Dedicated Trialist, Nurse Navigators Help Advance Cancer Therapy Into Accelerated Approval
A conversation with Sally Lau, MD, thoracic medical oncologist, Perlmutter Cancer Center, NYU Langone Health
Thoracic medical oncologist Sally Lau, MD, considers herself a true trialist. She’s a clinician, yes, but takes immense pride and enjoyment in her role as an investigator in clinical trials. Recently, Lau spoke with Clinical Leader about her work on DeLLphi-304, studying the efficacy of tarlatamab (now marketed as Imdelltra), a bispecific T-cell engager therapy, as compared with standard-of-care treatments in patients with relapsed small-cell lung cancer (SCLC) after platinum-based first-line chemotherapy.
Lau discusses the FDA’s accelerated approval pathway in expanding care to patients with limited resources, how to accommodate and retain a challenging patient population, and her reasons for becoming — and remaining — a dedicated investigator.
Clinical Leader: In May, the FDA granted accelerated approval for Imdelltra. How does accelerated approval enable a broader patient population to take advantage of this novel therapy?
Lau: The Phase 1 data is early, but it's very promising. It's something that we haven't seen before with any other agents in small-cell lung cancer. Because of the promising early efficacy of Imdelltra, the FDA allowed enrollment in the accelerated approval program, which then led to the approval of Imdelltra while the confirmatory Phase 3 studies, which is the 304 study in which I'm participating, are still ongoing. Being in that accelerated program has led to an earlier approval of Imdelltra for patients who are otherwise not eligible for the 304 study or do not live in a location where they would have access to clinical trials. If we were to wait until the confirmatory studies are done before showing efficacy, there would be a lot of patients who were not able to access this therapy.
Can you tell me about small-cell lung cancer patients and their specific care needs, especially while participating in trials?
Small-cell lung cancer predominantly affects patients who are heavy smokers. This also tends to be a patient population who is very sick, doesn't have health literacy, and doesn't always have the financial means to travel to major academic centers that run clinical trials. What was very helpful with the program is that it provides support to get patients to the centers for trials, which gets the therapies out into the community where they are needed the most.
That seems to be a trifecta of challenging factors. What have sites or sponsor companies done to help keep these patients enrolled?
One thing that I found to be very effective is the use of a nurse navigator so that these patients have a point person to go to. That navigator goes over the treatment plans and schedules appointments with them. And I also find that these patients have a lot of mistrust of their healthcare system. Some people think that we're doing clinical trials to make money, and I've had one patient tell me that we're giving him chemotherapy instead of surgery because we're trying to scam them for money.
Having that nurse navigator is really important in that case. There's someone that they have rapport with and having that person be a nurse instead of a social worker is helpful because they know more about the medicines. But that point person should also not be a nurse practitioner or a doctor. Even if I tell the patients they can call me directly, they don't often do that. There's still that level of mistrust and having that nurse navigator seems to be the sweet spot in which they can build rapport and trust over time.
It sounds like these nurse navigators could be the key to keeping a participant in a trial through its duration.
The nurse navigator is key. And then also providing transportation is something that we were able to do through a diversity grant. A lot of trials offer reimbursement, but the patients have to pay up front, and there are often delays in processing those receipts. Then the patients become more worried that “I paid for this out of pocket up front; when am I going to get the money back?” For those who have trust issues, the bigger the delay, the more they worry they're not going to get paid and that we're scamming them.
It sounds like you have a genuine interest and investment in bringing investigational therapies to patients. How did you get started in clinical trials, and why do continue conducting them?
I'm a thoracic medical oncologist by training. I'm a clinical trialist, which means that I do a lot of these clinical trials, whether it's cell or other therapies. I do it because you can see these new therapies being translated into patients directly, and there is nothing more satisfying than to have a patient come back and see the tumor has gone away.
It's innovative that you can bring these therapies to patients immediately, rather than waiting until they are approved. It's a chance to think outside the box for the patients and get creative with their treatments. Also, as a clinician, you see the immediate results and you see the patients in front of you get better.
That's a big part of my practice with Imdelltra. It's the first-in-class BiTE [bispecific T cell engager] therapy to be approved in solid tumors and the first time we're able to leverage the immune system and bring that immune cell right up close to the cancer.
Take us back to your first awareness of clinical trials. How did you know this was an avenue you could go down?
That was probably during my fellowship at Princess Margaret Cancer Center for training in thoracic oncology. They have a big trial portfolio there. That was the first time I saw investigational therapies making a major difference in a patient's care, especially in lung cancers.
As you continue to work as a trialist, what advice do you have about partnering with sponsor companies? What makes for a good experience?
What makes for a good experience for me as an investigator is being involved early on, being able to have input into the study design, and having a sponsor that is receptive to feedback. For example, with Imdelltra, we talked about how this is a patient population that is traditionally very difficult to enroll and study. Amgen has been particularly good about the study design and they've made inclusion/exclusion criteria very tailored to this population. It was fairly easy to enroll these patients even though they were really sick. Even on studies where I wasn't involved in the steering committee or the planning of the design, if I identified barriers to enrollment — for example, the tissue turnaround time was too slow — then they worked with our team to expedite the process so the patient could be treated on time.
About The Expert:
Sally Lau, MD is a medical oncologist at the NYU Langone Health's Perlmutter Cancer Center. She specializes in lung cancer, thoracic cancer, and other lung diseases. Dr. Lau participates in clinical trials exploring new treatments for lung cancer, including targeted therapy, immunotherapy, and cellular therapy.