Nav: Home

PharmaMar presents positive results from a Phase II study of PM1183 in Ewing's sarcoma

November 13, 2017

In abstract #2768194 entitled "Efficacy and safety of lurbinectedin (PM1183) in Ewing Sarcoma: results from a Phase 2 study" the efficacy and safety results from the Phase II basket trial were presented, in which a group of patients with this type of advanced sarcoma, that hadn´t received more than 2 prior chemotherapeutic treatment in metastatic disease, were included. The study is ongoing, although the cohort of patients with Ewing´s sarcoma has now closed.

At the moment of this abstract, 25 patients with Ewing´s sarcoma were enrolled. The observed disease control rate (overall response, partial response and stabilization of the disease) was 60%, including partial responses in 12% of cases, and a stabilization of the disease in the 48% of cases. The observed median duration of response was 2.9 months and 3 months of median progression free survival was reached.

The study showed that adverse effects were generally related to myelosuppression, which were reported to be manageable with dose adjustments. No treatment withdrawals due to toxicity or toxic deaths occurred. The patients with Ewing´s sarcoma have a poor outcome. The authors of the abstract would like to highlight that new therapeutic agents with different mechanism of action are needed, as in the case of lurbinectedin, which has exhibited a favorable safety and tolerability profile as a single agent in pre-treated patients with advanced Ewing´s sarcoma.

Main studies presented at CTOS

  • A matching indirect adjusted comparison of trabectedin and pazopanib for the treatment of advanced, metastatic, leiomyosarcomas. Sponsored by Janssen Research & Development, LLC. And PharmaMar. Lead author: Robin Jones et al.

  • SAR-3007: Efficacy and safety of trabectedin, when administered as Inpatient vs. Outpatient Site of Care. Sponsored by Janssen Research & Development, LLC. Lead author: Robin Jones et al.

  • SAR-3007: Genomic Characterization of Uterine Leiomyosarcoma Patients to Define Exploratory Biomarkers in the Phase III Randomized Trial of Trabectedin versus Dacarbazine. Sponsored by Janssen Research & Development, LLC. Lead author: Gurpreet Kapoor et al.

  • SAR-3007: Efficacy and Safety of Trabectedin in an Elderly Patient Subgroup ??65 years? with Advanced Leiomyosarcoma ?LMS? or Liposarcoma ?LPS? from the Expanded Access Program ?EAP? Sponsored by Janssen Research & Development, LLC. Lead author: Robin Jones et al.

  • SAR-3002: Efficacy and Safety of Patients Treated Long?Term with Trabectedin ?T? on the Expanded Access Program: A Retrospective Analysis Sponsored by Janssen Research & Development, LLC. Lead author: Elizabeth Davis et al.

About YONDELIS® (trabectedin)

YONDELIS® (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL®/CAELYX® (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS® globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

About lurbinectedin

Lurbinectedin is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a Phase III study for small cell lung cancer.

About PharmaMar

Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has other clinical-stage programs under development for several types of solid and hematological cancers, Zepsyr® (PM1183), plitidepsin, PM184 and PM14. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other companies: GENOMICA, a leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at


Related Sarcoma Articles:

Immune responses from early study of novel sarcoma vaccine
The critical component of an experimental vaccine led to an escalating immune response in patients with sarcoma, an indicator of its potential anti-cancer effects.
A protein, a 'molecular staple' and CRISPR to develop an Ewing sarcoma model
A team from the Spanish National Cancer Research Centre (CNIO) has optimized a system capable of generating a cellular model of Ewing sarcoma.
'Jumonji' protein key to Ewing's sarcoma rampage
A University of Colorado Cancer Center study published in the journal Oncogene pinpoints a protein that may be essential to Ewing's sarcoma metastasis -- when researchers knocked down the protein KDM3A in Ewing's sarcoma tumor cells, one of a family known as Jumonji proteins, they also inhibited the cancer's metastatic ability.
Regional chemotherapy technique for extremity sarcoma salvages limbs from amputation
Patients with a type of advanced malignant cancer of the arms or legs have typically faced amputation of the afflicted limb as the only treatment option.
The first analysis of Ewing's sarcoma methyloma opens doors to new treatments
IDIBELL researchers describe the Ewing's sarcoma (ES) methylation profile for the first time.
Mayo Clinic investigators pinpoint cause, possible treatment for rare form of sarcoma
Researchers at Mayo Clinic Center for Individualized Medicine have discovered a potential cause and a promising new treatment for inflammatory myofibroblastic tumors, a rare soft tissue cancer that does not respond to radiation or chemotherapy.
IU research finds link between molecular mechanisms in prostate cancer and Ewing's sarcoma
Medical researchers at Indiana University have found evidence for a link between prostate cancer, which affects millions of men age 50 and older, and Ewing's sarcoma, a rare form of cancer that affects children and young adults.
Significant survival gains from neoadjuvant chemotherapy for high-risk soft tissue sarcoma
Neoadjuvant chemotherapy with an anthracycline plus ifosfamide was associated with significant survival gains in patients with soft tissue sarcoma of the trunk or extremities who are at high-risk of recurrence, in an interim analysis that led to the early discontinuation of a trial presented today at the ESMO 2016 Congress in Copenhagen.
The Lancet Oncology: Australian researchers uncover complex genetic secrets of cancer risk
In a landmark multi-country study, Australian researchers have transformed our understanding of the genes that affect our risk of cancer.
Immunotherapy effective against some types of sarcoma
An existing cancer immunotherapy drug reduces tumor size in some types of rare connective tissue cancers, called sarcomas, report researchers at the University of Pittsburgh Cancer Institute.

