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3. Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study

Author

Passaro, A., Wang, J., Wang, Y., Lee, S.-H., Melosky, B., Shih, J.-Y., Azuma, K., Juan-Vidal, O., Cobo, M., Felip, E., Girard, N., Cortot, A.B., Califano, R., Cappuzzo, F., Owen, S., Popat, S., Tan, J.-L., Salinas, J., Tomasini, P., Gentzler, R.D., William, W.N., Jr., Reckamp, K.L., Takahashi, T., Ganguly, S., Kowalski, D.M., Bearz, A., MacKean, M., Barala, P., Bourla, A.B., Girvin, A., Greger, J., Millington, D., Withelder, M., Xie, J., Sun, T., Shah, S., Diorio, B., Knoblauch, R.E., Bauml, J.M., Campelo, R.G., and Cho, B.C.

Published
2024
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4. Efficacy of Lorlatinib in Treatment-Naive Patients With ALK-Positive Advanced NSCLC in Relation to EML4::ALK Variant Type and ALK With or Without TP53 Mutations

Author

Bearz, Alessandra, Martini, Jean-François, Jassem, Jacek, Kim, Sang-We, Chang, Gee-Chen, Shaw, Alice T., Shepard, Deborah A., Dall’O’, Elisa, Polli, Anna, Thurm, Holger, Zalcman, Gerard, Garcia Campelo, Maria Rosario, Penkov, Konstantin, Hayashi, Hidetoshi, and Solomon, Benjamin J.

Published
2023
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6. Efficacy of Brigatinib in Patients With Advanced ALK-Positive NSCLC Who Progressed on Alectinib or Ceritinib: ALK in Lung Cancer Trial of brigAtinib-2 (ALTA-2)

Author

Ou, Sai-Hong Ignatius, Nishio, Makoto, Ahn, Myung-Ju, Mok, Tony, Barlesi, Fabrice, Zhou, Caicun, Felip, Enriqueta, de Marinis, Filippo, Kim, Sang-We, Pérol, Maurice, Liu, Geoffrey, Migliorino, Maria Rita, Kim, Dong-Wan, Novello, Silvia, Bearz, Alessandra, Garrido, Pilar, Mazieres, Julien, Morabito, Alessandro, Lin, Huamao M., Yang, Hui, Niu, Huifeng, Zhang, Pingkuan, and Kim, Edward S.

Published
2022
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8. Anetumab ravtansine versus vinorelbine in patients with relapsed, mesothelin-positive malignant pleural mesothelioma (ARCS-M): a randomised, open-label phase 2 trial

Author

Kindler, Hedy L, Novello, Silvia, Bearz, Alessandra, Ceresoli, Giovanni L, Aerts, Joachim G J V, Spicer, James, Taylor, Paul, Nackaerts, Kristiaan, Greystoke, Alastair, Jennens, Ross, Calabrò, Luana, Burgers, Jacobus A, Santoro, Armando, Cedrés, Susana, Serwatowski, Piotr, Ponce, Santiago, Van Meerbeeck, Jan P, Nowak, Anna K, Blumenschein, George, Jr, Siegel, Jonathan M, Kasten, Linda, Köchert, Karl, Walter, Annette O, Childs, Barrett H, Elbi, Cem, Hassan, Raffit, and Fennell, Dean A

Published
2022
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9. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non–Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy.

Author

Neal, Joel, Pavlakis, Nick, Kim, Sang-We, Goto, Yasushi, Lim, Sun Min, Mountzios, Giannis, Fountzilas, Elena, Mochalova, Anastasia, Christoph, Daniel C., Bearz, Alessandra, Quantin, Xavier, Palmero, Ramon, Antic, Vladan, Chun, Elaine, Edubilli, Tirupathi Rao, Lin, Ya-Chen, Huseni, Mahrukh, Ballinger, Marcus, Graupner, Vilma, and Curran, Dominic

Published
2024
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10. Atezolizumab Plus Carboplatin and Etoposide in Patients with Untreated Extensive-Stage Small-Cell Lung Cancer: Interim Results of the MAURIS Phase IIIb Trial

Author

Bria, Emilio, primary, Morgillo, Floriana, additional, Garassino, Marina Chiara, additional, Ciardiello, Fortunato, additional, Ardizzoni, Andrea, additional, Stefani, Alessio, additional, Verderame, Francesco, additional, Morabito, Alessandro, additional, Chella, Antonio, additional, Tonini, Giuseppe, additional, Gilli, Marina, additional, Del Signore, Ester, additional, Berardi, Rossana, additional, Mencoboni, Manlio, additional, Bearz, Alessandra, additional, Delmonte, Angelo, additional, Migliorino, Marta Rita, additional, Gridelli, Cesare, additional, Pazzola, Antonio, additional, Iero, Manuela, additional, and De Marinis, Filippo, additional

Published
2024
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13. Radical Hemithoracic Radiotherapy Versus Palliative Radiotherapy in Non-metastatic Malignant Pleural Mesothelioma: Results from a Phase 3 Randomized Clinical Trial

Author

Trovo, Marco, Relevant, Alberto, Polesel, Jerry, Muraro, Elena, Barresi, Loredana, Drigo, Annalisa, Baresic, Tanja, Bearz, Alessandra, Fanetti, Giuseppe, Del Conte, Alessandro, Matrone, Fabio, Reverberi, Chiara, Furlan, Carlo, Zuccon, Umberto, Fontana, Paolo, Franchin, Giovanni, and Minatel, Emilio

Published
2021
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16. Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study

