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2. Multi-omic profiling reveals discrepant immunogenic properties and a unique tumor microenvironment among melanoma brain metastases

Author

In, Gino K, Ribeiro, Jennifer R, Yin, Jun, Xiu, Joanne, Bustos, Matias A, Ito, Fumito, Chow, Frances, Zada, Gabriel, Hwang, Lindsay, Salama, April KS, Park, Soo J, Moser, Justin C, Darabi, Sourat, Domingo-Musibay, Evidio, Ascierto, Maria L, Margolin, Kim, Lutzky, Jose, Gibney, Geoffrey T, Atkins, Michael B, Izar, Benjamin, Hoon, Dave SB, and VanderWalde, Ari M

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Immunization, Brain Disorders, Cancer, Inflammatory and immune system, Oncology and carcinogenesis
Abstract

Melanoma brain metastases (MBM) are clinically challenging to treat and exhibit variable responses to immune checkpoint therapies. Prior research suggests that MBM exhibit poor tumor immune responses and are enriched in oxidative phosphorylation. Here, we report results from a multi-omic analysis of a large, real-world melanoma cohort. MBM exhibited lower interferon-gamma (IFNγ) scores and T cell-inflamed scores compared to primary cutaneous melanoma (PCM) or extracranial metastases (ECM), which was independent of tumor mutational burden. Among MBM, there were fewer computationally inferred immune cell infiltrates, which correlated with lower TNF and IL12B mRNA levels. Ingenuity pathway analysis (IPA) revealed suppression of inflammatory responses and dendritic cell maturation pathways. MBM also demonstrated a higher frequency of pathogenic PTEN mutations and angiogenic signaling. Oxidative phosphorylation (OXPHOS) was enriched in MBM and negatively correlated with NK cell and B cell-associated transcriptomic signatures. Modulating metabolic or angiogenic pathways in MBM may improve responses to immunotherapy in this difficult-to-treat patient subset.

Published
2023

3. Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma

Author

Liau, Linda M, Ashkan, Keyoumars, Brem, Steven, Campian, Jian L, Trusheim, John E, Iwamoto, Fabio M, Tran, David D, Ansstas, George, Cobbs, Charles S, Heth, Jason A, Salacz, Michael E, D’Andre, Stacy, Aiken, Robert D, Moshel, Yaron A, Nam, Joo Y, Pillainayagam, Clement P, Wagner, Stephanie A, Walter, Kevin A, Chaudhary, Rekha, Goldlust, Samuel A, Lee, Ian Y, Bota, Daniela A, Elinzano, Heinrich, Grewal, Jai, Lillehei, Kevin, Mikkelsen, Tom, Walbert, Tobias, Abram, Steven, Brenner, Andrew J, Ewend, Matthew G, Khagi, Simon, Lovick, Darren S, Portnow, Jana, Kim, Lyndon, Loudon, William G, Martinez, Nina L, Thompson, Reid C, Avigan, David E, Fink, Karen L, Geoffroy, Francois J, Giglio, Pierre, Gligich, Oleg, Krex, Dietmar, Lindhorst, Scott M, Lutzky, Jose, Meisel, Hans-Jörg, Nadji-Ohl, Minou, Sanchin, Lhagva, Sloan, Andrew, Taylor, Lynne P, Wu, Julian K, Dunbar, Erin M, Etame, Arnold B, Kesari, Santosh, Mathieu, David, Piccioni, David E, Baskin, David S, Lacroix, Michel, May, Sven-Axel, New, Pamela Z, Pluard, Timothy J, Toms, Steven A, Tse, Victor, Peak, Scott, Villano, John L, Battiste, James D, Mulholland, Paul J, Pearlman, Michael L, Petrecca, Kevin, Schulder, Michael, Prins, Robert M, Boynton, Alton L, and Bosch, Marnix L

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Prevention, Brain Disorders, Brain Cancer, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Rare Diseases, Neurosciences, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Humans, Glioblastoma, Temozolomide, Prospective Studies, Brain Neoplasms, Recurrence, Dendritic Cells, Vaccination, Public Health and Health Services, Oncology and carcinogenesis
Abstract

ImportanceGlioblastoma is the most lethal primary brain cancer. Clinical outcomes for glioblastoma remain poor, and new treatments are needed.ObjectiveTo investigate whether adding autologous tumor lysate-loaded dendritic cell vaccine (DCVax-L) to standard of care (SOC) extends survival among patients with glioblastoma.Design, setting, and participantsThis phase 3, prospective, externally controlled nonrandomized trial compared overall survival (OS) in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) treated with DCVax-L plus SOC vs contemporaneous matched external control patients treated with SOC. This international, multicenter trial was conducted at 94 sites in 4 countries from August 2007 to November 2015. Data analysis was conducted from October 2020 to September 2021.InterventionsThe active treatment was DCVax-L plus SOC temozolomide. The nGBM external control patients received SOC temozolomide and placebo; the rGBM external controls received approved rGBM therapies.Main outcomes and measuresThe primary and secondary end points compared overall survival (OS) in nGBM and rGBM, respectively, with contemporaneous matched external control populations from the control groups of other formal randomized clinical trials.ResultsA total of 331 patients were enrolled in the trial, with 232 randomized to the DCVax-L group and 99 to the placebo group. Median OS (mOS) for the 232 patients with nGBM receiving DCVax-L was 19.3 (95% CI, 17.5-21.3) months from randomization (22.4 months from surgery) vs 16.5 (95% CI, 16.0-17.5) months from randomization in control patients (HR = 0.80; 98% CI, 0.00-0.94; P = .002). Survival at 48 months from randomization was 15.7% vs 9.9%, and at 60 months, it was 13.0% vs 5.7%. For 64 patients with rGBM receiving DCVax-L, mOS was 13.2 (95% CI, 9.7-16.8) months from relapse vs 7.8 (95% CI, 7.2-8.2) months among control patients (HR, 0.58; 98% CI, 0.00-0.76; P

