Riess on the FAVOUR Trial Furmonertinib in EGFR Exon20Ins Mut+ NSCLC

Jonathan W. Riess, MD, medical director of thoracic oncology, University of California, Davis Comprehensive Cancer Center, discusses the phase 1b FAVOUR trial (NCT04858958) of furmonertinib in patients with advanced non–small cell lung cancer (NSCLC) harboring EGFR Exon20 insertion (Exon20ins) mutations.

FAVOUR is an ongoing study evaluating furmonertinib in patients aged 18 years and older with locally advanced or metastatic NSCLC with a presence of EGFR Exon20ins mutations, an ECOG performance status of 0 or 1, and at least 1 measurable lesion.

Thirty patients who are treatment-naive were treated with furmonertinib at a dose of 240 mg once a day (QD), and 60 previously treated patients were randomized into 1 of 2 cohorts and given either furmonertinib 240 mg QD (n = 30) or furmonertinib 160 mg QD (n = 30). Patients continued to receive treatment until disease progression, intolerable toxicity, or death, and they received follow-up until disease progression every 6 weeks, and after disease progression or initiation of new therapy every 12 weeks.

According to findings previously presented at the 2023 World Conference on Lung Cancer, in the treatment-naïve furmonertinib 240 mg QD cohort, the confirmed objective response rate (ORR) by IRC (independent review committee) was 78.6% (95% CI, 59.05%-91.70%). In the previously treated furmonertinib 240 and 160 mg cohorts, the ORRs were 46.2% (n = 28; 95% CI, 26.59%-66.63%) and 38.5% (n = 28; 95% CI, 20.23%-59.43%), respectively. A total of 22 (78.6%), 12 (46.2%), and 10 (38.5%) patients had partial responses in the treatment-naïve furmonertinib 240 mg QD, previously treated 240 mg, and previously treated 160 mg groups, respectively. Further, 6 (21.4%), 12 (46.2%), and 12 (46.2%) patients had stable disease in these cohorts.

Safety data also showed that treatment with furmonertinib was well-tolerated. The most common treatment-related adverse event observed at the 240 mg dose was low-grade diarrhea, and no new or unexpected safety signals were seen.

Transcription:

0:10 | The FAVOUR trial is looking at furmonertinib, which has activity in EGFR Exon20 insertions. It escalated the dose from what's FDA-approved in China for more common EGFR mutations. It's escalating doses up to 240 mg daily. As mentioned in that cohort for EGFR Exon20 insertions, [in the] first-line, the response rate was 78.6%, and [in the] second-line for previously-treated patients was 46.2%.

0:50 | I think that looks to be pretty exciting data looking at an EGFR Exon20 insertion drug. It is now being studied first-line, in the FURVENT trial [NCT05607550] compared with platinum pemetrexed chemotherapy.

References:

1. Han B, Zhou C, Zheng W, et al. A phase 1b study of furmonertinib, an oral, brain penetrant, selective EGFR inhibitor, in patients with advanced NSCLC with EGFR exon 20 insertions. Presented at: International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer; September 9-12, 2023; Singapore. Abstract OA03.04.

2. Study of FURMONERTINIB in patients with NSCLC having exon 20 insertion mutation (FAVOUR). ClinicalTrials.gov. Updated January 18, 2023. Accessed September 10, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04858958