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1. Figure S4 from Differential Expression of OATP1B3 Mediates Unconjugated Testosterone Influx

Author

Sissung, Tristan M., primary, Ley, Ariel M., primary, Strope, Jonathan D., primary, McCrea, Edel M., primary, Beedie, Shaunna, primary, Peer, Cody J., primary, Shukla, Suneet, primary, van Velkinburgh, Jennifer, primary, Reece, Kelie, primary, Troutman, Sarah, primary, Campbell, Tessa, primary, Fernandez, Elena, primary, Huang, Phoebe, primary, Smith, Jordan, primary, Thakkar, Nilay, primary, Venzon, David J., primary, Brenner, Stefan, primary, Lee, Wooin, primary, Merino, Maria, primary, Luo, Ji, primary, Jager, Walter, primary, Price, Douglas K., primary, Chau, Cindy H., primary, and Figg, William D., primary

Published
2023
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2. Data from Differential Expression of OATP1B3 Mediates Unconjugated Testosterone Influx

Author

Sissung, Tristan M., primary, Ley, Ariel M., primary, Strope, Jonathan D., primary, McCrea, Edel M., primary, Beedie, Shaunna, primary, Peer, Cody J., primary, Shukla, Suneet, primary, van Velkinburgh, Jennifer, primary, Reece, Kelie, primary, Troutman, Sarah, primary, Campbell, Tessa, primary, Fernandez, Elena, primary, Huang, Phoebe, primary, Smith, Jordan, primary, Thakkar, Nilay, primary, Venzon, David J., primary, Brenner, Stefan, primary, Lee, Wooin, primary, Merino, Maria, primary, Luo, Ji, primary, Jager, Walter, primary, Price, Douglas K., primary, Chau, Cindy H., primary, and Figg, William D., primary

Published
2023
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3. Supplemental Figure Legends from Differential Expression of OATP1B3 Mediates Unconjugated Testosterone Influx

Author

Sissung, Tristan M., primary, Ley, Ariel M., primary, Strope, Jonathan D., primary, McCrea, Edel M., primary, Beedie, Shaunna, primary, Peer, Cody J., primary, Shukla, Suneet, primary, van Velkinburgh, Jennifer, primary, Reece, Kelie, primary, Troutman, Sarah, primary, Campbell, Tessa, primary, Fernandez, Elena, primary, Huang, Phoebe, primary, Smith, Jordan, primary, Thakkar, Nilay, primary, Venzon, David J., primary, Brenner, Stefan, primary, Lee, Wooin, primary, Merino, Maria, primary, Luo, Ji, primary, Jager, Walter, primary, Price, Douglas K., primary, Chau, Cindy H., primary, and Figg, William D., primary

Published
2023
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4. Table S1 from Differential Expression of OATP1B3 Mediates Unconjugated Testosterone Influx

Author

Sissung, Tristan M., primary, Ley, Ariel M., primary, Strope, Jonathan D., primary, McCrea, Edel M., primary, Beedie, Shaunna, primary, Peer, Cody J., primary, Shukla, Suneet, primary, van Velkinburgh, Jennifer, primary, Reece, Kelie, primary, Troutman, Sarah, primary, Campbell, Tessa, primary, Fernandez, Elena, primary, Huang, Phoebe, primary, Smith, Jordan, primary, Thakkar, Nilay, primary, Venzon, David J., primary, Brenner, Stefan, primary, Lee, Wooin, primary, Merino, Maria, primary, Luo, Ji, primary, Jager, Walter, primary, Price, Douglas K., primary, Chau, Cindy H., primary, and Figg, William D., primary

Published
2023
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6. FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Author

Duke, Elizabeth S., primary, Stapleford, Liza, additional, Drezner, Nicole, additional, Amatya, Anup K., additional, Mishra-Kalyani, Pallavi S., additional, Shen, Yuan-Li, additional, Maxfield, Kimberly, additional, Zirkelbach, Jeanne Fourie, additional, Bi, Youwei, additional, Liu, Jiang, additional, Zhang, Xinyuan, additional, Wang, Hezhen, additional, Yang, Yuching, additional, Zheng, Nan, additional, Reece, Kelie, additional, Wearne, Emily, additional, Glen, Jacqueline J., additional, Ojofeitimi, Idara, additional, Scepura, Barbara, additional, Nair, Abhilasha, additional, Bikkavilli, Rama Kamesh, additional, Ghosh, Soma, additional, Philip, Reena, additional, Pazdur, Richard, additional, Beaver, Julia A., additional, Singh, Harpreet, additional, and Donoghue, Martha, additional

