The IDeate-Lung01, we basically focussed on this presentation and this is a follow-up analysis from the study presented by Dr Rudin at the World Lung Congress earlier this summer, in September in Barcelona, where we showed promising results from ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer that received at least one prior line of therapy. Now at ESMO we focussed the analysis on those patients with baseline brain metastasis. What we wanted to highlight with this study was the intracranial activity of infinatamab deruxtecan in this population that usually, again, are a poor prognosis population, the ones with baseline brain metastasis.
Basically, looking at our entire cohort it was 137 patients and from those patients 65 patients presented with baseline brain metastasis. More interestingly, we also have data on those patients, actually in 26 patients that did not have prior brain radiotherapy. That means that we can actually assess the value or the efficacy of this drug intracranially.
What we observed overall was that the intracranial confirmed overall response rate was 46.2% including 30.8% of patients achieving a complete response in the brain. So that’s really, really changing the treatment landscape for these patients and actually, a disease control rate of 90.8%.
Additionally, when we compared the median overall survival for patients with brain metastasis that unfortunately they have a worse prognosis, and we compared those patients with patients without baseline brain metastasis, actually we are seeing similar median overall survivals – 10.4 months for patients with baseline brain metastasis and 10.1 months for patients without baseline brain metastasis. So this is very, very important for us since this is clinically relevant that we now can have a treatment that actually we have a high percentage of patients that would benefit although they have brain metastasis.
More interestingly, although it’s a small number, if we take a look on those patients without prior radiotherapy and we measure the response rate, actually in this population without prior radiotherapy the response rate is 57.7%. More interestingly, when we look for those patients without brain metastasis and we see the number of patients that progress in the brain, we actually see that it’s only 12% of the patients that progress in the brain. That means that somehow this drug is also conferring CNS protection so this is very relevant for our patients.
We also compared and we took a look on the concordance between systemic and CNS objective response and that was very high – 70% of the patients respond systemically and also at the CNS level. When we take a look on those patients with brain target lesions we are actually seeing an overall response rate of 65.5% with a complete response in 31% of the patients. This is very relevant for our patients.
We also presented data on the time to treatment response and this is a response that is usually quick and it was rapid with a time to treatment response of 1.3 months and a duration of response of 5.7 months.
From a safety perspective there are no new safety signals or no new safety signals were identified in these patients with baseline brain metastasis. Overall what we can say as a brief summary of this study is that I-DXd has some activity, very high activity in the brain, with patients achieving a disease control rate in 90% of the patients and actually 30% of the patients achieving a complete response in the brain. This is changing, probably, the way we are treating in the future our patients with brain metastasis.
Is there anything else you would like to add?
Now we are seeing these drugs moving to frontline so we also see some encouraging results at ESMO with new drugs such as tarlatamab and [??] moving to front line. We also have new drugs like lurbinectedin also moving to first line so I guess the future is encouraging. We have new drugs for our patients, better drugs and we are changing the treatment landscape in this disease. This is very important.