Published
2023

7. PD-L1 blockade in combination with inhibition of MAPK oncogenic signaling in patients with advanced melanoma.

Author

Ribas, Antoni, Algazi, Alain, Ascierto, Paolo A, Butler, Marcus O, Chandra, Sunandana, Gordon, Michael, Hernandez-Aya, Leonel, Lawrence, Donald, Lutzky, Jose, Miller, Wilson H, Campbell, Katie M, Delafont, Bruno, Marshall, Shannon, Mueller, Nancy, and Robert, Caroline

Subjects
Humans, Melanoma, Skin Neoplasms, Exanthema, Diarrhea, Oximes, Imidazoles, Pyridones, Pyrimidinones, Proto-Oncogene Proteins B-raf, Mitogen-Activated Protein Kinases, Antineoplastic Combined Chemotherapy Protocols, Antibodies, Monoclonal, Cohort Studies, Mutation, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Young Adult, B7-H1 Antigen, Progression-Free Survival
Abstract

Combining PD-L1 blockade with inhibition of oncogenic mitogen-activated protein kinase (MAPK) signaling may result in long-lasting responses in patients with advanced melanoma. This phase 1, open-label, dose-escalation and -expansion study (NCT02027961) investigated safety, tolerability and preliminary efficacy of durvalumab (anti-PD-L1) combined with dabrafenib (BRAF inhibitor) and trametinib (MEK inhibitor) for patients with BRAF-mutated melanoma (cohort A, n = 26), or durvalumab and trametinib given concomitantly (cohort B, n = 20) or sequentially (cohort C, n = 22) for patients with BRAF-wild type melanoma. Adverse events and treatment discontinuation rates were more common than previously reported for these agents given as monotherapy. Objective responses were observed in 69.2% (cohort A), 20.0% (cohort B) and 31.8% (cohort C) of patients, with evidence of improved tumor immune infiltration and durable responses in a subset of patients with available biopsy samples. In conclusion, combined MAPK inhibition and anti-PD-L1 therapy may provide treatment options for patients with advanced melanoma.

Published
2020

9. First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma

Author

Liau, Linda M, Ashkan, Keyoumars, Tran, David D, Campian, Jian L, Trusheim, John E, Cobbs, Charles S, Heth, Jason A, Salacz, Michael, Taylor, Sarah, D’Andre, Stacy D, Iwamoto, Fabio M, Dropcho, Edward J, Moshel, Yaron A, Walter, Kevin A, Pillainayagam, Clement P, Aiken, Robert, Chaudhary, Rekha, Goldlust, Samuel A, Bota, Daniela A, Duic, Paul, Grewal, Jai, Elinzano, Heinrich, Toms, Steven A, Lillehei, Kevin O, Mikkelsen, Tom, Walbert, Tobias, Abram, Steven R, Brenner, Andrew J, Brem, Steven, Ewend, Matthew G, Khagi, Simon, Portnow, Jana, Kim, Lyndon J, Loudon, William G, Thompson, Reid C, Avigan, David E, Fink, Karen L, Geoffroy, Francois J, Lindhorst, Scott, Lutzky, Jose, Sloan, Andrew E, Schackert, Gabriele, Krex, Dietmar, Meisel, Hans-Jorg, Wu, Julian, Davis, Raphael P, Duma, Christopher, Etame, Arnold B, Mathieu, David, Kesari, Santosh, Piccioni, David, Westphal, Manfred, Baskin, David S, New, Pamela Z, Lacroix, Michel, May, Sven-Axel, Pluard, Timothy J, Tse, Victor, Green, Richard M, Villano, John L, Pearlman, Michael, Petrecca, Kevin, Schulder, Michael, Taylor, Lynne P, Maida, Anthony E, Prins, Robert M, Cloughesy, Timothy F, Mulholland, Paul, and Bosch, Marnix L

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Brain Cancer, Neurosciences, Immunization, Clinical Research, Cancer, Brain Disorders, Rare Diseases, Patient Safety, Prevention, Vaccine Related, Orphan Drug, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Brain Neoplasms, Cancer Vaccines, Dendritic Cells, Endpoint Determination, Female, Glioblastoma, Humans, Male, Middle Aged, Prognosis, Survival Analysis, Treatment Outcome, Young Adult, Immunotherapy, Dendritic cell, Vaccine, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundStandard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax®-L) to standard therapy for newly diagnosed glioblastoma.MethodsAfter surgery and chemoradiotherapy, patients were randomized (2:1) to receive temozolomide plus DCVax-L (n = 232) or temozolomide and placebo (n = 99). Following recurrence, all patients were allowed to receive DCVax-L, without unblinding. The primary endpoint was progression free survival (PFS); the secondary endpoint was overall survival (OS).ResultsFor the intent-to-treat (ITT) population (n = 331), median OS (mOS) was 23.1 months from surgery. Because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L. For patients with methylated MGMT (n = 131), mOS was 34.7 months from surgery, with a 3-year survival of 46.4%. As of this analysis, 223 patients are ≥ 30 months past their surgery date; 67 of these (30.0%) have lived ≥ 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are ≥ 36 months past surgery; 44 of these (24.2%) have lived ≥ 36 months and have a KM-derived mOS of 88.2 months. A population of extended survivors (n = 100) with mOS of 40.5 months, not explained by known prognostic factors, will be analyzed further. Only 2.1% of ITT patients (n = 7) had a grade 3 or 4 adverse event that was deemed at least possibly related to the vaccine. Overall adverse events with DCVax were comparable to standard therapy alone.ConclusionsAddition of DCVax-L to standard therapy is feasible and safe in glioblastoma patients, and may extend survival. Trial registration Funded by Northwest Biotherapeutics; Clinicaltrials.gov number: NCT00045968; https://clinicaltrials.gov/ct2/show/NCT00045968?term=NCT00045968&rank=1 ; initially registered 19 September 2002.

