Search Results - "Samineni, Divya"

Model‐Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates? by Liao, Michael Z., Lu, Dan, Kågedal, Matts, Miles, Dale, Samineni, Divya, Liu, Stephanie N., Li, Chunze

“…Antibody–drug conjugates (ADCs) combine the specificity of an antibody with the cytotoxicity of a chemical agent. They represent a rapidly evolving area of…”
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A randomized trial of quilizumab in adults with refractory chronic spontaneous urticaria by Harris, Jeffrey M., MD, PhD, Cabanski, Christopher R., PhD, Scheerens, Heleen, PhD, Samineni, Divya, PhD, Bradley, Mary S., MS, Cochran, Colette, BSN, Staubach, Petra, MD, Metz, Martin, MD, Sussman, Gordon, MD, FRCPC, Maurer, Marcus, MD

“…To the Editor: Chronic spontaneous urticaria (CSU) presents as recurrent itchy wheals, angioedema, or both for at least 6 weeks without a specific trigger.1…”
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Clinical pharmacology of vc-MMAE antibody-drug conjugates in cancer patients: learning from eight first-in-human Phase 1 studies by Li, Chunze, Zhang, Cindy, Li, Zao, Samineni, Divya, Lu, Dan, Wang, Bei, Chen, Shang-Chiung, Zhang, Rong, Agarwal, Priya, Fine, Bernard M, Girish, Sandhya

“…vc-MMAE antibody-drug conjugates (ADCs) consist of a monoclonal antibody (mAb) covalently bound with a potent anti-mitotic toxin (MMAE) through a…”
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Phase I study of the anti-FcRH5 antibody-drug conjugate DFRF4539A in relapsed or refractory multiple myeloma by Stewart, A. Keith, Krishnan, Amrita Y., Singhal, Seema, Boccia, Ralph V., Patel, Manish R., Niesvizky, Ruben, Chanan-Khan, Asher A., Ailawadhi, Sikander, Brumm, Jochen, Mundt, Kirsten E., Hong, Kyu, McBride, Jacqueline, Shon-Nguyen, Quyen, Xiao, Yuanyuan, Ramakrishnan, Vanitha, Polson, Andrew G., Samineni, Divya, Leipold, Douglas, Humke, Eric W., McClellan, James Scott, Berdeja, Jesus G.

“…FcRH5 is a cell surface marker enriched on malignant plasma cells when compared to other hematologic malignancies and normal tissues. DFRF4539A is an…”
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Physiologically Based Pharmacokinetic Modeling as a Tool to Predict Drug Interactions for Antibody-Drug Conjugates by Chen, Yuan, Samineni, Divya, Mukadam, Sophie, Wong, Harvey, Shen, Ben-Quan, Lu, Dan, Girish, Sandhya, Hop, Cornelis, Jin, Jin Yan, Li, Chunze

“…Background and Objectives Monomethyl auristatin E (MMAE, a cytotoxic agent), upon releasing from valine-citrulline-MMAE (vc-MMAE) antibody-drug conjugates…”
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Prediction of Human Pharmacokinetics of Antibody–Drug Conjugates From Nonclinical Data by Li, Chunze, Zhang, Cindy, Deng, Rong, Leipold, Douglas, Li, Dongwei, Latifi, Brandon, Gao, Yuying, Zhang, Crystal, Li, Zao, Miles, Dale, Chen, Shang‐Chiung, Samineni, Divya, Wang, Bei, Agarwal, Priya, Lu, Dan, Prabhu, Saileta, Girish, Sandhya, Kamath, Amrita V.

“…Prediction of human pharmacokinetics (PK) based on preclinical information for antibody–drug conjugates (ADCs) provide important insight into first‐in‐human…”
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Time‐to‐Event Modeling of Peripheral Neuropathy: Platform Analysis of Eight Valine‐Citrulline‐Monomethylauristatin E Antibody–Drug Conjugates by Kågedal, Matts, Samineni, Divya, Gillespie, William R., Lu, Dan, Fine, Bernard M., Girish, Sandhya, Li, Chunze, Jin, Jin Y.

