Evinova and Quantum Leap Healthcare Collaborative (QLHC) announced a partnership to integrate remote patient monitoring technology into I-SPY 2.2, the largest and longest-running platform trial for locally advanced breast cancer. The collaboration will implement Evinova's remote patient monitoring (RPM) solution to detect early symptoms of interstitial lung disease (ILD), a potential serious adverse event associated with one of the treatment arms in the study.
The I-SPY 2.2 trial provides a framework for evaluating multiple novel therapeutic approaches for women with newly diagnosed, locally advanced breast cancer. By incorporating real-time monitoring capabilities, the trial aims to enhance patient safety while testing promising new treatments.
Early Detection of Treatment Complications
Dr. Laura Esserman, founder of the I-SPY trials and QLHC, emphasized the importance of this technology: "One of the primary goals of I-SPY 2.2 is to get better treatments to patients faster and with fewer side effects. New bispecific antibodies and antibody drug conjugates have the promise of eliminating traditional chemotherapy, but they too are associated with potential serious side effects."
Interstitial lung disease represents one such complication that, if detected early, may be prevented from becoming serious. The Evinova platform enables daily monitoring of patients from their homes, allowing healthcare providers to identify and intervene promptly when symptoms first appear.
"Evinova makes it possible for us to monitor people using the drug every day, from the comfort of their home," Dr. Esserman noted. "We are studying how this solution can improve the patient experience and minimize toxicity – that is what we all want to achieve."
How the Technology Works
Evinova's RPM solution monitors patients' health status and treatment intake between clinical visits, generating real-time alerts to healthcare providers when symptoms potentially related to ILD appear or worsen. This approach allows medical teams to triage patients who may need further clinical evaluation and intervene based on established guidelines.
The technology could significantly reduce the likelihood of progression to high-grade ILD and prevent the need for dose reductions, holds, or treatment interruptions – all critical factors in maintaining effective cancer therapy.
Expanding Applications for Patient Monitoring
Cristina Duran, President of Evinova, highlighted the broader implications: "With real-time alerts to both patients and sites, Evinova's RPM solution for toxicity monitoring enables care teams to review and take proactive actions based on guidelines."
Beyond pulmonary toxicity monitoring, Evinova has developed additional RPM modules for monitoring gastrointestinal symptoms, stomatitis, and oral thrush, with more capabilities in development based on patient needs and drug side effect profiles.
"At Evinova, we're passionate about accelerating better health outcomes through technology like RPM that enables global life science leaders to overcome critical research challenges and deliver a better clinical trial experience for both sites and patients," Duran added.
Platform Trials and the Future of Cancer Research
The I-SPY 2.2 trial represents an innovative approach to clinical research, using a platform design that allows multiple treatment arms to be evaluated simultaneously against a common control group. This methodology accelerates the testing of promising therapies and provides more efficient pathways to identify effective treatments.
By incorporating advanced digital health technologies like Evinova's RPM solution, platform trials can further enhance their efficiency while prioritizing patient safety. The real-time monitoring capabilities address one of the key challenges in testing novel cancer therapies – balancing efficacy with toxicity management.
The partnership between Evinova and QLHC demonstrates how technology integration can potentially transform clinical trials, making them safer for participants while accelerating the development of new treatment options for patients with locally advanced breast cancer.
Evinova, a separate health-tech business within the AstraZeneca Group, specializes in digital solutions designed to improve health outcomes across the life sciences sector. Quantum Leap Healthcare Collaborative, a 501(c)(3) nonprofit organization, focuses on accelerating healthcare innovation through approaches that challenge conventional science and care models.
