CytRx Aldoxorubicin Clinical Trial Phase 2B Information & Results Presented at ASCO
Connective Tissue Oncology (CTOS) 2012 Annual Conference held in Prague, Czech Republic. Our presentations:
1) PHASE 3, PLACEBO-CONTROLLED TRIAL (SUCCEED) EVALUATING RIDAFOROLIMUS AS MAINTENANCE THERAPY IN
ADVANCED SARCOMA PATIENTS FOLLOWING CLINICAL BENEFIT FROM PRIOR STANDARD CYTOTOXIC
CHEMOTHERAPY: SUBGROUP ANALYSIS OF PATIENTS AFTER SECOND- AND THIRD-LINE THERAPY
Sant Chawla1; Peter Reichardt2; Isabelle Ray-Coquard3; Axel Le Cesne4; Arthur P. Staddon5; Mohammed M. Milhem6; Nicolas
Penel7; B. Bui Nguyen8; Yang Song9; Scot Ebbinghaus10; Frank G. Haluska11; Pierre F. Dodion12; Jean-Yves Blay3; George D.
1Sarcoma Oncology Center, Santa Monica, CA, USA; 2Hematology, Oncology and Palliative Care,
Helios Klinikum Bad Saarow, Bad Saarow, Germany; 3Medicine, Centre Léon Bérard Cancer Center, Lyon, France;4Medical
Oncology, Institut Gustave Roussy, Villejuif, France; 5Oncology Hematology, Joan Karnell Cancer Center-Pennsylvania Hospital,
Philadelphia, PA, USA; 6Internal Medicine, University of Iowa, Iowa City, IA, USA; 7General Oncology, Centre Oscar Lambert, Lille,
France; 8Medical Oncology, Institut Bergonié, Bordeaux, France; 9Clinical Biostatistics Oncology, Merck, Whitehouse Station, NJ,
USA; 10Clinical Research/Oncology, Merck, Whitehouse Station, NJ, USA; 11Clinical Research and Development, ARIAD,
Cambridge, MA, USA; 12Oncology,
2) A PHASE II TRIAL OF NOVEL ANTHRACYCLINE AMRUBICIN IN PATIENTS WITH ADVANCED SOFT TISSUE SARCOMA
Launce G. Gouw, MD, PhD1; R Lor Randall2; Sant Chawla3, Sunil Sharma1
1Oncology, Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT, USA; 2Orthopaedics, Huntsman Cancer Institute
at the University of Utah, Salt Lake City, UT, USA; 3Sarcoma Oncology Center, Santa Monica, CA, USA
3) TH-302 MAINTENANCE FOLLOWING TH-302 PLUS DOXORUBICIN INDUCTION: THE RESULTS OF A PHASE 2 STUDY OF
TH-302 IN COMBINATION WITH DOXORUBICIN IN SOFT TISSUE SARCOMA
Kristen N. Ganjoo1; Lee Cranmer2; Brian Van Tine3; Damon R. Reed4; Scott H. Okuno5; James E. Butrynski6; Douglas Adkins3;
Andrew Hendifar7; Esther D. Chu8; Stew Kroll8; Sant P. Chawla7
1Oncology, Stanford University Medical Center, Stanford, CA, USA; 2Oncology, Arizona Cancer Center, Tucson, AZ,
USA; 3Oncology, Washington University, St. Louis, MO, USA; 4Oncology, Moffitt Cancer Center, Tampa, FL, USA; 5Oncology, Mayo
Clinic Rochester, Rochester, MN, USA; 6Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; 7Oncology, Sarcoma Oncology
Center, Santa Monica, CA, USA; 8Clinical Operations, Threshold Pharmaceuticals, South San Francisco, CA, USA
4) ALDOXORUBICIN (INNO-206) IS AN ACTIVE DRUG FOR THE TREATMENT OF RELAPSED OR REFRACTORY SOFT TISSUE
Sant Chawla2; Victoria Chua2; Andrew Hendifar2; Lita Fernandez2; Scott Wieland1; Vivek Narasimhan2; Harsha Rajashekharaiah2;
Kamalesh Sankhala3; Kristen Ganjoo4; Daniel Levitt1
1CytRx Corporation, Los Angeles, CA, USA; 2Medical Oncology, Sarcoma Cancer Center, Los Angeles, CA, USA; 3Medical
Oncology, University of Texas San ANtonio Medical Center, San Antonio, TX, USA; 4Medical Oncology, Stanford University Medical
Center, Stanford, CA, USA
5) LOW DOSE GEMCITABINE, DOXORUBICIN, AND DOCETAXEL COMBINATION IN PATIENTS
WITH ADVANCED, UNRESECTABLE AND/OR METASTATIC SARCOMA WHO HAD FAILED
PRIOR CHEMOTHERAPY, AN UPDATED ANALYSIS
Sant P. Chawla; Vivek Narasimhan; Andrew E. Hendifar; Victoria Chua; Doris Quon; Lita Fernandez; Harsha
Rajashekaraiah; David Shin;
Sarcoma Oncology Center, Santa Monica, CA, USA
6) 14 DAY CONTINUOUS INFUSION OF HIGH-DOSE IFOSFAMIDE IN ADOLESCENT AND
ADULT SARCOMA PATIENTS, AN UPDATED ANALYSIS
Sant Chawla1; Harsha Rajashekharaiah1; Andrew Hendifar1; Victoria Chua1; Doris Quon1; Lita Fernandez1;
Kristen Ganjoo3; Kamalesh Sankhala1; Vivek Narasimhan1; David Shin2;
1Sarcoma Oncology Center, Santa Monica, CA, USA; 2UCLA, Santa Monica, CA,
USA; 3STANFORD, Palo Alto, CA, USA
Connective Tissue Oncology (CTOS) 2011 Annual Conference
This years meeting, held in Chicago, Illinois, was the first combined Musculoskeletal Tumor Society and Connective Tissue Oncology meeting in their prestigious histories.