Author

Passaro, A., primary, Wang, J., additional, Wang, Y., additional, Lee, S.-H., additional, Melosky, B., additional, Shih, J.-Y., additional, Azuma, K., additional, Juan-Vidal, O., additional, Cobo, M., additional, Felip, E., additional, Girard, N., additional, Cortot, A.B., additional, Califano, R., additional, Cappuzzo, F., additional, Owen, S., additional, Popat, S., additional, Tan, J.-L., additional, Salinas, J., additional, Tomasini, P., additional, Gentzler, R.D., additional, William, W.N., additional, Reckamp, K.L., additional, Takahashi, T., additional, Ganguly, S., additional, Kowalski, D.M., additional, Bearz, A., additional, MacKean, M., additional, Barala, P., additional, Bourla, A.B., additional, Girvin, A., additional, Greger, J., additional, Millington, D., additional, Withelder, M., additional, Xie, J., additional, Sun, T., additional, Shah, S., additional, Diorio, B., additional, Knoblauch, R.E., additional, Bauml, J.M., additional, Campelo, R.G., additional, and Cho, B.C., additional

Published
2023
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17. Sorafenib Versus Observation Following Radical Metastasectomy for Clear-cell Renal Cell Carcinoma: Results from the Phase 2 Randomized Open-label RESORT Study

Author

Procopio, Giuseppe, Apollonio, Giulia, Cognetti, Francesco, Miceli, Rosalba, Milella, Michele, Mosca, Alessandra, Chiuri, Vincenzo Emanuele, Bearz, Alessandra, Morelli, Franco, Ortega, Cinzia, Atzori, Francesco, Donini, Maddalena, Ratta, Raffaele, Raimondi, Alessandra, Claps, Melanie, Martinetti, Antonia, Capitanio, Umberto, de Braud, Filippo G., Cappelletti, Vera, and Verzoni, Elena

Published
2019
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19. Is multidisciplinary management possible in the treatment of lung cancer? A report from three Italian meetings

Author

Franceschini, Davide, Bruni, Alessio, Borghetti, Paolo, Giaj-Levra, Niccolò, Ramella, Sara, Buffoni, Lucio, Badellino, Serena, Andolina, Maria, Comin, Camilla, Vattemi, Emanuela, Bezzi, Michela, Trovò, Marco, Passaro, Antonio, Bearz, Alessandra, Chiari, Rita, Tindara, Franchina, Ferrari, Katia, Piperno, Gaia, Filippi, Andrea Riccardo, Genovesi, Domenico, and Scotti, Vieri

Published
2020
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20. Efficacy and Safety of Ceritinib (450 mg/d or 600 mg/d) With Food Versus 750-mg/d Fasted in Patients With ALK Receptor Tyrosine Kinase (ALK)–Positive NSCLC: Primary Efficacy Results From the ASCEND-8 Study

Author

Cho, Byoung Chul, Obermannova, Radka, Bearz, Alessandra, McKeage, Mark, Kim, Dong-Wang, Batra, Ullas, Borra, Gloria, Orlov, Sergey, Kim, Sang-We, Geater, Sarayut L., Postmus, Pieter E., Laurie, Scott A., Park, Keunchil, Yang, Cheng-Ta, Ardizzoni, Andrea, Bettini, Anna C., de Castro, Gilberto, Jr., Kiertsman, Flavia, Chen, Zhe, Lau, Yvonne Y., Viraswami-Appanna, Kalyanee, Passos, Vanessa Q., and Dziadziuszko, Rafal

Published
2019
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21. Evaluation of the Effect of Lorlatinib on CYP2B6, CYP2C9, UGT, and P-Glycoprotein Substrates in Patients with Advanced Non-Small Cell Lung Cancer.

Author

Chen, Joseph, Bearz, Alessandra, Kim, Dong-Wan, Mamdani, Hirva, Bauman, Jessica, Chiari, Rita, Ou, Sai-Hong Ignatius, Solomon, Benjamin J., Soo, Ross A., Felip, Enriqueta, Shaw, Alice T., Thurm, Holger, Clancy, Jill S., Lee, Kimberly, O'Gorman, Melissa, Tanski, Cherie, and Pithavala, Yazdi K.

Subjects
*ANAPLASTIC lymphoma kinase, *NON-small-cell lung carcinoma, *PHARMACOKINETICS, *P-glycoprotein, *PROTEIN-tyrosine kinase inhibitors, *CYTOCHROME P-450
Abstract

Background and Objective: Lorlatinib is a tyrosine kinase inhibitor approved for the treatment of advanced anaplastic lymphoma kinase–positive non-small cell lung cancer. This study assessed the effect of steady-state lorlatinib on the metabolic enzymes cytochrome P450 (CYP) 2B6, CYP2C9, and uridine 5′-diphospho-glucuronosyltransferase (UGT) and the P-glycoprotein (P-gp) transporter. Methods: Thirty-two patients received a single oral dose of a probe drug on Day − 2 to determine the pharmacokinetics of the probe drug alone. Starting on Day 1, patients received 100 mg oral lorlatinib daily. On Day 15, a single oral dose of the probe drug was administered concurrently with lorlatinib. Pharmacokinetic parameters for these probe substrates were assessed. Results: Plasma exposures of all probe substrates were reduced by lorlatinib compared with the probe alone. The greatest reduction in area under the plasma concentration–time curve from time zero to infinity (AUC∞) and maximum (peak) plasma drug concentration (Cmax) (67% and 63% decrease, respectively) was observed with the P-gp probe substrate fexofenadine. Lorlatinib coadministration also decreased the AUC∞ and Cmax of bupropion (CYP2B6 probe substrate) by 25% and 27%, tolbutamide (CYP2C9 probe substrate) by 43% and 15%, and acetaminophen (UGT probe substrate) by 45% and 28%, respectively. Conclusions: Lorlatinib is a net moderate inducer of P-gp and a weak inducer of CYP2B6, CYP2C9, and UGT after steady state is achieved with daily dosing. Medications that are P-gp substrates with a narrow therapeutic window should be avoided in patients taking lorlatinib; no dose modifications are needed with substrates of CYP2B6, CYP2C9, or UGT. ClinicalTrials.gov: NCT01970865. [ABSTRACT FROM AUTHOR]

