Telemedicine Allows for First-of-its-Kind Trial Administering Subcutaneous Immunotherapy at Home

As more agents are developed in subcutaneous forms rather than or in addition to intravenous forms, delivery methods can evolve to allow for home administration of certain agents, according to Jorge J. Nieva, MD, who added that telemedicine will allow physicians to monitor patients throughout the course of at-home care. A first-of-its-kind phase 2 study (NCT05340309) conducted by University of Southern California (USC)/Norris Comprehensive Cancer Center is examining atezolizumab (Tecentriq) given subcutaneously at home by nurses to patients with non–small cell lung cancer (NSCLC).¹

“The biggest problem with telemedicine is it’s very hard to assess performance status and functionality of a patient because you don’t get to see the patient move as cameras tend to be fixed. One of the things that we wanted to do in this clinical trial was incorporate technologies that gave us access to information about fitness, functionality, and movement,” Nieva, who is the principal investigator of the study, said in an interview with OncLive^®. “The study continues to be open to enrollment at USC. Patients who have high copays or who have difficulty with health maintenance organization coverage of these checkpoint inhibitors for lung cancer [treatment] are welcome to contact us, and we’d be happy to determine if they are eligible for clinical trial participation.”

The trial will be the first to test the at-home administration of a subcutaneous immunotherapy product and is currently open for enrollment.¹ Atezolizumab and recombinant human hyaluronidase (rHuPH20) will be given subcutaneously for 3 to 8 minutes on day 1 with cycles repeating every 3 weeks for 1 year for patients with early-stage disease or up to 2 years for patients with late-stage disease until disease progression or unacceptable toxicity.²

In the interview, Nieva, a medical oncologist at Keck Medicine of USC and an associate professor of clinical medicine at Keck School of Medicine in Los Angeles, discussed the pros and cons of telemedicine as well as the first-of-its-kind trial being conducted in patients with NSCLC.

OncLive: How have your experiences with telemedicine been so far compared with in-person care?

Nieva: I spent approximately 7 years practicing medicine in Montana, and we did a lot of telemedicine long before the COVID-19 [pandemic]. It was an essential aspect of care for patients who lived in rural environments near critical access hospitals. It was an opportunity for us to engage with patients who lived hundreds of miles away and were getting their care at critical access hospitals—we could interface with them and take care of problems more frequently than when we traveled to those destinations to see them which was sometimes only once per month.

I have been around telemedicine for a long time and since COVID-19, I find it’s been much more convenient. The loosening of regulations around payments for telemedicine have done wonders for the field. Before, patients had to do telemedicine visits at their rural critical access hospitals—they weren’t able to be at home. Being able to use consumer platform technologies does simplify the process. There’s no need for special equipment or unusual technological requirements as we had before the COVID-19 pandemic.

What guidance would you offer to other clinicians who are not as familiar with providing cancer care this way?

First, patients like it. Many patients like in person visits, many like remote visits, and I believe a lot of it has to do with the distance that they are from your cancer center and the convenience with arriving at your center. It’s helpful to try to find ways of gathering fitness information about patients. Many people now have a smartphone [which] will tell you how many steps they’re taking, and many also wear wearable fitness monitors—you just ask them for that information.

In oncology the most important functional assessment that we do is assignment of performance status. This has been around since the 1950s first recognized by David Karnovsky as an incredibly important predictive factor in how patients are going to do [on treatment] and what their outcomes are going to be. Using as many tools at your disposal to try to get an accurate assessment of your patients’ performance status is going to be important, and I believe it can be done by telemedicine. Although, it’s always easier to do the assessments when people are walking in because you can see them walk in and we don’t get to do that with telemedicine. But, trying to leverage some other orthogonal information that informs patient performance is a key feature of providing good telemedicine visits for your patients.

What was the rationale for conducting this first-of-its kind clinical trial at Keck Medicine and how was the trial designed?

The rationale for this trial began during the COVID-19 [pandemic when] a patient I had was too afraid to come to the hospital for his treatments because he was concerned about interfacing with the hospital system and getting an infection while he was there. I thought it would be good if we could find ways to deliver more treatments at home to patients and this drug, [atezolizumab], and indication seemed like a very good opportunity to do that. [Although] atezolizumab in the subcutaneous form is not yet FDA approved, it is anticipated to be FDA approved in the coming year and will likely provide oncologists with an additional option if they want to treat patients at home using subcutaneous delivery methods.

