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1. Correction to: 33rd Annual Meeting & Pre-Conference Programs of the Society for Immunotherapy of Cancer (SITC 2018)

Author

Berry, Sneha, Giraldo, Nicolas, Nguyen, Peter, Green, Benjamin, Xu, Haiying, Ogurtsova, Aleksandra, Soni, Abha, Succaria, Farah, Wang, Daphne, Roberts, Charles, Stein, Julie, Engle, Elizabeth, Pardoll, Drew, Anders, Robert, Cottrell, Tricia, Taube, Janis M., Tran, Ben, Voskoboynik, Mark, Kuo, James, Bang, Yung-Lue, Chung, Hyun-Cheo, Ahn, Myung-Ju, Kim, Sang-We, Perera, Ayesh, Freeman, Daniel, Achour, Ikbel, Faggioni, Raffaella, Xiao, Feng, Ferte, Charles, Lemech, Charlotte, Meric-Bernstam, Funda, Werner, Theresa, Hodi, Stephen, Messersmith, Wells, Lewis, Nancy, Talluto, Craig, Dostalek, Mirek, Tao, Aiyang, McWhirter, Sarah, Trujillo, Damian, Luke, Jason, Xu, Chunxiao, BoMarelli, Qi, Jin, Qin, Guozhong, Yu, Huakui, Jenkins, Molly, Lo, Kin-Ming, Halle, Joern-Peter, Lan, Yan, Taylor, Matthew, Vogelzang, Nicholas, Cohn, Allen, Stepan, Daniel, Shumaker, Robert, Dutcus, Corina, Guo, Matthew, Schmidt, Emmett, Rasco, Drew, Brose, Marcia, Vogelzang, Nicholas, Di Simone, Christopher, Jain, Sharad, Richards, Donald, Encarnacion, Carlos, Rasco, Drew, Shumaker, Robert, Dutcus, Corina, Stepan, Daniel, Guo, Matthew, Schmidt, Emmett, Taylor, Matthew, Vogelzang, Nicholas, Encarnacion, Carlos, Cohn, Allen, Di Simone, Christopher, Rasco, Drew, Richards, Donald, Taylor, Matthew, Dutcus, Corina, Stepan, Daniel, Shumaker, Robert, Guo, Matthew, Schmidt, Emmett, Mier, James, An, Jeongshin, Yang, Yeun-yeoul, Lee, Won-Hee, Yang, Jinho, Kim, Jong-kyu, Kim, Hyun Goo, Paek, Se Hyun, Lee, Jun Woo, Woo, Joohyun, Kim, Jong Bin, Kwon, Hyungju, Lim, Woosung, Paik, Nam Sun, Kim, Yoon-Keun, Moon, Byung-In, Janku, Filip, Tan, David, Martin-Liberal, Juan, Takahashi, Shunji, Geva, Ravit, Gucalp, Ayca, Chen, Xueying, Subramanian, Kulandayan, Mataraza, Jennifer, Wheler, Jennifer, and Bedard, Philippe

Published
2019
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2. Lenvatinib in Combination With Pembrolizumab in Patients with Treatment-Naïve and Treatment-Experienced Metastatic Renal Cell Carcinoma: Results From a Phase 1b/2 Study

Author

Lee, Chung-Han, Shah, Amishi Yogesh, Rasco, Drew, Rao, Arpit, Taylor, Matthew H., Di Simone, Christopher, Hsieh, James J., Pinto, Alvaro, Shaffer, David R., Sarrio, Regina Girones, Cohn, Allen Lee, Vogelzang, Nicholas J., Bilen, Mehmet Asim, Ribe, Sara Gunnestad, Goksel, Musaberk, Tennøe, Øyvind Krohn, Richards, Donald, Sweis, Randy F., Courtright, Jay, Heinrich, Daniel, Jain, Sharad, Wu, Jane, Schmidt, Emmett V., Perini, Rodolfo F., Kubiak, Peter, Okpara, Chinyere E., Smith, Alan D., and Motzer, Robert J.

