation with B-cell lymphoma-2 (BCL-2) and programmed death-ligand 1 inhibition may improve efficacy. This phase Ib/II trial (NCT03312530) evaluated safety and efficacy of cobimetinib (cobi) alone and in combination with veneto-clax (ven) with/without atezolizumab (atezo) in patients with R/R MM. Patients and Methods: Forty-nine patients were randomized 1:2:2 to cobi 60 mg/day on days 1-21 (n = 6), cobi 40 mg/day on days 1-21 + ven 800 mg/day on days 1-28 with/without atezo 840 mg on days 1 and 15 of 28-day cycles (cobi-ven, n = 22; cobi-ven-atezo, n = 21). Safety run-in cohorts evaluated cobi-ven and cobi-ven-atezo dose levels. Results: Any-grade common adverse events (AEs) with cobi, cobi-ven, and cobi-ven-atezo, respectively, included diarrhea (33.3%, 81.8%, 90.5%) and nausea (16.7%, 50.0%, 66.7%); common grade >= 3 AEs included anemia (0%, 22.7%, 23.8%), neutropenia (0%, 13.6%, 38.1%), and thrombocytopenia (0%, 18.2%, 23.8%). The overall response rate for all-comers was 0% (cobi), 27.3% (cobi-ven), and 28.6% (cobi-ven-atezo), and 0%, 50.0%, and 100%, respectively, in patients with t(11;14) + . Biomarker analysis demon-strated non-t(11;14) patient selection with NRAS /KRAS /BRAF mutation or high BCL-2/BCL-2-L1 ratio ( > 52% of the study population) could enrich for responders to the cobi-ven combination. Conclusions: Cobi-ven and cobi-ven-atezo demonstrated manageable safety with moderate activity in all-comers, and higher activity in patients with t(11;14) + MM, supporting a biomar ker-dr iven approach for ven in MM.

Published
2023

17. 461P Overview of patients inclusions and outcomes into modern phase I trials at Gustave Roussy over the last 5 years, OVATION study

Author

Alouani, E., primary, Gazzah, A., additional, Mercier, S., additional, Bahleda, R., additional, Hollebecque, A., additional, Michot, J-M., additional, Baldini, C., additional, Champiat, S., additional, Marabelle, A., additional, Postel-Vinay, S., additional, Ribrag, V., additional, Loriot, Y., additional, Ponce, S., additional, and Mahjoubi, L., additional

Published
2022
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20. S208: EFFICACY AND SAFETY OF ZANDELISIB ADMINISTERED BY INTERMITTENT DOSING (ID) IN PATIENTS WITH RELAPSED OR REFRACTORY (R/R) FOLLICULAR LYMPHOMA: PRIMARY ANALYSIS OF THE GLOBAL PHASE 2 STUDY TIDAL

Author

Zelenetz, A., primary, Jurczak, W., additional, Ribrag, V., additional, Linton, K., additional, Collins, G., additional, Lopéz-Jiménez, J., additional, Reddy, N., additional, Mengarelli, A., additional, Phillips, T., additional, Musuraca, G., additional, Sheehy, O., additional, Li, J., additional, Xu, W., additional, Azoulay, M., additional, Ghalie, R., additional, and Zinzani, P. L., additional

Published
2022
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21. S216: CLINICAL ACTIVITY OF CC-99282, A CEREBLON E3 LIGASE MODULATOR (CELMOD) AGENT, IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMA (R/R NHL) – RESULTS FROM A PHASE 1, OPEN-LABEL STUDY

Author

Michot, J.-M., primary, Chavez, J. C., additional, Carpio, C, additional, Ferrari, S., additional, Feldman, T. A., additional, Morillo, D., additional, Kuruvilla, J., additional, Pinto, A., additional, Ribrag, V., additional, Bachy, E, additional, Buchholz, T. J., additional, Carrancio, S., additional, Chou, W.-C., additional, Guarinos, C., additional, Wu, F., additional, Li, S., additional, Patah, P., additional, Pourdehnad, M., additional, and Nastoupil, L., additional

Published
2022
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22. P939: SYNERGISTIC EFFECTS OF LOW DOSE BELANTAMAB MAFODOTIN IN COMBINATION WITH A GAMMA-SECRETASE INHIBITOR (NIROGACESTAT) IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): DREAMM-5 STUDY

