EXKIVITY has demonstrated a clinically meaningful overall response rate and durable responses in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, whose disease has progressed following platinum-based chemotherapy.

Clinical Efficacy of EXKIVITY in EGFR Exon 20 NSCLC 

EXKIVITY is indicated for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, detected by an FDA-approved test, after progression on or after platinum-based chemotherapy. This indication received accelerated approval based on overall response rate (ORR) and duration of response (DOR). In the pivotal clinical trial (AP32788-15-101), among 114 patients, EXKIVITY (160 mg once daily) achieved an ORR of 28% (95% Confidence Interval [CI]: 20%, 37%), as assessed by blinded independent central review (BICR). All observed responses were partial responses. The median DOR was 17.5 months (95% CI: 7.4, 20.3). Furthermore, 59% of responders maintained their response for at least 6 months. The efficacy population had a median age of 60 years, and most had metastatic disease (99%) and adenocarcinoma histology (98%). The mechanism involves irreversible inhibition of EGFR exon 20 insertion mutations.