Expert Discusses PD-1 Inhibitors as Treatment of NSCLC

In an interview with Pharmacy Times® at the American Society of Health-System Pharmacists Midyear Meetings and Exhibition, Scott Soefje, PharmD, MBA, BCOP, FCCP, FHOPA, director of Pharmacy Cancer Care and assistant professor of Pharmacy at Mayo Clinic, discusses the role of PD-1 inhibitors in treating non–small cell lung cancer.

Q: What are the current guidelines for treatment of non–small cell lung cancer?

Scott Soefje: The guidelines have really evolved over the last 10 to 15 years. What we're really looking at is biomarker driven therapy. What we really want to see is “Is there a biomarker on the tumor that will direct the therapy we're going to get.” So something like EGFR, ALK, ROSS MET, those kinds of things. That's the first step in the algorithm. You look to see whether there's something that can be driven.

If not, then you look at PD-1 status. If the PD-1 status is there, that's going to guide you on how you do your PD-1 inhibitors. Then when we talk about non–small cell lung cancer from a chemotherapy perspective, it's then based upon whether it is squamous cell histology, or adenocarcinoma histology, and that kind of guide you in your direction of chemotherapy. The guidelines are becoming a little more truly algorithmic, where you say if you have this, you do this, then this, then this, kind of thing. That's kind of helping us as we develop. However, lung cancer is still like it was many years ago, it's got a limited number. Then when you get beyond that, then clinical trial really becomes what you really want to do.

Q: How have PD-1 inhibitors changed the treatment landscape for patients with lung cancer?

Scott Soefje: They really began to alter and offer an alternative to chemotherapy in those patients in which we don't have a driver marker. There are times when PD-1 as a single agent, is appropriate in locally advanced or metastatic disease.

We're also seeing that PD-1 combined with the traditional chemotherapy improves overall outcome. There are real important components. I think some of the question marks that are still around PD-1 at this point in time is, “do we really need a PD one level to treat? And if we do, what level do we need?” Some of the indications say greater than 50% of the marker, some say greater than 1%. There's even data out there that suggests patients still respond without PD-1 markers evidence.

I think those are still some of the questions, and then to me, some of the questions with PD-1 that I'm starting to think about is, are they all the same? Are we reaching a point where we can say, “these drugs are like beta blockers, and we can pick a preferred product, and this is the one we're going to go with, and this is the one we want to use”? I don't think we're there yet, but I think we're headed that way. I think as the indications begin to line up, as some of the data begins to come together, we're going to get to a point where we start treating these drugs, like we've treated other drugs and a class that they're all the same in the class.

Q: What are the benefits of using PD-1 inhibitors for NSCLC? What are some challenges?

Scott Soefje: Some of the some of the benefits, it's they're not traditional chemotherapy. From a logistical perspective, they're easier to administer, they're easier to mix. A lot of times, if you're giving it as a single agent, we can get the patient in and out pretty quickly. There's this ease of use. There's good data, there's data suggesting that there's prolong survival, prolong progression free survival, those kinds of things.

I think some of the challenges are that they're not chemotherapy; they're different. We get a different brand, a different type of side effects, that a lot of times, particularly oncology pharmacist don't see until they start dealing with the PD-1. All the itis is the dermatitis, colitis, pneumonitis, all of those kinds of things that are not your traditional chemotherapy type side effects. Those are some of the challenges that we're seeing at this point in time.

Q: What should pharmacists know about PD-1 inhibitors for the treatment of patients with NSCLC?

Scott Soefje: I think you should know that most patients will probably end up on them at some point in time, so that they're going to be part of the overall armamentarium that a cancer patient gets. Then I think it really becomes important for the pharmacist to dig into those toxicities, and how do you track those? How do you monitor them? What do you do if you see somebody with a TSH and you need to start treating the thyroid problems and those kinds of things? It's not those traditional side effects. As I said before, it's not nausea and vomiting. It's not hair loss and some of these other things and so pharmacists need to really get into that.

I know at our institution and some of the other institutions have done this. We have formed an immunotherapy toxicity management clinic. We have a pharmacist in that clinic that sees patients and has become an expert in how to manage those toxicities. I think there's a role for pharmacists there, particularly in the larger cancer centers, that can dedicate a pharmacist to do that type of work. Even in the smaller centers, though, the pharmacists can become that go to person and say, “how do you how do I treat this itis? And what do I need to do? And how do I do it?” And there's guidelines out there, there's data to support. You need to really kind of focus on those kinds of things.

Q: How can pharmacists help to manage the AEs associated with treatment?

Scott Soefje: The guidelines, the NCCN has some nice guidelines. There are some publications out there with guidelines, and begin to understand what are the differences between things like colitis and hepatitis? And when do you use one type of drug versus the other? Understand the severity of the different toxicities: When does therapy need to escalate? When does the patient need to be admitted? Those kind of things is what a pharmacist really knows.

The guidelines are pretty specific. We like those kinds of things, right? We like the specific type of treatment algorithms or treatment guidelines. They're out there, and we really need to focus and then we need to talk to patients about what they're going through.

I've been amazed over the years of things patients will tell me that they won't tell their providers, and so go in and do that focused conversation, look for those specific side effects that are specific to the PD-1s, and go to that processing. You may find that you're much more helpful to the team than most people realize.

Q: How important is personalized care for patients with NSCLC?

Scott Soefje: It's kind of interesting. We talked about personalized care, and a few minutes ago, I said, are all these drugs the same? Can we just use the same? I think the personalized care in non–small cell lung cancer comes from the biomarker driven therapy. One of the things pharmacists can really do is we can make sure that the biomarker is present if the drug is being given. I keep teaching my students the most expensive drug in the world is the one that doesn't work. If we know a drug is going to work, because we have a biomarker, then we need to use that drug and not use something that's not going to work.

Then some of the most complicated parts of non–small cell right now is the sequencing of all of this process. When do you do this? When do you do that? Helping people put that whole process together can really, really be helpful. It can really help personalize that medicine for patients. We still have algorithm driven therapies, but what we're looking at is this patient has this histology, this performance status, this biomarker, and that really drives us down to that specific drug. That's what we're kind of looking for in that personalized space.

Q: Any closing thoughts?

Scott Soefje: Like I said, I think PD-1s are still growing, I don't think we're finished with knowing all of the data for PD-1s in non–small cell lung cancer. Then I think we're not through knowing all of the biomarkers that are still out there. There are still other drugs in development, there's still things, and then the question starts becoming down the line, you know oncologists are, right? If this one works, and this one works, what happens if we put them together?

We still are in some of those early development phases with that kind of stuff. I think it is a fun time to be in a non–small cell lung cancer because there is growth in therapies, there's opportunities to treat patients, and we're starting to see responses. We're getting response rates that when I started in this job 35 years ago, I would have never expected that we were going to get in non–small cell lung cancer, so it's a good time to be in that area.