Published
2024
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23. Acquired Resistance to Osimertinib in EGFR-Mutated Non-Small Cell Lung Cancer: How Do We Overcome It?

Author

Elisa Bertoli, Elisa De Carlo, Alessandro Del Conte, Brigida Stanzione, Alberto Revelant, Kelly Fassetta, Michele Spina, and Alessandra Bearz

Subjects
osimertinib, acquired resistance, EGFR-mutated, NSCLC, Biology (General), QH301-705.5, Chemistry, QD1-999
Abstract

Osimertinib is currently the preferred first-line therapy in patients with non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutation and the standard second-line therapy in T790M-positive patients in progression to previous EGFR tyrosine kinase inhibitor. Osimertinib is a highly effective treatment that shows a high response rate and long-lasting disease control. However, a resistance to the treatment inevitably develops among patients. Understanding the secondary mechanisms of resistance and the possible therapeutic options available is crucial to define the best management of patients in progression to osimertinib. We provide a comprehensive review of the emerging molecular resistance mechanism in EGFR-mutated NSCLC pre-treated with osimertinib and its future treatment applications.

Published
2022
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24. Targeted Therapy and Immunotherapy in Early-Stage Non-Small Cell Lung Cancer: Current Evidence and Ongoing Trials

Author

Marco de Scordilli, Anna Michelotti, Elisa Bertoli, Elisa De Carlo, Alessandro Del Conte, and Alessandra Bearz

Subjects
non-small cell lung cancer, early stage, adjuvant therapy, neoadjuvant therapy, targeted therapy, tyrosine kinase inhibitors, Biology (General), QH301-705.5, Chemistry, QD1-999
Abstract

The scenario of neoadjuvant and adjuvant settings in non-small cell lung cancer (NSCLC) is rapidly evolving. As already happened for the advanced disease, also early stages have entered the era of precision medicine, with molecular analysis and Programmed death-ligand 1 (PD-L1) evaluation that by now can be considered a routine assessment. New treatment options have been recently approved, with osimertinib now part of clinical practice for Epidermal Growth Factor Receptor mutated (EGFRm) patients, and immune checkpoint inhibitors (ICIs) available after FDA approval both in the adjuvant (atezolizumab) and neoadjuvant (nivolumab) setting. No mature data on overall survival benefits are available yet, though. Several clinical trials with specific-tyrosine kinase inhibitors (TKIs) and ICIs are currently ongoing, both with and without concomitant chemotherapy. As therapeutic strategies are rapidly expanding, quite a few questions remain unsettled, such as the optimal duration of adjuvant targeted therapy or the effective benefit of ICIs in early-stage EGFRm or ALK (Anaplastic Lymphoma Kinase) rearranged patients, or the possibility to individuate high-risk patients after surgical resection assessing minimal residual disease (MRD) by ctDNA evaluation. We hereby report already available literature data and summarize ongoing trials with targeted therapy and immunotherapy in early-stage NSCLC, focusing on practice-changing results and new perspectives for potentially cured patients.

Published
2022
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25. The Change in Paradigm for NSCLC Patients with EML4–ALK Translocation

Author

Alessandra Bearz, Elisa De Carlo, Alessandro Del Conte, Michele Spina, Valentina Da Ros, Elisa Bertoli, Alberto Revelant, Brigida Stanzione, and Umberto Tirelli

Subjects
NSCLC, ALK, targeted therapies, Biology (General), QH301-705.5, Chemistry, QD1-999
Abstract

The severe prognosis linked with a lung cancer diagnosis has changed with the discovery of oncogenic molecularly driven subgroups and the use of tailored treatment. ALK-translocated advanced lung cancer is the most interesting model, having achieved the longest overall survival. Here, we report the most important paradigmatic shifts in the prognosis and treatment for this subgroup population occurred among lung cancer.

Published
2022
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26. Therapeutic decision based on molecular detection of resistance mechanism in an ALK-rearranged lung cancer patient: a case report

Author

De Carlo E, Schiappacassi M, Urbani M, Doliana R, Baldassarre G, Da Ros V, Santarossa S, Chimienti E, Berto E, Fratino L, and Bearz A

