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1. Supplementary Table S1 from Atezolizumab plus Magrolimab, Niraparib, or Tocilizumab versus Atezolizumab Monotherapy in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Multicenter, Randomized Umbrella Study (MORPHEUS Urothelial Carcinoma)

Author

Drakaki, Alexandra, primary, Powles, Thomas, primary, Bamias, Aristotelis, primary, Martin-Liberal, Juan, primary, Shin, Sang Joon, primary, Friedlander, Terence, primary, Tosi, Diego, primary, Park, Chandler, primary, Gomez-Roca, Carlos, primary, Joly Lobbedez, Florence, primary, Castellano, Daniel, primary, Morales-Barrera, Rafael, primary, Moreno-Candilejo, Irene, primary, Fléchon, Aude, primary, Yuen, Kobe, primary, Rishipathak, Deepali, primary, DuPree, Kelly, primary, Young, Fiona, primary, Michielin, Francesca, primary, Shemesh, Colby S., primary, Steinberg, Elizabeth E., primary, Williams, Patrick, primary, and Lee, Jae Lyun, primary

Published
2023
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2. Supplementary Figure S3 from Atezolizumab plus Magrolimab, Niraparib, or Tocilizumab versus Atezolizumab Monotherapy in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Multicenter, Randomized Umbrella Study (MORPHEUS Urothelial Carcinoma)

Author

Drakaki, Alexandra, primary, Powles, Thomas, primary, Bamias, Aristotelis, primary, Martin-Liberal, Juan, primary, Shin, Sang Joon, primary, Friedlander, Terence, primary, Tosi, Diego, primary, Park, Chandler, primary, Gomez-Roca, Carlos, primary, Joly Lobbedez, Florence, primary, Castellano, Daniel, primary, Morales-Barrera, Rafael, primary, Moreno-Candilejo, Irene, primary, Fléchon, Aude, primary, Yuen, Kobe, primary, Rishipathak, Deepali, primary, DuPree, Kelly, primary, Young, Fiona, primary, Michielin, Francesca, primary, Shemesh, Colby S., primary, Steinberg, Elizabeth E., primary, Williams, Patrick, primary, and Lee, Jae Lyun, primary

Published
2023
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3. Data from Atezolizumab plus Magrolimab, Niraparib, or Tocilizumab versus Atezolizumab Monotherapy in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Multicenter, Randomized Umbrella Study (MORPHEUS Urothelial Carcinoma)

Author

Drakaki, Alexandra, primary, Powles, Thomas, primary, Bamias, Aristotelis, primary, Martin-Liberal, Juan, primary, Shin, Sang Joon, primary, Friedlander, Terence, primary, Tosi, Diego, primary, Park, Chandler, primary, Gomez-Roca, Carlos, primary, Joly Lobbedez, Florence, primary, Castellano, Daniel, primary, Morales-Barrera, Rafael, primary, Moreno-Candilejo, Irene, primary, Fléchon, Aude, primary, Yuen, Kobe, primary, Rishipathak, Deepali, primary, DuPree, Kelly, primary, Young, Fiona, primary, Michielin, Francesca, primary, Shemesh, Colby S., primary, Steinberg, Elizabeth E., primary, Williams, Patrick, primary, and Lee, Jae Lyun, primary

Published
2023
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4. A phase Ib/II study of HER3-targeting lumretuzumab in combination with carboplatin and paclitaxel as first-line treatment in patients with advanced or metastatic squamous non-small cell lung cancer

Author

Cejalvo, Juan-Miguel, Jacob, Wolfgang, Fleitas Kanonnikoff, Tania, Felip, Enriqueta, Navarro Mendivil, Alejandro, Martinez Garcia, Maria, Taus Garcia, Alvaro, Leighl, Natasha, Lassen, Ulrik, Mau-Soerensen, Morten, Adessi, Celine, Michielin, Francesca, James, Ian, Ceppi, Maurizio, Hasmann, Max, Weisser, Martin, and Cervantes, Andrés

Published
2019
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5. Atezolizumab plus Magrolimab, Niraparib, or Tocilizumab versus Atezolizumab Monotherapy in Platinum-Refractory Metastatic Urothelial Carcinoma: A Phase Ib/II Open-Label, Multicenter, Randomized Umbrella Study (MORPHEUS Urothelial Carcinoma)

Author

Drakaki, Alexandra, primary, Powles, Thomas, additional, Bamias, Aristotelis, additional, Martin-Liberal, Juan, additional, Shin, Sang Joon, additional, Friedlander, Terence, additional, Tosi, Diego, additional, Park, Chandler, additional, Gomez-Roca, Carlos, additional, Joly Lobbedez, Florence, additional, Castellano, Daniel, additional, Morales-Barrera, Rafael, additional, Moreno-Candilejo, Irene, additional, Fléchon, Aude, additional, Yuen, Kobe, additional, Rishipathak, Deepali, additional, DuPree, Kelly, additional, Young, Fiona, additional, Michielin, Francesca, additional, Shemesh, Colby S., additional, Steinberg, Elizabeth E., additional, Williams, Patrick, additional, and Lee, Jae Lyun, additional

