Children’s Oncology Group and Signify Health Collaborate to Broaden In-Home Administration for Investigational Immuno-oncology Therapy for Patients Enrolled in COG AALL1731

Rhea-AI Summary

Signify Health (NYSE: SGFY) and The Children’s Oncology Group (COG) announce a partnership to facilitate at-home clinical trial participation for pediatric patients with B-cell acute lymphoblastic leukemia (B-ALL). This initiative expands in-home infusion services for patients involved in COG Study AALL1731, allowing them to receive experimental treatments without traveling to treatment centers. The collaboration aims to alleviate the emotional and financial burden on families, improve clinical trial access, and enhance treatment adherence through a national network of credentialed clinicians.

Positive

• Partnership aims to facilitate in-home clinical trial participation, increasing access to experimental therapies for pediatric patients.
• Improves adherence to treatment by providing in-home infusion services, reducing the burden on families.
• Support from Amgen under the CRADA helps finance expanded treatment options for pediatric patients.

Negative

• None.

The Children’s Oncology Group (COG), the world's largest organization devoted exclusively to childhood and adolescent cancer research, and Signify Health, Inc. (NYSE:SGFY), a leading platform that leverages advanced analytics, technology and nationwide healthcare provider networks, today announced a partnership to facilitate clinical trial participation for pediatric patients through in-home clinical services.

Through this new collaboration, pediatric patients participating in COG Study AALL1731, a clinical trial for a therapy to treat B-cell acute lymphoblastic leukemia (B-ALL), now have expanded options to facilitate receipt of experimental treatment at home. Participating in clinical trials that involve infusion therapies can be challenging for families because infusions require a credentialed provider to administer them, and because home health agencies are unable to bill insurance for investigational therapies.

AALL1731 (NCT03914625) is sponsored by the National Cancer Institute under a Cooperative Research and Development Agreement (CRADA) with Amgen, and is currently open at 195 U.S. COG sites. This in-home infusion service is for the patients assigned to receive blinatumomab on AALL1731 who are unable to access outpatient pumps and homecare. Amgen has provided funding to NCI under the CRADA to support more pediatric patients to receive blinatumomab at home.

B-ALL is the most prevalent childhood cancer, representing 20% of diagnoses in children younger than 15 years old and is the leading disease-related cause of death for children ages one to 19. Although improved treatments have led to higher survival rates for children with B-ALL, approximately 15% of children will have their leukemia return after remission is achieved. More effective treatment is needed for these children. Promising new therapies have the potential to alter the course of disease progression and removing barriers to participating in clinical trial programs is a primary focus for researchers and drug sponsors.

“This collaboration to provide in-home clinical services will allow more children to spend time at home receiving the investigational therapy while enabling much-needed research to deliver safer, and hopefully more effective therapies,” said Mignon Loh, M.D., Chair of the COG ALL Committee. “A decentralized clinical trial approach will relieve unnecessary stress on families who are struggling financially and emotionally from their child’s cancer diagnosis. We hope that home access to investigational agents will increase participation in these important clinical trials.”

Signify Health’s home-based clinical support services can help patients initiate investigational and approved therapies faster, improve their adherence, and provide a better overall experience for patients and families. Signify Health’s national network of credentialed clinicians will provide in-home infusion pumps and infusion bag changes to pediatric patients who have requested the in-home alternative. Signify clinicians will document patient metrics in real-time and be on call for the first 24 hours after a bag change to address any potential pump malfunctions.

“There is no better use of our network than to help children with cancer access potentially life-changing therapies,” said Kyle Armbrester, CEO of Signify Health. “By activating the home as an alternate site of care, we hope to alleviate some of the burden and stress for families so that they can spend more time and energy focusing on what matters most.”

About The Children's Oncology Group (COG)

COG, a member of the NCI National Clinical Trials Network (NCTN), is the world's largest organization devoted exclusively to childhood and adolescent cancer research. COG unites over 10,000 experts in childhood cancer at more than 200 leading children's hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Today, more than 90% of the 14,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by COG institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG's mission is to improve the cure rate and outcomes for all children with cancer.

About Signify Health

Signify Health is a leading healthcare platform that leverages advanced analytics, technology, and nationwide healthcare provider networks to create and power value-based payment programs. Our mission is to transform how care is paid for and delivered so that people can enjoy more healthy, happy days at home. Our solutions support value-based payment programs by aligning financial incentives around outcomes, providing tools to health plans and healthcare organizations designed to assess and manage risk and identify actionable opportunities for improved patient outcomes, coordination and cost-savings. Through our platform, we coordinate what we believe is a holistic suite of clinical, social, and behavioral services to address an individual’s healthcare needs and prevent adverse events that drive excess cost, all while shifting services towards the home. For more information on how we are taking health homeward, visit us at signifyhealth.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210617005208/en/

FAQ

What is the significance of the partnership between Signify Health and the Children’s Oncology Group?

The partnership aims to provide pediatric patients with B-ALL expanded access to experimental treatments through in-home clinical trial participation, reducing the need for travel to treatment centers.

How does the in-home infusion service benefit patients in COG Study AALL1731?

The in-home infusion service allows patients who cannot access outpatient pumps to receive necessary treatments at home, improving comfort and adherence to therapy.

What is the current status of COG Study AALL1731?

COG Study AALL1731 is open at 195 U.S. COG sites and focuses on treating B-ALL, the most prevalent childhood cancer.

Who is supporting the funding for this partnership?

The National Cancer Institute is sponsoring the AALL1731 study under a Cooperative Research and Development Agreement with Amgen, which provides funding to support in-home treatment options.