(Melanoma) Clinical Report on Epacadostat + KEYTRUDA

• September 14, 2018
• Reading time: 1 minute

From June 1 to 5, 2018, at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, Illinois, results were presented for the Phase III ECHO-301/KEYNOTE-252 trial (NCT02752074). This multicenter, randomized, double-blind study evaluated the combination of the IDO1 inhibitor Epacadostat and the anti-PD-1 antibody Keytruda (Pembrolizumab) versus placebo in patients with unresectable or metastatic melanoma. The findings were presented by Dr. Georgina V. Long from the University of Sydney.

The ECHO-301/KEYNOTE-252 trial enrolled 706 patients with unresectable melanoma. Participants were randomized 1:1 to receive either Epacadostat 100 mg twice daily plus Keytruda 200 mg every three weeks (N=354) or a placebo plus Keytruda (N=352). The primary endpoints were progression-free survival (PFS) and overall survival (OS), with secondary endpoints including objective response rate (ORR).

The results of this clinical trial showed that the median PFS was 4.7 months for the Epacadostat group and 4.9 months for the placebo group. There was no statistically significant difference between the two groups (HR: 1.00; 95% CI: 0.83–1.21; P=0.517). Furthermore, the 12-month PFS rate was 37% for both groups.

Regarding the other primary endpoint, overall survival (OS), there was also no significant difference in the risk of death (HR: 1.13; 95% CI: 0.86–1.49; P=0.807). The 12-month OS rate was 74% for both groups.

The objective response rate (ORR) was 34.2% in the Epacadostat group and 31.5% in the placebo group. Finally, the safety profile of the combination therapy was consistent with previously reported data for Epacadostat.

In summary, based on the results of the ECHO-301/KEYNOTE-252 trial, Dr. Georgina V. Long concluded that for patients with unresectable or metastatic melanoma, the combination of Epacadostat and the anti-PD-1 antibody Keytruda failed to demonstrate any clinically significant improvement in PFS or OS compared to Keytruda alone.

Epacadostat (E) plus pembrolizumab (P) versus pembrolizumab alone in patients (pts) with unresectable or metastatic melanoma: Results of the phase 3 ECHO-301/KEYNOTE-252 study. (ASCO 2018, Abstract No. 108)

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