Published
2018

10. Correction to: First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma

Author

Liau, Linda M, Ashkan, Keyoumars, Tran, David D, Campian, Jian L, Trusheim, John E, Cobbs, Charles S, Heth, Jason A, Salacz, Michael, Taylor, Sarah, D’Andre, Stacy D, Iwamoto, Fabio M, Dropcho, Edward J, Moshel, Yaron A, Walter, Kevin A, Pillainayagam, Clement P, Aiken, Robert, Chaudhary, Rekha, Goldlust, Samuel A, Bota, Daniela A, Duic, Paul, Grewal, Jai, Elinzano, Heinrich, Toms, Steven A, Lillehei, Kevin O, Mikkelsen, Tom, Walbert, Tobias, Abram, Steven R, Brenner, Andrew J, Brem, Steven, Ewend, Matthew G, Khagi, Simon, Portnow, Jana, Kim, Lyndon J, Loudon, William G, Thompson, Reid C, Avigan, David E, Fink, Karen L, Geoffroy, Francois J, Lindhorst, Scott, Lutzky, Jose, Sloan, Andrew E, Schackert, Gabriele, Krex, Dietmar, Meisel, Hans-Jorg, Wu, Julian, Davis, Raphael P, Duma, Christopher, Etame, Arnold B, Mathieu, David, Kesari, Santosh, Piccioni, David, Westphal, Manfred, Baskin, David S, New, Pamela Z, Lacroix, Michel, May, Sven-Axel, Pluard, Timothy J, Tse, Victor, Green, Richard M, Villano, John L, Pearlman, Michael, Petrecca, Kevin, Schulder, Michael, Taylor, Lynne P, Maida, Anthony E, Prins, Robert M, Cloughesy, Timothy F, Mulholland, Paul, and Bosch, Marnix L

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Neurosciences, Brain Disorders, Medical and Health Sciences, Immunology, Biomedical and clinical sciences, Health sciences
Abstract

Following publication of the original article [1], the authors reported an error in the spelling of one of the author names. In this Correction the incorrect and correct author names are indicated and the author name has been updated in the original publication. The authors also reported an error in the Methods section of the original article. In this Correction the incorrect and correct versions of the affected sentence are indicated. The original article has not been updated with regards to the error in the Methods section.

Published
2018

12. Phase II Study of Nilotinib in Melanoma Harboring KIT Alterations Following Progression to Prior KIT Inhibition

Author

Carvajal, Richard D, Lawrence, Donald P, Weber, Jeffrey S, Gajewski, Thomas F, Gonzalez, Rene, Lutzky, Jose, O'Day, Steven J, Hamid, Omid, Wolchok, Jedd D, Chapman, Paul B, Sullivan, Ryan J, Teitcher, Jerrold B, Ramaiya, Nikhil, Giobbie-Hurder, Anita, Antonescu, Cristina R, Heinrich, Michael C, Bastian, Boris C, Corless, Christopher L, Fletcher, Jonathan A, and Hodi, F Stephen

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Cancer, Rare Diseases, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Brain Neoplasms, Disease Progression, Drug Resistance, Neoplasm, Female, Humans, Male, Melanoma, Middle Aged, Proto-Oncogene Proteins c-kit, Pyrimidines, Skin Neoplasms, Treatment Outcome, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeAlthough durable responses can be achieved with tyrosine kinase inhibitors such as imatinib in melanomas harboring KIT mutations, the efficacy of alternative inhibitors after progression to imatinib and the activity of these agents on brain metastases are unknown.Experimental designWe conducted a phase II study of nilotinib 400 mg twice a day in two cohorts of patients with melanomas harboring KIT mutations or amplification: (A) those refractory or intolerant to a prior KIT inhibitor; and (B) those with brain metastases. The primary endpoint was 4-month disease control rate. Secondary endpoints included response rate, time-to-progression (TTP), and overall survival (OS). A Simon two-stage and a single-stage design was planned to assess for the primary endpoint in cohorts A and B, respectively.ResultsTwenty patients were enrolled and 19 treated (11 in cohort A; 8 in cohort B). Three patients on cohort A [27%; 95% confidence interval (CI), 8%-56%] and 1 on cohort B (12.5%; 90% CI, 0.6%-47%) achieved the primary endpoint. Two partial responses were observed in cohort A (18.2%; 90% CI, 3%-47%); none were observed in cohort B. The median TTP and OS was 3.3 (90% CI, 2.1-3.9 months) and 9.1 months (90% CI, 4.3-14.2 months), respectively, in all treated patients.ConclusionsNilotinib may achieve disease control in patients with melanoma harboring KIT alterations and whose disease progressed after imatinib therapy. The efficacy of this agent in KIT-altered melanoma with brain metastasis is limited.

Published
2015

13. Clinical Activity, Tolerability, and Long-Term Follow-Up of Durvalumab in Patients With Advanced NSCLC

Author

Antonia, Scott J., Balmanoukian, Ani, Brahmer, Julie, Ou, Sai-Hong I., Hellmann, Matthew D., Kim, Sang-We, Ahn, Myung-Ju, Kim, Dong-Wan, Gutierrez, Martin, Liu, Stephen V., Schöffski, Patrick, Jäger, Dirk, Jamal, Rahima, Jerusalem, Guy, Lutzky, Jose, Nemunaitis, John, Calabrò, Luana, Weiss, Jared, Gadgeel, Shirish, Bhosle, Jaishree, Ascierto, Paolo A., Rebelatto, Marlon C., Narwal, Rajesh, Liang, Meina, Xiao, Feng, Antal, Joyce, Abdullah, Shaad, Angra, Natasha, Gupta, Ashok K., Khleif, Samir N., and Segal, Neil H.