Author

Nooka, A., primary, Lonial, S., additional, Grosicki, S., additional, Hus, M., additional, Song, K., additional, Facon, T., additional, Callander, N. S., additional, Ribrag, V., additional, Uttervall, K., additional, Quach, H., additional, Vorobyev, V., additional, Min, C.-K., additional, Cheng, S., additional, Smith, L. M., additional, Yu, J., additional, Collingwood, T., additional, Holkova, B., additional, Kremer, B. E., additional, Gupta, I. V., additional, Richardson, P. G., additional, and Minnema, M. C., additional

Published
2022
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23. P1351: CHARACTERIZING ALLOGENEIC STEM CELL TRANSPLANTATION SAFETY IN PATIENTS WITH HEMATOLOGIC MALIGNANCIES AFTER PEMBROLIZUMAB THERAPY

Author

Kuruvilla, J., primary, Armand, P., additional, Herrera, A. F., additional, Ribrag, V., additional, Brice, P., additional, Thieblemont, C., additional, Von Tresckow, B., additional, Kim, E., additional, Marinello, P., additional, Chakraborty, S., additional, Orlowski, R., additional, and Zinzani, P. L., additional

Published
2022
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24. S217: PRELIMINARY ANALYSIS OF THE PHASE II STUDY USING TOLINAPANT (ASTX660) MONOTHERAPY IN 98 PERIPHERAL T-CELL LYMPHOMA AND 51 CUTANEOUS T-CELL LYMPHOMA SUBJECTS WITH RELAPSED REFRACTORY DISEASE.

Author

Michot, J.-M., primary, Mehta, A., additional, Samaniego, F., additional, Bachy, E., additional, Zinzani, P. L., additional, Prica, A., additional, Colins, G. P., additional, Ribrag, V, additional, Wagner-Johnston, N., additional, El-Sharkawi, D., additional, O’Connor, O. A., additional, Wilcox, R., additional, Wang, L., additional, Wilson, L., additional, Sims, M., additional, Taylor, J. A., additional, Keer, H. N., additional, and Foss, F., additional

Published
2022
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25. Differential association of calreticulin type 1 and type 2 mutations with myelofibrosis and essential thrombocytemia: relevance for disease evolution

Author

Cabagnols, X, Defour, J P, Ugo, V, Ianotto, J C, Mossuz, P, Mondet, J, Girodon, F, Alexandre, J H, Mansier, O, Viallard, J F, Lippert, E, Murati, A, Mozziconacci, M J, Saussoy, P, Vekemans, M C, Knoops, L, Pasquier, F, Ribrag, V, Solary, E, Plo, I, Constantinescu, S N, Casadevall, N, Vainchenker, W, Marzac, C, and Bluteau, O

Published
2015
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30. 1452P Use of the Pallia 10 score in patients enrolled in phase I trials at Gustave Roussy Cancer Center

Author

Ouali, K., primary, Mateus, C., additional, Laparra, A., additional, Pavliuc, E., additional, Martin Romano, P., additional, Sampetrean, A., additional, Varga, A., additional, Champiat, S., additional, Verlingue, L., additional, Geraud, A., additional, Marabelle, A., additional, Hollebecque, A., additional, Gazzah, A., additional, Bahleda, R., additional, Postel-Vinay, S., additional, Ribrag, V., additional, Soria, J-C., additional, Scotté, F., additional, Massard, C., additional, and Baldini, C., additional

Published
2021
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33. 1198P Anti-ALK autoantibodies in patients with ALK positive non-small cell lung cancer (NSCLC)

Author

Parisi, C., primary, Benitez, J.C., additional, Lecourt, H., additional, Dall'Olio, F.G., additional, Aldea, M., additional, Blanc-Durand, F., additional, Vergé, V., additional, Quivoron, C., additional, Naltet, C., additional, Abdayem, P., additional, Lavaud, P., additional, Ghigna, M.R., additional, Loriot, Y., additional, De Botton, S., additional, Planchard, D., additional, Barlesi, F., additional, Soria, J-C., additional, Ribrag, V., additional, Friboulet, L., additional, and Besse, B., additional

Published
2021
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34. 1617P Sustained cancer clinical trial activity during the COVID-19 pandemic

