Sunvozertinib shows promise in pretreated NSCLC with EGFR exon 20 insertions

The oral selective tyrosine kinase inhibitor sunvozertinib demonstrates therapeutic potential in patients with nonsmall cell lung cancer (NSCLC) with EGFR exon 20 insertions (exon20ins) who have previously received platinum-based chemotherapy, according to the results of a phase II WU-KONG6 study.

Conducted across 37 medical centres in China, WU-KONG6 included 104 adult patients with pathologically or cytologically confirmed locally advanced or metastatic NSCLC harbouring an EGFR exon20ins mutation. All patients had received at least one line of previous systemic therapy, with at least one line containing platinum-based chemotherapy.

The patients were given sunvozertinib 300 mg once daily until meeting discontinuation criteria per the protocol. The primary endpoint was objective response rate (ORR), as assessed by the independent review committee.

Among 97 patients evaluable for efficacy analysis, 61 percent achieved tumour response, with a confirmed ORR of 61 percent (95 percent confidence interval [CI], 50–71). All tumour responses were partial responses and were observed irrespective of age, sex, smoking history, EGFR exon20ins subtypes, brain metastasis at baseline, previous lines of therapy, and history of onco-immunotherapy.

Nineteen deaths were recorded over a median follow-up of 7.6 months.

Once-daily dosing of sunvozertinib 300 mg was well tolerated. The most frequent grade ≥3 treatment-related adverse events (TEAEs) included blood creatine phosphokinase elevation (17 percent), diarrhoea (8 percent), and anaemia (6 percent). Serious TEAEs were interstitial lung disease (5 percent), anaemia (3 percent), vomiting (2 percent), nausea (2 percent), and pneumonia (2 percent).