Published
2019
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14. Pembrolizumab plus pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (KEYNOTE-183): a randomised, open-label, phase 3 trial

Author

Nicol, Andrew, Grigoriadis, George, Catalano, John, LeBlanc, Richard, Elemary, Mohamed, Bahlis, Nizar, Facon, Thierry, Karlin, Lionel, Ribrag, Vincent, Attal, Michel, Goldschmidt, Hartmut, Engelhardt, Monika, Weisel, Katja, Mackensen, Andreas, Nagler, Arnon, Ben Yehuda, Dina, Avivi, Irit, Benyamini, Noam, Magen-Nativ, Hila, Palumbo, Antonio, Cavo, Michele, Tobinai, Kensei, Iida, Shinsuke, Chou, Takaai, Suzuki, Kenshi, Kosugi, Hiroshi, Taniwaki, Masafumi, Sunami, Kazutaka, Matsumoto, Morio, Ando, Kiyoshi, Ganly, Peter, Blacklock, Hilary, Simpson, David, George, Anupkumar, Schjesvold, Fredrik, Gjertsen, Bjorn, Lahuerta, Juan, Blade, Joan, Oriol Rocafiguera, Albert, Mateos, Maria, Rodriguez-Otero, Paula, Larson, Sarah, Atanackovic, Djordje, Devarakonda, Srinivas, Bitran, Jacob, Zonder, Jeffrey, Morganstein, Neil, Hay, Mohammad, Chanan-Khan, Asher, Saylors, Gene, Kio, Ebenezer, Oliff, Ira, Kirkel, Dean, Shtivelband, Mikhail, Yuen, Carrie, Yee, Andrew, Shah, Jatin, Htut, Myo, Raza, Shahzad, Chhabra, Saurabh, Stiff, Patrick, Hari, Parameswaran, Bank, Bruce, Malek, Ehsan, Gasparetto, Cristina, Faroun, Ycaoub, Sherbenou, Daniel, Kreisle, William, Singhal, Seema, Rosenblatt, Jacalyn, Usmani, Saad, Lee, Wes, Safah, Hana, Lutzky, Jose, Suh, Jason, Pan, Dorothy, Baron, Ari, Manges, Robert, Steis, Ronald, Oliveira, Moacyr, Moreb, Jan, Callander, Natalie, Anz, Bertrand, Raptis, Anastasios, Stampleman, Laura, Melear, Jason, Boyd, Thomas, Garbo, Lawrence, Klein, Leonard, Shao, Spencer, Lyons, Roger, McIntyre, Kristi, Tarantolo, Stefano, Yasenchak, Christopher, Yimer, Habte, Mateos, Maria-Victoria, Oriol, Albert, Larocca, Alessandra, Usmani, Saad Z, Jagannath, Sundar, Ocio, Enrique M, San Miguel, Jesus, Kher, Uma, Farooqui, Mohammed, Liao, Jason, Marinello, Patricia, and Lonial, Sagar

Published
2019
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15. Pembrolizumab plus lenalidomide and dexamethasone for patients with treatment-naive multiple myeloma (KEYNOTE-185): a randomised, open-label, phase 3 trial

Author

Lim, Andrew, Grigoriadis, George, Walker, Trish, Nicol, Andrew, LeBlanc, Richard, Reece, Donna, Elemary, Mohamed, Boudreault Pedneault, Jean Samuel, Karlin, Lionel, Facon, Thierry, Attal, Michel, Weisel, Katja, Engelhardt, Monika, Mackensen, Andreas, Quinn, John, Avivi, Irit, Cohen, Amos, Magen-Nativ, Hila, Benyamini, Noam, Cavo, Michele, Larocca, Alessandra, Takezako, Naoki, Suzuki, Kenshi, Kosugi, Hiroshi, Matsumoto, Morio, Iida, Shinsuke, Ishikawa, Takayuki, Kondo, Yukio, Sunami, Kazutaka, Ando, Kiyoshi, Teshima, Takanori, Chou, Takaaki, Iwasaki, Hiromi, Miki, Hirokazu, Matsumura, Itaru, Onishi, Yasushi, Izutsu, Koji, Kizaki, Masahiro, George, Anupkumar, Blacklock, Hillary, Simpson, David, Schjesvold, Fredrik, Waage, Anders, Samoilova, Olga, Nikitin, Evgeniy, Chagorova, Tatiana, McDonald, Andrew, Patel, Moosa, Oriol Rocafiguera, Albert, San Miguel Izquierdo, Jesus, Mateos, Maria, Streetly, Matthew, Forsyth, Peter, Jackson, Graham, Jenkins, Stephen, Rifkin, Robert, Yimer, Habte, McCroskey, Robert, Martincic, Danko, Tarantolo, Stefano, Larson, Sarah, Faroun, Yacoub, Vaughn, Jennifer, Baz, Rachid, Saylors, Gene, Neppalli, Amarendra, Raptis, Anastasios, Fung, Henry, Janosky, Maxwell, Stevens, Don, Coleman, Morton, Costa, Dennis, Cross, Scott, Fanning, Suzanne, Berges, Daniel Farray, Harris, Thomas, Zackon, Ira, Atanackovic, Djordje, Lee, Kelvin, Oliff, Ira, Lee, Wes, Bensinger, William, Lutzky, Jose, Baron, Ari, Hayek, Fadi, Kirschner, Eli, Bharany, Neeraj, Overton, Lindsay, Mannem, Siva, Harroff, Allyson, Jain, Sharad, Roque, Tammy, McIntyre, Kristi, Yasencha, Christopher K, Houck, William, Usmani, Saad Zafar, Oriol, Albert, Rifkin, Robert M, Yimer, Habte Aragaw, McCroskey, Robert Donald, Lim, Andrew Boon Ming, Jagannath, Sundar, Lonial, Sagar, Ghori, Razi Uddin, Farooqui, Mohammed Z H, Marinello, Patricia, and San-Miguel, Jesus

