
Dr Christopher Arendt on Positive Mobocertinib Results Seen in Metastatic NSCLC
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.
Transcript
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
It's a first-in-class tyrosine kinase inhibitor and has just completed a study that we're now updating at the
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.
Reference
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
Newsletter
Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics.