Cancer research and treatment continue to evolve with innovative approaches, and Lisata Therapeutics is at the forefront of these advancements. The company has partnered with Haystack Oncology, a Quest Diagnostics company, to utilize Haystack’s minimal residual disease (MRD) test in a Phase II trial of its solid tumor therapy, certepetide. This collaboration aims to enhance the evaluation of certepetide’s efficacy in patients with metastatic pancreatic cancer.
The MRD test will be employed to detect circulating tumor DNA (ctDNA) at multiple points throughout the clinical study. These measurements will serve as an exploratory endpoint, providing insights into the therapeutic effects of certepetide. The use of MRD to evaluate drug efficacy has gained significant attention, with the Oncologic Drugs Advisory Committee (ODAC) for the US Food and Drug Administration (FDA) endorsing MRD as a surrogate endpoint. This endorsement is particularly notable as it can lead to accelerated approvals of new therapies in conditions like multiple myeloma, allowing for earlier readouts compared to conventional endpoints such as overall and progression-free survival.
Cancer Research: Early Response Measurement Crucial in Pancreatic Cancer Treatment
Dr. Kristen K. Buck, executive vice president of R&D and chief medical officer of Lisata, emphasized the importance of this approach: “A significant challenge in the development of anti-cancer therapies for pancreatic tumors is the early measurement of response to treatment. Most clinical trials evaluating pancreatic cancer require waiting for long-term survival outcomes to discern treatment effect. Conventional response assessment via imaging may lack sensitivity in certain situations, and highly sensitive ctDNA assays offer the potential to quickly identify clinically meaningful biologic activity in difficult-to-treat cancers.”
Certepetide, the focus of the FROTIFIED trial, is a bifunctional cyclic peptide designed to enhance tumor penetration through its interaction with alphav-integrins and activation of neuropilin-1 (NRP-1). This mechanism transforms the solid tumor microenvironment into a temporary agent conduit, potentially increasing the efficacy of therapeutic agents.
The FROTIFIED trial is evaluating certepetide in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). This study is crucial as pancreatic cancer is one of the most challenging cancers to treat, often diagnosed at an advanced stage with limited treatment options. By incorporating MRD testing, Lisata aims to provide a more sensitive and timely assessment of the therapeutic response, which could significantly impact the management and outcomes of pancreatic cancer.
Cancer Treatment: Lisata Expands Certepetide Research to Multiple Solid Tumors
In addition to pancreatic cancer, Lisata is exploring the potential of certepetide in other advanced solid tumors, including colon cancer, cholangiocarcinoma, and glioblastoma multiforme. This broad investigation underscores the versatility of certepetide and its potential to address various difficult-to-treat cancers.
The integration of Haystack’s MRD test in Lisata’s clinical trials represents a significant step forward in cancer research. MRD testing, particularly in its ability to detect ctDNA, offers a promising avenue for early and accurate assessment of treatment efficacy. This approach not only expedites the drug development process but also provides patients with the possibility of quicker access to effective therapies.
The partnership between Lisata and Haystack highlights the collaborative efforts within the biotech industry to leverage cutting-edge technologies for improved cancer treatment. As the trial progresses, the data gathered from these MRD tests will be instrumental in shaping future marketing submissions to the FDA, potentially paving the way for new, effective treatment options for pancreatic and other solid tumors.
In conclusion, Lisata Therapeutics’ use of Haystack’s MRD tests in the FROTIFIED trial marks a significant advancement in the clinical evaluation of cancer therapies. By focusing on early and precise measurement of treatment response, this collaboration aims to improve the landscape of pancreatic cancer treatment and beyond, offering hope for better patient outcomes and accelerated therapeutic development.
Cancer research and treatment continue to evolve with innovative approaches, and Lisata Therapeutics is at the forefront of these advancements. The company has partnered with Haystack Oncology, a Quest Diagnostics company, to utilize Haystack’s minimal residual disease (MRD) test in a Phase II trial of its solid tumor therapy, certepetide. This collaboration aims to enhance the evaluation of certepetide’s efficacy in patients with metastatic pancreatic cancer.
Resource: Lisata, July 18, 2024
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