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28 results on '"Waldron-Lynch, Maeve"'

2. Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study

Author

Belada, David, Kopeckova, Katerina, Bergua Burgues, Juan Miguel, Stevens, Don, André, Marc, Persona, Ernesto Perez, Pichler, Petra, Staber, Philipp B., Trneny, Marek, Duell, Johannes, Waldron-Lynch, Maeve, Wagner, Steve, Mukhopadhyay, Amitava, Dirnberger-Hertweck, Maren, Burke, John M., and Nowakowski, Grzegorz S.

Published
2023
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6. Safety and efficacy of tafasitamab ± lenalidomide added to first-line R‑CHOP for DLBCL: Phase 1b First-MIND study

Author

Belada, David, Kopeckova, Katerina, Bergua Burgues, Juan Miguel, Stevens, Don, André, Marc, Perez Persona, Ernesto, Pichler, Petra, Staber, Philipp B, Trněný, Marek, Duell, Johannes, Waldron-Lynch, Maeve, Wagner, Steve, Mukhopadhyay, Amitava, Dirnberger-Hertweck, Maren, Burke, John M, Nowakowski, Grzegorz S, UCL - SSS/IREC/MONT - Pôle Mont Godinne, and UCL - (MGD) Service d'hématologie

Abstract

Anti-CD19 immunotherapy tafasitamab in combination with lenalidomide is used in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem cell transplant. Open-label, phase 1b, First-MIND study assessed safety and preliminary efficacy of tafasitamab + R-CHOP ± lenalidomide as first-line therapy in patients with DLBCL. Adults with newly-diagnosed, untreated DLBCL (ECOG PS 0-2, IPI 2-5), were randomly assigned to R-CHOP+tafasitamab (Arm T) or R-CHOP+tafasitamab+lenalidomide (Arm T/L) for six cycles. Primary endpoint was safety; secondary endpoints included overall response rate (ORR) and complete response (CR) rate at end of treatment (EoT). From Dec2019-Aug2020, 83 patients were screened, 66 treated (n=33 per arm). All patients had ≥1 treatment-emergent adverse event, mostly grade 1/2. Grade ≥3 neutropenia and thrombocytopenia occurred in 57.6% and 12.1% of patients (Arm T), and 84.8% and 36.4% (Arm T/L). Non-hematologic toxicities occurred at similar rates between arms. Mean relative dose intensity of R-CHOP was 89% or higher in both arms. ORR at EoT was 75.8% (CR 72.7%) in Arm T and 81.8% (CR 66.7%) in Arm T/L; best ORR across visits was 90.0% and 93.9%. Eighteen-month duration of response and duration of CR rates were 72.7% and 74.5% (Arm T), and 78.7% and 86.5% (Arm T/L); 24-month progression-free survival and overall survival rates were 72.7% and 90.3% (Arm T), and 76.8% and 93.8% (Arm T/L). Manageable safety and promising signals of efficacy were observed in both arms. Potential benefit of adding tafasitamab+lenalidomide to R-CHOP is being investigated in phase 3 frontMIND (NCT04824092).

Published
2023

7. First-Mind: Final Analysis from a Phase Ib, Open-Label, Randomized Study to Assess Safety of Tafasitamab or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma

Author

Nowakowski, Grzegorz S., primary, Duell, Johannes, additional, Kopeckova, Katerina, additional, Trneny, Marek, additional, Pott, Christiane, additional, Khouja, Mouhamad, additional, Burke, John M., additional, Waldron-Lynch, Maeve, additional, Wagner, Steve, additional, Mukhopadhyay, Amitava, additional, Blair, Derek, additional, and Belada, David, additional

Published
2022
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8. Frontmind: A Phase III, Multicenter, Randomized, Double-Blind Study of Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP Alone for Newly Diagnosed High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma

Author

Vitolo, Umberto, primary, Nowakowski, Grzegorz S., additional, Burke, John M., additional, Fox, Christopher P., additional, Trneny, Marek, additional, Chiappella, Annalisa, additional, Waldron-Lynch, Maeve, additional, Wagner, Steve, additional, Pachori, Alok, additional, and Lenz, Georg, additional

Published
2022
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9. Poster: ABCL-023 frontMIND: A Phase III, Randomized, Double-Blind Study of Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP Alone for Newly Diagnosed High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma

Author

Vitolo, Umberto, primary, Nowakowski, Grzegorz S., additional, Burke, John M., additional, Fox, Christopher P., additional, Trneny, Marek, additional, Chiappella, Annalisa, additional, Waldron-Lynch, Maeve, additional, Hadar, Nira, additional, Pachori, Alok, additional, and Lenz, Georg, additional

