Datopotamab deruxtecan (Dato-DXd) demonstrates a favorable safety profile in first-line treatment of metastatic triple negative breast cancer, with comparable grade 3+ adverse events to standard chemotherapy but significantly lower treatment discontinuation rates (approximately half), and manageable adverse events of special interest including ocular surface events (dry eyes, primarily low-grade, onset >2 months, rarely causing discontinuation) and stomatitis/oral mucositis (onset ~26 days, >90% resolved, prophylaxable with oral steroid rinses), with less than 1% of patients experiencing IL events.
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[STO Spotlight] Unedited Tiffany Traina on TROPION Breast02 Safety Analysis UpdateAdded:
Hi, I'm Dr. Tiffany Trainer of breast oncologist at Memorial Stone Kettering Cancer Center joining you from San Antonio today and I'm happy to just chat with you about this poster which is looking at additional safety data from data DXD in the first line metastatic triple negative breast cancer trial tropium breastto that we presented at ESMO just a couple months ago. So this was a study in the firstline setting for patients with metastatic triple negative breast cancer that were not candidates for imunotherapy. Um amazing efficacy data was shown there was a significant improvement with se with data DXD over chemotherapy both in progression free survival but also a meaningful difference here in overall survival median OS of two years compared to just 18 months with chemotherapy. So super impressive efficacy and what we wanted to share here was more information about the safety profile of the drug. So about 300 patients here had received data DXD.
About another 300 received standard of care chemotherapy. We need to acknowledge that patients were on the antibbody drug conjugate for much longer than they were on cytotoxic chemotherapy. Um fortunately if we come down here you see that the incidence of grade three or greater adverse events was pretty comparable between the antibbody drug conjugate and standard chemotherapy. Um but fortunately treatment discontinuation was about half that with data DXD compared to chemo. So very very well tolerated and this um really held up if you look at the comparison adjusting for the amount of time that folks were on treatment. You actually see that there was more toxicity in folks getting chemo than there was in the folks getting the antibbody drug conjugate. So this is really reassuring data. Um I do want to talk about what some of the adverse events of special interest are with this antibbody drug conjugate. So one are ocular surface events or essentially a fancy word for just dry eyes. These tended to be very lowgrade events. So primarily, you know, grade one or grade two events also incredibly uncommon um higher grade and these could be mitigated with eye drops, lubricants, um you know, steroid eye drops as need be.
Time to onset was longer than two months. It was about 78 days and it rarely led to discontinuation. Less than 1% of patients had to stop. The other really good news is that these resolved to grade one or less with um stopping the drug and by the data cuto off. And then the last adverse event I want to sort of touch on is stomatitis and oral mucusitis. This is another one of special interest. Time to onset is pretty quick. It's within about the first cycle around median of 26 days to onset. But again they are primarily lowgrade grade grade one or grade two more than 90% resolved by the time of the day of cutoff. This is something that can be prophylaxed for as well with oral steroid rinse and none of this led to discontinuation of a highly effective um treatment. Last toxicity not shown on here but is worth noting is because this is the same payload as tresstmap droxicanan there's been some question about you know whether this is going to introduce IL concerns and in this study less than 1% of patients had an IL of any grade so very reassuring in terms of safety profile and a drug that's got an overall survival advantage for firstline TNBC is very much so meeting an unmet need for this patient population.
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