Published
2019
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16. Impact of Sequencing Targeted Therapies With High-dose Interleukin-2 Immunotherapy: An Analysis of Outcome and Survival of Patients With Metastatic Renal Cell Carcinoma From an On-going Observational IL-2 Clinical Trial: PROCLAIMSM

Author

Clark, Joseph I., Wong, Michael K.K., Kaufman, Howard L., Daniels, Gregory A., Morse, Michael A., McDermott, David F., Agarwala, Sanjiv S., Lewis, Lionel D., Stewart, John H., Vaishampayan, Ulka, Curti, Brendan, Gonzalez, René, Lutzky, Jose, Rudraptna, Venkatesh, Cranmer, Lee D., Jeter, Joanne M., Hauke, Ralph J., Miletello, Gerald, Milhem, Mohammed M., Amin, Asim, Richart, John M., Fishman, Mayer, Hallmeyer, Sigrun, Patel, Sapna P., Van Veldhuizen, Peter, Agarwal, Neeraj, Taback, Bret, Treisman, Jonathan S., Ernstoff, Marc S., Perritt, Jessica C., Hua, Hong, Rao, Tharak B., Dutcher, Janice P., and Aung, Sandra

Published
2017
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19. Relationship between physician-adjudicated adverse events and patient-reported health-related quality of life in a phase II clinical trial (NCT01143402) of patients with metastatic uveal melanoma

Author

Atkinson, Thomas M., Hay, Jennifer L., Shoushtari, Alexander, Li, Yuelin, Paucar, Daniel J., Smith, Sloane C., Kudchadkar, Ragini R., Doyle, Austin, Sosman, Jeffrey A., Quevedo, Jorge Fernando, Milhem, Mohammed M., Joshua, Anthony M., Linette, Gerald P., Gajewski, Thomas F., Lutzky, Jose, Lawson, David H., Lao, Christopher D., Flynn, Patrick J., Albertini, Mark R., Sato, Takami, Lewis, Karl, Marr, Brian, Abramson, David H., Dickson, Mark Andrew, Schwartz, Gary K., and Carvajal, Richard D.

Published
2017
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22. An update on the Society for Immunotherapy of Cancer consensus statement on tumor immunotherapy for the treatment of cutaneous melanoma: version 2.0

Author

Sullivan, Ryan J., Atkins, Michael B., Kirkwood, John M., Agarwala, Sanjiv S., Clark, Joseph I., Ernstoff, Marc S., Fecher, Leslie, Gajewski, Thomas F., Gastman, Brian, Lawson, David H., Lutzky, Jose, McDermott, David F., Margolin, Kim A., Mehnert, Janice M., Pavlick, Anna C., Richards, Jon M., Rubin, Krista M., Sharfman, William, Silverstein, Steven, Slingluff, Jr, Craig L., Sondak, Vernon K., Tarhini, Ahmad A., Thompson, John A., Urba, Walter J., White, Richard L., Whitman, Eric D., Hodi, F. Stephen, and Kaufman, Howard L.

Published
2018
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25. Adjuvant crizotinib in high-risk uveal melanoma following definitive therapy.

Author

Khan, Shaheer, Lutzky, Jose, Shoushtari, Alexander N., Jeter, Joanne, Marr, Brian, Olencki, Thomas E., Cebulla, Colleen M., Abdel-Rahman, Mohamed, Harbour, J. William, Sender, Naomi, Nesson, Alexandra, Singh-Kandah, Shahnaz, Hernandez, Susana, King, Jeanelle, Katari, Manpreet S., Dimapanat, Lyssa, Izard, Stephanie, Ambrosini, Grazia, Surriga, Oliver, and Rai, Alex J.

Subjects
UVEA cancer, CRIZOTINIB, EXTRACELLULAR vesicles, MELANOMA, BLOOD testing, DISEASE relapse, ELEMENTAL diet
Abstract

Introduction: Approximately 40% of patients with uveal melanoma (UM) will develop metastatic disease. Tumors measuring at least 12mm in basal diameter with a class 2 signature, as defined by a widely used gene expression-profiling test, are associated with significantly higher risk of metastasis, with a median time to recurrence of 32 months. No therapy has been shown to reduce this risk. Materials and Methods: This was a single-arm, multicenter study in patients with high-risk UM who received definitive treatment of primary disease and had no evidence of metastasis. Patients were consecutively enrolled to receive 12 four-week cycles of adjuvant crizotinib at a starting dose of 250mg twice daily and were subsequently monitored for 36 months. The primary outcome of this study was to assess recurrence-free survival (RFS) of patients with high-risk UM who received adjuvant crizotinib. Results: 34 patients enrolled and received at least one dose of crizotinib. Two patients were unevaluable due to early withdrawal and loss to follow-up, leaving 32 patients evaluable for efficacy. Eight patients (25%) did not complete the planned 48-week course of treatment due to disease recurrence (n=5) or toxicity (n=3). All patients experienced at least one adverse event (AE), with 11/34 (32%) experiencing a Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 AE. After a median duration of follow up of 47.1 months, 21 patients developed distant recurrent disease. The median RFS was 34.9 months (95% CI (Confidence Interval), 23-55 months), with a 32-month recurrence rate of 50% (95% CI, 33-67%). Analysis of protein contents from peripheral blood extracellular vesicles in a subset of patient samples from baseline, on-treatment, and off-treatment, revealed a change in protein content associated with crizotinib exposure, however without a clear association with disease outcome. Conclusions: The use of adjuvant crizotinib in patients with high-risk UM did not result in improved RFS when compared to historical controls. Analysis of blood extracellular vesicles revealed changes in protein content associated with treatment, raising the possibility of future use as a biomarker. Further investigation of adjuvant treatment options are necessary for this challenging disease. [ABSTRACT FROM AUTHOR]

Published
2022
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26. Improved survival with ipilimumab in patients with metastatic melanoma

Author

Hodi, F. Stephen, OEDay, Steven J., McDermott, David F., Weber, Robert W., Sosman, Jeffrey A., Haanen, John B., Gonzalez, Rene, Robert, Caroline, Schadendorf, Dirk, Hassel, Jessica C., Akerley, Wallace, van den Eertwegh, Alfons J.M., Lutzky, Jose, Lorigan, Paul, Vaubel, Julia M., Linette, Gerald P., Hogg. David, Ottensmeier, Christian H., Lebbe, Celeste, Peschel, Christian, Quirt, Ian, Clark, Joseph I., Wolchok, Jedd D., Weber, Jeffrey S., Tian, Jason, Yellin, Michael J., Nichol, Geoffrey M., Hoos, Axel, and Urba, Walter J.