Published
2022
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10. Poster: ABCL-022 Pharmacokinetics and Pharmacodynamics in First-MIND: A Phase Ib, Open-Label, Randomized Study of Tafasitamab ± Lenalidomide + R-CHOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

Author

Belada, David, primary, Kopeckova, Katerina, additional, Burgues, Juan Miguel Bergua, additional, Stevens, Don, additional, Nowakowski, Grzegorz S., additional, Waldron-Lynch, Maeve, additional, Hadar, Nira, additional, Weirather, Johannes, additional, Lässig, Charlotte, additional, Blair, Derek, additional, and Dreyling, Martin, additional

Published
2022
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11. Pharmacokinetics (PK) and pharmacodynamics (PD) in First-MIND: A phase Ib, open-label, randomized study of tafasitamab (tafa) ± lenalidomide (LEN) in addition to R-CHOP in patients (pts) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

Author

Belada, David, primary, Kopeckova, Katerina, additional, Bergua Burgues, Juan Miguel, additional, Stevens, Don A., additional, Nowakowski, Grzegorz S., additional, Waldron-Lynch, Maeve, additional, Hadar, Nira, additional, Weirather, Johannes, additional, Lässig, Charlotte, additional, Blair, Derek, additional, and Dreyling, Martin H., additional

Published
2022
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12. frontMIND: A phase III, randomized, double-blind study of tafasitamab + lenalidomide + R-CHOP versus R-CHOP alone for newly diagnosed high-intermediate and high-risk diffuse large B-cell lymphoma.

Author

Vitolo, Umberto, primary, Nowakowski, Grzegorz S., additional, Burke, John M., additional, Fox, Christopher P., additional, Trneny, Marek, additional, Chiappella, Annalisa, additional, Waldron-Lynch, Maeve, additional, Hadar, Nira, additional, Pachori, Alok, additional, and Lenz, Georg, additional

Published
2022
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13. Capmatinib in METex14-mutated (mut) advanced non-small cell lung cancer (NSCLC): Results from the phase II GEOMETRY mono-1 study, including efficacy in patients (pts) with brain metastases (BM)

Author

Garon, Edward B., Heist, Rebecca S., Seto, Takashi, Han, Ji-Youn, Reguart, Noemi, Groen, Harry J., Tan, Daniel S. W., Hida, Toyoaki, de Jonge, Maja J., Orlov, Sergey, Smit, Egbert F., Souquet, Pierre-Jean, Vansteenkiste, Johan, Le Mouhaer, Sylvie, Robeva, Anna, Waldron-Lynch, Maeve, Giovannini, Monica, Wolf, Juergen, Guided Treatment in Optimal Selected Cancer Patients (GUTS), and Damage and Repair in Cancer Development and Cancer Treatment (DARE)

Published
2020

14. Capmatinib inMETExon 14–Mutated orMET-Amplified Non–Small-Cell Lung Cancer

Author

Wolf, Jürgen, primary, Seto, Takashi, additional, Han, Ji-Youn, additional, Reguart, Noemi, additional, Garon, Edward B., additional, Groen, Harry J.M., additional, Tan, Daniel S.W., additional, Hida, Toyoaki, additional, de Jonge, Maja, additional, Orlov, Sergey V., additional, Smit, Egbert F., additional, Souquet, Pierre-Jean, additional, Vansteenkiste, Johan, additional, Hochmair, Maximilian, additional, Felip, Enriqueta, additional, Nishio, Makoto, additional, Thomas, Michael, additional, Ohashi, Kadoaki, additional, Toyozawa, Ryo, additional, Overbeck, Tobias R., additional, de Marinis, Filippo, additional, Kim, Tae-Min, additional, Laack, Eckart, additional, Robeva, Anna, additional, Le Mouhaer, Sylvie, additional, Waldron-Lynch, Maeve, additional, Sankaran, Banu, additional, Balbin, O. Alejandro, additional, Cui, Xiaoming, additional, Giovannini, Monica, additional, Akimov, Mikhail, additional, and Heist, Rebecca S., additional

Published
2020
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15. Abstract CT082: Capmatinib in METex14-mutated (mut) advanced non-small cell lung cancer (NSCLC): Results from the phase II GEOMETRY mono-1 study, including efficacy in patients (pts) with brain metastases (BM)

Author

Garon, Edward B., primary, Heist, Rebecca S., additional, Seto, Takashi, additional, Han, Ji-Youn, additional, Reguart, Noemi, additional, Groen, Harry J., additional, Tan, Daniel SW, additional, Hida, Toyoaki, additional, de Jonge, Maja J., additional, Orlov, Sergey V., additional, Smit, Egbert F., additional, Souquet, Pierre-Jean, additional, Vansteenkiste, Johan, additional, Mouhaer, Sylvie Le, additional, Robeva, Anna, additional, Waldron-Lynch, Maeve, additional, Giovannini, Monica, additional, and Wolf, Juergen, additional

Published
2020
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16. Capmatinib in patients with high-level MET-amplified advanced non–small cell lung cancer (NSCLC): results from the phase 2 GEOMETRY mono-1 study.