Subjects
Non-small cell lung cancer, EML4-ALK, ALK tyrosine kinase inhibitors, G1202R resistance mutation, liquid biopsy, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Elisa De Carlo,1,* Monica Schiappacassi,2,* Martina Urbani,3 Roberto Doliana,2 Gustavo Baldassarre,2 Valentina Da Ros,1 Sandra Santarossa,1 Emanuela Chimienti,1 Eleonora Berto,1 Lucia Fratino,1 Alessandra Bearz1 1Clinical Oncology Department, IRCCS CRO Centro di Riferimento Oncologico Aviano, Aviano, Italy; 2Molecular Oncology Department, IRCCS CRO Centro di Riferimento Oncologico Aviano, Aviano, Italy; 3Radiology Department, IRCCS CRO Centro di Riferimento Oncologico Aviano, Aviano, Italy *These authors contributed equally to this work Background: The use of tyrosine kinase inhibitors (TKIs) of ALK is the therapy of choice for ALK-fusion patients. Unfortunately, all patients under this kind of treatment eventually develop acquired resistance through several well-known mechanisms, such as acquisition of a secondary mutation within the kinase domain, activation of a bypass signaling pathway, or a histological change like small-cell lung cancer transformation. At the time of progression, a tissue re-biopsy may give important molecular and morphological information regarding the mechanisms driving resistance to ALK TKIs. However, this procedure is not always feasible and it may not reflect the tumor heterogeneity, and therefore gives incomplete information. To overcome these drawbacks, the analysis of circulating tumor DNA (ctDNA) isolated from plasma, the so-called liquid biopsy, is emerging as a noninvasive and useful tool for detecting resistance mutations. Secondary resistance mutations are common in second-generation TKIs resistant patients and among these, Gly1202Arg (p.G1202R) emerged as the most frequent mutation. Case presentation: We have treated an ALK-positive lung adenocarcinoma patient with a sequential strategy of ALK TKIs. Patient follow-up was performed combining clinical, radiological, and molecular profiling. ctDNA was isolated from plasma and by means of ultra-deep next generation sequencing; we searched for secondary ALK resistance mutations on exons 21–25. ALK mutation Gly1202Arg (G1202R) was detected. We have documented consistency between plasma levels of G1202R mutation and radiological progression or improvement. Conclusion: Liquid biopsy appears to be a promising tool to anticipate progression and to drive the therapeutic strategy based upon ALK resistance mutations. Keywords: non-small-cell lung cancer, EML4-ALK, ALK tyrosine kinase inhibitors, G1202R resistance mutation, liquid biopsy

Published
2018

27. Outcomes of First-Generation EGFR-TKIs Against Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Post Hoc Analysis of the BE-POSITIVE Study

Author

Pilotto, Sara, Rossi, Antonio, Vavalà, Tiziana, Follador, Alessandro, Tiseo, Marcello, Galetta, Domenico, Morabito, Alessandro, Di Maio, Massimo, Martelli, Olga, Caffo, Orazio, Piovano, Pier Luigi, Cortinovis, Diego, Zilembo, Nicoletta, Casartelli, Clelia, Banna, Giuseppe Luigi, Ardizzoia, Antonio, Barzelloni, Maria Luisa, Bearz, Alessandra, Genestreti, Giovenzio, Mucciarini, Claudia, Filipazzi, Virginio, Menis, Jessica, Rizzo, Elisa, Barbieri, Fausto, Rijavec, Erika, Cecere, Fabiana, Spitaleri, Gianluca, Bria, Emilio, and Novello, Silvia

Published
2018
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28. Efficacy of Brigatinib in Patients With Advanced ALK-Positive NSCLC Who Progressed on Alectinib or Ceritinib: ALK in Lung Cancer Trial of brigAtinib-2 (ALTA-2)

Author

Sai-Hong Ignatius, Ou, Makoto, Nishio, Myung-Ju, Ahn, Tony, Mok, Fabrice, Barlesi, Caicun, Zhou, Enriqueta, Felip, Filippo, de Marinis, Sang-We, Kim, Maurice, Pérol, Geoffrey, Liu, Maria Rita, Migliorino, Dong-Wan, Kim, Silvia, Novello, Alessandra, Bearz, Pilar, Garrido, Julien, Mazieres, Alessandro, Morabito, Huamao M, Lin, Hui, Yang, Huifeng, Niu, Pingkuan, Zhang, Edward S, Kim, Institut Català de la Salut, [Ou SI] Department of Medicine, Division of Hematology-Oncology, Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, California. [Nishio M] Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. [Ahn MJ] Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. [Mok T] State Key Laboratory of Translational Oncology, The Chinese University of Hong Kong, Hong Kong, People’s Republic of China. [Barlesi F] Aix-Marseille University, CNRS, INSERM, CRCM, Marseille, France. Multidisciplinary Oncology & Therapeutic Innovations Department, Gustave Roussy Cancer Campus, Villejuif, France. [Zhou C] Shanghai Pulmonary Hospital, Shanghai, People’s Republic of China. [Felip E] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Pulmonary and Respiratory Medicine, Lung Neoplasms, Otros calificadores::/uso terapéutico [Otros calificadores], Carbazoles, Medicaments antineoplàstics - Ús terapèutic, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos [COMPUESTOS QUÍMICOS Y DROGAS], diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung [DISEASES], neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas [ENFERMEDADES], Other subheadings::Other subheadings::/drug therapy [Other subheadings], Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Oncology, Carcinoma, Non-Small-Cell Lung, Avaluació de resultats (Assistència sanitària), Humans, Anaplastic Lymphoma Kinase, Other subheadings::/therapeutic use [Other subheadings], Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents [CHEMICALS AND DRUGS], Pulmons - Càncer - Tractament, Protein Kinase Inhibitors
Abstract

