Trial to test feasibility of at-home immunotherapy administration
Click Here to Manage Email Alerts
Researchers at Keck Medicine of USC launched the first clinical trial to evaluate the feasibility of at-home, subcutaneous immunotherapy treatment for non-small cell lung cancer.
The trial will investigate whether a new formulation of atezolizumab (Tecentriq, Genentech/Roche) — an anti-PD-L1 monoclonal antibody — can be safely and effectively delivered subcutaneously by a nurse in the patient’s home rather than via IV in a clinic or hospital setting.
The in-home treatment regimen will be accompanied by telemedicine appointments and remote monitoring through wearable trackers.
“Prior to the COVID-19 pandemic, the rules around telemedicine administration were relatively strict. Patients had to travel to rural critical access hospitals, and visits had to be nurse-facilitated for telemedicine to be reimbursed,” lead investigator Jorge Nieva, MD, medical oncologist and lung cancer specialist with Keck Medicine, told Healio. “We now have telemedicine available using consumer devices and commercial platforms. This democratization of telemedicine is something that’s very good for health care in general.”
Healio spoke with Nieva about the motivation for the study, how it will be conducted and the potential advantages subcutaneous formulations of immunotherapy drugs may offer patients.
Healio: Can you describe the challenges associated with immunotherapy administration?
Nieva: IV medicines always present challenges. These include starting the IV and getting the treatment going, and infusion times are typically in excess of an hour. Many patients don’t want to come into infusion centers. This was particularly true during the COVID-19 pandemic, when many patients were afraid to visit health care institutions.
Healio: What prompted this trial?
Nieva: This came out of COVID-19. I had a patient who was too afraid to come into the infusion center for his lung cancer treatments and decided to defer them. He died shortly thereafter. Having alternative ways to deliver medicine became very valuable, and that is one of the factors that spurred this trial.
The other development has been the conversion of monoclonal antibodies from IV to subcutaneous formulations. They have to be specially formulated, usually with an enzyme called hyaluronidase. The availability of this made the trial that we proposed a bit more feasible. It’s always easier to administer medicines when you don’t have to start an IV in the home.
Healio: How will this trial be conducted?
Nieva: We have enrolled the first four patients. All of them completed the initial phase, which includes the first three administrations in the office, then subsequent administrations transferred to home. We expect this trial will complete next summer, regardless of the number of patients enrolled, because we want to get the experience out there. So far, we are getting a very nice experience and very good feedback from patients. We are finding that they really do appreciate not having to come into the cancer center to get their treatments.
Healio: How might this trial change clinical practice?
Nieva: Fewer patients will need to come into the infusion centers, and there will be a demand from some patients for the checkpoint inhibitors that offer a subcutaneous route. Not every PD-1-blocking agent is available in subcutaneous formulation — in fact, the majority are not. I think the manufacturers who make the effort to create these formulations are going to have an advantage. Now that we have nearly 10 PD-1 blockers on the market, there will be some competition among manufacturers for market share.
Healio: How has the availability of remote monitoring through wearable devices made at-home treatment more feasible?
Nieva: This has made patient assessment better, because now we can track how many steps the patient has taken in the past week, and see how that changed from the previous visit. It helps us get a better sense of our patients’ physical functioning, even when they’re not in the office.
In the office, it’s very easy to tell how a patient is functioning — even by just watching them move from the chair onto the examination table. Depending on how that movement is conducted, we get a sense of how sick or frail a patient is. It’s a bit harder to do by telemedicine. You have to ask additional questions, and you may need to bring in additional data. In this trial, we will capture that data from a smartphone that we provide to participants. They also use a wrist-worn, consumer-grade fitness monitor, like a Fitbit, to capture that information. We then present all of this information to the physician in a database form.
Reference:
- Keck Medicine of USC. Study explores the future of at-home cancer treatment (press release). Available at: https://news.keckmedicine.org/study-explores-the-future-of-at-home-cancer-treatment/. Posted March 28, 2024. Accessed May 8, 2024.
For more information:
Jorge Nieva, MD, can be reached at jorge.nieva@med.usc.edu.
Collapse
Healio Interviews
Read more about
Click Here to Manage Email Alerts