The Phase 2 clinical trial will analyze blood-based biomarkers versus conventional radiography for cancer patients treated with immunotherapy; findings could change direction of lung cancer treatment.
NEW YORK, July 29, 2020 — The Cancer Research Institute (CRI) and The Mark Foundation for Cancer Research have launched an innovative clinical trial that aims to demonstrate the utility of a novel, ultra-sensitive biomarker-directed blood test, or liquid biopsy, in assessing cancer patient responses to immunotherapy. If this and future studies show that this approach can more accurately characterize these responses to therapy, oncologists may gain a new and more reliable, less costly, and less invasive means to help them identify earlier in a cancer patient’s treatment course whether immunotherapy may be effective or whether other therapeutic options may offer a better alternative.
The phase 2, multi-center trial will be conducted by the Canadian Cancer Trials Group (CCTG) with clinical investigators at five sites in Canada and at John Hopkins University in the United States. Valsamo Anagnostou, M.D., Ph.D., assistant professor of Oncology, director of the Thoracic Oncology Biorepository and a Swim Across America investigator at the Johns Hopkins Kimmel Comprehensive Cancer Center is the study’s chair.
In the trial’s first stage, investigators will explore whether distinct dynamic changes in levels of circulating cell-free tumor DNA (ctDNA) associated with patterns of clinical response or resistance to immunotherapy are superior to radiographic response assessments. Liquid biopsies from patients in the trial will be analyzed by Personal Genome Diagnostics (PGDx). In the trial’s second stage, investigators will prospectively examine whether these patterns can effectively guide treatment decisions for patients with non-small cell lung cancer, currently the leading cause of cancer deaths worldwide. In the second stage of the study, ctDNA analysis will be used to determine whether a patient should receive immunotherapy alone or in combination with chemotherapy.
“This novel clinical trial exemplifies the power of science-driven collaboration directed by the CRI Anna-Maria Kellen Clinical Accelerator, which brings together industry, academic, and nonprofit partners to address critical unanswered questions in immuno-oncology and expand immunotherapy’s benefits to more patients,” said Vanessa M. Lucey, Ph.D., MBA, director of CRI’s Venture Fund and Clinical Accelerator. “We are excited to partner for the first time with The Mark Foundation for Cancer Research as well as continue our ongoing clinical research partnerships with CCTG and PGDx, who together are working with CRI to design, fund, and carry out this important study.”
“We are committed to catalyzing liquid biopsy projects because of the technique’s transformative potential to ensure patients have the best chance to receive therapies that will be effective for them,” said Michele Cleary, Ph.D., CEO of The Mark Foundation for Cancer Research. “The results of this team’s work could eventually change how clinical studies are conducted and decisions about patient treatments are made.”
“Accurately assessing who may be benefiting from treatment is challenging, especially for immunotherapy as the change in tumor size may not reflect the anti-cancer effect. This trial will identify whether testing blood for evidence of tumor DNA correlates with patient benefit. If so, it can lead to better assessment of patient status, whether patients are benefiting from treatment or should consider a different treatment and result in fewer imaging tests and exposure to X-rays,” said Janet Dancey, M.D., FRCPC, director of the Canadian Cancer Trials Group.
Building on a groundbreaking study
Evidence of ctDNA as a clinically relevant dynamic biomarker for assessment and prediction of cancer patient responses to immunotherapy was recently first demonstrated in a groundbreaking paper published last March in the journal Cancer Research. Lead author Anagnostou and colleagues showed that post-treatment changes in ctDNA levels reliably predicted later clinical responses.
Specifically, Anagnostou and her team reported that patients whose ctDNA levels fell after receiving immunotherapy had better clinical responses, whereas patients whose ctDNA levels remained unchanged or increased responded poorly or not at all. Importantly, ctDNA measurement allowed for a more accurate prediction of patient responses up to 8.7 weeks earlier on average than is possible with current conventional CT imaging.
Key industry and academic partners
This clinical trial is the second to result from the collaboration formed in 2018 between CRI and CCTG, a Canada-based cooperative oncology group that is sponsoring the study. It is also the second CRI Clinical Accelerator trial to leverage in-kind support from industry partner PGDx, which is supplying centralized analysis of patient-derived liquid biopsies.
About the trial
Title: Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients With NSCLC (NCT04093167)
- Vancouver Cancer Centre (Canadian Study Chair: Cheryl Ho, M.D., FRCPC)
- CancerCare Manitoba
- Juravinski Cancer Centre at Hamilton Health Sciences
- The Ottawa Hospital Research Institute
- University Health Network Princess Margaret Cancer Centre
- Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University (Study Chair: Valsamo Anagnostou, M.D., Ph.D.)
About the Cancer Research Institute
The Cancer Research Institute (CRI), established in 1953, is a highly-rated U.S. nonprofit organization dedicated exclusively to saving more lives by fueling the discovery and development of powerful immunotherapies for all types of cancer. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 26 members of the National Academy of Sciences, CRI has invested $444 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate immunotherapy’s potential to transform cancer treatment. To learn more, go to www.cancerresearch.org.
About the CRI Anna-Maria Kellen Clinical Accelerator
CRI’s clinical program, the Anna-Maria Kellen Clinical Accelerator, is a unique academic-nonprofit-industry collaboration model that serves as an “incubator” delivering multi-center clinical trials for promising new immunotherapy combinations. CRI’s venture philanthropy fund supports trials within this program, which fosters a collaborative environment enabling scientists to advance their most ambitious research ideas while facilitating science-driven studies that one group or company could not do alone. To learn more about the CRI Anna-Maria Kellen Clinical Accelerator, go to www.cancerresearch.org/clinical-accelerator.
About The Mark Foundation for Cancer Research
The Mark Foundation for Cancer Research actively partners with scientists to accelerate research that will transform the prevention, diagnosis, and treatment of cancer. The Mark Foundation fulfills its mission by supporting groundbreaking science carried out by individual investigators, multi-disciplinary teams, and inter-institutional collaborations in the United States and across the globe. Recognizing the obstacles that prevent scientific advances from improving patient outcomes, The Mark Foundation maintains a nimble, high-impact approach to funding research through grants for basic and translational cancer research and investments in early-stage companies that bridge the gap between bench and bedside. Since its launch in 2017, the Mark Foundation has awarded over $90 million in grant funding to over 50 institutions in the U.S., the U.K. and Europe. To learn more, visit www.themarkfoundation.org.
About the Canadian Cancer Trials Group
Celebrating its 40th year, the Canadian Cancer Trials Group (CCTG) is a cancer clinical trials research cooperative that runs phase I-III trials to test anti-cancer and supportive therapies in over 80 institutions across Canada and internationally. From their operations center at Queen’s University, they have led and participated in over 500 trials in over 40 countries aimed at improving survival and quality of life for all people with cancer. CCTG is a national program of the Canadian Cancer Society that provides core funding for the Group. To learn more about the CCTG, go to www.ctg.queensu.ca.
About Personal Genome Diagnostics
Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. PGDx is committed to improving clinical insight, speed of results, and healthcare economics by delivering a portfolio of regulated tissue-based and liquid biopsy genomic products for health systems worldwide. PGDx was established by researchers from Johns Hopkins University who are pioneers in cancer genome sequencing and liquid biopsy technologies. For additional information, visit www.PersonalGenome.com.