Author

Bayle, A., primary, Baldini, C., additional, Romano, P. Martin, additional, Michot, J-M., additional, Champiat, S., additional, Bahleda, R., additional, Gazzah, A., additional, Marabelle, A., additional, Verlingue, L., additional, Geraud, A., additional, Morel, D., additional, Michiels, S., additional, Ribrag, V., additional, Hollebecque, A., additional, Albiges, L., additional, Besse, B., additional, Soria, J-C., additional, Massard, C., additional, Barlesi, F., additional, and Postel-Vinay, S., additional

Published
2021
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37. HIGH‐RISK MANTLE CELL LYMPHOMA IN THE LYMA TRIAL: A LYSA STUDY

Author

Cheminant, M., primary, Burroni, B., additional, Bris, Y., additional, Chartier, L., additional, Oberic, L., additional, Ribrag, V., additional, Delfau, M.‐H., additional, Thieblemont, C., additional, Gressin, R., additional, Canioni, D., additional, Peyre, M., additional, Laurent, C., additional, Steimle, T., additional, Kaltenbach, S., additional, Asnafi, V., additional, Macintyre, E., additional, Callanan, M., additional, Gouill, S., additional, and Hermine, O., additional

Published
2021
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38. PREDICTION OF RELAPSE BY STANDARDIZED IG‐BASED ALLEL‐SPECIFIC QPCR, DDPCR AND AMPLICON NGS FOR MRD MONITORING IN MANTLE CELL LYMPHOMA: A COMPARATIVE ANALYSIS BY THE EU‐MCL NETWORK

Author

Pott, C., primary, Macintyre, E., additional, Delfau, M.‐H., additional, Weiß, A., additional, Schilhabel, A., additional, Soehlbrand, A., additional, Kehden, B., additional, Darzentas, N., additional, Kotrova, M., additional, Schoen, F., additional, Ribrag, V., additional, Brueggemann, M., additional, Villarese, P., additional, Dreyling, M., additional, Hermine, O., additional, Kluin‐Nelemans, H., additional, Jiang, L., additional, and Hoster, E., additional

Published
2021
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39. CIRCULATING TUMOR DNA LOAD AND TOTAL METABOLIC TUMOR VOLUME IN DIFFUSE LARGE B CELL LYMPHOMA (DLBCL) PATIENTS TREATED BY R‐CHOP – FROM REMARC, A LYSA STUDY

Author

Bohers, E, primary, Delfau‐Larue, M, additional, Vercellino, L, additional, Cottereau, A, additional, Viennot, M, additional, Viailly, P, additional, Salles, G, additional, Tilly, H, additional, Damaj, G, additional, Haioun, C, additional, Ribrag, V, additional, Morschhauser, F, additional, Casasnovas, R, additional, Nicolas‐Virelizier, E, additional, Feugier, P, additional, Bouabdallah, R, additional, Cartron, G, additional, Renaud, L, additional, Chartier, L, additional, Portugues, C, additional, Meignan, M, additional, Jardin, F, additional, and Thieblemont, C, additional

Published
2021
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40. CHARACTERISTICS OF PATIENTS ACHIEVING COMPLETE OR PARTIAL RESPONSE (CR/PR) WITH TAZEMETOSTAT (TAZ) IN WILD‐TYPE RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL)

Author

Batlevi, C. L., primary, Salles, G., additional, Tilly, H., additional, Chaidos, A., additional, McKay, P., additional, Phillips, T., additional, Assouline, S., additional, Campbell, P., additional, Ribrag, V., additional, Damaj, G. Laurent, additional, Dickinson, M., additional, Jurczak, W., additional, Kaźmierczak, M., additional, Opat, S., additional, Radford, J. R., additional, Schmitt, A., additional, Rajarethinam, A., additional, Shang, G., additional, and Morschhauser, F., additional

Published
2021
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42. GENDER DISPARITIES IN QUALITY OF LIFE OF FRENCH PATIENTS ONE YEAR AFTER THE DIAGNOSIS OF LYMPHOMA. A LYSA STUDY

Author

Paunescu, A.‐C., primary, Paget, J., additional, Bergman, C. Copie, additional, Malak, S., additional, Le Gouill, S., additional, Ribrag, V., additional, Bouabdallah, K., additional, Sibon, D., additional, Rumpold, G., additional, Preau, M., additional, Mounier, N., additional, Haioun, C., additional, Jardin, F., additional, and Besson, C., additional

