Improving Access to Nivolumab by Lowering Age Restrictions in Clinical Trial

Improving access to newer therapies will benefit not only short-term outcomes, but also long-term survivorship for children with cancer, says Kara Kelly, MD, chair of pediatrics, Roswell Park Oishei Children's Cancer and Blood Disorders Program, member of the Lymphoma Research Foundation’s Scientific Advisory Board.

Transcript

Can you provide a brief overview of the childhood cancer treatment landscape, and any progress regarding access to innovative therapies?

It's a very exciting time in childhood cancer and adolescent cancer treatment. Especially with significant advances in bringing more targeted therapies to not only treatment for patients with relapse, but also for frontline management. Additionally, through advances in our understanding of the biology of so many childhood cancers, especially the leukemias and lymphomas, we have much improved diagnostic testing that allows us to be able to better stratify the treatment, to be able to deliver exactly what treatment is needed for a given patient rather than treating patients more broadly.

I would add that's especially important for this younger population. Many lymphomas are highly curable, but the challenge we've had with our more conventional chemotherapy- and radiation therapy–based treatments is that they leave these young survivors with risk for complications from these therapies that either shorten their lifespan or lead to significant organ complications. So, with these new therapies, there's great promise to improve not only short-term cure, but also long-term survivorship.

What are some of the biggest challenges you encounter as a pediatric oncologist, and what do you believe would help alleviate these challenges/burdens?

One of the challenges we have in bringing new therapies into treatment, especially frontline treatment, is that there's often a long lag between when the therapies are first either shown to be efficacious or receive FDA approval in adults before there's that same opportunity in children. It's been estimated that the median time from approval of a drug by the FDA for adult patients 18 [years] and up is at least 6.5 years before that same therapy is approved for use in pediatrics. So, that's really been a challenge for us. We've been advocating—especially for adolescent patients, where the physiology of the patients suggests that they should probably tolerate the therapy pretty similarly, or for diseases like many of the common lymphomas we treat in the adolescent/young adult age group, like Hodgkin lymphoma—that instead of setting the age at entry into clinical trials at 18 [years], that we look to lower it down to 12 [years]. We believe that this will help to improve earlier access to many of these therapies for the younger population.

An example of this is a big phase 3 clinical trial that we recently reported out for advanced-stage Hodgkin lymphoma. This was a clinical trial that was run by the NTCN, the National Cancer Trial Network. In this trial, for the first time, we lowered the age to 12 [years], and it was a collaboration between the pediatric oncology research groups and the adult research groups. In this trial, we found that adding nivolumab to standard chemotherapy was much better than the standard therapy for this group of patients. And so, this is now having significant practice-changing results, and it's allowing much earlier access to nivolumab in the adolescent population than it would have in the past.