Published
2023
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6. Phase Ib study evaluating safety and clinical activity of the anti-HER3 antibody lumretuzumab combined with the anti-HER2 antibody pertuzumab and paclitaxel in HER3-positive, HER2-low metastatic breast cancer

Author

Schneeweiss, Andreas, Park-Simon, Tjoung-Won, Albanell, Joan, Lassen, Ulrik, Cortés, Javier, Dieras, Veronique, May, Marcus, Schindler, Christoph, Marmé, Frederik, Cejalvo, Juan Miguel, Martinez-Garcia, Maria, Gonzalez, Iria, Lopez-Martin, Jose, Welt, Anja, Levy, Christelle, Joly, Florence, Michielin, Francesca, Jacob, Wolfgang, Adessi, Céline, Moisan, Annie, Meneses-Lorente, Georgina, Racek, Tomas, James, Ian, Ceppi, Maurizio, Hasmann, Max, Weisser, Martin, and Cervantes, Andrés

Published
2018
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7. Supplementary Figures S1-S2 and Full unedited western blots from Mechanistic Investigations of Diarrhea Toxicity Induced by Anti-HER2/3 Combination Therapy

Author

Moisan, Annie, primary, Michielin, Francesca, primary, Jacob, Wolfgang, primary, Kronenberg, Sven, primary, Wilson, Sabine, primary, Avignon, Blandine, primary, Gérard, Régine, primary, Benmansour, Fethallah, primary, McIntyre, Christine, primary, Meneses-Lorente, Georgina, primary, Hasmann, Max, primary, Schneeweiss, Andreas, primary, Weisser, Martin, primary, and Adessi, Céline, primary

Published
2023
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8. Data from Mechanistic Investigations of Diarrhea Toxicity Induced by Anti-HER2/3 Combination Therapy

Author

Moisan, Annie, primary, Michielin, Francesca, primary, Jacob, Wolfgang, primary, Kronenberg, Sven, primary, Wilson, Sabine, primary, Avignon, Blandine, primary, Gérard, Régine, primary, Benmansour, Fethallah, primary, McIntyre, Christine, primary, Meneses-Lorente, Georgina, primary, Hasmann, Max, primary, Schneeweiss, Andreas, primary, Weisser, Martin, primary, and Adessi, Céline, primary

Published
2023
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9. Table S1, Table S2 from Phase Ib Study of Lumretuzumab Plus Cetuximab or Erlotinib in Solid Tumor Patients and Evaluation of HER3 and Heregulin as Potential Biomarkers of Clinical Activity

Author

Meulendijks, Didier, primary, Jacob, Wolfgang, primary, Voest, Emile E., primary, Mau-Sorensen, Morten, primary, Martinez-Garcia, Maria, primary, Taus, Alvaro, primary, Fleitas, Tania, primary, Cervantes, Andres, primary, Lolkema, Martijn P., primary, Langenberg, Marlies H.G., primary, De Jonge, Maja J., primary, Sleijfer, Stefan, primary, Han, Ji-Youn, primary, Calles, Antonio, primary, Felip, Enriqueta, primary, Kim, Sang-We, primary, Schellens, Jan H.M., primary, Wilson, Sabine, primary, Thomas, Marlene, primary, Ceppi, Maurizio, primary, Meneses-Lorente, Georgina, primary, James, Ian, primary, Vega-Harring, Suzana, primary, Dua, Rajiv, primary, Nguyen, Maitram, primary, Steiner, Lori, primary, Adessi, Celine, primary, Michielin, Francesca, primary, Bossenmaier, Birgit, primary, Weisser, Martin, primary, and Lassen, Ulrik N., primary

Published
2023
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10. Figure S1, Figure S2, Figure S3, Figure S4, Figure S5, Figure S6 from Phase Ib Study of Lumretuzumab Plus Cetuximab or Erlotinib in Solid Tumor Patients and Evaluation of HER3 and Heregulin as Potential Biomarkers of Clinical Activity

Author

Meulendijks, Didier, primary, Jacob, Wolfgang, primary, Voest, Emile E., primary, Mau-Sorensen, Morten, primary, Martinez-Garcia, Maria, primary, Taus, Alvaro, primary, Fleitas, Tania, primary, Cervantes, Andres, primary, Lolkema, Martijn P., primary, Langenberg, Marlies H.G., primary, De Jonge, Maja J., primary, Sleijfer, Stefan, primary, Han, Ji-Youn, primary, Calles, Antonio, primary, Felip, Enriqueta, primary, Kim, Sang-We, primary, Schellens, Jan H.M., primary, Wilson, Sabine, primary, Thomas, Marlene, primary, Ceppi, Maurizio, primary, Meneses-Lorente, Georgina, primary, James, Ian, primary, Vega-Harring, Suzana, primary, Dua, Rajiv, primary, Nguyen, Maitram, primary, Steiner, Lori, primary, Adessi, Celine, primary, Michielin, Francesca, primary, Bossenmaier, Birgit, primary, Weisser, Martin, primary, and Lassen, Ulrik N., primary

Published
2023
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11. Supplementary Figure 1, Figure 2, Table 1, Table 2, Table 3, Table 4, Table 5, Table 6 from First-in-Human Phase I Study of Lumretuzumab, a Glycoengineered Humanized Anti-HER3 Monoclonal Antibody, in Patients with Metastatic or Advanced HER3-Positive Solid Tumors