Author

Wolf, Juergen, primary, Overbeck, Tobias R., additional, Han, Ji-Youn, additional, Hochmair, Maximilian, additional, de Marinis, Filippo, additional, Ohashi, Kadoaki, additional, Smit, Egbert F., additional, Power, Danielle, additional, Garon, Edward B., additional, Groen, Harry J.M., additional, Tan, Daniel Shao-Weng, additional, Waldron-Lynch, Maeve, additional, Le Mouhaer, Sylvie, additional, Nwana, Ngozi, additional, Giovannini, Monica, additional, and Heist, Rebecca Suk, additional

Published
2020
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17. Capmatinib in patients with METex14-mutated or high-level MET-amplified advanced non–small-cell lung cancer (NSCLC): results from cohort 6 of the phase 2 GEOMETRY mono-1 study.

Author

Groen, Harry J.M., primary, Akerley, Wallace L., additional, Souquet, Pierre Jean, additional, Laack, Eckart, additional, Han, Ji-Youn, additional, Smit, Egbert F., additional, Mansfield, Aaron Scott, additional, Garon, Edward B., additional, Wolf, Juergen, additional, Tan, Daniel Shao-Weng, additional, Heist, Rebecca Suk, additional, Waldron-Lynch, Maeve, additional, Le Mouhaer, Sylvie, additional, Nwana, Ngozi, additional, Giovannini, Monica, additional, and Orlov, Sergey, additional

Published
2020
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18. Capmatinib (INC280) in MET Delta exI4-mutated advanced non-small cell lung cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study

Author

Wolf, Juergen, Seto, Takashi, Han, Ji-Youn, Reguart, Noemi, Garon, Edward B., Groen, Harry J. M., Tan, Daniel Shao-Weng, Hida, Toyoaki, De Jonge, Maja J., Orlov, Sergey V., Smit, Egbert F., Souquet, Pierre Jean, Vansteenkiste, Johan F., Giovannini, Monica, Le Mouhaer, Sylvie, Robeva, Anna, Waldron-Lynch, Maeve, and Heist, Rebecca Suk

Published
2019

19. Capmatinib in patients with high-level MET-amplified advanced non-small cell lung cancer (NSCLC): results from the phase 2 GEOMETRY mono-1 study.

Author

Wolf, Juergen, Overbeck, Tobias R., Han, Ji-Youn, Hochmair, Maximilian, de Marinis, Filippo, Ohashi, Kadoaki, Smit, Egbert F., Power, Danielle, Garon, Edward B., Groen, Harry J. M., Tan, Daniel Shao-Weng, Waldron-Lynch, Maeve, Le Mouhaer, Sylvie, Nwana, Ngozi, Giovannini, Monica, Heist, Rebecca Suk, Wolf, Juergen, Overbeck, Tobias R., Han, Ji-Youn, Hochmair, Maximilian, de Marinis, Filippo, Ohashi, Kadoaki, Smit, Egbert F., Power, Danielle, Garon, Edward B., Groen, Harry J. M., Tan, Daniel Shao-Weng, Waldron-Lynch, Maeve, Le Mouhaer, Sylvie, Nwana, Ngozi, Giovannini, Monica, and Heist, Rebecca Suk

Published
2020

20. Capmatinib in patients with METex14-mutated or high-level MET-amplified advanced non-small-cell lung cancer (NSCLC): results from cohort 6 of the phase 2 GEOMETRY mono-1 study.