The conference was excellent and new therapies in the treatment of Ewing’s sarcoma, osteosarcoma, and soft tissue sarcom a were presented. Their was an excellent talk by Dempsey Springfield who honored Frederick Eilber and Jeffery Eckardt for heir contributions to the care of sarcoma patients.
Our center presented several papers describing new advances in the care of sarcoma patients.
1. A PHASE 2 STUDY OF TH-302 IN COMBINATION WITH DOXORUBICIN
IN ADVANCED SOFT TISSUE SARCOMA
Sant P. Chawla1, Kristin N. Ganjoo2, Douglas Adkins3, Damon Reed4, Scott H. Okuno5,
James E. Butrynski6, Daniel Rushing7, Brain Van Tine3, Esther D. Chu8, Stew Kroll8,
2. 14 DAY CONTINUOUS INFUSION HIGH-DOSE IFOSFAMIDE IN ADOLESCENT AND ADULT SARCOMA PATIENTS
Andrew Hendifar, Shelly Chawla, Sandeep Nagre, Vicky Chua, Lita Fernandez, Bartosz Chmielowski, James Hu, and Sant Chawla
3. Denosumab Safety and Efficacy in Giant Cell Tumor of Bone (GCTB): Interim Results From a Phase 2 study
Sant Chawla,1 Jean-Yves Blay,2 Javier Martin Broto,3 Edwin Choy,4 Martin Dominkus,5 Jacob Engellau,6 Robert Grimer,7 Robert Henshaw,8 Emanuela Palmerini,9 Peter Reichardt,10 Piotr Rutkowski,11 Keith Skubitz,12
David Thomas,13 Yufan Zhao,14 Yi Qian,14 Ira Jacobs14
4.Exploratory Analysis of Potential Predictive Markers to Identify Sensitive/Responder Sarcoma Patients with Ridaforolimus in the Phase 3 Randomized Placebo-controlled Trial (SUCCEED)
G. D. Demetri, S. P. Chawla, I. Ray-Coquard, A. Le Cesne, A. P. Staddon, M. M. Milhem, N. Penel, R. F. Riedel, B. Bui Nguyen, L. D. Cranmer, P. Reichardt, E. Bompas, Y. Song, R. M. Lee, J. E. Eid, J. Loewy, F. G. Haluska, P. F. Dodion, J. Y. Blay
American Society of Clinical Oncology (ASCO) 2011 Annual Meeting
This years meeting was very exciting for sarcoma patients and doctors!! The biggest presentation this year was a discussion on the length of treatment for gastro-intestinal stromal tumors. We are also very proud to announce that several of the research studies that our patients contributed to have made a large impact on how we will treat sarcoma in the future. It appears that 4 new drugs will be vying for FDA approval based on the results from this year’s conference.
The SUCCEED trial demonstrated that placing a patient on a maintenance therapy of Ridafarolimus, an oral pill, can help keep the cancer under control with minimal side effects. This was discussed by Sant Chawla and other experts from Dana Farber and MD Anderson at the oral presentations.
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Another breakthrough was the PALLETE study which examined the angiogenesis inhibitor Pazopanib. This study demonstrated that by taking this medication orally you can help control metastatic sarcomas. Our patients contributed more than any other site in the United States!
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The combination of a new medication named Threshold appears to be very promising in combination with adriamycin. This medication has very few side effects and it is highly active in patients with soft tissue sarcomas. We are looking forward to the phase 3 study that will be opening shortly.
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Finally there is a new medicine for patients with giant cell tumor of the bone. After years of ineffective therapy for unresectable tumors we now have a new medicine that can control this disease in 90% of patients!! Our center and generous patients were vital in having this medication studied. This will be approved shortly and will improve the lives of many people.
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Our patients have also been instrumental in the development of a 3rd generation anthracycline named Amrubicin. We will continue to study this medication and hope that will prove to be a new and highly effective medication for our patients.
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Ariad News Release
The Sarcoma Oncology Center is pleased to see preliminary results from the Ariad/Merck clinical trial for advanced sarcoma. The SUCCEED trial is studying a targeted investigational drug, ridaforolimus, as maintenance therapy for patients who have responded to their chemotherapy. 711 patients from all over the world participated in the trial. In the their press release, Ariad said the results so far show treatment with ridaforolimus reduced the risk of disease progression by 28% compared to placebo treatment, and increased progression free survival by a statistically significant amount of time.
Of 155 global sites that participated in the study, the Sarcoma Oncology Center had the highest patient participation, with 60 of our patients with advanced sarcoma receiving treatment under this important clinical trial. As the highest enrolling investigator, Dr. Chawla will present the study results at the upcoming American Society of Clinical Oncology annual meeting June 4-8 in Chicago IL. Dr. Chawla says, “We are pleased by the strong positive trend of the data, and we anticipate seeing the response data improve a bit further as patients continue to receive ridaforolimus. The greatest credit belongs to our patients, who have kept the commitment to try these new research medicines and help us to develop the new treatments for sarcoma. We are most grateful for every patient who takes part in clinical research with us. You are the most important members of the research team.”
For more information on the SUCCEED trial
Connective Tissue Oncology (CTOS) 2010 Annual Conference
CTOS is an international group comprised of physicians and scientists with a primary interest in the tumors of connective tissues. The goal of the society is to advance the care of patients with connective tissue tumors and to increase knowledge of all aspects of the biology of these tumors, including basic and clinical research.
In 2010, the Sarcoma Oncology Center presented several new therapies for the treatment of sarcoma:
1. Efficacy and Safety of Conatumumab Plus AMG 479 in Patients With Advanced Sarcoma. S Chawla,1 AC Lockhart,2 N Azad,3 E Elez,4 F Galimi,5 N Baker,6 YJ Hei,5 H Kindler7
AMG 479 is an investigational, fully human monoclonal antibody against the type 1 insulin-like growth factor receptor (IGF1R). Binds to IGF1R and prevents binding of its ligands, IGF-1 and IGF-2. Conatumumab is an investigational, fully human monoclonal antibody against human death receptor 5 (DR5). It binds to DR5, activates caspases, and induces apoptosis. Prolonged stable disease was noted in 3 patients and it was very well tolerated.
2. A Phase 2 Study of Nanoparticle Albumin-Bound (NAB) Paclitaxel in the Treatment of of Patients with Unresectable or Metastaic Sarcoma. James E. Butrynski1, Rangarajan Nadadur2, Thierry Jahan3, Victoria Chua4, Claire Bautista Lazaro4, Sant Chawla4
nab-Paclitaxel is a novel biologically interactive, albumin-bound Paclitaxel combining a protein with a chemotherapeutic agent in a particle form. In principle, this composition provides a novel approach of increasing intra-tumoral concentration of the drug by a receptor-mediated transport process allowing transcytosis across the endothelial cell wall.
3. Denosumab in Giant Cell Tumor of Bone: Interim Results From a Phase 2 Study. Sant Chawla1, Angela Cioffi2, Judith R. Kroep3; Alex Powell4, Peter Reichardt5, Scott M. Schuetze6, Silvia Stacchiotti7, Arthur Staddon8, Yi Qian9, Kay Noonan9, Ira Jacobs9
This interim analysis reports: 1. Safety results for all patients who received = 1 dose of denosumab as of the 6-month data cut-off date 2. Efficacy results for patients who had the opportunity to receive denosumab treatment for = 6 monthsAfter 6 months, 47 patients (96%) were free of disease progression based on subjective assessment of disease status
4.Threshold + Adriamycin for Soft Tissue Sarcomas
"We are very pleased to have achieved a response rate of 33% in a meaningful number of patients which compares favorably with historic, albeit controlled data. The durability of response is also quite promising," said John Curd, M.D., Threshold's chief medical officer. "If confirmed in a controlled trial, the potential benefit to sarcoma patients of TH-302 plus doxorubicin would be greatsignificantly better than the current standard of doxorubicin alone for these patients who are in serious need of better treatment options."