FDA Approves New ADC for Lung Cancer Treatment
Hello. It's Mark Kris, from Memorial Sloan Kettering, talking about a birthday gift I received on June 23 when the FDA approved the indication of datopotamab deruxtecan for people with lung cancers. We have another drug, our third ADC (antibody-drug conjugate) to fight lung cancer, so that's a gift.
Let's talk a little bit about that agent. It's an interesting twist in our practice patterns. What can the drug do? It had a response rate of 45%, which is really important in patients that had EGFR mutations with progression on osimertinib. We really need drugs in that space. The duration of response was about 7 months, which is significant.
One interesting thing in the approval, [was] that the response rate of the blinded folks was greater than that in the investigator-assessed response by about 10%. It's very interesting. Clearly, we have another drug, and we have it in a space where we need it.
Let's talk a bit about the toxicity. I'm going to focus more on the paper by Bardia et al that compared datopotamab deruxtecan to various chemo drugs in breast cancer, not in lung cancer. You can take this a little bit with a grain of salt.
First, they saw a whole different array of side effects with datopotamab deruxtecan, things that we don't normally deal with here. Nausea, stomatitis, alopecia, dry eye, and vomiting. All of those were more than 10% more common in patients that received datopotamab deruxtecan compared to the control. The only things that were more common with the control were neutropenia, leukopenia, and hand-foot syndrome in patients that had capecitabine.
One thing, though, is while you say, 'Oh, these weren't dangerous side effects,' they surely were lifestyle altering. Nobody wants to have these side effects on a daily basis. Again, there's an increasing awareness about these kinds of lower-grade but still lifestyle-disrupting side effects. When it goes on day after day, you really have to balance that into the benefit you're going to receive.
I think the second important point is how, when we use this drug, we're going to have to go to another level to deal with the adverse effects that we are going to see. The first would be nausea and emesis. It is a highly emetogenic regimen based on the NCCN (National Comprehensive Cancer Network) guidelines, so you would need either three or four antiemetic drugs. That's number one.
Number two, because of the potential eye problems, you need an eye exam before treatment — and the label says at least annually — with any symptoms. I think it's very important that you give the patients eyedrops, and in general, the preservative-free eyedrops are the ones that are most effective.
Stomatitis is a very common side effect with that agent. It's really not seen with the other drugs that even contain the same warhead. There, dexamethasone rinses are important. Now, this is a compounded medicine so you need to be very careful in making sure that you identify pharmacies that will prepare this and will have it available for the patients that need it.
Last, there is the risk of hypersensitivity reactions and there's a recommendation for premedication for that. As you think about using datopotamab deruxtecan, you need to have all your ducks in a row to treat side effects. You need prophylaxis for hypersensitivity reactions, nausea, and emesis.
The patient will need an eye exam. You need to prepare the patient for possible dry eye and teach them which eyedrops are the best. You also need to ensure the availability of dexamethasone rinses and mouth washes. All that needs to be in place to make sure that the patient can safely use the drug.
I think it's going to be a useful drug. We don't yet have a uniformly available way to select patients for its use other than EGFR . I should note that the approval is for EGFR -mutated lung cancers. It doesn't say which type of mutation, so that would give you some latitude in giving it for exon 20 atypicals as well as for the common sensitizing mutation.
We have another drug. It's clearly going to be a useful one. It clearly comes with many adverse effects that we don't normally treat on an everyday basis, we're used to the diarrhea and skin changes that come on with the EGFR TKIs.
This pattern of side effects is different and requires some additional attention, but with it, the drug can be useful. I'm glad that we have yet another way to fight this disease.
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