Author

Groen, Harry J. M., Akerley, Wallace L., Souquet, Pierre Jean, Laack, Eckart, Han, Ji-Youn, Smit, Egbert F., Mansfield, Aaron Scott, Garon, Edward B., Wolf, Juergen, Tan, Daniel Shao-Weng, Heist, Rebecca Suk, Waldron-Lynch, Maeve, Le Mouhaer, Sylvie, Nwana, Ngozi, Giovannini, Monica, Orlov, Sergey, Groen, Harry J. M., Akerley, Wallace L., Souquet, Pierre Jean, Laack, Eckart, Han, Ji-Youn, Smit, Egbert F., Mansfield, Aaron Scott, Garon, Edward B., Wolf, Juergen, Tan, Daniel Shao-Weng, Heist, Rebecca Suk, Waldron-Lynch, Maeve, Le Mouhaer, Sylvie, Nwana, Ngozi, Giovannini, Monica, and Orlov, Sergey

Published
2020

21. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer

Author

Wolf, Juergen, Seto, Takashi, Han, Ji-Youn, Reguart, Noemi, Garon, Edward B., Groen, Harry J. M., Tan, Daniel S. W., Hida, Toyoaki, de Jonge, Maja, Orlov, Sergey V., Smit, Egbert F., Souquet, Pierre-Jean, Vansteenkiste, Johan, Hochmair, Maximilian, Felip, Enriqueta, Nishio, Makoto, Thomas, Michael, Ohashi, Kadoaki, Toyozawa, Ryo, Overbeck, Tobias R., de Marinis, Filippo, Kim, Tae-Min, Laack, Eckart, Robeva, Anna, Le Mouhaer, Sylvie, Waldron-Lynch, Maeve, Sankaran, Banu, Balbin, O. Alejandro, Cui, Xiaoming, Giovannini, Monica, Akimov, Mikhail, Heist, Rebecca S., Wolf, Juergen, Seto, Takashi, Han, Ji-Youn, Reguart, Noemi, Garon, Edward B., Groen, Harry J. M., Tan, Daniel S. W., Hida, Toyoaki, de Jonge, Maja, Orlov, Sergey V., Smit, Egbert F., Souquet, Pierre-Jean, Vansteenkiste, Johan, Hochmair, Maximilian, Felip, Enriqueta, Nishio, Makoto, Thomas, Michael, Ohashi, Kadoaki, Toyozawa, Ryo, Overbeck, Tobias R., de Marinis, Filippo, Kim, Tae-Min, Laack, Eckart, Robeva, Anna, Le Mouhaer, Sylvie, Waldron-Lynch, Maeve, Sankaran, Banu, Balbin, O. Alejandro, Cui, Xiaoming, Giovannini, Monica, Akimov, Mikhail, and Heist, Rebecca S.

Abstract

BACKGROUND Among patients with non-small-cell lung cancer (NSCLC),METexon 14 skipping mutations occur in 3 to 4% andMETamplifications occur in 1 to 6%. Capmatinib, a selective inhibitor of the MET receptor, has shown activity in cancer models with various types of MET activation. METHODS We conducted a multiple-cohort, phase 2 study evaluating capmatinib in patients withMET-dysregulated advanced NSCLC. Patients were assigned to cohorts on the basis of previous lines of therapy andMETstatus (METexon 14 skipping mutation orMETamplification according to gene copy number in tumor tissue). Patients received capmatinib (400-mg tablet) twice daily. The primary end point was overall response (complete or partial response), and the key secondary end point was response duration; both end points were assessed by an independent review committee whose members were unaware of the cohort assignments. RESULTS A total of 364 patients were assigned to the cohorts. Among patients with NSCLC with aMETexon 14 skipping mutation, overall response was observed in 41% (95% confidence interval [CI], 29 to 53) of 69 patients who had received one or two lines of therapy previously and in 68% (95% CI, 48 to 84) of 28 patients who had not received treatment previously; the median duration of response was 9.7 months (95% CI, 5.6 to 13.0) and 12.6 months (95% CI, 5.6 to could not be estimated), respectively. Limited efficacy was observed in previously treated patients withMETamplification who had a gene copy number of less than 10 (overall response in 7 to 12% of patients). Among patients withMETamplification and a gene copy number of 10 or higher, overall response was observed in 29% (95% CI, 19 to 41) of previously treated patients and in 40% (95% CI, 16 to 68) of those who had not received treatment previously. The most frequently reported adverse events were peripheral edema (in 51%) and nausea (in 45%); these events were mostly of grade 1 or 2. CONCLUSIONS Capmatinib showed substantial antitu

Published
2020

22. CMET-22. CAPMATINIB (INC280) IN METΔEX14-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC): EFFICACY DATA FROM THE PHASE 2 GEOMETRY MONO-1 STUDY

Author

Heist, Rebecca S, primary, Seto, Takashi, additional, Han, Ji-Youn, additional, Reguart, Noemi, additional, Garon, Edward B, additional, Groen, Harry J M, additional, Tan, Daniel S W, additional, Hida, Toyoaki, additional, de Jonge, Maja, additional, V Orlov, Sergey, additional, Smit, Egbert F, additional, Souquet, Pierre-Jean, additional, Vansteenkiste, Johan, additional, Le Mouhaer, Sylvie, additional, Robeva, Anna, additional, Waldron-Lynch, Maeve, additional, Giovannini, Monica, additional, and Wolf, Juergen, additional

Published
2019
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23. Capmatinib (INC280) in METΔex14-mutated advanced non-small cell lung cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study.

