Jonathan S. Zager, MD, on Results of Phase 3 FOCUS Trial Examining Percutaneous Hepatic Perfusion in Ocular Melanoma With Hepatic Metastases

At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, CancerNetwork^® spoke with Jonathan S. Zager, MD, chief academic officer in the departments of Cutaneous Oncology and Sarcoma at Moffitt Cancer Center and chair in the department of Oncologic Sciences at the University of Southern Florida, about the phase 3 FOCUS trial (NCT02678572) in which patients with hepatic-dominant ocular melanoma were randomized 1:1 to either percutaneous hepatic perfusion (PHP) or best alternative care (BAC).

In patients receiving PHP compared with BAC, the median overall survival was 19.25 months (95% CI, 16.72-24.35) vs 14.49 months (95% CI, 11.10-19.78), the median duration of response was 14 months (95% CI, 8.31-17.74) vs not calculable (NC; 95% CI, 6.93-NC), and objective response rates were 36.3% (95% CI, 26.44%-47.01%) vs 12.5% (95% CI, 3.51%-28.99%), respectively.

Transcript:

The trial initially was a randomized trial of percutaneous hepatic perfusion vs best alternative care. Four [regimens were included for the] best alternative care arm which was chemotherapy embolization, pembrolizumab [Keytruda], ipilimumab [Yervoy], or dacarbazine, and it was a 1:1 randomization. At some point, we realized that patients who were randomized to the best alternative care arm were refusing their treatment and/or flying off to Europe where this is approved. We talked to the FDA and we made it a single-arm trial from the midpoint onwards. When it was a randomized trial, we have shown that percutaneous hepatic perfusion triples progression-free survival vs best alternative care. It was a successful trial that doubled the response rate, tripled the progression-free survival in terms of months at 9.03 months [95% CI, 6.34-11.56] vs 3.09 months [95% CI, 2.89-5.65; P = .0003], and it showed that this treatment makes a difference for these patients.

Reference

Zager JS, Orloff MM, Ferrucci PF, et al. FOCUS phase 3 trial results: Percutaneous hepatic perfusion (PHP) with melphalan for patients with ocular melanoma liver metastases (PHP-OCM-301/301A). J Clin Oncol. 2022;40(suppl 16):9510. doi:10.1200/JCO.2022.40.16_suppl.9510