This is a single-arm trial where we use atezolizumab in the subcutaneous form and deliver it at home rather than in the office infusion center. Having a nurse come to a patient’s home to deliver the medicine is convenient and it’s a much more pleasant environment. In this clinical trial, we ensure safety by [administering] the first 3 infusions in the office to be sure that there aren’t going to be problems with allergic reactions. This medicine, [atezolizumab], is a monoclonal antibody, and there is a long experience with biological agents and monoclonal antibodies being delivered at home through subcutaneous infusions. Gamma globulin is one example; recombinant factors for people with hemophilia is another. There isn’t a priori reason that monoclonal antibodies could not be delivered at home through subcutaneous routes.

What makes this clinical trial unique is it’s the first home administration of immunotherapy for solid tumors and it’s [a trial] where we’re leveraging consumer-grade technologies for fitness monitoring and using them for performance status assessments. We’ve also built a network for getting laboratory studies into our electronic medical record through our partnerships with third-party laboratory vendors such as Labcorp and Quest Diagnostics. We try to ensure that CT monitoring is done in ways where we can view the images and deliver the results to the patients through telemedicine.

Please discuss the logistics with nurses who will be administering the subcutaneous atezolizumab.

So far, we’ve contracted with Mobile Medical LA which is a company that provides at home nursing services across a broad range of indications. We have them traveling throughout Southern California to our patients’ homes to deliver the medicines. They’re not specifically research nurses, but they follow the research protocol in terms of delivering the medications. The key logistics, and probably the most important logistical challenges, are making sure that the medicine is shipped to the patient’s home and that it’s shipped cool.

We have the nurse open the shipping container rather than the patient to ensure that there’s no temperature variance that would lead to instability of the product. That works out well, but it does require a bit of coordination on our end and [for] our pharmacy to go from the order [of] administering the medicine after the results of laboratory studies are obtained to having the medicine shipped to the patient’s home, and then coordinating that with the arrival of the nurse.

What will the process look like for the oncologist on this trial?

In this clinical trial, we have a dashboard that gives us patient-derived information such as vital signs, weight, results from patient-reported outcome survey questionnaires, and other metrics of health and well-being that we can look at to provide optimal care for patients. That’s something that we’ve custom designed for this clinical trial. [For] other telemedicine appointments, I don’t currently have that dashboard created, so we have to do more in terms of questioning patients [and] sometimes doing things such as asking the camera to be repositioned and having the patient get up and walk around a little bit in the room while I watch them walk.

I check the dashboard at the time of appointments with patients. There is no expectation that their activity is being monitored daily and we make that very clear to patients. If they’re not feeling well, they still need to contact us and reach out and shouldn’t expect that we will have any alert that they’ve started moving a little bit less.

How could findings from this trial impact community and academic oncologists?

There are a number of community oncologists who may prefer home administration for many of their medications including those who are practicing in environments where their infusion center may be impacted or there are unusual costs associated with use of their infusion center. Home delivery of medications may be something that’s preferred by some insurance providers because it lets them select the pharmacy that will be dispensing the medicine and contracting issues could play a role in favoring this type of administration.

There are also health systems that are relatively impacted where the infusion center appointments are not immediately available. Some of the safety net hospitals may have a wait [time] to get into the infusion center and use of a home delivery strategy may be beneficial.

Additionally, the time to delivering the medicines is much shorter in general. There are some medications such as rituximab [Rituxan] that when given intravenously have relatively long infusion times, but relatively short infusion times when given subcutaneously. We expect that there will be a number of other drugs that become available as subcutaneous delivery routes and formulations are created.

To convert a monoclonal antibody from an intravenous formulation to a subcutaneous formulation, one needs to add a product called hyaluronidase that lets these proteins be absorbed through the subcutaneous route a little bit easier, and not create a big bleb on the skin surface. Having those formulations created is somewhat complex, but not hugely complex.

References

1. Study explores the future of at-home cancer treatment. News release. Keck Medicine of USC. March 28, 2024. Accessed May 16, 2024. https://news.keckmedicine.org/study-explores-the-future-of-at-home-cancer-treatment/
2. Subcutaneous atezolizumab for the treatment of non-small cell lung cancer. ClinicalTrials.gov. Updated February 13, 2024. Accessed May 16, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT05340309