Subjects
Melanoma -- Drug therapy, Monoclonal antibodies -- Usage, Monoclonal antibodies -- Health aspects, T cells -- Research
Abstract

A study was conducted to evaluate the efficacy and safety of ipilimumab as a form of treatment and survival in the case of patients with metastatic melanoma. Results indicated that ipilimumab improved the overall survival rate in the case of such patients.

Published
2010

27. Effect of Selumetinib vs Chemotherapy on Progression-Free Survival in Uveal Melanoma: A Randomized Clinical Trial

Author

Carvajal, Richard D., Sosman, Jeffrey A., Quevedo, Jorge Fernando, Milhem, Mohammed M., Joshua, Anthony M., Kudchadkar, Ragini R., Linette, Gerald P., Gajewski, Thomas F., Lutzky, Jose, Lawson, David H., Lao, Christopher D., Flynn, Patrick J., Albertini, Mark R., Sato, Takami, Lewis, Karl, Doyle, Austin, Ancell, Kristin, Panageas, Katherine S., Bluth, Mark, Hedvat, Cyrus, Erinjeri, Joseph, Ambrosini, Grazia, Marr, Brian, Abramson, David H., Dickson, Mark Andrew, Wolchok, Jedd D., Chapman, Paul B., and Schwartz, Gary K.

Published
2014
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28. Recognising immunotherapy-induced meningoencephalitis: a case during treatment for primary metastatic melanoma of the bladder neck.

Author

Grunhut, Joel, Brown, Shimron, Lutzky, Jose, and Skoczylas, Leor

Abstract

Although novel immunotherapy has shown promise for patients with melanoma, a more activated state of the immune system may lead to adverse systemic effects. Immunotherapy-induced meningoencephalitis is a rare and seldom reported adverse effect of immunotherapy but with the expanding role of immunotherapy in cancer treatments it must be recognised. Patients receiving immunotherapy should receive a proper warning about the potential for this life-threatening condition. Herein, we report a patient in his 70s with neurological changes after his second treatment with dual immunotherapy for a primary metastatic melanoma of the bladder neck. [ABSTRACT FROM AUTHOR]

Published
2022
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30. The Society for Immunotherapy of Cancer consensus statement on tumour immunotherapy for the treatment of cutaneous melanoma

Author

Kaufman, Howard L., Kirkwood, John M., Hodi, Stephen F., Agarwala, Sanjiv, Amatruda, Thomas, Bines, Steven D., Clark, Joseph I., Curti, Brendan, Ernstoff, Marc S., Gajewski, Thomas, Gonzalez, Rene, Hyde, Laura Jane, Lawson, David, Lotze, Michael, Lutzky, Jose, Margolin, Kim, McDermott, David F., Morton, Donald, Pavlick, Anna, Richards, Jon M., Sharfman, William, Sondak, Vernon K., Sosman, Jeffrey, Steel, Susan, Tarhini, Ahmad, Thompson, John A., Titze, Jill, Urba, Walter, White, Richard, and Atkins, Michael B.

Published
2013
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31. KIT as a Therapeutic Target in Metastatic Melanoma

Author

Carvajal, Richard D., Antonescu, Cristina R., Wolchok, Jedd D., Chapman, Paul B., Roman, Ruth-Ann, Teitcher, Jerrold, Panageas, Katherine S., Busam, Klaus J., Chmielowski, Bartosz, Lutzky, Jose, Pavlick, Anna C., Fusco, Anne, Cane, Lauren, Takebe, Naoko, Vemula, Swapna, Bouvier, Nancy, Bastian, Boris C., and Schwartz, Gary K.

Published
2011
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37. Efficacy and safety of melphalan, arsenic trioxide and ascorbic acid combination therapy in patients with relapsed or refractory multiple myeloma: a prospective, multicentre, phase II, single-arm study

Author

Berenson, James R., Boccia, Ralph, Siegel, David, Bozdech, Marek, Bessudo, Alberto, Stadtmauer, Edward, Talisman Pomeroy, J., Steis, Ronald, Flam, Marshall, Lutzky, Jose, Jilani, Syed, Volk, Joseph, Wong, Siu-Fun, Moss, Robert, Patel, Ravi, Ferretti, Delina, Russell, Kit, Louie, Robert, Yeh, Howard S., and Swift, Regina A.

Published
2006

40. Pembrolizumab Plus Ipilimumab Following Anti-PD-1/L1 Failure in Melanoma.

Author

Olson, Daniel J, Eroglu, Zeynep, Brockstein, Bruce, Poklepovic, Andrew S, Bajaj, Madhuri, Babu, Sunil, Hallmeyer, Sigrun, Velasco, Mario, Lutzky, Jose, Higgs, Emily, Bao, Riyue, Carll, Timothy C, Labadie, Brian, Krausz, Thomas, Zha, Yuanyuan, Karrison, Theodore, Sondak, Vernon K, Gajewski, Thomas F, Khushalani, Nikhil I, and Luke, Jason J

Published
2021
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41. Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma.

