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: 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

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

The Official Patient's Sourcebook on Kaposi's Sarcoma: A Revised and Updated Directory for the Internet Age
by Icon Health Publications (Author)

This sourcebook has been created for patients who have decided to make education and Internet-based research an integral part of the treatment process. Although it gives information useful to doctors, caregivers and other health professionals, it also tells patients where and how to look for information covering virtually all topics related to kaposi's sarcoma, from the essentials to the most advanced areas of research. The title of this book includes the word official. This reflects the fact that the sourcebook draws from public, academic, government, and peer-reviewed research. Selected... View Details

Bone Sarcoma (MD Anderson Cancer Care Series)
by Patrick P. Lin (Editor), Shreyaskumar Patel (Editor)

Bone Sarcoma is a succinct volume within the M.D. Anderson Cancer Care Series that summarizes the key elements of different specialties as they pertain to these cancers. It is a vital resource for physicians working with these uncommon yet fascinating bone sarcomas and uses a multidisciplinary team approach that is essential to maximizing a patient’s chances of a successful outcome. Written for physicians who have an interest in how the entire treatment process works and how their efforts are intertwined with those of their colleagues, Bone Sarcoma covers topics such as... 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

A Simple Guide to Kaposi's Sarcoma, Treatment and Related Diseases (A Simple Guide to Medical Conditions)


Ode To Kaposi Sarcoma

In the past Kaposi Sarcoma is synonymous with HIV disease
KS was very rare isolated to men of Jewish or African of elderly age
In the 1980s the increased number of AIDS was associated with Kaposi Sarcoma
Highly Active AntiRetroviral Therapy (HAART) has now reduced the KS number

Skin lesions may be blotchy, nodular and papular
Lesions may also involve the lymphatics resulting in lymphedema
Full examination includes skin, mucosa and lymph node examination
CXR should be performed to pick up... View Details

Skin manifestation in patients with HIV infections: Cutaneous manifestations of human immunodeficiency virus infection
by Dr. Daniel Cebo (Author)

Cutaneous manifestations are common in patients with HIV infection and mainly due to the immunodeficiency. In the initial stage of HIV infection, we frequently observe a rash of macular lesions. During the asymptomatic phase, the patients may typically show the following skin diseases: seborrhoic dermatitis, acneiform folliculitis, persistent herpes simplex, and infections with the human papilloma virus. In ARC and AIDS patients, 3 groups of skin disorders are found: cutaneous infections, skin tumors, and other mixed skin diseases. Herpes simplex and herpes zoster may develop into ulcerating... View Details

Musculoskeletal Cancer Surgery: Treatment of Sarcomas and Allied Diseases
by Martin M. Malawer (Editor), Paul H. Sugarbaker (Editor)

Steven A. Rosenberg, MD In the past two decades significant progress has quality of life. The use of local radiation therapy has occurred, in the management of patients with mus- had a profound impact on the ability to achieve local loskeletal cancers, that has improved both the survival control. Cooperation between surgeons and radiation and the quality of life of afflicted patients. Changes in therapists often results in the tailoring of surgical p- the management of these patients have mirrored cedures to maximize the combined application of these trends in the entire field of oncology.... View Details

21st Century Pediatric Cancer Sourcebook: Ewing Sarcoma Family of Tumors (Bone, PNET, Extraosseous) - Clinical Data and Practical Information for Patients, Families, and Physicians
by Progressive Management

Authoritative information and practical advice from the nation's cancer experts about the ewing sarcoma family of tumors (bone, PNET, extraosseous). Starting with the basics, and advancing to detailed patient-oriented and physician-quality information, this comprehensive compilation gives empowered patients, families, caregivers, nurses, and physicians the information they need to understand the diagnosis and treatment of these diseases. In addition to disease-specific information, this ebook includes a glossary and information on the late effects of treatment for childhood cancer and... View Details

Fitzpatrick's Color Atlas, 8th Ed
by Klaus Wolff (Author), Richard Allen Johnson (Author), Arturo P. Saavedra (Author), Ellen K. Roh (Author)


A Doody's Core Title for 2017!

More than 1,000 full-color photographs speed diagnosis of the dermatologic conditions most often encountered in primary care

One of the bestselling dermatology books in the world, this quick-reference clinical guide has virtually defined the field for thousands of physicians, dermatology residents, and medical students for more than three decades. Spanning the entire spectrum of skin... View Details

Best Science Podcasts 2017

We have hand picked the best science podcasts for 2017. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Going Undercover
Are deception and secrecy categorically wrong? Or can they be a necessary means to an end? This hour, TED speakers share stories of going undercover to explore unknown territory, and find the truth. Guests include poet and activist Theo E.J. Wilson, journalist Jamie Bartlett, counter-terrorism expert Mubin Shaikh, and educator Shabana Basij-Rasikh.
Now Playing: Science for the People

#452 Face Recognition and Identity
This week we deep dive into the science of how we recognize faces and why some of us are better -- or worse -- at this than others. We talk with Brad Duchaine, Professor of Psychology at Dartmouth College, about both super recognizers and face blindness. And we speak with Matteo Martini, Psychology Lecturer at the University of East London, about a study looking at twins who have difficulty telling which one of them a photo was of. Charity Links: Union of Concerned Scientists Evidence For Democracy Sense About Science American Association for the Advancement of Science Association for Women...