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Dr. Paz-Ares:
This is CE on ReachMD, and I am Dr. Luis Paz-Ares. Today, I will provide a bit of overview about clinical criteria but also emerging strategies for B7-H3-directed ADCs in extensive-stage small cell lung cancer.
If we look at the literature, I think there are clinical data on about 6 or 7 ADCs directed to B7-H3. For example, we have seen the data with ifinatamab deruxtecan on the IDeate-Lung01 study, where 137 patients were treated with 12 mg/kg every 3 weeks, and responses were seen in about 48% of the patients.
Looking at this data, but also the data with other agents, I would say most of the phase 3 trials are recruiting patients in this context that had histologically documented small cell lung cancer. Good PS, 0 to 1, and patients typically have not been treated with topoisomerase-1 inhibitors, nor with B7-H3. And I suppose this is something that we will try to do in the future clinical practice, where those agents are widely available for the treatment of small cell lung cancer.
Importantly, we have to look and these patients should not have had prior pneumonitis or ILD, or at least those are criteria that we typically see into the clinical trials.
Another point that’s going to be relevant is related to the presence of symptomatic or untreated brain metastasis. This had been a rule in most of the trials that we have commanded, and this inclusion criteria are ongoing in phase 3 trials.
That is particularly true, that looking for evidence of brain metastasis is going to be relevant, and I think we have to monitor very well that type of disease. About 50% to 60% of the patients are developing brain metastasis all along the natural history of the disease, and therefore, it's important to really detect those metastases and monitor them over the course of the treatment. And for that, CT scan, brain CT scan with IV contrast, and particularly brain MRI are good ways to detect.
The final thing I think we have to very carefully check, particularly all along the treatment, for the detection of ILD and pneumonitis. We know that may happen, and it's important to detect it rapidly so that we can stop therapy or even start treatment with steroids as needed.
Well, I think this is very much what I'd like to say for today, and now my time is up. So I hope you find this overview useful and thank you very much for listening.
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