Author

Meulendijks, Didier, primary, Jacob, Wolfgang, primary, Martinez-Garcia, Maria, primary, Taus, Alvaro, primary, Lolkema, Martijn P., primary, Voest, Emile E., primary, Langenberg, Marlies H.G., primary, Fleitas Kanonnikoff, Tania, primary, Cervantes, Andres, primary, De Jonge, Maja J., primary, Sleijfer, Stefan, primary, Soerensen, Morten Mau, primary, Thomas, Marlene, primary, Ceppi, Maurizio, primary, Meneses-Lorente, Georgina, primary, James, Ian, primary, Adessi, Celine, primary, Michielin, Francesca, primary, Abiraj, Keelara, primary, Bossenmaier, Birgit, primary, Schellens, Jan H.M., primary, Weisser, Martin, primary, and Lassen, Ulrik N., primary

Published
2023
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12. Figure 1, Figure 2, Table 1, Table 2, Table 3, Table 4, Table 5, Table 6 from First-in-Human Phase I Study of Lumretuzumab, a Glycoengineered Humanized Anti-HER3 Monoclonal Antibody, in Patients with Metastatic or Advanced HER3-Positive Solid Tumors

Author

Meulendijks, Didier, primary, Jacob, Wolfgang, primary, Martinez-Garcia, Maria, primary, Taus, Alvaro, primary, Lolkema, Martijn P., primary, Voest, Emile E., primary, Langenberg, Marlies H.G., primary, Fleitas Kanonnikoff, Tania, primary, Cervantes, Andres, primary, De Jonge, Maja J., primary, Sleijfer, Stefan, primary, Soerensen, Morten Mau, primary, Thomas, Marlene, primary, Ceppi, Maurizio, primary, Meneses-Lorente, Georgina, primary, James, Ian, primary, Adessi, Celine, primary, Michielin, Francesca, primary, Abiraj, Keelara, primary, Bossenmaier, Birgit, primary, Schellens, Jan H.M., primary, Weisser, Martin, primary, and Lassen, Ulrik N., primary

Published
2023
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13. Phase 1 Study of CD19 Targeted CD28 Costimulatory Agonist in Combination with Glofitamab to Enhance T Cell Effector Function in Relapsed/Refractory B Cell Lymphoma

Author

Dickinson, Michael, primary, Gritti, Giuseppe, additional, Carlo-Stella, Carmelo, additional, Walter, Harriet S, additional, Carlile, David, additional, Getzmann, Nicole, additional, Curdt, Samira, additional, Harrop, Emma, additional, Keelara, Abiraj, additional, Korfi, Koorosh, additional, Labatut, Remi, additional, Michielin, Francesca, additional, Mycroft, Sarah Louise, additional, Moore, Tom, additional, Nutbrown, Robert, additional, Palldino, Giuseppe, additional, Whayman, Matt, additional, Sam, Johannes, additional, Weisser, Martin, additional, Lechner, Katharina E, additional, Morschhauser, Franck, additional, and Hutchings, Martin, additional

Published
2022
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14. Anti-CSF-1R emactuzumab in combination with anti-PD-L1 atezolizumab in advanced solid tumor patients naïve or experienced for immune checkpoint blockade

Author

Gomez-Roca, Carlos, primary, Cassier, Philippe, additional, Zamarin, Dmitriy, additional, Machiels, Jean-Pascal, additional, Luis Perez Gracia, Jose, additional, Stephen Hodi, F, additional, Taus, Alvaro, additional, Martinez Garcia, Maria, additional, Boni, Valentina, additional, Eder, Joseph P, additional, Hafez, Navid, additional, Sullivan, Ryan, additional, Mcdermott, David, additional, Champiat, Stephane, additional, Aspeslagh, Sandrine, additional, Terret, Catherine, additional, Jegg, Anna-Maria, additional, Jacob, Wolfgang, additional, Cannarile, Michael A, additional, Ries, Carola, additional, Korski, Konstanty, additional, Michielin, Francesca, additional, Christen, Randolph, additional, Babitzki, Galina, additional, Watson, Carl, additional, Meneses-Lorente, Georgina, additional, Weisser, Martin, additional, Rüttinger, Dominik, additional, Delord, Jean-Pierre, additional, and Marabelle, Aurelien, additional

Published
2022
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15. Anti-CSF-1R emactuzumab in combination with anti-PD-L1 atezolizumab in advanced solid tumor patients naïve or experienced for immune checkpoint blockade

