NEW YORK, NY – The Cancer Research Institute (CRI) is pleased to announce the enrollment of the first patient in the second stage of BR.36 (NCT04093167), a Phase 2/3 clinical trial using circulating tumor DNA (ctDNA) – tiny DNA fragments shed by dying cancer cells – to measure early responses to immunotherapy and guide treatment decisions for advanced lung cancer patients.
Liquid biopsy holds immense promise in revolutionizing cancer care by enabling precision medicine: delivering the right treatments — to the right patients — at the right time. These tests analyze bodily fluids like blood, urine, or saliva to detect ctDNA and provide critical insights into a patient’s cancer without the need for invasive tissue biopsies when insufficient tissue samples are available, or when the patient is not a viable candidate for a biopsy procedure.
The study is being led by researchers at the Johns Hopkins Kimmel Cancer Center, the Bloomberg-Kimmel Institute for Cancer Immunotherapy, BC Cancer, and the Canadian Cancer Trials Group (CCTG). It follows the successful completion and readout of stage 1 of the trial, which was published on October 9, 2023, in Nature Medicine.
The interventional, second stage of the trial builds on promising results from stage 1. Leveraging Labcorp® Plasma Focus™, a liquid biopsy test from Labcorp, the trial will measure ctDNA response after two cycles of the immunotherapy pembrolizumab (Keytruda®). Patients identified as being at high risk for disease progression based on their ctDNA results will be randomized to receive an intensified treatment regimen combining pembrolizumab with chemotherapy or remain on pembrolizumab monotherapy. Based on ctDNA findings, this study will evaluate whether patients will live longer and potentially become disease-free when chemotherapy is added.
“CRI is deeply committed to advancing transformative innovations in cancer care,” said Alicia Zhou, PhD, CEO of CRI. “The second stage of the BR.36 trial represents a pivotal moment in integrating liquid biopsy technologies with immunotherapy, enabling us to tailor treatments with unprecedented precision. By leveraging ctDNA to guide real-time treatment decisions, this study has the potential to redefine how we manage advanced-stage lung cancers and improve outcomes for patients worldwide.”
“Labcorp is committed to enhancing patient access to precision oncology tests through leading scientific innovation and discoveries,” said Shakti Ramkissoon, MD, PhD, MBA, vice president, medical lead for oncology at Labcorp. “The results from the next stage of the BR.36 study will provide critical insights to power better outcomes at every step of a patient’s journey, helping to transform the use of diagnostics and how they can inform therapy decisions.”
Valsamo Anagnostou, MD, PhD, associate professor of oncology at Johns Hopkins School of Medicine and CRI-Torrey Coast Foundation GEMINI CLIP investigator, who is the study chair, echoed enthusiastically, “I am thrilled to see the next stage of BR.36 taking off, bridging liquid biopsy scientific discoveries with clinical cancer care.” Underlining the importance of the trial, Dr. Anagnostou said, “This ctDNA molecular response adaptive clinical trial brings molecular resolution to the assessment of immunotherapy response and has the potential to establish ctDNA monitoring as an early endpoint of immunotherapy response, allowing us to deliver the best available care with precision.”
This trial underscores the transformative potential of liquid biopsies, not just as a diagnostic tool but also as a guide for personalized cancer care. By identifying patients most likely to benefit from specific treatments, this approach could maximize the effectiveness of immunotherapies and improve outcomes for people living with cancer.
This innovative trial is made possible through funding from CRI and Labcorp.