Circulating tumor DNA; Non–small cell lung cancer; Tumor biomarker ADN tumoral circulante; Cáncer de pulmón de células no pequeñas; Biomarcador tumoral ADN tumoral circulant; Càncer de pulmó de cèl·lules no petites; Biomarcador tumoral Introduction Brigatinib is a potent next-generation ALK tyrosine kinase inhibitor approved for treatment-naive and crizotinib-refractory advanced ALK-positive (ALK+) NSCLC. We evaluated brigatinib after other next-generation ALK tyrosine kinase inhibitors. Methods In this single-arm, phase 2, ALK in Lung Cancer Trial of brigAtinib-2 (NCT03535740), patients with advanced ALK+ NSCLC whose disease progressed on alectinib or ceritinib received brigatinib 180 mg once daily (after 7-d 90-mg lead-in). Primary end point was independent review committee (IRC)-assessed overall response rate (ORR). Circulating tumor DNA (ctDNA) was analyzed. Results Among 103 patients (data cutoff: September 30, 2020; median follow-up [range]: 10.8 [0.5–17.7] mo), confirmed IRC-ORR was 26.2% (95% confidence interval [CI]: 18.0–35.8), median duration of response, 6.3 months (95% CI: 5.6–not reached), and median progression-free survival (mPFS), 3.8 months (95% CI: 3.5–5.8). mPFS was 1.9 months (95% CI: 1.8–3.7) in patients with ctDNA-detectable baseline ALK fusion (n = 64). Among 86 patients who progressed on alectinib, IRC-ORR was 29.1% (95% CI: 19.8–39.9); mPFS was 3.8 months (95% CI: 1.9–5.4). Resistance mutations were present in 33.3% (26 of 78) of baseline ctDNA; 54% (14 of 26) of mutations were G1202R; 52% (33 of 64) of patients with detectable ALK fusion had EML4-ALK variant 3. Most common all-grade treatment-related adverse events were increased creatine phosphokinase (32%) and diarrhea (27%). The mean dose intensity of brigatinib (180 mg once daily) was 85.9%. Conclusions In ALK in Lung Cancer Trial of brigAtinib-2, brigatinib was found to have a limited activity in patients with ALK+ NSCLC post-ceritinib or post-alectinib therapy. mPFS was longer with brigatinib in patients without baseline detectable plasma ALK fusion.

Published
2022

29. Post Hoc Analysis of Lorlatinib Intracranial Efficacy and Safety in Patients With ALK-Positive Advanced Non–Small-Cell Lung Cancer From the Phase III CROWN Study

Author

Benjamin J. Solomon, Todd M. Bauer, Sai-Hong Ignatius Ou, Geoffrey Liu, Hidetoshi Hayashi, Alessandra Bearz, Konstantin Penkov, Yi-Long Wu, Oscar Arrieta, Jacek Jassem, Anna M. Calella, Gerson Peltz, Anna Polli, Holger Thurm, and Tony Mok

Subjects
Cancer Research, Oncology
Abstract

PURPOSE Lorlatinib significantly improved progression-free survival (PFS) versus crizotinib and showed robust intracranial activity in patients with previously untreated advanced ALK-positive non–small-cell lung cancer (NSCLC) in the phase III CROWN trial. Here, we report post hoc efficacy outcomes in patients with and without brain metastases at baseline, and present data on the incidence and management of CNS adverse events (AEs) in CROWN. METHODS Eligible patients were randomly assigned 1:1 to first-line lorlatinib (100 mg once daily) or crizotinib (250 mg twice a day); no crossover between treatment arms was permitted. Tumor assessments, including CNS magnetic resonance imaging, were performed at screening and then at 8-week intervals. Regular assessments of patient-reported outcomes were conducted. RESULTS PFS by blinded independent central review was improved with lorlatinib versus crizotinib in patients with and without brain metastases at baseline (12-month PFS rates: 78% v 22% and 78% v 45%, respectively). Lorlatinib was associated with lower 12-month cumulative incidence of CNS progression versus crizotinib in patients with (7% v 72%) and without (1% v 18%) brain metastases at baseline. In total, 35% of patients had CNS AEs with lorlatinib, most of grade 1 severity. Occurrence of CNS AEs did not result in a clinically meaningful difference in patient-reported quality of life. At analysis, 56% of CNS AEs had resolved (33% without intervention; 17% with lorlatinib dose modification), and 38% were unresolved; most required no intervention. Lorlatinib dose modification did not notably influence PFS. CONCLUSION First-line lorlatinib improved PFS outcomes and reduced CNS progression versus crizotinib in patients with advanced ALK-positive non–small-cell lung cancer with or without brain metastases at baseline. Half of all CNS AEs resolved without intervention or with lorlatinib dose modification.

Published
2022

32. 60 CONTACT-01: Efficacy and safety from a phase III study of atezolizumab (atezo) + cabozantinib (cabo) vs docetaxel (doc) monotherapy in patients (pts) with metastatic NSCLC (mNSCLC) previously treated with checkpoint inhibitors and chemotherapy

Author

Neal, J., primary, Pavlakis, N., additional, Kim, S-W., additional, Goto, Y., additional, Lim, S.M., additional, Mountzios, G., additional, Fountzilas, E., additional, Mochalova, A., additional, Christoph, D.C.C., additional, Bearz, A., additional, Quantin, X., additional, Palmero, R., additional, Antic, V., additional, Chun, E., additional, Edubilli, T. Rao, additional, Lin, Y-C., additional, Huseni, M., additional, Scheffold, C., additional, Vervaet, P., additional, and Newsom-Davis, T., additional

Published
2023
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33. 21P Bevacizumab plus atezolizumab and chemotherapy in NSCLC harbouring EGFR mutation previously treated with EGFR tyrosine kinase inhibitor: The BACH-NET study

