Analyst notes: Could the Keytruda-epacadostat combo become the new standard of care in melanoma?

Immunotherapies, including Yervoy (ipilimumab; Bristol-Myers Squibb), Keytruda (pembrolizumab; Merck & Co.) and Opdivo (nivolumab; Bristol-Myers Squibb), have meaningfully improved the prognosis for melanoma patients. Nevertheless, demand persists to move the treatment plateau onwards and upwards to improve treatment outcomes for patients.

Insights, Analysis & Opinion

Several promising agents are progressing through late-stage clinical development for melanoma. One of the most keenly anticipated is Incyte's indoleamine 2,3-dioxygenase-1 (IDO1) inhibitor, epacadostat, which is currently being investigated in in patients with unresectable or metastatic melanoma in the Phase III Keynote-252/ECHO-301 trial in combination with Keytruda.

Previously, in the Phase I/II ECHO-202 (KEYNOTE-037) trial, the combination of Keytruda with epacadostat showed an overall response rate (ORR) of 53 percent. Based on these promising early data, there is notable excitement amongst the key opinion leaders (KOLs) interviewed by FirstWord for the forthcoming report Melanoma: KOL Insight (2017). Expectations are high that a combination strategy with the IDO inhibitor further augments the strong benefits already realised with anti-PD-1 agents. Indeed, according to some KOLs, the epacadostat plus Keytruda combination regimen has the potential to become the new standard of care for melanoma patients.

"If you could just take an oral pill like an IDO inhibitor instead of having to do an intratumoral injection, people would probably just take the oral pill. It's easier and physicians also probably prefer that. And I think that there's probably going to be less toxicity with the epacadostat combinations than the BRAF/MEK combinations." - US Key Opinion Leader

"If the data show that pembrolizumab and epacadostat is very impressive, and it's better than the combinations of BRAF/MEK inhibitors, then it could become the standard of care in both the wild type BRAF, the muted BRAF and in people that have accessible tumours." - US Key Opinion Leader

In addition to Keytruda, epacadostat is also being evaluated in combination with Imlygic (talimogene laherparepvec; Amgen). In addition to Incyte, several other companies are also trying to develop IDO inhibitors. Amongst these, early data suggest that a combination of BMS-986205/Opdivo (both from Bristol-Myers Squibb) has the potential to challenge Incyte's epacadostat.

For companies operating in the melanoma market in Europe and the US, Melanoma: KOL Insight (2017) is a must read. The report provides actionable insights and commentary on some of the most critical issues in the melanoma market, and provides perspectives on pipeline therapies and their potential in a rapidly increasing market. The report also discusses how treatment paradigms could change in melanoma. For more information, please click here.

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