Published
2021
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43. EARLY POSITRON EMISSION TOMOGRAPHY RESPONSE‐ADAPTED TREATMENT IN LOCALIZED DIFFUSE LARGE B‐CELL LYMPHOMA (AAIPI=0) : RESULTS OF THE PHASE 3 LYSA LNH 09‐1B TRIAL

Author

Bologna, S, primary, Vander Borght, T, additional, Briere, J, additional, Ribrag, V, additional, Damaj, G. L, additional, Thieblemont, C, additional, Feugier, P, additional, Peyrade, F, additional, Lebras, L, additional, Coso, D, additional, Sibon, D, additional, Bonnet, C, additional, Morschhauser, F, additional, Ghesquieres, H, additional, Becker, S, additional, Olivier, P, additional, Fabiani, B, additional, Tilly, H, additional, Haioun, C, additional, and Bastie, J. N, additional

Published
2021
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44. Phase I Basket Study of Taselisib, an Isoform-Selective PI3K Inhibitor, in Patients with PIK3CA-Mutant Cancers

Author

Jhaveri K, Chang M, Juric D, Saura C, Gambardella V, Melnyk A, Patel M, Ribrag V, Ma C, Aljumaily R, Bedard P, Sachdev J, Dunn L, Won H, Bond J, Jones S, Savage H, Scaltriti M, Wilson T, Wei M, and Hyman D

Abstract

PURPOSE: Somatic mutations in phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA), which encodes the p110alpha catalytic subunit of phosphatidylinositol 3-kinase (PI3K), are found in multiple human cancers. While recurrent mutations in PIK3CA helical, regulatory, and kinase domains lead to constitutive PI3K pathway activation, other mutations remain uncharacterized. To further evaluate their clinical actionability, we designed a basket study for patients with PIK3CA-mutant cancers with the isoform-specific PI3K inhibitor, taselisib. PATIENTS AND METHODS: Patients were enrolled based on local PIK3CA mutation testing into 1 of 11 histology-specific cohorts and treated with taselisib at 6 mg or 4 mg daily until progression. Tumor DNA from baseline and progression (when available) was sequenced using a next-generation sequencing panel. Exploratory analyses correlating genomic alterations with treatment outcomes were performed. RESULTS: 166 patients with PIK3CA-mutant cancers were enrolled. The confirmed response rate was 9.0%. Activity varied by tumor type and mutant allele, with confirmed responses observed in head and neck squamous (15.4%), cervical (10.0%), and other cancers, plus tumors containing helical domain mutations. Genomic analyses identified mutations potentially associated with resistance to PI3K inhibition upfront (TP53 and PTEN) and post-progression through reactivation of the PI3K pathway (PTEN, STK11, and PIK3R1). Higher rates of dose modification occurred at higher doses of taselisib, indicating a narrow therapeutic index. CONCLUSIONS: Taselisib had limited activity in the tumor types tested and is no longer in development. This genome-driven study improves understanding of the activity, limitations, and resistance mechanisms of using PI3K inhibitors as monotherapy to target PIK3CA-mutant tumors.

Published
2021

46. Pembrolizumab plus pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (KEYNOTE-183): a randomised, open-label, phase 3 trial

Author

Mateos, Maria-Victoria, Blacklock, Hilary, Schjesvold, Fredrik, Oriol, Albert, Simpson, David, George, Anupkumar, Goldschmidt, Hartmut, Larocca, Alessandra, Chanan-Khan, Asher, Sherbenou, Daniel, Avivi, Irit, Benyamini, Noam, Iida, Shinsuke, Matsumoto, Morio, Suzuki, Kenshi, Ribrag, Vincent, Usmani, Saad Z, Jagannath, Sundar, Ocio, Enrique M, Rodriguez-Otero, Paula, San Miguel, Jesus, Kher, Uma, Farooqui, Mohammed, Liao, Jason, Marinello, Patricia, Lonial, Sagar, KEYNOTE-183 Investigators, Nicol A, Grigoriadis G, Catalano J, LeBlanc R, Elemary M, Bahlis N, Facon T, Karlin L, Ribrag V, Attal M, Goldschmidt H, Engelhardt M, Weisel K, Mackensen A, Nagler A, Ben Yehuda D, Avivi I, Benyamini N, Magen-Nativ H, Palumbo A, Cavo M, Tobinai K, Iida S, Chou T, Suzuki K, Kosugi H, Taniwaki M, Sunami K, Matsumoto M, Ando K, Ganly P, Blacklock H, Simpson D, George A, Schjesvold F, Gjertsen B, Lahuerta J, Blade J, Oriol Rocafiguera A, Mateos M, Rodriguez-Otero P, Larson S, Atanackovic D, Devarakonda S, Bitran J, Zonder J, Morganstein N, Hay M, Chanan-Khan A, Saylors G, Kio E, Oliff I, Kirkel D, Shtivelband M, Yuen C, Yee A, Shah J, Htut M, Raza S, Chhabra S, Stiff P, Hari P, Bank B, Malek E, Gasparetto C, Faroun Y, Sherbenou D, Kreisle W, Singhal S, Rosenblatt J, Usmani S, Lee W, Safah H, Lutzky J, Suh J, Pan D, Baron A, Manges R, Steis R, Oliveira M, Moreb J, Callander N, Anz B, Raptis A, Stampleman L, Melear J, Boyd T, Garbo L, Klein L, Shao S, Lyons R, McIntyre K, Tarantolo S, Yasenchak C, Yimer H., Mateos, Maria-Victoria, Blacklock, Hilary, Schjesvold, Fredrik, Oriol, Albert, Simpson, David, George, Anupkumar, Goldschmidt, Hartmut, Larocca, Alessandra, Chanan-Khan, Asher, Sherbenou, Daniel, Avivi, Irit, Benyamini, Noam, Iida, Shinsuke, Matsumoto, Morio, Suzuki, Kenshi, Ribrag, Vincent, Usmani, Saad Z, Jagannath, Sundar, Ocio, Enrique M, Rodriguez-Otero, Paula, San Miguel, Jesu, Kher, Uma, Farooqui, Mohammed, Liao, Jason, Marinello, Patricia, Lonial, Sagar, KEYNOTE-183 Investigator, and Nicol A, Grigoriadis G, Catalano J, LeBlanc R, Elemary M, Bahlis N, Facon T, Karlin L, Ribrag V, Attal M, Goldschmidt H, Engelhardt M, Weisel K, Mackensen A, Nagler A, Ben Yehuda D, Avivi I, Benyamini N, Magen-Nativ H, Palumbo A, Cavo M, Tobinai K, Iida S, Chou T, Suzuki K, Kosugi H, Taniwaki M, Sunami K, Matsumoto M, Ando K, Ganly P, Blacklock H, Simpson D, George A, Schjesvold F, Gjertsen B, Lahuerta J, Blade J, Oriol Rocafiguera A, Mateos M, Rodriguez-Otero P, Larson S, Atanackovic D, Devarakonda S, Bitran J, Zonder J, Morganstein N, Hay M, Chanan-Khan A, Saylors G, Kio E, Oliff I, Kirkel D, Shtivelband M, Yuen C, Yee A, Shah J, Htut M, Raza S, Chhabra S, Stiff P, Hari P, Bank B, Malek E, Gasparetto C, Faroun Y, Sherbenou D, Kreisle W, Singhal S, Rosenblatt J, Usmani S, Lee W, Safah H, Lutzky J, Suh J, Pan D, Baron A, Manges R, Steis R, Oliveira M, Moreb J, Callander N, Anz B, Raptis A, Stampleman L, Melear J, Boyd T, Garbo L, Klein L, Shao S, Lyons R, McIntyre K, Tarantolo S, Yasenchak C, Yimer H.

Subjects
Male, medicine.medical_specialty, Pembrolizumab, Antibodies, Monoclonal, Humanized, Dexamethasone, Drug Administration Schedule, 03 medical and health sciences, Pembrolizumab, pomalidomide, dexamethasone, KEYNOTE-183, 0302 clinical medicine, Recurrence, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Progression-free survival, Survival rate, Multiple myeloma, Aged, Proportional Hazards Models, Lenalidomide, Aged, 80 and over, Performance status, business.industry, Hematology, medicine.disease, Pomalidomide, Interim analysis, Progression-Free Survival, Thalidomide, Survival Rate, Myocarditis, Editorial Commentary, Treatment Outcome, Stevens-Johnson Syndrome, 030220 oncology & carcinogenesis, Female, Multiple Myeloma, business, 030215 immunology, medicine.drug
Abstract

Summary Background Pomalidomide and dexamethasone is a standard of care for patients with multiple myeloma in whom bortezomib and lenalidomide treatment has failed. KEYNOTE-183 assessed efficacy and safety of pomalidomide and dexamethasone with or without pembrolizumab in patients with relapsed or refractory multiple myeloma. Here, we present the findings of an unplanned, ad-hoc interim analysis at the request of the US Food and Drug Administration (FDA). Methods KEYNOTE-183 was a randomised, open-label, phase 3 trial done at 97 medical centres across 11 countries (Australia, Canada, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Spain, and USA). Patients aged at least 18 years with multiple myeloma, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, previously treated with at least two lines of therapy (excluding pomalidomide) and refractory to the last line were randomly assigned 1:1 to the pembrolizumab plus pomalidomide and dexamethasone group or the pomalidomide and dexamethasone group via an interactive voice response or integrated web response system. Patients received oral pomalidomide 4 mg daily on days 1–21 and oral low-dose dexamethasone 40 mg on days 1, 8, 15, and 22 in 28-day cycles, with or without intravenous pembrolizumab 200 mg every 3 weeks. The dual primary endpoints were progression-free survival and overall survival. Efficacy was assessed in all randomly assigned patients and safety was assessed in patients who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov , number NCT02576977 , and it is closed for accrual. Findings Between Jan 18, 2016, and June 7, 2017, 249 patients were randomly assigned to either the pembrolizumab plus pomalidomide and dexamethasone group (n=125) or the pomalidomide and dexamethasone group (n=124). On July 3, 2017, the FDA established that risks associated with the triple combination outweighed benefits and halted the study. Median follow-up was 8·1 months (IQR 4·5–10·9). Median progression-free survival was 5·6 months (95% CI 3·7–7·5) in the pembrolizumab plus pomalidomide and dexamethasone group versus 8·4 months (5·9–not reached) in the pomalidomide and dexamethasone group; progression-free survival estimates at 6 months were 48% (95% CI 37–58) versus 60% (49–69) at 6 months (hazard ratio [HR] 1·53; 95% CI 1·05–2·22; p=0·98). Median overall survival was not reached (95% CI 12·9–not reached) versus 15·2 months (12·7–not reached; HR 1·61; 95% CI 0·91–2·85; p=0·95); overall survival estimates at 6 months were 82% (95% CI 74–88) versus 90% (82–95). Serious adverse events occurred in 75 (63%) of 120 patients in the pembrolizumab plus pomalidomide and dexamethasone group versus 56 (46%) of 121 patients in the pomalidomide and dexamethasone group. Four (3%) treatment-related deaths occurred in the pembrolizumab plus pomalidomide and dexamethasone group (one each of unknown cause, neutropenic sepsis, myocarditis, and Stevens–Johnson syndrome); myocarditis and Stevens-Johnson syndrome were considered related to pembrolizumab. No treatment-related deaths were reported in the pomalidomide and dexamethasone group. Interpretation The results from this unplanned, FDA-requested, interim analysis showed that the benefit–risk profile of pembrolizumab plus pomalidomide and dexamethasone is unfavourable for patients with relapsed or refractory multiple myeloma. Funding Merck Sharp & Dohme, a subsidiary of Merck & Co (Kenilworth, NJ, USA).

Published
2019

47. 22P Toxicity profile of immune and non-immune therapies in phase I/II trials: A comprehensive longitudinal analysis

Author

Missri, L., primary, Martin-Romano, P., additional, Helissey, C., additional, Lanoy, E., additional, Baldini, C., additional, Varga, A., additional, Hollebecque, A., additional, Michot, J-M., additional, Gazzah, A., additional, Bahleda, R., additional, Champiat, S., additional, Italiano, A., additional, Ribrag, V., additional, Angevin, E., additional, Armand, J-P., additional, Deutsch, E., additional, Marabelle, A., additional, Soria, J-C., additional, Massard, C., additional, and Postel-Vinay, S., additional

Published
2021
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