Author

Sarnaik, Amod A, Hamid, Omid, Khushalani, Nikhil I, Lewis, Karl D, Medina, Theresa, Kluger, Harriet M, Thomas, Sajeve S, Domingo-Musibay, Evidio, Pavlick, Anna C, Whitman, Eric D, Martin-Algarra, Salvador, Corrie, Pippa, Curti, Brendan D, Oláh, Judit, Lutzky, Jose, Weber, Jeffrey S, Larkin, James M G, Shi, Wen, Takamura, Toshimi, and Jagasia, Madan

Published
2021
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45. Association of BRAF V600E/K Mutation Status and Prior BRAF/MEK Inhibition With Pembrolizumab Outcomes in Advanced Melanoma: Pooled Analysis of 3 Clinical Trials.

Author

Puzanov, Igor, Ribas, Antoni, Robert, Caroline, Schachter, Jacob, Nyakas, Marta, Daud, Adil, Arance, Ana, Carlino, Matteo S., O'Day, Steven J., Long, Georgina V., Margolin, Kim A., Dummer, Reinhard, Schadendorf, Dirk, Lutzky, Jose, Ascierto, Paolo A., Tarhini, Ahmad, Lin, Jianxin, Mogg, Robin, Homet Moreno, Blanca, and Ibrahim, Nageatte

Published
2020
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46. Intracranial antitumor activity with encorafenib plus binimetinib in patients with melanoma brain metastases: A case series.

Author

Holbrook, Kourtney, Lutzky, Jose, Davies, Michael A., Davis, Jessica Michaud, Glitza, Isabella C., Amaria, Rodabe N., Diab, Adi, Patel, Sapna P., Amin, Asim, and Tawbi, Hussein

Subjects
*BRAIN metastasis, *MELANOMA, *CANCER treatment, *CLINICAL trials
Abstract

Background: Sixty percent of patients with stage IV melanoma may develop brain metastases, which result in significantly increased morbidity and a poor overall prognosis. Phase 3 studies of melanoma usually exclude patients with untreated brain metastases; therefore, clinical data for intracranial responses to treatments are limited.Methods: A multicenter, retrospective case series investigation of consecutive BRAF-mutant patients with melanoma brain metastases (MBMs) treated with a combination of BRAF inhibitor encorafenib and MEK inhibitor binimetinib was conducted to evaluate the antitumor response. Assessments included the intracranial, extracranial, and global objective response rates (according to the modified Response Evaluation Criteria in Solid Tumors, version 1.1); the clinical benefit rate; the time to response; the duration of response; and safety.Results: A total of 24 patients with stage IV BRAF-mutant MBMs treated with encorafenib plus binimetinib in 3 centers in the United States were included. Patients had received a median of 2.5 prior lines of treatment, and 88% had prior treatment with BRAF/MEK inhibitors. The intracranial objective response rate was 33%, and the clinical benefit rate was 63%. The median time to a response was 6 weeks, and the median duration of response was 22 weeks. Among the 21 patients with MBMs and prior BRAF/MEK inhibitor treatment, the intracranial objective response rate was 24%, and the clinical benefit rate was 57%. Similar outcomes were observed for extracranial and global responses. The safety profile for encorafenib plus binimetinib was similar to that observed in patients with melanoma without brain metastases.Conclusions: Combination therapy with encorafenib plus binimetinib elicited intracranial activity in patients with BRAF-mutant MBMs, including patients previously treated with BRAF/MEK inhibitors. Further prospective studies are warranted and ongoing. [ABSTRACT FROM AUTHOR]

Published
2020
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47. A phase 2 study of glembatumumab vedotin, an antibody-drug conjugate targeting glycoprotein NMB, in patients with advanced melanoma.

Author

Ott, Patrick A., Pavlick, Anna C., Johnson, Douglas B., Hart, Lowell L., Infante, Jeffrey R., Luke, Jason J., Lutzky, Jose, Rothschild, Neal E., Spitler, Lynn E., Cowey, C. Lance, Alizadeh, Aaron R., Salama, April K., He, Yi, Hawthorne, Thomas R., Bagley, Rebecca G., Zhang, Joshua, Turner, Christopher D., and Hamid, Omid

Subjects
MELANOMA, IPILIMUMAB, ANTIBODY-drug conjugates, THERAPEUTIC use of immunoglobulins, THERAPEUTIC use of monoclonal antibodies, CLINICAL trials, COMPARATIVE studies, RESEARCH methodology, MEDICAL cooperation, RESEARCH, SKIN tumors, TUMOR classification, EVALUATION research, TREATMENT effectiveness, PROPORTIONAL hazards models, MEMBRANE glycoproteins
Abstract

Background: Glembatumumab vedotin is an antibody-drug conjugate that produced preliminary clinical activity against advanced melanoma in a phase 1 dose-escalation trial. The objective of the current study was to investigate further the antitumor activity of glembatumumab vedotin at the recommended phase 2 dose in heavily pretreated patients with melanoma.Methods: This single-arm, phase 2 study enrolled patients with stage IV melanoma who were refractory to checkpoint inhibition and to B-raf proto-oncogene, serine/threonine kinase (BRAF)/mitogen-activated protein kinase kinase (MEK) inhibition (in the presence of a BRAF valine mutation at codon 600). Patients received 1.9 mg/kg glembatumumab vedotin intravenously every 3 weeks until they developed disease progression or intolerance. The primary endpoint was objective response rate (ORR), which was determined according to Response Evaluation Criteria in Solid Tumors, version 1.1. Secondary endpoints included progression-free survival (PFS), duration of response, overall survival (OS), safety, and clinical efficacy versus tumor glycoprotein NMB (gpNMB) expression. Tumor expression of gpNMB was assessed using immunohistochemistry.Results: In total, 62 patients received treatment. The ORR was 11% and the median response duration was 6.0 months (95% confidence interval [CI], 4.1 months to not reached). The median PFS was 4.4 months (95% CI, 2.6-5.5 months), and the median OS was 9.0 months (95% CI, 6.1-11.7 months). For patients who developed rash during the first cycle versus those who did not, the ORR was 21% versus 7%, respectively, and there was an overall improvement in PFS (hazard ratio, 0.43; P = .013) and OS (hazard ratio, 0.43; P = .017). The most frequent adverse events were alopecia, neuropathy, rash, fatigue, and neutropenia. With one exception, all evaluable tumors were positive for gpNMB, and 46 of 59 tumors (76%) had 100% gpNMB-positive epithelial cells.Conclusions: Glembatumumab vedotin had modest activity and an acceptable safety profile in patients with advanced melanoma who were refractory to checkpoint inhibitors and MEK/BRAF inhibition. Treatment-related rash may be associated with response. [ABSTRACT FROM AUTHOR]