Author

Pasello, G., primary, Lorenzi, M., additional, Crivellaro, G., additional, Capelletto, E., additional, Butticè, S., additional, Perrone, F., additional, Tiseo, M., additional, Scotti, V., additional, Polo, V., additional, Favaretto, A., additional, Montrone, M., additional, Berardi, R., additional, Zustovich, F., additional, Toschi, L., additional, Bearz, A., additional, Milella, M., additional, Frega, S., additional, Bonanno, L., additional, and Guarneri, V., additional

Published
2023
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35. ASCEND-8: A Randomized Phase 1 Study of Ceritinib, 450 mg or 600 mg, Taken with a Low-Fat Meal versus 750 mg in Fasted State in Patients with Anaplastic Lymphoma Kinase (ALK)-Rearranged Metastatic Non–Small Cell Lung Cancer (NSCLC)

Author

Cho, Byoung Chul, Kim, Dong-Wan, Bearz, Alessandra, Laurie, Scott A., McKeage, Mark, Borra, Gloria, Park, Keunchil, Kim, Sang-We, Ghosn, Marwan, Ardizzoni, Andrea, Maiello, Evaristo, Greystoke, Alastair, Yu, Richard, Osborne, Karen, Gu, Wen, Scott, Jeffrey W., Passos, Vanessa Q., Lau, Yvonne Y., and Wrona, Anna

Published
2017
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36. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial

Author

Shaw, Alice T, Kim, Tae Min, Crinò, Lucio, Gridelli, Cesare, Kiura, Katsuyuki, Liu, Geoffrey, Novello, Silvia, Bearz, Alessandra, Gautschi, Oliver, Mok, Tony, Nishio, Makoto, Scagliotti, Giorgio, Spigel, David R, Deudon, Stéphanie, Zheng, Cheng, Pantano, Serafino, Urban, Patrick, Massacesi, Cristian, Viraswami-Appanna, Kalyanee, and Felip, Enriqueta

Published
2017
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37. Prospective phase II study of sunitinib rechallenge in metastatic renal cell carcinoma: The 'retry' study from the Italian Group of Onco-Nephrology (G.I.O.N.)

Author

Camillo Porta, Vittorio Ferrari, Paolo A. Zucali, Giuseppe Fornarini, Antonio Bernardo, Andrea Falconeri, Sandra Santarossa, Carmine Tinelli, Mimma Rizzo, Giovanni Pappagallo, and Alessandra Bearz

Abstract

Background: Sunitinib is still a recommended treatment option for metastatic renal cell carcinoma (RCC) patients; lack of cross-resistance to sequential antiangiogenic drugs has been postulated. Objective: The possibility of a successful rechallenge with sunitinib was tested in this prospective phase II trial. Methods: Main inclusion criteria were: histologically proven RCC with clear cell component, previous first-line sunitinib with a Disease Control Rate lasting ⩾10 months, and second-line everolimus. The primary end-point was 6-months progression-free survival (PFS). A Simon’s 2-stage design was used; after testing sunitinib on 12 patients, the trial would have been terminated if ⩽5 had a PFS Results: A total of 39 patients (30 males, 9 females) were enrolled. The study reached the second stage, and ultimately succeeded; indeed, 6-months PFS was 64.1%, median PFS being 14.9 months (95% confidence interval: 9.06–20.91). Treatment-related grade 3–4 adverse events observed in ⩾5% of the patients were: hand-foot skin reaction, fatigue, nausea, hypertriglyceridemia, hypophosphatemia, hypocalcemia, hyperglycemia, and neutropenia. One case each of myocardial infarction, atrial flutter, and spontaneous pneumothorax, were also reported. Conclusions: Despite an ineluctable time-lead-bias, median PFS on sunitinib rechallenge was high, clearly showing that many patients may become sensitive again to antiangiogenic treatment. In countries where treatment options are still limited, sunitinib rechallenge could represent an option. EudraCT number: 2012-000473-23.

Published
2022

38. Continuation of Lorlatinib in ALK-Positive NSCLC Beyond Progressive Disease

Author

Sai-Hong I. Ou, Benjamin J. Solomon, Alice T. Shaw, Shirish M. Gadgeel, Benjamin Besse, Ross A. Soo, Antonello Abbattista, Francesca Toffalorio, Robin Wiltshire, and Alessandra Bearz

Subjects
Pulmonary and Respiratory Medicine, Lung Neoplasms, Lactams, Oncology, Carcinoma, Non-Small-Cell Lung, Lactams, Macrocyclic, Aminopyridines, Humans, Pyrazoles, Receptor Protein-Tyrosine Kinases, Protein Kinase Inhibitors, Retrospective Studies
Abstract

Lorlatinib, a potent, selective third-generation ALK tyrosine kinase inhibitor (TKI), exhibited overall and intracranial antitumor activity in patients with ALK-positive NSCLC.Retrospective analyses in the ongoing phase 2 trial (NCT01970865) investigated the clinical benefit of continuing lorlatinib beyond progressive disease (LBPD). Patients with previous crizotinib treatment as the only ALK TKI were group A (n = 28); those with at least one previous second-generation ALK TKIs were group B (n = 74). LBPD was defined as greater than 3 weeks of lorlatinib treatment after investigator-assessed progressive disease. Only patients with the best overall response of complete or partial response or stable disease were included.There were no major differences in baseline characteristics between groups. The median duration of treatment for patients who continued LBPD was 32.4 months (group A) and 16.4 months (group B) versus 12.5 months (group A) and 7.7 months (group B) for patients who did not continue LBPD. The median overall survival in group A was not reached (NR) in patients who continued LBPD versus 24.4 months (95% confidence interval [CI]: 12.1-NR); group B's median was 26.5 months (95% CI: 18.7-35.5) in patients who continued LBPD versus 14.7 months (95% CI: 9.3-38.5) in patients who did not continue LBPD. The median overall survival postprogression for groups A and B was NR (95% CI: 21.4-NR) and 14.6 months (95% CI: 11.2-19.2) in patients who continued LBPD and 8.0 months (95% CI: 1.5-NR) versus 5.3 months (95% CI: 2.8-14.3) in patients who did not continue LBPD.Continuing LBPD is a viable treatment strategy for select patients with ALK-positive NSCLC who progressed on lorlatinib.

