NEW YORK – Takeda Pharmaceutical on Thursday said it will submit to the US Food and Drug Administration and other regulators updated results from a Phase I/II trial of mobocertinib in EGFR exon20 insertion-mutated, metastatic non-small cell lung cancer.
Researchers are studying the safety and efficacy of mobocertinib in NSCLC in a Phase I/II trial, which includes a Phase I dose escalation portion assessing the drug as a monotherapy and in combination with chemotherapy, and a Phase II portion that is enrolling seven cohorts and an extension cohort. The latest analysis focuses on 114 EGFR exon20 insertion-mutated, metastatic NSCLC patients who had previously received platinum-based chemotherapy in the dose escalation and expansion phases of the study.
Patients in this group received a 160 mg daily oral dose of mobocertinib, and 28 percent had an objective response as assessed by an independent review committee, while 35 percent had an objective response as determined by investigators. Additionally, the median duration of response was 17.5 months; median progression-free survival was 7.3 months; and the disease control rate was 78 percent. The safety profile of mobocertinib was manageable, with patients commonly experiencing diarrhea, rash, and paronychia; 19 patients discontinued the drug due to adverse events.
Takeda said it will present these updated results at the International Association for the Study of Lung Cancer's 2020 World Conference on Lung Cancer on Jan. 29. The latest data updates earlier results researchers presented in May 2020 from 28 mobocertinib-treated patients.
"The importance of advancing research for people living with EGFR exon20 insertion-positive, metastatic NSCLC — a complex and devastating disease with no approved targeted therapies — cannot be overstated, as existing treatment options provide limited benefit and patients often have poor survival outcomes," Christopher Arendt, head of Takeda's oncology therapeutic area unit, said in a statement. "We look forward to submitting data from the platinum-pretreated population analysis to the US Food and Drug Administration and other regulatory agencies around the globe."