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Gomez-Roca, Carlos, Cassier, Philippe, Zamarin, Dmitriy, Machiels, Jean-Pascal, Luis Perez Gracia, Jose, Stephen Hodi, F, Taus, Alvaro, Martinez Garcia, Maria, Boni, Valentina, Eder, Joseph P, Hafez, Navid, Sullivan, Ryan, Mcdermott, David, Champiat, Stephane, Aspeslagh, Sandrine, Terret, Catherine, Jegg, Anna-Maria, Jacob, Wolfgang, Cannarile, Michael A, Ries, Carola, Korski, Konstanty, Michielin, Francesca, Christen, Randolph, Babitzki, Galina, Watson, Carl, Meneses-Lorente, Georgina, Weisser, Martin, Rüttinger, Dominik, Delord, Jean-Pierre, Marabelle, Aurelien, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Centre du cancer, Gomez-Roca, Carlos, Cassier, Philippe, Zamarin, Dmitriy, Machiels, Jean-Pascal, Luis Perez Gracia, Jose, Stephen Hodi, F, Taus, Alvaro, Martinez Garcia, Maria, Boni, Valentina, Eder, Joseph P, Hafez, Navid, Sullivan, Ryan, Mcdermott, David, Champiat, Stephane, Aspeslagh, Sandrine, Terret, Catherine, Jegg, Anna-Maria, Jacob, Wolfgang, Cannarile, Michael A, Ries, Carola, Korski, Konstanty, Michielin, Francesca, Christen, Randolph, Babitzki, Galina, Watson, Carl, Meneses-Lorente, Georgina, Weisser, Martin, Rüttinger, Dominik, Delord, Jean-Pierre, and Marabelle, Aurelien

Abstract

Background This phase 1b study (NCT02323191) evaluated the safety, antitumor activity, pharmacokinetics, and pharmacodynamics of colony-stimulating factor-1 receptor-blocking monoclonal antibody (mAb) emactuzumab in combination with the programmed cell death-1 ligand (PD-L1)-blocking mAb atezolizumab in patients with advanced solid tumors naïve or experienced for immune checkpoint blockers (ICBs). Methods Emactuzumab (500–1350 mg flat) and atezolizumab (1200 mg flat) were administered intravenously every 3 weeks. Dose escalation of emactuzumab was conducted using the 3+3 design up to the maximum tolerated dose (MTD) or optimal biological dose (OBD). Extension cohorts to evaluate pharmacodynamics and clinical activity were conducted in metastatic ICB-naive urothelial bladder cancer (UBC) and ICB-pretreated melanoma (MEL), non-small cell lung cancer (NSCLC) and UBC patients. Results Overall, 221 patients were treated. No MTD was reached and the OBD was determined at 1000 mg of emactuzumab in combination with 1200 mg of atezolizumab. Grade ≥3 treatment-related adverse events occurred in 25 (11.3%) patients of which fatigue and rash were the most common (14 patients (6.3%) each). The confirmed objective response rate (ORR) was 9.8% for ICB-naïve UBC, 12.5% for ICB-experienced NSCLC, 8.3% for ICB-experienced UBC and 5.6% for ICB-experienced MEL patients, respectively. Tumor biopsy analyses demonstrated increased activated CD8 +tumor infiltrating T lymphocytes (TILs) associated with clinical benefit in ICB-naïve UBC patients and less tumor-associated macrophage (TAM) reduction in ICB-experienced compared with ICB-naïve patients. Conclusion Emactuzumab in combination with atezolizumab demonstrated a manageable safety profile with increased fatigue and skin rash over usual atezolizumab monotherapy. A considerable ORR was particularly seen in ICB-experienced NSCLC patients. Increase ofCD8 +TILs under therapy appeared to be associated with persistence of a TAM subpopulation.

Published
2022

19. Phase Ib study of anti-CSF-1R antibody emactuzumab in combination with CD40 agonist selicrelumab in advanced solid tumor patients

Author

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Service d'oto-rhino-laryngologie, Machiels, Jean-Pascal, Gomez-Roca, Carlos, Michot, Jean-Marie, Zamarin, Dmitriy, Mitchell, Tara, Catala, Gaetan, Eberst, Lauriane, Jacob, Wolfgang, Jegg, Anna-Maria, Cannarile, Michael A, Watson, Carl, Babitzki, Galina, Korski, Konstanty, Klaman, Irina, Teixeira, Priscila, Hoves, Sabine, Ries, Carola, Meneses-Lorente, Georgina, Michielin, Francesca, Christen, Randolph, Rüttinger, Dominik, Weisser, Martin, Delord, Jean-Pierre, Cassier, Philippe, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, UCL - (SLuc) Service d'oto-rhino-laryngologie, Machiels, Jean-Pascal, Gomez-Roca, Carlos, Michot, Jean-Marie, Zamarin, Dmitriy, Mitchell, Tara, Catala, Gaetan, Eberst, Lauriane, Jacob, Wolfgang, Jegg, Anna-Maria, Cannarile, Michael A, Watson, Carl, Babitzki, Galina, Korski, Konstanty, Klaman, Irina, Teixeira, Priscila, Hoves, Sabine, Ries, Carola, Meneses-Lorente, Georgina, Michielin, Francesca, Christen, Randolph, Rüttinger, Dominik, Weisser, Martin, Delord, Jean-Pierre, and Cassier, Philippe

Abstract

BACKGROUND: This phase Ib study evaluated the safety, clinical activity, pharmacokinetics, and pharmacodynamics (PD) of emactuzumab (anti-colony stimulating factor 1 receptor monoclonal antibody (mAb)) in combination with selicrelumab (agonistic cluster of differentiation 40 mAb) in patients with advanced solid tumors. METHODS: Both emactuzumab and selicrelumab were administered intravenously every 3 weeks and doses were concomitantly escalated (emactuzumab: 500 to 1000 mg flat; selicrelumab: 2 to 16 mg flat). Dose escalation was conducted using the product of independent beta probabilities dose-escalation design. PD analyzes were performed on peripheral blood samples and tumor/skin biopsies at baseline and on treatment. Clinical activity was evaluated using investigator-based and Response Evaluation Criteria In Solid Tumors V.1.1-based tumor assessments. RESULTS: Three dose-limiting toxicities (all infusion-related reactions (IRRs)) were observed at 8, 12 and 16 mg of selicrelumab together with 1000 mg of emactuzumab. The maximum tolerated dose was not reached at the predefined top doses of emactuzumab (1000 mg) and selicrelumab (16 mg). The most common adverse events were IRRs (75.7%), fatigue (54.1%), facial edema (37.8%), and increase in aspartate aminotransferase and creatinine phosphokinase (35.1% both). PD analyzes demonstrated an increase of Ki67+-activated CD8+ T cells accompanied by a decrease of B cells and the reduction of CD14Dim CD16bright monocytes in peripheral blood. The best objective clinical response was stable disease in 40.5% of patients. CONCLUSION: Emactuzumab in combination with selicrelumab demonstrated a manageable safety profile and evidence of PD activity but did not translate into objective clinical responses. TRIALREGISTRATION NUMBER: NCT02760797.

Published
2020

20. Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour

Author

Cassier, Philippe A., primary, Italiano, Antoine, additional, Gomez-Roca, Carlos, additional, Le Tourneau, Christophe, additional, Toulmonde, Maud, additional, D'Angelo, Sandra P., additional, Weber, Kristy, additional, Loirat, Delphine, additional, Jacob, Wolfgang, additional, Jegg, Anna-Maria, additional, Michielin, Francesca, additional, Christen, Randolph, additional, Watson, Carl, additional, Cannarile, Michael, additional, Klaman, Irina, additional, Abiraj, Keelara, additional, Ries, Carola H., additional, Weisser, Martin, additional, Rüttinger, Dominik, additional, Blay, Jean-Yves, additional, and Delord, Jean-Pierre, additional

Published
2020
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25. Phase Ib study of anti-CSF-1R antibody emactuzumab in combination with CD40 agonist selicrelumab in advanced solid tumor patients

Author

Machiels, Jean-Pascal, primary, Gomez-Roca, Carlos, additional, Michot, Jean-Marie, additional, Zamarin, Dmitriy, additional, Mitchell, Tara, additional, Catala, Gaetan, additional, Eberst, Lauriane, additional, Jacob, Wolfgang, additional, Jegg, Anna-Maria, additional, Cannarile, Michael A, additional, Watson, Carl, additional, Babitzki, Galina, additional, Korski, Konstanty, additional, Klaman, Irina, additional, Teixeira, Priscila, additional, Hoves, Sabine, additional, Ries, Carola, additional, Meneses-Lorente, Georgina, additional, Michielin, Francesca, additional, Christen, Randolph, additional, Rüttinger, Dominik, additional, Weisser, Martin, additional, Delord, Jean-Pierre, additional, and Cassier, Philippe, additional

Published
2020
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27. A phase Ib/II study of HER3-targeting lumretuzumab in combination with carboplatin and paclitaxel as first-line treatment in patients with advanced or metastatic squamous non-small cell lung cancer

Author

Cejalvo, Juan Miguel, Jacob, Wolfgang, Fleitas Kanonnikoff, Tania, Felip, Enriqueta, Navarro Mendivil, Alejandro, Martinez Garcia, Maria, Taus Garcia, Alvaro, Leighl, Natasha, Lassen, Ulrik, Mau-Soerensen, Morten, Adessi, Celine, Michielin, Francesca, James, Ian, Ceppi, Maurizio, Hasmann, Max, Weisser, Martin, Cervantes, Andrés, Cejalvo, Juan Miguel, Jacob, Wolfgang, Fleitas Kanonnikoff, Tania, Felip, Enriqueta, Navarro Mendivil, Alejandro, Martinez Garcia, Maria, Taus Garcia, Alvaro, Leighl, Natasha, Lassen, Ulrik, Mau-Soerensen, Morten, Adessi, Celine, Michielin, Francesca, James, Ian, Ceppi, Maurizio, Hasmann, Max, Weisser, Martin, and Cervantes, Andrés

Abstract

Purpose This study investigated the safety and clinical activity of lumretuzumab, a humanised antihuman epidermal growth factor receptor 3 (HER3) monoclonal antibody, in combination with carboplatin and paclitaxel in first-line treatment of patients with squamous non-small cell lung cancer (sqNSCLC). HER3 ligand heregulin and HER3 protein expression were evaluated as potential biomarkers of clinical activity. Patients and methods This open-label, phase Ib/II study enrolled patients receiving lumretuzumab at 800 mg (flat) in combination with carboplatin (area under the curve (AUC) 6 mg/mL×min) and paclitaxel (200 mg/m 2) administered intravenously on a every 3-week schedule. Adverse event (AE) rates and tumour responses were determined. Heregulin messenger RNA (mRNA) and HER3 protein expression were investigated in archival tumour biopsies. Results Altogether, 12 patients received lumretuzumab in combination with carboplatin and paclitaxel. The most frequent AEs were gastrointestinal, haematological and nervous system toxicities, which were generally mild and manageable. Partial responses were observed in 3 of 12 patients lasting 81, 177 and 207 days. All responses were achieved in tumours expressing higher heregulin mRNA levels. Conclusion Lumretuzumab in combination with carboplatin and paclitaxel was well tolerated. Objective responses were enriched in tumours expressing higher heregulin mRNA levels.

Published
2019

29. Mechanistic Investigations of Diarrhea Toxicity Induced by Anti-HER2/3 Combination Therapy

Author

Moisan, Annie, primary, Michielin, Francesca, additional, Jacob, Wolfgang, additional, Kronenberg, Sven, additional, Wilson, Sabine, additional, Avignon, Blandine, additional, Gérard, Régine, additional, Benmansour, Fethallah, additional, McIntyre, Christine, additional, Meneses-Lorente, Georgina, additional, Hasmann, Max, additional, Schneeweiss, Andreas, additional, Weisser, Martin, additional, and Adessi, Céline, additional

Published
2018
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32. Phase Ib Study of Lumretuzumab Plus Cetuximab or Erlotinib in Solid Tumor Patients and Evaluation of HER3 and Heregulin as Potential Biomarkers of Clinical Activity

Author

Meulendijks, Didier, Jacob, Wolfgang, Voest, Emile E, Mau-Sorensen, Morten, Martinez-Garcia, Maria, Taus, Alvaro, Fleitas, Tania, Cervantes, Andres, Lolkema, Martijn P, Langenberg, Marlies H G, De Jonge, Maja J, Sleijfer, Stefan, Han, Ji-Youn, Calles, Antonio, Felip, Enriqueta, Kim, Sang-We, Schellens, Jan H M, Wilson, Sabine, Thomas, Marlene, Ceppi, Maurizio, Meneses-Lorente, Georgina, James, Ian, Vega-Harring, Suzana, Dua, Rajiv, Nguyen, Maitram, Steiner, Lori, Adessi, Celine, Michielin, Francesca, Bossenmaier, Birgit, Weisser, Martin, Lassen, Ulrik N, Meulendijks, Didier, Jacob, Wolfgang, Voest, Emile E, Mau-Sorensen, Morten, Martinez-Garcia, Maria, Taus, Alvaro, Fleitas, Tania, Cervantes, Andres, Lolkema, Martijn P, Langenberg, Marlies H G, De Jonge, Maja J, Sleijfer, Stefan, Han, Ji-Youn, Calles, Antonio, Felip, Enriqueta, Kim, Sang-We, Schellens, Jan H M, Wilson, Sabine, Thomas, Marlene, Ceppi, Maurizio, Meneses-Lorente, Georgina, James, Ian, Vega-Harring, Suzana, Dua, Rajiv, Nguyen, Maitram, Steiner, Lori, Adessi, Celine, Michielin, Francesca, Bossenmaier, Birgit, Weisser, Martin, and Lassen, Ulrik N

Abstract

Purpose: This study investigated the safety, clinical activity, and target-associated biomarkers of lumretuzumab, a humanized, glycoengineered, anti-HER3 monoclonal antibody (mAb), in combination with the EGFR-blocking agents erlotinib or cetuximab in patients with advanced HER3-positive carcinomas.Experimental Design: The study included two parts: dose escalation and dose extension phases with lumretuzumab in combination with either cetuximab or erlotinib, respectively. In both parts, patients received lumretuzumab doses from 400 to 2,000 mg plus cetuximab or erlotinib according to standard posology, respectively. The effect of HRG mRNA and HER3 mRNA and protein expression were investigated in a dedicated extension cohort of squamous non-small cell lung cancer (sqNSCLC) patients treated with lumretuzumab and erlotinib.Results: Altogether, 120 patients were treated. One dose-limiting toxicity (DLT) in the cetuximab part and two DLTs in the erlotinib part were reported. The most frequent adverse events were gastrointestinal and skin toxicities, which were manageable. The objective response rate (ORR) was 6.1% in the cetuximab part and 4.2% in the erlotinib part. In the sqNSCLC extension cohort of the erlotinib part, higher tumor HRG and HER3 mRNA levels were associated with a numerically higher disease control rate but not ORR.Conclusions: The toxicity profile of lumretuzumab in combination with cetuximab and erlotinib was manageable, but only modest clinical activity was observed across tumor types. In the sqNSCLC cohort, there was no evidence of meaningful clinical benefit despite enriching for tumors with higher HRG mRNA expression levels. Clin Cancer Res; 23(18); 5406-15. ©2017 AACR.

Published
2017

34. Family events and the residential mobility of couples

Author

Michielin, Francesca and Mulder, Clara H.

Subjects
Residential mobility -- Research, Couples -- Emigration and immigration, Domestic relations -- Influence, Domestic relations -- Demographic aspects, Environmental issues
Published
2008

35. Phase Ib Study of Lumretuzumab Plus Cetuximab or Erlotinib in Solid Tumor Patients and Evaluation of HER3 and Heregulin as Potential Biomarkers of Clinical Activity

Author

Meulendijks, Didier, primary, Jacob, Wolfgang, additional, Voest, Emile E., additional, Mau-Sorensen, Morten, additional, Martinez-Garcia, Maria, additional, Taus, Alvaro, additional, Fleitas, Tania, additional, Cervantes, Andres, additional, Lolkema, Martijn P., additional, Langenberg, Marlies H.G., additional, De Jonge, Maja J., additional, Sleijfer, Stefan, additional, Han, Ji-Youn, additional, Calles, Antonio, additional, Felip, Enriqueta, additional, Kim, Sang-We, additional, Schellens, Jan H.M., additional, Wilson, Sabine, additional, Thomas, Marlene, additional, Ceppi, Maurizio, additional, Meneses-Lorente, Georgina, additional, James, Ian, additional, Vega-Harring, Suzana, additional, Dua, Rajiv, additional, Nguyen, Maitram, additional, Steiner, Lori, additional, Adessi, Celine, additional, Michielin, Francesca, additional, Bossenmaier, Birgit, additional, Weisser, Martin, additional, and Lassen, Ulrik N., additional

Published
2017
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36. First-in-Human Phase I Study of Lumretuzumab, a Glycoengineered Humanized Anti-HER3 Monoclonal Antibody, in Patients with Metastatic or Advanced HER3-Positive Solid Tumors

Author

Meulendijks, Didier, Jacob, Wolfgang, Martinez-Garcia, Maria, Taus, Alvaro, Lolkema, Martijn P, Voest, Emile E, Langenberg, Marlies H G, Fleitas Kanonnikoff, Tania, Cervantes, Andres, De Jonge, Maja J, Sleijfer, Stefan, Soerensen, Morten Mau, Thomas, Marlene, Ceppi, Maurizio, Meneses-Lorente, Georgina, James, Ian, Adessi, Celine, Michielin, Francesca, Abiraj, Keelara, Bossenmaier, Birgit, Schellens, Jan H M, Weisser, Martin, Lassen, Ulrik N, Meulendijks, Didier, Jacob, Wolfgang, Martinez-Garcia, Maria, Taus, Alvaro, Lolkema, Martijn P, Voest, Emile E, Langenberg, Marlies H G, Fleitas Kanonnikoff, Tania, Cervantes, Andres, De Jonge, Maja J, Sleijfer, Stefan, Soerensen, Morten Mau, Thomas, Marlene, Ceppi, Maurizio, Meneses-Lorente, Georgina, James, Ian, Adessi, Celine, Michielin, Francesca, Abiraj, Keelara, Bossenmaier, Birgit, Schellens, Jan H M, Weisser, Martin, and Lassen, Ulrik N

Published
2016

37. First-in-Human Phase I Study of Lumretuzumab, a Glycoengineered Humanized Anti-HER3 Monoclonal Antibody, in Patients with Metastatic or Advanced HER3-Positive Solid Tumors

Author

Externen Med. Onco, MS Medische Oncologie, Meulendijks, Didier, Jacob, Wolfgang, Martinez-Garcia, Maria, Taus, Alvaro, Lolkema, Martijn P, Voest, Emile E, Langenberg, Marlies H G, Fleitas Kanonnikoff, Tania, Cervantes, Andres, De Jonge, Maja J, Sleijfer, Stefan, Soerensen, Morten Mau, Thomas, Marlene, Ceppi, Maurizio, Meneses-Lorente, Georgina, James, Ian, Adessi, Celine, Michielin, Francesca, Abiraj, Keelara, Bossenmaier, Birgit, Schellens, Jan H M, Weisser, Martin, Lassen, Ulrik N, Externen Med. Onco, MS Medische Oncologie, Meulendijks, Didier, Jacob, Wolfgang, Martinez-Garcia, Maria, Taus, Alvaro, Lolkema, Martijn P, Voest, Emile E, Langenberg, Marlies H G, Fleitas Kanonnikoff, Tania, Cervantes, Andres, De Jonge, Maja J, Sleijfer, Stefan, Soerensen, Morten Mau, Thomas, Marlene, Ceppi, Maurizio, Meneses-Lorente, Georgina, James, Ian, Adessi, Celine, Michielin, Francesca, Abiraj, Keelara, Bossenmaier, Birgit, Schellens, Jan H M, Weisser, Martin, and Lassen, Ulrik N

Published
2016

38. Phase I clinical study of RG7356, an anti-CD44 humanized antibody, in patients with acute myeloid leukemia

Author

Vey, Norbert, primary, Delaunay, Jacques, additional, Martinelli, Giovanni, additional, Fiedler, Walter, additional, Raffoux, Emmanuel, additional, Prebet, Thomas, additional, Gomez-Roca, Carlos, additional, Papayannidis, Cristina, additional, Kebenko, Maxim, additional, Paschka, Peter, additional, Christen, Randolph, additional, Guarin, Ernesto, additional, Bröske, Ann-Marie, additional, Baehner, Monika, additional, Brewster, Michael, additional, Walz, Antje-Christine, additional, Michielin, Francesca, additional, Runza, Valeria, additional, Meresse, Valerie, additional, and Recher, Christian, additional

Published
2016
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39. First-in-Human Phase I Study of Lumretuzumab, a Glycoengineered Humanized Anti-HER3 Monoclonal Antibody, in Patients with Metastatic or Advanced HER3-Positive Solid Tumors