“…Peripheral neuropathy (PN) is a common long‐term debilitating toxicity of antimicrotubule agents. PN was the most frequent adverse event resulting in dose…”
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Quantification of human hepatocyte cytochrome P450 enzymes and transporters induced by HIV protease inhibitors using newly validated LC-MS/MS cocktail assays and RT-PCR by Liu, Li, Mugundu, Ganesh M., Kirby, Brian J., Samineni, Divya, Desai, Pankaj B., Unadkat, Jashvant D.

“…ABSTRACT Human immunodeficiency virus (HIV) protease inhibitors (PIs) produce profound and unpredictable drug–drug interactions (DDIs) that cannot be explained…”
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A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma by Morschhauser, Franck, Feugier, Pierre, Flinn, Ian W., Gasiorowski, Robin, Greil, Richard, Illés, Árpád, Johnson, Nathalie A., Larouche, Jean-François, Lugtenburg, Pieternella J., Patti, Caterina, Salles, Gilles A., Trněný, Marek, de Vos, Sven, Mir, Farheen, Samineni, Divya, Kim, Su Y., Jiang, Yanwen, Punnoose, Elizabeth, Sinha, Arijit, Clark, Emma, Spielewoy, Nathalie, Humphrey, Kathryn, Bazeos, Alexandra, Zelenetz, Andrew D.

“…The phase 2 CAVALLI (NCT02055820) study assessed efficacy and safety of venetoclax, a selective B-cell lymphoma-2 (Bcl-2) inhibitor, with rituximab plus…”
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Multiple Myeloma Disease Model to Predict PFS Outcomes across Lines of Therapy, an Analysis Based on Commpass Observational Study by Chanu, Pascal, Balasubramanian, Sandhya, Samineni, Divya, Susilo, Monica, Onishi, Maika, Castro, Felipe A, Breuleux, Madlaina, Jin, Jin, Li, Chunze, Bruno, René

“…Introduction Multiple Myeloma (MM) remains incurable despite advances in treatment. Model-based approaches based on tumor dynamics have successfully been used…”
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Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial by Zelenetz, Andrew D., Salles, Gilles, Mason, Kylie D., Casulo, Carla, Le Gouill, Steven, Sehn, Laurie H., Tilly, Herve, Cartron, Guillaume, Chamuleau, Martine E.D., Goy, Andre, Tam, Constantine S., Lugtenburg, Pieternella J., Petrich, Adam M., Sinha, Arijit, Samineni, Divya, Herter, Sylvia, Ingalla, Ellen, Szafer-Glusman, Edith, Klein, Christian, Sampath, Deepak, Kornacker, Martin, Mobasher, Mehrdad, Morschhauser, Franck

“…Novel strategies, such as chemosensitization with targeted agents, that build on the success of standard immunochemotherapy show promise for the treatment of…”
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Venetoclax-rituximab with or without bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma by Zinzani, Pier Luigi, Flinn, Ian W., Yuen, Sam L.S., Topp, Max S., Rusconi, Chiara, Fleury, Isabelle, Le Dû, Katell, Arthur, Christopher, Pro, Barbara, Gritti, Giuseppe, Crump, Michael, Petrich, Adam, Samineni, Divya, Sinha, Arijit, Punnoose, Elizabeth A., Szafer-Glusman, Edith, Spielewoy, Nathalie, Mobasher, Mehrdad, Humphrey, Kathryn, Kornacker, Martin, Hiddemann, Wolfgang

“…This open-label phase 2 study (CONTRALTO) assessed the safety and efficacy of BCL-2 inhibitor venetoclax (VEN) plus rituximab (R), and VEN plus bendamustine…”
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Abstract 641: Clinical assessment of the bioavailability of venetoclax tablet and powder formulations by Badawi, Mohamed, Tong, Bo, Chen, Xin, Palenski, Tammy, Kim, Su Young, Samineni, Divya, Hoffman, David, Menon, Rajeev, Salem, Ahmed Hamed