Author

Wolf, Juergen, primary, Seto, Takashi, additional, Han, Ji-Youn, additional, Reguart, Noemi, additional, Garon, Edward B., additional, Groen, Harry J.M., additional, Tan, Daniel Shao-Weng, additional, Hida, Toyoaki, additional, De Jonge, Maja J., additional, Orlov, Sergey V., additional, Smit, Egbert F., additional, Souquet, Pierre Jean, additional, Vansteenkiste, Johan F., additional, Giovannini, Monica, additional, Le Mouhaer, Sylvie, additional, Robeva, Anna, additional, Waldron-Lynch, Maeve, additional, and Heist, Rebecca Suk, additional

Published
2019
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28. Capmatinib in MET Exon 14-Mutated or MET -Amplified Non-Small-Cell Lung Cancer.

Author

Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, Tan DSW, Hida T, de Jonge M, Orlov SV, Smit EF, Souquet PJ, Vansteenkiste J, Hochmair M, Felip E, Nishio M, Thomas M, Ohashi K, Toyozawa R, Overbeck TR, de Marinis F, Kim TM, Laack E, Robeva A, Le Mouhaer S, Waldron-Lynch M, Sankaran B, Balbin OA, Cui X, Giovannini M, Akimov M, and Heist RS

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents adverse effects, Antineoplastic Agents therapeutic use, Benzamides, Carcinoma, Non-Small-Cell Lung genetics, Edema chemically induced, Exons, Female, Gene Dosage, Humans, Imidazoles adverse effects, Lung Neoplasms genetics, Male, Middle Aged, Nausea chemically induced, Protein Kinase Inhibitors adverse effects, Proto-Oncogene Proteins c-met genetics, Triazines adverse effects, Carcinoma, Non-Small-Cell Lung drug therapy, Imidazoles therapeutic use, Lung Neoplasms drug therapy, Mutation, Protein Kinase Inhibitors therapeutic use, Proto-Oncogene Proteins c-met antagonists & inhibitors, Triazines therapeutic use
Abstract

Background: Among patients with non-small-cell lung cancer (NSCLC), MET exon 14 skipping mutations occur in 3 to 4% and MET amplifications occur in 1 to 6%. Capmatinib, a selective inhibitor of the MET receptor, has shown activity in cancer models with various types of MET activation., Methods: We conducted a multiple-cohort, phase 2 study evaluating capmatinib in patients with MET -dysregulated advanced NSCLC. Patients were assigned to cohorts on the basis of previous lines of therapy and MET status ( MET exon 14 skipping mutation or MET amplification according to gene copy number in tumor tissue). Patients received capmatinib (400-mg tablet) twice daily. The primary end point was overall response (complete or partial response), and the key secondary end point was response duration; both end points were assessed by an independent review committee whose members were unaware of the cohort assignments., Results: A total of 364 patients were assigned to the cohorts. Among patients with NSCLC with a MET exon 14 skipping mutation, overall response was observed in 41% (95% confidence interval [CI], 29 to 53) of 69 patients who had received one or two lines of therapy previously and in 68% (95% CI, 48 to 84) of 28 patients who had not received treatment previously; the median duration of response was 9.7 months (95% CI, 5.6 to 13.0) and 12.6 months (95% CI, 5.6 to could not be estimated), respectively. Limited efficacy was observed in previously treated patients with MET amplification who had a gene copy number of less than 10 (overall response in 7 to 12% of patients). Among patients with MET amplification and a gene copy number of 10 or higher, overall response was observed in 29% (95% CI, 19 to 41) of previously treated patients and in 40% (95% CI, 16 to 68) of those who had not received treatment previously. The most frequently reported adverse events were peripheral edema (in 51%) and nausea (in 45%); these events were mostly of grade 1 or 2., Conclusions: Capmatinib showed substantial antitumor activity in patients with advanced NSCLC with a MET exon 14 skipping mutation, particularly in those not treated previously. The efficacy in MET -amplified advanced NSCLC was higher in tumors with a high gene copy number than in those with a low gene copy number. Low-grade peripheral edema and nausea were the main toxic effects. (Funded by Novartis Pharmaceuticals; GEOMETRY mono-1 ClinicalTrials.gov number, NCT02414139.)., (Copyright © 2020 Massachusetts Medical Society.)

Published
2020
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