Published
2022
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7. FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Author

Mathieu, Luckson N., primary, Larkins, Erin, additional, Akinboro, Oladimeji, additional, Roy, Pourab, additional, Amatya, Anup K., additional, Fiero, Mallorie H., additional, Mishra-Kalyani, Pallavi S., additional, Helms, Whitney S., additional, Myers, Claire E., additional, Skinner, Amy M., additional, Aungst, Stephanie, additional, Jin, Runyan, additional, Zhao, Hong, additional, Xia, Huiming, additional, Zirkelbach, Jeanne Fourie, additional, Bi, Youwei, additional, Li, Yangbing, additional, Liu, Jiang, additional, Grimstein, Manuela, additional, Zhang, Xinyuan, additional, Woods, Stacie, additional, Reece, Kelie, additional, Abukhdeir, Abdelrahmman M., additional, Ghosh, Soma, additional, Philip, Reena, additional, Tang, Shenghui, additional, Goldberg, Kirsten B., additional, Pazdur, Richard, additional, Beaver, Julia A., additional, and Singh, Harpreet, additional

Published
2022
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9. FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma.

Author

Nair, Abhilasha, Reece, Kelie, Donoghue, Martha B., Yuan, Weishi (Vivian), Rodriguez, Lisa, Keegan, Patricia, and Pazdur, Richard

Subjects
DRUG approval, CONFIDENCE intervals, CANCER chemotherapy, RANDOMIZED controlled trials, PROTEIN-tyrosine kinases, DESCRIPTIVE statistics, VASCULAR endothelial growth factors, HEPATOCELLULAR carcinoma
Abstract

On August 16, 2018, the U.S. Food and Drug Administration approved lenvatinib (Lenvima, Eisai Inc.) for first‐line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open‐label, noninferiority trial (REFLECT; NCT01761266) conducted in 954 patients with previously untreated metastatic or unresectable HCC. Patients were randomized (1:1) to receive lenvatinib (12 mg orally once daily for patients with a baseline body weight ≥60 kg and 8 mg orally once daily for patients with a baseline body weight <60 kg) or sorafenib (400 mg orally twice daily) until radiological disease progression or unacceptable toxicity. REFLECT demonstrated that lenvatinib was noninferior but not statistically superior to sorafenib for overall survival (OS; hazard ratio, [HR] 0.92; 95% confidence intervals [CI], 0.79–1.06), with median OS of 13.6 and 12.3 months in the lenvatinib and sorafenib arms, respectively. REFLECT also demonstrated statistically significant improvements in investigator‐assessed progression‐free survival (PFS; HR, 0.66; 95% CI, 0.57–0.77]; p < 0.001), corresponding to median PFS of 7.4 and 3.7 months and overall response rate of 24.1% vs 9.2% per modified RECIST for HCC (mRECIST) in the lenvatinib and sorafenib arms, respectively. Consistent results were observed by an independent review facility per RECISTv1.1 and per mRECIST. The most common adverse reactions observed in the lenvatinib‐treated patients (≥20%) in decreasing frequency were hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar‐plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea. Implications for Practice: This article describes the U.S. Food and Drug Administration's review of data from a single trial, REFLECT, that supported the approval of lenvatinib, as a single agent, for the first‐line treatment of unresectable hepatocellular carcinoma (HCC). REFLECT was an open‐label, noninferiority trial that randomized 954 patients with HCC who were ineligible for liver‐directed therapy with no prior systemic therapy for HCC to lenvatinib or sorafenib. REFLECT demonstrated that lenvatinib‐treated patients had similar survival, more responses, and longer time to progression than those receiving sorafenib. Serious side effects were more common among lenvatinib‐treated patients. Lenvatinib is an effective treatment for patients with previously untreated HCC. This article reviews the data and basis for FDA approval of lenvatinib for the first‐line treatment of patients with unresectable hepatocellular carcinoma. [ABSTRACT FROM AUTHOR]

Published
2021
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10. Differential Expression of OATP1B3 Mediates Unconjugated Testosterone Influx

Author

Sissung, Tristan M., primary, Ley, Ariel M., additional, Strope, Jonathan D., additional, McCrea, Edel M., additional, Beedie, Shaunna, additional, Peer, Cody J., additional, Shukla, Suneet, additional, van Velkinburgh, Jennifer, additional, Reece, Kelie, additional, Troutman, Sarah, additional, Campbell, Tessa, additional, Fernandez, Elena, additional, Huang, Phoebe, additional, Smith, Jordan, additional, Thakkar, Nilay, additional, Venzon, David J., additional, Brenner, Stefan, additional, Lee, Wooin, additional, Merino, Maria, additional, Luo, Ji, additional, Jager, Walter, additional, Price, Douglas K., additional, Chau, Cindy H., additional, and Figg, William D., additional

