Christopher Arendt, PhD, head, Oncology Therapeutic Area Unit, Takeda, speaks on the efficacy data of mobocertinib in patients with EGFR exon 20 mutations within metastatic non–small cell lung cancer (NSCLC) and its potential significance for these patient populations.
With clinically meaningful benefits of mobocertinib observed in patients with metastatic non–small cell lung cancer (NSCLC) who have EGFR exon 20 mutations, the indication may serve as the first oral therapy in these patient populations pending priority review by the FDA, said Christopher Arendt, PhD, head, Oncology Therapeutic Area Unit, Takeda.
Can you discuss updated data on mobocertinib presented at ASCO 2021?
Let me start by just reminding that mobocertinib is a once-a-day oral therapy that was specifically designed to be able to target these exon 20–specific mutations in EGFR, so shut down EGFR that has that particular disease profile.
It's a first-in-class tyrosine kinase inhibitor and has just completed a study that we're now updating at the ASCO meeting. Again, this is provided to patients as an oral medicine; it's dosed once daily. We're very excited to have a little bit of additional data since our last update that provides really a full picture of patient benefit.
These are patients who progressed on platinum chemotherapy that are in the cohort that we call platinum-pretreated patients. What we've seen in this population who receives mobocertinib is disease control in 78% of the patient population. So those are patients whose disease did not progress—so representing benefit to these individuals.
The overall response rate was 28%. The median progression-free survival for that total cohort was 7.3 months. What's exciting is that we've now got a picture that allows us to estimate the duration of response for those patients benefiting on mobocertinib; that's estimated at 17.5 months currently. And the overall survival, which we're updating now at ASCO, with a little bit of a more recent data cut, is 24 months in that study.
Another important update is that, as we looked across the genetic sequencing analysis of tumors from this patient population, what we noticed is, of course, different exon 20 insertional mutations, and that's something that's appreciated to be a signature of this disease. It means that 2 patients can have different exon 20 insertion sequences, and both have the same disease.
What we found is that when we ask the question, does mobocertinib benefit only certain types of exon 20 mutation patients or is there kind of no pattern specifically that emerges, it's actually the latter—so no pattern. We see that patients across a diversity of exon 20 variants are benefiting from this therapy. So, that's incredibly encouraging.
Right now, mobocertinib is under priority review with the FDA and our PDUFA [Prescription Drug User Fee Act] target date is the end of October. So, we're very hopeful that this can be the first oral therapy made available to patients who have, again, this very devastating subtype of lung cancer that is really not very responsive to chemotherapies.
Cortes JE, Apperley J, Lomaia E, et al. Mobocertinib (TAK-788) in EGFR exon 20 insertion (ex20ins)+ metastatic NSCLC (mNSCLC): Additional results from platinum-pretreated patients (pts) and EXCLAIM cohort of phase 1/2 study. J Clin Oncol. 2021;(suppl 15; abstr 9014). doi:10.1200/JCO.2021.39.15_suppl.9014