Recommendations for managing patients who receive belantamab mafodotin, an anti-BCMA therapy, for relapsed/refractory multiple myeloma, with special considerations regarding the ocular health of patients.
Bhavesh Shah, RPh, BCOP: In talking about relapsed/refractory myeloma, you can’t not talk about the newest kid on the block: anti-BCMA. It’s the first time we have such a target in myeloma, and it’s really fascinating. But a lot of baggage comes with it. We need to talk about this and share our best practices. Because Ryan has everything figured out on anti-BCMA, he comes from the land of anti BCMA—no, I’m kidding. I’m just saying that because you know from memory, and they did a lot of the trials. I want to hear from Ryan. Talk a little about anti-BCMAs and how they’ve actually tackled the beast.
Ryan Haumschild, PharmD, MS, MBA: Thanks, Bhavesh. We are still tackling the beast, but we’ve got some great team members. A lot of our physicians are familiar with the trial, and our pharmacist in multiple myeloma has done a great job helping us spearhead a lot of these initiatives. But Bhavesh is talking about Blenrep [belantamab mafodotin], from the DREAMM 2 study, which really focuses on the relapsed/refractory multiple myeloma population that we’ve spoken so much about.
When we think about the past, we think about how many lines of therapy we had to switch. When we came to fourth- and fifth-line therapies, we really struggled with what to put patients on. Do we enroll them on a clinical trial? That’s why the BCMA-targeted therapy is so exciting for us: It’s meeting a patient need that we otherwise didn’t. If you guys remember, when we look at the data, the overall response rate was pretty strong at 31%, especially in these heavily pretreated patients. That’s something that we were excited about when it came to launch, so we wanted to be ready to operationalize it. The medication does come with some considerations. It was FDA approved with a REMS [Risk Evaluation and Mitigation Strategies] program.
Obviously there’s consideration there. When they looked at the trial, they focused on patients who had keratopathy. That was 1 of the adverse effects of the medication that we had to actively manage, not only for the patients to be successful but to make sure we were taking care of them outside their cancer. When we focus on BCMA, keep in mind that Blenrep is probably being used in a lot of places by the fourth and fifth lines, but it’s FDA approved with 4 prior distinct therapies. Something to call out is that it can be for an agents, however you want to define that. There are a lot of ongoing DREAMM trials studying Blenrep earlier on in therapy. But in the current state, for which it’s FDA approved, we have a lot of patients who fall into this category. A lot of considerations have to be made.
First, in clinical, we have to get our providers registered. Make sure they’ve taken the competencies and that they can participate in REMS. We have a pathway of having either our clinical pharmacy specialist in multiple myeloma or our physicians or advance practitioners involved in a patient discussion. So we work up that patient. We know where they’re going to fall in the line of therapy; we know who might be a good consideration. We need to have that conversation to enroll them in the REMS process.
On the health care facility side, you have to have an authorized representative because Blenrep involves not just the clinic decision-making, the treatment decision, and enrolling the patient. It also involves the health care facility side where you have to have an authorized representative make sure that you are checking that you’re not dispensing a dose until the patient has been seen appropriately by the hematologist and eye care professional and the health care facility.
Then there’s a checklist that you submit once the patient has been infused to make sure everything went OK, and it restarts the cycle. But when I think about the REMS, I think about a Blenrep or Blenrep process where the patient gets enrolled, we have that conversation, and they agree to participate. Then we send them to an eye care professional, and they get a baseline eye exam. We do that to figure out their grading, so we can monitor it throughout treatment, as we mentioned.
REMS was required by the FDA. When we think about this, the way we’ve tried to translate it is: When you have a REMS, that’s not necessarily a bad thing. It means there is an adverse effect that you need to be aware of, and the REMS focuses everybody to make sure we’re providing robust oversight for it. You’re really going to focus on the corneal adverse reactions. One things I want to call out is that it can be any eye professional, as it’s not an ophthalmologist or a retinal specialist. It can be an optometrist.
We have them examine the retina and the eye about every 3 weeks to make sure that before the subsequent dose, they’ve been evaluated by an eye care professional. The provider can verify that before they go into the REMS program. That enables the health care facility where that patient is going to get infused to get the go-ahead. There are a lot of considerations, as you can imagine. We have to educate the eye care professionals on what to look for and make sure they feel comfortable seeing these patients. There is a pretty tight turnaround from when we want the patient seen by the eye care professional to make sure they’re getting their approved dose and they’re staying on an every-3-weeks cycle.
If anyone has any issues, we know that there are different grades and dose-modification recommendations. If someone has a grade 2 or 3, then we’re going to withhold treatment until they’re observed or it changes back to a grade 1 or better. The great thing about Blenrep for the BCMA is that even when we withhold treatment, the drug is still working against their cancer. That’s exciting, at least to us and our patients as we’ve been able to discuss it. With that being said, make sure they’re getting their eye drops, we’re managing that ocular toxicity, we’re educating patients about the adverse effects. At the same time, make sure the great infrastructure is there to see them successful.
We’ve seen a lot of improvement. A lot of patients are excited about this treatment option who previously didn’t have much. We’ve had a good relationship with our eye care professionals in the community and near us with our faculty practice. That’s been my experience; it’s going to be an innovative area. It will be interesting to see how much that creeps up the treatment pathway that you had me speak about earlier. But so far, things are looking up for patients, especially when you think about BCMAs.
Transcript edited for clarity.