The FDA granted accelerated approval to mobocertinib (Exkivity) to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed following platinum-based chemotherapy.
Under this indication, EGFR positive tumors must be detected using an FDA-approved companion diagnostic, the Oncomine Dx Target Test, for patients to receive mobocertinib treatment.
This accelerated approval was based on results from Study 101, “an international, non-randomized, open-label, multicohort clinical trial which included patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations,” the FDA explained. “Efficacy was evaluated in 114 patients whose disease had progressed on or after platinum-based chemotherapy. Patients received mobocertinib 160 mg orally daily until disease progression or intolerable toxicity.
“The main efficacy outcome measures were overall response rate (ORR) according to RECIST 1.1 as evaluated by blinded independent central review (BICR) and response duration,” the agency continued. “The ORR was 28% (95% CI: 20%, 37%) with a median response duration of 17.5 months (95% CI: 7.4, 20.3).” The FDA noted that the accelerated approval was based on the ORR and duration of response found in the clinical trial—and, as with all accelerated approvals, continued authorization is contingent upon verification and description of clinical benefit in further confirmatory trials.