July 21, 2016
PRELIMINARY RESULTS OF SARC028
In this first investigator-led study of pembrolizumab in multiple subtypes of sarcoma, researchers reported encouraging results at the recent ASCO (American Society of Clinical Oncology) meeting. Pembrolizumab is an immunotherapeutic approach to treating cancer.
Thirty-three percent (33%) of patients with undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma treated on this trial had a reduction in tumor size.
Additionally, because the patients allowed additional tumor tissue to be obtained as well as blood samples, there is an opportunity to better understand the potential benefit of this therapy in sarcoma.
Immunotherapies work by using a patient’s own immune cells to target cancer cells.
This breakthrough exemplifies the collaborative work of a dedicated group of researchers, physicians, universities, pharma/biotech organizations, and patient advocates working to improve outcomes for sarcoma patients. This important trial was conducted through the network of SARC (Sarcoma Alliance for Research Through Collaboration), a non-profit research cooperative solely dedicated to fostering progress in the prevention and treatment of sarcoma, a rare form of cancer.
“This is an incredible example of the impact of our community of sarcoma specialists coming together with the support of patients and pharma to explore innovative therapies and improve the outcomes of patients with sarcoma,” said Denise Reinke, President and CEO of SARC.
These interim results from this phase II clinical trial were presented by Principal Investigator Hussein A. Tawbi, MD, PhD, of the University of Texas MD Anderson Cancer Center, formerly of the University of Pittsburgh Cancer Institute (UPCI) on Sunday, June 5, 2016 during the sarcoma oral presentation session at ASCO.
“We are very encouraged and excited by the results,” says Dr. Tawbi. “Immunotherapy has finally realized the prospects of actual cures in metastatic cancer, but until now we have not managed to prove the efficacy of this exciting modality in sarcoma patients. Our results will serve to identify subsets of patients in which treatment with the safe single agent anti-PD-1 antibodies may help achieve potential cures. It will also pave the way to combination therapies that may require the addition of other drugs to anti-PD-1 antibodies to induce an immune response.”
“This study was proposed, designed, and conducted by SARC investigators and is a significant milestone that brings new hope to sarcoma patients worldwide,” Dr. Tawbi added.
The results of this study presented in the ASCO 2016 sarcoma oral abstract session were also highlighted by discussant Dr. Breelyn Wilky, MD, Assistant Professor, Sarcoma Program in the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, Miami, Florida in her presentation, Immunotherapy in Sarcomas: Where Do We Go From Here?
“These results really pave the way for combination studies to try to improve the proportion of patients who benefit,” says Dr. Wilky. “The most important thing we can do is to use the amazing collection of blood and tumor samples from SARC028 to try to learn something about which patients responded – the ability to find a biomarker and direct patients more likely to benefit would be a huge step forward.”
Merck & Co. provided their compound, pembrolizumab, and a portion of the financial support to do the study. The remaining funds for this work were provided by the Sarcoma Foundation of America, the QuadW Foundation, a philanthropic donation, and SARC.
“What makes this trial special is that we collected biopsies and blood samples to really study how the treatment is working or not working in these patients. These immune-monitoring studies will offer unique insights into the biology of immunotherapy in sarcoma,” explained Melissa Burgess, MD, assistant professor of medicine at UPCI and the current lead investigator for the UPCI site.
The network of SARC centers collaborating in support of this immunotherapy breakthrough include:
Duke University Medical Center (Richard Riedel, MD);
Fox Chase Cancer Center (Sujana Movva, MD);
Mayo Clinic Rochester (Scott Okuno, MD);
Mayo Clinic Jacksonville (Steven Attia, DO);
MedStar Washington Hospital Center (Dennis Priebat, MD);
Memorial Sloan Kettering Cancer Center (Sandra D’Angelo, MD);
Moffitt Cancer Center (Damon Reed, MD);
Oregon Health and Sciences University – Knight Cancer Institute (Lara Davis, MD);
Tisch Cancer Institute (Robert Maki, M.D., PhD);
University of Michigan (Scott Schuetze, MD, and Laurence Baker, DO);
University of Pittsburgh (Hussein Tawbi, MD, PhD and Melissa Burgess, MD);
University of Southern California Norris Comprehensive Cancer Center (James Hu, MD);
University of Texas MD Anderson Cancer Center (Shreyaskumar Patel, MD);
Washington University in St. Louis (Brian Van Tine, MD, PhD).