Author

Meulendijks, Didier, primary, Jacob, Wolfgang, additional, Martinez-Garcia, Maria, additional, Taus, Alvaro, additional, Lolkema, Martijn P., additional, Voest, Emile E., additional, Langenberg, Marlies H.G., additional, Fleitas Kanonnikoff, Tania, additional, Cervantes, Andres, additional, De Jonge, Maja J., additional, Sleijfer, Stefan, additional, Soerensen, Morten Mau, additional, Thomas, Marlene, additional, Ceppi, Maurizio, additional, Meneses-Lorente, Georgina, additional, James, Ian, additional, Adessi, Celine, additional, Michielin, Francesca, additional, Abiraj, Keelara, additional, Bossenmaier, Birgit, additional, Schellens, Jan H.M., additional, Weisser, Martin, additional, and Lassen, Ulrik N., additional

Published
2016
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40. Le seconde generazioni in Italia: una nuova vecchia storia

Author

Dalla Zuanna, Gianpiero, Michielin, Francesca, IMPICCIATORE, ROBERTO, Livi Bacci, Massimo, Dalla Zuanna, Gianpiero, Impicciatore, Roberto, and Michielin, Francesca

Subjects
istruzione, seconde generazioni, capitale umano, immigrazione
Abstract

Le seconde generazioni in Italia: una nuova vecchia storia

Published
2005

41. Compatibility of children and work preferences: two European cases

Author

Giraldo, Anna, Mazzuco, Stefano, and Michielin, Francesca

Subjects
SECS-S/01 Statistica
Abstract

Nowadays female participation in the labor market and motherhood are competing and the conciliation between them can be solved in different ways. In this paper we analyze children and work preferences in two European countries with very different behaviour: Italy and France. Italy shares with Spain the lowest fertility level (the TFR is around 1.25) whereas French TFR reaches the highest level (1.89) among the European Community countries. Moreover female employment rate in Italy is about 40% whereas in France reaches 70%. In these two contexts, using data from the European Community Household Panel, we model jointly fertility and female participation in the labor market, taking into account the potential correlation across unobserved heterogeneity in children and work preferences.

Published
2005

45. GSK1614343, a Novel Ghrelin Receptor Antagonist, Produces an Unexpected Increase of Food Intake and Body Weight in Rodents and Dogs

Author

Costantini, Vivian J.A., primary, Vicentini, Elena, additional, Sabbatini, Fabio M., additional, Valerio, Enzo, additional, Lepore, Stefano, additional, Tessari, Michela, additional, Sartori, Matteo, additional, Michielin, Francesca, additional, Melotto, Sergio, additional, Merlo Pich, Emilio, additional, and Corsi, Mauro, additional

Published
2011
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47. Household and Union Formation in a Mediterranean Fashion: Italy and Spain

Author

Castro Martín, Teresa [0000-0002-7791-9977], Billari, Francesco, Castiglioni, Maria, Castro Martín, Teresa, Michielin, Francesca, Ongaro, Fausta, Castro Martín, Teresa [0000-0002-7791-9977], Billari, Francesco, Castiglioni, Maria, Castro Martín, Teresa, Michielin, Francesca, and Ongaro, Fausta

Published
2002

50. Slow dissociation of partial agonists from the D2 receptor is linked to reduced prolactin release.

Author

Carboni, Lucia, Negri, Michele, Michielin, Francesca, Bertani, Simone, Fratte, Sonia Delle, Oliosi, Beatrice, and Cavanni, Paolo

Subjects
ANTIPSYCHOTIC agents, DOPAMINE receptors, PROLACTIN, PHARMACOKINETICS, LIGANDS (Biochemistry), LABORATORY rats
Abstract

In this study we investigated the correlation between affinity, efficacy, peripheral receptor occupancy, and kinetic properties of D2 dopamine receptor ligands with time-course evaluations of prolactin release in rat blood. We profiled typical and atypical antipsychotic antagonists at D2 receptors, the partial agonist aripiprazole, and four novel partial agonist compounds with different properties. Clozapine and quetia-pine revealed lower prolactin release and fast dissociation kinetics, linking fast dissociation and prolactin-sparing properties. Surprisingly, haloperidol, a highly prolactin-releasing antagonist, shared intermediate dissociation properties. Factors other than kinetic properties may thus contribute to prolactin-releasing properties of antagonists. Partial agonists sharing similar efficacies and receptor occupancies differed markedly in their ability to induce hyperprolactinaemia. Aripiprazole moderately released prolactin even at high receptor occupancies, with slow dissociation from D2 receptors. Other compounds displaying low affinities and fast dissociations released prolactin substantially, although less than haloperidol. The effect augmented after repeated administrations. Compounds with high affinities and slow dissociation rates stimulated moderate prolactin release at high receptor occupancies, reaching a ceiling effect at 50-60 % occupancy. Moreover, the effect developed tolerance. In conclusion, we investigated the affinity and kinetic properties of D2 partial agonists associated with their ability to induce prolactin release in blood. We propose that for D2 partial agonists, at comparable intrinsic activities and peripheral occupancies, the prolactin-releasing properties are linked to their kinetic rate properties. Differently from D2 antagonists, partial agonists display slow dissociation and high affinity associated with a low prolactin release profile. [ABSTRACT FROM AUTHOR]

Published
2012
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