Subjects
Male, Time Factors, Phenylurea Compounds, Middle Aged, Antibodies, Monoclonal, Humanized, Article, Kidney Neoplasms, United States, Europe, Antineoplastic Agents, Immunological, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols, Quinolines, Humans, Female, Carcinoma, Renal Cell, Immune Checkpoint Inhibitors, Protein Kinase Inhibitors, Aged
Abstract

Despite advances in the first-line treatment of metastatic renal cell carcinoma (RCC), there is an unmet need for options to address disease progression during or after treatment with immune checkpoint inhibitors (ICIs). Pembrolizumab and lenvatinib are active as monotherapies in RCC; thus, we aimed to evaluate the combination of lenvatinib plus pembrolizumab in these patients.We report results of the metastatic RCC cohort from an open-label phase 1b/2 study of lenvatinib plus pembrolizumab in patients aged at least 18 years with selected solid tumours and an Eastern Cooperative Oncology Group performance status of 0-1. Oral lenvatinib at 20 mg was given once daily along with intravenous pembrolizumab at 200 mg once every 3 weeks. Patients remained on study drug treatment until disease progression, development of unacceptable toxicity, or withdrawal of consent. Efficacy was analysed in patients with clear cell metastatic RCC receiving study drug by previous therapy grouping: treatment naive, previously treated ICI naive (previously treated with at least one line of therapy but not with an anti-PD-1 or anti-PD-L1 ICI), and ICI pretreated (ie, anti-PD-1 or anti-PD-L1) patients. Safety was analysed in all enrolled and treated patients. The primary endpoint was the objective response rate at week 24 per immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) by investigator assessment. This trial is registered with ClinicalTrials.gov (NCT02501096) and with the EU Clinical Trials Register (EudraCT2017-000300-26), and is closed to new participants.Between July 21, 2015, and Oct 16, 2019, 145 patients were enrolled in the study. Two patients had non-clear cell RCC and were excluded from the efficacy analysis (one in the treatment-naive group and one in the ICI-pretreated group); thus, the population evaluated for efficacy comprised 143 patients (n=22 in the treatment-naive group, n=17 in the previously treated ICI-naive group, and n=104 in the ICI-pretreated group). All 145 enrolled patients were included in the safety analysis. The median follow-up was 19·8 months (IQR 14·3-28·4). The number of patients with an objective response at week 24 by irRECIST was 16 (72·7%, 95% CI 49·8-89·3) of 22 treatment-naive patients, seven (41·2%, 18·4-67·1) of 17 previously treated ICI-naive patients, and 58 (55·8%, 45·7-65·5) of 104 ICI-pretreated patients. Of 145 patients, 82 (57%) had grade 3 treatment-related adverse events and ten (7%) had grade 4 treatment-related adverse events. The most common grade 3 treatment-related adverse event was hypertension (30 [21%] of 145 patients). Treatment-related serious adverse events occurred in 36 (25%) patients, and there were three treatment-related deaths (upper gastrointestinal haemorrhage, sudden death, and pneumonia).Lenvatinib plus pembrolizumab showed encouraging antitumour activity and a manageable safety profile and might be an option for post-ICI treatment of metastatic RCC.Eisai and Merck SharpDohme.

Published
2021

3. The Membrane Fusion Activities of Native and Reconstituted Mumps and Sendai Viruses

Author

Di Simone, Christopher, Di Simone, Christopher, Di Simone, Christopher, and Di Simone, Christopher

Abstract

The structure and activities of whole and reconstituted Sendai and mumps viruses were examined using a number of physical and biological techniques: electron microscopy, photon correlation spectroscopy, perturbed angular correlation spectroscopy, gel electrophoresis, hemagglutination assays, plaque assays, fluorescence microscopy and fluorescent assays of membrane fusion. The fluorescent probe octadecyl rhodamine (RIB) was found to have a proximal transfer behavior which reduced usage of the probe as a membrane fusion indicator to short time periods. Simple bireactant and mass action kinetic models were sufficent to fit the data provided by the fluorescent assays on viral fusion with cell membranes. The reconstitution of mumps virus was optimized by using the detergent Triton X-IOO. Reconstituted virus envelopes which were the same size as whole virus and which were active in binding and fusing to cells were produced. The reconstituted Sendai and mumps virus accumulated in the reticuloendothelial system when injected into mice and hamsters, respectively. The kinetics of the membrane fusion activity of mumps with ghost erythrocytes and CV-I cells was measured and analysed. A general rate of reaction of 3 (±1) x 10^9 M^-l sec^-1 was found. The membrane fusion activity of reconstituted Sendai with HL60, U937, Cos, H9 and PBL cell lines was also measured and analyzed. The fusion activity was utilized to deliver plasmids for transfection to the interiors of the HL60 and Cos cells. Luciferase expression was found in the Cos cells but not in the HL60 cells. Loading of plasm ids into the vesicle interiors was enhanced by a factor of ten by complexing the DNA with the positive proteins polylysine, lysozyme and protamine.

Published
1992

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