Related Sarcoma Reading:

Sarcoma, An Issue of Hematology/Oncology Clinics of North America, 1e (The Clinics: Internal Medicine)
by Andrew J. Wagner MD PhD (Author)

This issue focuses on Sarcoma in areas such as: Gastrointestinal Stromal Tumors: Risk assessment and adjuvant therapy, Gastrointestinal Stromal Tumors: Management of metastatic disease and emerging therapies, Liposarcoma, Leiomyosarcoma, Update in treatment and targets in cartilage and bone tumors, Update in treatment and targets in Ewing sarcoma, Angiosarcoma and Epithelioid Hemangioendothelioma, Emerging therapies for sarcoma, and Treatment of localized sarcomas. View Details

Sarcoma: A Multidisciplinary Approach to Treatment
by Robert M. Henshaw (Editor)

The purpose of this book is to define and demonstrate how a multidisciplinary team can be organized, integrated, and utilized in the care of sarcoma patients. Real world experiences related by multiple sarcoma specialists working as members of a multidisciplinary team along with specific case examples highlighting sarcomas of bone and soft tissue in children and adults are presented in a framework geared toward practicing oncologists and surgeons in order to foster the creation and development of care teams for sarcoma patients. It is explained how a truly multidisciplinary approach, with... View Details

Management of Soft Tissue Sarcoma
by Murray F. Brennan (Author), Cristina R. Antonescu (Author), Kaled M. Alektiar (Author), Robert G. Maki (Author)

Management of Soft Tissue Sarcoma, 2nd Edition provides the most comprehensive analysis of demographics and natural history currently available for  these lesions, based on the authors’ experience with over 10,000 patients. Sections regarding radiation therapy not found in the previous text have been expanded, as have updates on molecular characteristics of sarcomas and chemotherapy studies published since the prior edition. Clinical and molecular diagnoses are addressed, and tumor histopathology is employed as the basis of treatment recommendations including surgery, radiation and... View Details

New Trends in the Treatment of Sarcoma: An Issue of Surgical Clinics of North America, 1e (The Clinics: Surgery)
by Jeffrey M. Farma MD (Author), Andrea S. Porpiglia MD (Author)

This issue of Surgical Clinics of North America, guest edited by Drs. Jeffrey M. Farma and Andrea Porpiglia, is devoted to Sarcoma. They have assembled expert authors to review the following topics: Epidemiology and Etiology of Sarcomas; Management of Extremity Sarcomas; Management of Retroperitoneal Sarcomas; Management of Dermatofibrosarcoma Protuberans; Management of Desmoids; Management of Truncal Sarcomas; Management of Bone Sarcomas; Management of Pediatric Sarcomas; Local Recurrence of Sarcomas; Management of Metastatic Disease; Imaging of Sarcomas; Management of Gastrointestinal... View Details

My Cancer Chronicles: Being Diagnosed with Ewing's Sarcoma (Volume 1)
by Justin Evans (Author)