Published
2019
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48. Radium‐223 Safety, Efficacy, and Concurrent Use with Abiraterone or Enzalutamide: First U.S. Experience from an Expanded Access Program.

Author

Sartor, Oliver, Vogelzang, Nicholas J., Sweeney, Christopher, Fernandez, Daniel C., Almeida, Fabio, Iagaru, Andrei, Brown Jr., Alan, Smith, Matthew R., Agrawal, Manish, Dicker, Adam P., Garcia, Jorge A., Lutzky, Jose, Wong, Yu‐Ning, Petrenciuc, Oana, Gratt, Jeremy, Shore, Neal D., Morris, Michael J., and for the U.S. Expanded Access Program Investigators

Subjects
ANTIANDROGENS, RADIUMTHERAPY, ABIRATERONE acetate, COMBINATION drug therapy, CLINICAL trials, DRUG side effects, HEALTH services accessibility, HEMOGLOBINS, INTRAVENOUS therapy, MEDICAL cooperation, PROSTATE tumors, RADIUM, RESEARCH, SURVIVAL, TREATMENT effectiveness, TUMOR grading, THERAPEUTICS
Abstract

Abstract: Background: In the phase III ALSYMPCA trial, metastatic castration‐resistant prostate cancer (mCRPC) patients had few prior life‐prolonging therapies. Following ALSYMPCA, which demonstrated radium‐223 survival benefit, and before radium‐223 U.S. commercial availability, an expanded access program (EAP) providing early‐access radium‐223 allowed life‐prolonging therapies in current use. Subjects, Materials, and Methods: This phase II, open‐label, single‐arm, multicenter U.S. EAP (NCT01516762) enrolled patients with symptomatic mCRPC, ≥2 bone metastases, and no lung, liver, or brain metastases. Patients received radium‐223 55 kBq/kg intravenously every 4 weeks × 6. Primary outcomes were acute and long‐term safety. Additional analyses were done by number of radium‐223 injections, and prior or concomitant abiraterone or enzalutamide use. Results: Of 252 patients, 184 received radium‐223: 165/184 (90%) had Eastern Cooperative Oncology Group (ECOG) performance status 0–1; 183 (99%) had prior systemic anticancer therapy. Treatment‐related adverse events occurred in 93/184 (51%) patients during treatment and 11 (6%) during follow‐up. Median overall survival was 17 months, with 134/184 (73%) patients censored because of short follow‐up due to radium‐223 approval. In post hoc analyses, patients with ≥3 prior anticancer medications, baseline ECOG performance status ≥2, and lower baseline hemoglobin were less likely to receive 5–6 radium‐223 injections and unlikely to benefit from radium‐223. Radium‐223 was well tolerated regardless of concurrent or prior abiraterone or enzalutamide. Conclusion: Radium‐223 was well tolerated, with no new safety concerns; safety was maintained with abiraterone or enzalutamide. Patients with more advanced disease were less likely to benefit from radium‐223. Clinicians should consider baseline characteristics and therapy sequence for greatest clinical value. Implications for Practice: In this phase II U.S. expanded access program, radium‐223 was well tolerated, with a median overall survival of 17 months in metastatic castration‐resistant prostate cancer patients. In post hoc analyses, radium‐223 was safe regardless of concurrent abiraterone or enzalutamide, and median overall survival appeared longer when radium‐223 was used earlier in patients with less prior treatment. Patients with more advanced disease were less likely to benefit from radium‐223. Clinicians should consider baseline clinical characteristics and therapy sequence to provide the greatest clinical value to patients. [ABSTRACT FROM AUTHOR]

Published
2018
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49. Randomized phase II trial of dabrafenib and trametinib with or without navitoclax in patients (pts) with BRAF-mutant (MT) metastatic melanoma (MM) (CTEP P9466).

Author

Eroglu, Zeynep, Mehnert, Janice M., Giobbie-Hurder, Anita, Kendra, Kari Lynn, In, Gino Kim, Salama, April K.S., Doolittle, Gary C., Sosman, Jeffrey A., Valerin, Jennifer Brooke, Medina, Theresa Michelle, Lutzky, Jose, Moschos, Stergios J., Khushalani, Nikhil I., Markowitz, Joseph, Takebe, Naoko, Chen, Helen X., Knight, Laura W., Davies, Michael A., and Sullivan, Ryan J.

Published
2023
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50. A phase 1 study of AGEN2373, a novel CD137 agonist antibody designed to avoid hepatoxicity, in patients with advanced solid tumors.

Author

Barve, Minal A., Tolcher, Anthony W., Carvajal, Richard D., Izar, Benjamin, El-Khoueiry, Anthony B., Hanna, Diana L., Tarhini, Ahmad A., Whitman, Eric D., Bhatia, Shailender, Davar, Diwakar, Lutzky, Jose, Taylor, Matthew H., Tello, Monique, Rosenthal, Katherine, Danielyan, Anna, Yip, Wai Ki, Song, James, Savitsky, David, Chand, Dhan, and Grossman, Joseph Elan

Published
2023
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