Published
2022

39. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial

Author

Ignatius Ou, SaiHong, Planchard, David, Park, Keunchil, Schuler, Martin, Yang, James, Chand, Vikram, Rohr, Klaus, Bagnes, Claudia, Martin, Claudio Marcelo, Recondo, Gonzalo, Zarba, Juan Jose, Blajman, Cesar, Richardet, Martín, McLachlan, Sue-Anne, Parente, Phillip, Underhill, Craig, Crombie, Catherine, Mainwaring, Paul, Greil, Richard, Humblet, Yves, Bustin, Frédérique, Carestia, Luciano, Galdermans, Danny, Lambrechts, Marc, Delval, Laetitia, Vercauter, Piet, Zhou, Caicun, Wang, Jin, Huang, Cheng, Lin, Xiaoyan, Wu, Yilong, Liu, Xiaoqing, Cheng, Ying, Qin, Shukui, Feng, Jifeng, Huang, Jianjin, Zhang, Yiping, Lu, Shun, Zereu, Manuela, Garicochea, Bernardo, Zadra, Cyntia Albuquerque, Riska, Henrik, Alanko, Tuomo, Cadranel, Jacques, Chouaid, Christos, Zalcman, Gérard, Sibilot, Denis Moro, Perol, Maurice, Bennouna, Jaafar, Fournel, Pierre, Gervais, Radj, Rotarski, Maciej, Coudert, Bruno, Thomas, Michael, Wehler, Thomas, Faehling, Martin, Keilholz, Ulrich, Laack, Eckart, von Pawel, Joachim, Huber, Rudolf, Dickgreber, Nicolas, Wiewrodt, Rainer, Mark, Zsuzsanna, Tehenes, Sandor, Strausz, Janos, Sarosi, Veronika, Prabhash, Kumar, Jain, Minish, Venkatesan, Srinivasan, Sharma, Lalit, Dadhich, Hemant, Nagarkar, Rajnish Vasant, Onn, Amir, Gottfried, Maya, Stemmer, Solomon, Migliorino, Maria Rita, Grossi, Francesco, Bidoli, Paolo, Bearz, Alessandra, Gridelli, Cesare, Milandri, Carlo, Platania, Marco, Ceresoli, Giovanni Luca, Cruciani, Giorgio, Delgado, Francisco Gutierrez, Gonzalez Perez, José Luis, Luna, Gabriela Alvarado, Baca, Othon Padilla, Aerts, J.G.J.V., Stigt, J.A., Dingemans, A.M.C., Herder, G.J.M., Gans, S.J.M., Salas Sánchez, Jorge Fernando, Alvarez Barreda, Renzo Luzgardo, Pantigoso, Wilbert Rodriguez, Palomino, Osbert Luis Mejia, Jaskiewicz, Piotr, Kazarnowicz, Andrzej, Serwatowski, Piotr, Szczesna, Aleksandra, Jassem, Jacek, Lubennikov, Vladimir, Karaseva, Nina, Orlov, Sergey, Ragulin, Yuri, Garrido, Pilar, González Larriba, José Luis, Camps, Carlos, Campelo, Rosario García, Lianes, Pilar, Cobo, Manuel, Felip, Enriqueta, Kim, Dong-Wan, Kim, Sang-We, Kim, Joo-Hang, Han, Ji-Youn, Kim, Young-Chul, Yang, Chih-Hsin, Hsia, Te-Chun, Chen, Yuh-Min, Tsai, Ying-Huang, Chang, Gee-Chen, Tsao, Thomas Chang-Yao, Su, Wu-Chou, Huang, Ming-Shyan, Ho, Ching-Liang, Hsieh, Ruey-Kuen, Vinnyk, Yuriy, Popovych, Oleksandr, Ponomarova, Olga, Bondarenko, Igor, Polishchuk, Iryna, Shah, Riyaz, Mitra, Sanka, Popat, Sanjaykumar, Spicer, James, Toy, Elizabeth, Talbot, Toby, Brown, Emma, Upadhyay, Sunil, Summers, Yvonne, Gurtler, Jayne, Meza, Luis, Thropay, John, Schuler, M., Yang, J.C.-H., Park, K., Kim, J.-H., Bennouna, J., Chen, Y.-M., Chouaid, C., De Marinis, F., Feng, J.-F., Grossi, F., Kim, D.-W., Liu, X., Lu, S., Strausz, J., Vinnyk, Y., Wiewrodt, R., Zhou, C., Wang, B., Chand, V.K., and Planchard, D.