“…Abstract Venetoclax is a first in class BCL-2 inhibitor that is approved for treatment of CLL and AML. It is currently under evaluation in other indications in…”
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Clinical pharmacology strategies to accelerate the development of polatuzumab vedotin and summary of key findings by Liao, Michael Z., Lu, Dan, Lu, Tong, Gibiansky, Leonid, Deng, Rong, Samineni, Divya, Dere, Randall, Lin, Andy, Hirata, Jamie, Shen, Ben-Quan, Zhang, Donglu, Li, Dongwei, Li, Chunze, Miles, Dale

“…[Display omitted] The favorable benefit–risk profile of polatuzumab vedotin, as demonstrated in a pivotal Phase Ib/II randomized study (GO29365; NCT02257567),…”
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CAMMA 1: A multicenter phase Ib trial evaluating the safety, pharmacokinetics, and activity of cevostamab-containing regimens in patients with relapsed or refractory multiple myeloma by Vij, Ravi, Schade, Henning, Trudel, Suzanne, Chang, Alice C., Huang, Jiangeng, Samineni, Divya, Sumiyoshi, Teiko, Tsai, Jennifer, Wong, Tiffany, Harrison, Simon J.

“…TPS8069 Background: Treatment of relapsed/refractory (R/R) multiple myeloma (MM) is challenging, especially in later lines where drug resistance reduces…”
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Abstract 3024: Relationship between venetoclax concentrations and undetectable MRD in patients with chronic lymphocytic leukemia by Gopalakrishnan, Sathej, Menon, Rajeev, Chyla, Brenda, Samineni, Divya, Jacobson, Amanda, Kim, Su Young, Mensing, Sven, Salem, Ahmed Hamed

“…Abstract Minimal residual disease (MRD) is an important clinical endpoint in chronic lymphocytic leukemia (CLL) because it correlates with progression free…”
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Impact of Shed/Soluble targets on the PK/PD of approved therapeutic monoclonal antibodies by Samineni, Divya, Girish, Sandhya, Li, Chunze

“…Suboptimal treatment for monoclonal antibodies (mAbs) directed against endogenous circulating soluble targets and the shed extracellular domains (ECD) of the…”
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CAMMA 2: A phase I/II trial evaluating the efficacy and safety of cevostamab in patients with relapsed/refractory multiple myeloma (RRMM) who have triple-class refractory disease and have received a prior anti-B-cell maturation antigen (BCMA) agent by Kumar, Shaji, Bachier, Carlos R., Cavo, Michele, Corradini, Paolo, Delforge, Michel, Janowski, Wojt, Lesokhin, Alexander M., Mina, Roberto, Paris, Laura, Rosiñol, Laura, Quach, Hang, Goodman, Grant R., Nakamura, Rin, Samineni, Divya, Shah, Vallari, Wassner Fritsch, Elisabeth, Berdeja, Jesus G.

“…TPS8064 Background: Multiple myeloma (MM) remains an incurable disease. Combinations of established agents, including proteasome inhibitors (PIs),…”
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Physiologically Based Pharmacokinetic Model‐Informed Drug Development for Polatuzumab Vedotin: Label for Drug‐Drug Interactions Without Dedicated Clinical Trials by Samineni, Divya, Ding, Hao, Ma, Fang, Shi, Rong, Lu, Dan, Miles, Dale, Mao, Jialin, Li, Chunze, Jin, Jin, Wright, Matthew, Girish, Sandhya, Chen, Yuan

“…Model‐informed drug development (MIDD) has become an important approach to improving clinical trial efficiency, optimizing drug dosing, and proposing drug…”
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Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper by Samineni, Divya, Venkatakrishnan, Karthik, Othman, Ahmed A., Pithavala, Yazdi K., Poondru, Srinivasu, Patel, Chirag, Vaddady, Pavan, Ankrom, Wendy, Ramanujan, Saroja, Budha, Nageshwar, Wu, Michael, Haddish‐Berhane, Nahor, Fritsch, Holger, Hussain, Azher, Kanodia, Jitendra, Li, Meng, Li, Mengyao, Melhem, Murad, Parikh, Apurvasena, Upreti, Vijay V., Gupta, Neeraj

“…The landscape of oncology drug development has witnessed remarkable advancements over the last few decades, significantly improving clinical outcomes and…”
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