Published
2017
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14. Epidithiodiketopiperazines (ETPs) exhibit in vitro antiangiogenic and in vivo antitumor activity by disrupting the HIF-1α/p300 complex in a preclinical model of prostate cancer

Author

Reece, Kelie M, primary, Richardson, Emily D, additional, Cook, Kristina M, additional, Campbell, Tessa J, additional, Pisle, Stephen T, additional, Holly, Alesia J, additional, Venzon, David J, additional, Liewehr, David J, additional, Chau, Cindy H, additional, Price, Douglas K, additional, and Figg, William D, additional

Published
2014
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27. Dual Targeting of the Androgen Receptor and Hypoxia-Inducible Factor 1αPathways Synergistically Inhibits Castration-Resistant Prostate Cancer Cells

Author

Fernandez, Elena V., Reece, Kelie M., Ley, Ariel M., Troutman, Sarah M., Sissung, Tristan M., Price, Douglas K., Chau, Cindy H., and Figg, William D.

Abstract

Enzalutamide is a potent second-generation androgen receptor (AR) antagonist with activity in metastatic castrate-resistant prostate cancer (CRPC). Although enzalutamide is initially effective, disease progression inevitably ensues with the emergence of resistance. Intratumoral hypoxia is also associated with CRPC progression and treatment resistance. Given that both AR and hypoxia inducible factor-1 α(HIF-1α) are key regulators of these processes, dual targeting of both signaling axes represents an attractive therapeutic approach. Crosstalk of the AR and HIF-1αsignaling pathways were examined in prostate cancer cell lines (LNCaP, 22Rv1) with assays measuring the effect of androgen and hypoxia on AR-dependent and hypoxia-inducible gene transcription, protein expression, cell proliferation, and apoptosis. HIF-1αinhibition was achieved by siRNA silencing HIF-1αor via chetomin, a disruptor of HIF-1α-p300 interactions. In prostate cancer cells, the gene expression of AR targets (KLK3, FKBP5, TMPRSS2) was repressed by HIF-signaling; conversely, specific HIF-1αtarget expression was induced by dihydrotestosterone-mediated AR signaling. Treatment of CRPC cells with enzalutamide or HIF-1αinhibition attenuated AR-regulated and HIF-1α–mediated gene transcription. The combination of enzalutamide and HIF-1αinhibition was more effective than either treatment alone. Similarly, the combination also reduced vascular endothelial growth factor protein levels. HIF-1αsiRNA synergistically enhanced the inhibitory effect of enzalutamide on cell growth in LNCaP and enzalutamide-resistant 22Rv1 cells via increased enzalutamide-induced apoptosis. In conclusion, the combination of enzalutamide with HIF-1αinhibition resulted in synergistic inhibition of AR-dependent and gene-specific HIF-dependent expression and prostate cancer cell growth.

Published
2015
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28. FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.

Author

Duke ES, Stapleford L, Drezner N, Amatya AK, Mishra-Kalyani PS, Shen YL, Maxfield K, Zirkelbach JF, Bi Y, Liu J, Zhang X, Wang H, Yang Y, Zheng N, Reece K, Wearne E, Glen JJ, Ojofeitimi I, Scepura B, Nair A, Bikkavilli RK, Ghosh S, Philip R, Pazdur R, Beaver JA, Singh H, and Donoghue M

Subjects
Adult, Humans, Mutagenesis, Insertional, Protein Kinase Inhibitors adverse effects, ErbB Receptors genetics, Exons, Mutation, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung genetics, Carcinoma, Non-Small-Cell Lung pathology, Lung Neoplasms drug therapy, Lung Neoplasms genetics, Lung Neoplasms pathology
Abstract

On September 15, 2021, the FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals USA, Inc.) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The approval was based on data from Study AP32788-15-101 (NCT02716116), an international, non-randomized, multi-cohort clinical trial that included patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The overall response rate in 114 patients whose disease had progressed on or after platinum-based chemotherapy was 28% [95% confidence interval (CI), 20%-37%] with a median duration of response of 17.5 months (95% CI, 7.4-20.3). The most common adverse reactions (>20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. Product labeling includes a Boxed Warning for QTc prolongation and torsades de pointes. This is the first approval of an oral targeted therapy for patients with advanced EGFR exon 20 insertion mutation-positive NSCLC., (©2022 American Association for Cancer Research.)

Published
2023
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