Published
2016
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42. 60 CONTACT-01: Efficacy and safety from a phase III study of atezolizumab (atezo) + cabozantinib (cabo) vs docetaxel (doc) monotherapy in patients (pts) with metastatic NSCLC (mNSCLC) previously treated with checkpoint inhibitors and chemotherapy

Author

J. Neal, N. Pavlakis, S-W. Kim, Y. Goto, S.M. Lim, G. Mountzios, E. Fountzilas, A. Mochalova, D.C.C. Christoph, A. Bearz, X. Quantin, R. Palmero, V. Antic, E. Chun, T. Rao Edubilli, Y-C. Lin, M. Huseni, C. Scheffold, P. Vervaet, and T. Newsom-Davis

Subjects
Pulmonary and Respiratory Medicine, Oncology
Published
2023

43. Efficacy of Lorlatinib in Treatment-Naive Patients With ALK-Positive Advanced NSCLC in Relation to EML4::ALKVariant Type and ALKWith or Without TP53Mutations

Author

Bearz, Alessandra, Martini, Jean-François, Jassem, Jacek, Kim, Sang-We, Chang, Gee-Chen, Shaw, Alice T., Shepard, Deborah A., Dall’O’, Elisa, Polli, Anna, Thurm, Holger, Zalcman, Gerard, Garcia Campelo, Maria Rosario, Penkov, Konstantin, Hayashi, Hidetoshi, and Solomon, Benjamin J.

Abstract

Lorlatinib, a third-generation ALK tyrosine kinase inhibitor, improved outcomes compared with crizotinib in patients with previously untreated ALK-positive advanced NSCLC in the phase 3 CROWN study. Here, we investigated response correlates using plasma circulating tumor DNA (ctDNA) and tumor tissue profiling.

Published
2023
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44. Post Hoc Analysis of Lorlatinib Intracranial Efficacy and Safety in Patients With ALK-Positive Advanced Non–Small-Cell Lung Cancer From the Phase III CROWN Study

Author

Solomon, Benjamin J., primary, Bauer, Todd M., additional, Ignatius Ou, Sai-Hong, additional, Liu, Geoffrey, additional, Hayashi, Hidetoshi, additional, Bearz, Alessandra, additional, Penkov, Konstantin, additional, Wu, Yi-Long, additional, Arrieta, Oscar, additional, Jassem, Jacek, additional, Calella, Anna M., additional, Peltz, Gerson, additional, Polli, Anna, additional, Thurm, Holger, additional, and Mok, Tony, additional

Published
2022
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45. Treatment of lung microcytoma with neuroendocrine differentiation in elderly patient

Author

Alessandra Bearz, Arben Lleshi, Lucia Fratino, Silvia Venturini, Massimiliano Berretta, and Umberto Tirelli

Subjects
Lung microcytoma, Octreotide, Comprehensive Geriatric Assessment (CGA), Elderly patient, Medicine (General), R5-920
Abstract

We describe the case of a 80-year-old patient with lung microcytoma and comorbidity (diabetes, COPD and hypertensive cardiomiopaty). To manage the complexity of the elderly patient with comorbidity, he was evaluated by a Comprehensive Geriatric Assessment (CGA). Radiotherapy and chemotherapy were excluded because of the low Performance Status of the patient. A treatment with octerotide LAR was administered, allowing a good clinical benefit.

Published
2015
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46. Brigatinib as a treatment of ALK-positive non-small cell lung cancer

Author

Alberto Revelant, Alessandra Bearz, Brigida Stanzione, Elisa De Carlo, and Alessandro Del Conte

Subjects
Pharmacology, Brigatinib, business.industry, ALK-Positive, medicine.disease, Fusion protein, respiratory tract diseases, hemic and lymphatic diseases, Drug Discovery, Genetics, medicine, Cancer research, Molecular Medicine, Anaplastic lymphoma kinase, Non small cell, Target therapy, Lung cancer, business, Gene
Abstract

Anaplastic lymphoma kinase (ALK) gene rearrangements and resulting fusion proteins occur in 3%-7% of patients with non-small-cell lung cancer (NSCLC), conferring sensitivity to treatment with ALK T...

Published
2021

48. EP02.04-001 Alectinib as Neoadjuvant Treatment in Surgically Resectable Stage III ALK-Positive NSCLC: ALNEO Phase II Trial (GOIRC-01-2020)

Author

Leonetti, A., primary, Minari, R., additional, Boni, L., additional, Gnetti, L., additional, Bordi, P., additional, Verzè, M., additional, Ampollini, L., additional, Gelsomino, F., additional, Toschi, L., additional, Cecere, F., additional, Pilotto, S., additional, Metro, G., additional, Passiglia, F., additional, Cortinovis, D., additional, Guaitoli, G., additional, Pasello, G., additional, Delmonte, A., additional, Mazzoni, F., additional, Bria, E., additional, Galetta, D., additional, Genova, C., additional, Rocco, D., additional, Soto Parra, H., additional, Bearz, A., additional, Migliorino, M.R., additional, Camerini, A., additional, Tognetto, M., additional, and Tiseo, M., additional

Published
2022
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49. Predictive value of a proteomic signature in patients with non-small-cell lung cancer treated with second-line erlotinib or chemotherapy (PROSE): a biomarker-stratified, randomised phase 3 trial

Author

Gregorc, Vanesa, Novello, Silvia, Lazzari, Chiara, Barni, Sandro, Aieta, Michele, Mencoboni, Manlio, Grossi, Francesco, Pas, Tommaso De, de Marinis, Filippo, Bearz, Alessandra, Floriani, Irene, Torri, Valter, Bulotta, Alessandra, Cattaneo, Angela, Grigorieva, Julia, Tsypin, Maxim, Roder, Joanna, Doglioni, Claudio, Levra, Matteo Giaj, Petrelli, Fausto, Foti, Silvia, Viganò, Mariagrazia, Bachi, Angela, and Roder, Heinrich

Published
2014
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