In findings presented at the recent American Society of Clinical Oncology Annual Meeting, Takeda presented results of recent Phase I/II research exploring the viability of using mobocertinib in treating certain non-small cell lung cancer patients.
Could you please tell us a bit about NSCLC-the nature of the disease, typical prognosis for a diagnosed patient up until now, and what treatment options have been available?.
Patients with EGFR Exon20 insertion+ mNSCLC make up only about 1-2% of patients with NSCLC. The disease is not as well-known as other lung cancer types and requires comprehensive genomic profiling in order to be diagnosed properly.
The Phase I/II trial is a global, single-arm, open-label trial that evaluated the safety and efficacy of mobocertinib in patients with mNSCLC.
The trial is comprised of a Phase 1 dose-escalation, which evaluated mobocertinib as a monotherapy and in combination with chemotherapy, several expansion cohorts, and an extension cohort investigating mobocertinib as a monotherapy in patients with EGFR Exon20 insertion+ mNSCLC. Takeda’s New Drug Application for mobocertinib, which is currently being reviewed by the US Food and Drug Administration on a priority six-month review cycle, is primarily based on results from an analysis of the platinum-pretreated population in the Phase 1/2 trial.
I understand the results of that study indicated “Demonstrate clinically meaningful benefit” in patient participants-could you offer a little more detail about that designation and anything you can share that’s making Takeda feel optimistic about the drug’s odds of eventual approval?.
Mobocertinib is the first small-molecule TKI specifically designed to selectively target EGFR Exon20 insertions in patients with mNSCLC and demonstrated clinical proof-of-concept in these patients.
At Takeda, we are committed to research and development in EGFR Exon20 insertion+ mNSCLC. With the current NDA for mobocertinib under review by the FDA, we are encouraged by the potential to introduce the first oral targeted treatment option for the over 35,000 patients diagnosed with the disease worldwide each year.