On January 18th, 2013, Justin went to the doctor due to days of vomiting and chest pains. The previous week Justin had the flu and the assumption was he still had not recovered. The family doctor was not available that morning so Justin decided to go to the local urgent care clinic to be seen and prescribed something for his symptoms. What started with a simple X-Ray to determine the source of pain and shortness of breath would lead to the biggest shock of Justin’s life. A tumor that measured almost 20cm in size was found in his left lung and the family’s life was forever changed. The... View Details

NCCN Guidelines for Patients®: Soft Tissue Sarcoma
by National Comprehensive Cancer Network® (NCCN®) (Author)

[OFFICIAL CURRENT VERSION] From the medical leaders of 27 of the world’s most renowned cancer centers united under the National Comprehensive Cancer Network® (NCCN®), comes this essential guide to soft tissue sarcoma. Adapted from clinical treatment guidelines used by physicians and oncology professionals around the world, these NCCN Guidelines for Patients® are packed with the latest information, treatment innovations, and resources about the diagnosis and treatment of soft tissue sarcoma. Each patient-friendly chapter prepares patients and caregivers to talk with their doctors and make... View Details

Soft Tissue Sarcomas (American Cancer Society Atlas of Clinical Oncology)
by Raphael E. Pollock MD (Author)

Part of the acclaimed American Cancer Society Atlas of Clinical Oncology series, this book offers an expert overview of soft tissue sarcomas. It discusses diagnosis and staging, surgical approaches, radiation therapy, chemotherapy, pediatric sarcomas, and much more. Topics covered include epidemiology, inherited syndromes, biopsy and surgical techniques, external beam irradiation, brachytherapy, intraoperative radiation therapy, neoadjuvant therapy, adjuvant therapy, regional perfusion, pain syndromes, and rehabilitation. View Details

Living Life 90 Days at a Time: A Sarcoma Survivors Journey
by Thom J Schmenk (Author)

Living Life 90 Days at a Time: A Sarcoma Survivor's Journey is a warm, inspiring memoir. It offers the details of a patient's battle with a life-threatening sarcoma while sharing many self-help recommendations, humor, comfort, and support along the way. The author's journey began with a discovery of an egg-sized bulge on the inside surface of his left hamstring. Some procrastination and difficulty in diagnosing the tumor caused delays in treatment. Then he and his wife finally found their way to the right physician and oncology team at the Medical University of South Carolina in Charleston.... View Details

Uterine Cancer: Screening, Diagnosis, and Treatment (Current Clinical Oncology)
by Franco Muggia (Editor), Esther Oliva (Editor)

For the Editors, the task of writing a Preface is most satisfying. It represents the completion of the book and a moment of reflection on whether the whole is more than the sum of all the parts. And also, one must reflect on how this book is likely to be utilized in this era of rapid communications. The Editors first met in May 2003 at a stimulating Italian symposium on endometrial cancer (organizers Drs. Luigi Frigerio, Roberto Grassi and Andrea Lissoni, with participation of the deans of Italian Gynecologic Oncology, Ugo Bianchi and Constantino Mangioni) that took place at Bergamo and... View Details

Sarcoma Messed With the Wrong Person: Blank Lined Journal - 6x9 - Humorous Gift for Cancer Patient
by Passion Imagination Journals (Author)

Are you looking for a unique gift for a friend or family member fighting Sarcoma?

Journaling is like therapy. This is a blank, lined journal that's perfect to write down thoughts during this stressful time. It has a humorous saying on the cover, which will help with a positive attitude.You will not be able to find a journal like this in other stores! Other features of this notebook include:
110 pages6x9 inchesExcellent and thick bindingDurable white paperMatte-finished cover for a professional look
This diary is a convenient and perfect size to carry anywhere for... View Details

Best Science Podcasts 2018

We have hand picked the best science podcasts for 2018. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

The Consequences Of Racism
What does it mean to be judged before you walk through the door? What are the consequences? This week, TED speakers delve into the ways racism impacts our lives, from education, to health, to safety. Guests include poet and writer Clint Smith, writer and activist Miriam Zoila Pérez, educator Dena Simmons, and former prosecutor Adam Foss.
Now Playing: Science for the People

#465 How The Nose Knows
We've all got a nose but how does it work? Why do we like some smells and not others, and why can we all agree that some smells are good and some smells are bad, while others are dependant on personal or cultural preferences? We speak with Asifa Majid, Professor of Language, Communication and Cultural Cognition at Radboud University, about the intersection of culture, language, and smell. And we level up on our olfactory neuroscience with University of Pennsylvania Professor Jay Gottfried.