Incyte’s latest cut on the data from a Phase I/II study of its combination therapy adding Merck’s checkpoint star Keytruda to its closely watched IDO1 enzyme inhibitor epacadostat for melanoma is continuing to impress observers. And that is all boding well for a newly launched Phase III study.
By all means, it’s still early days on outcomes, but in this new package released ahead of ESMO there was an improvement in the objective response data, which hit an ORR of 55% (or 12 out of 22 patients) among all patients, including 5 complete responses (23%) and 7 partial responses (32%). Among treatment-naive patients the ORR was 58% and other tumor types being studied demonstrated ORRs ranging from 27% to 60%, notes RBC.
PFS was not yet hit, though analysts are wondering if that may be revealed with more info at the upcoming conference. Incyte’s shares $INCY surged about 4% on the update.
RBC’s Simos Simeonidis likes what he sees. “(T)he fact that PFS wasn’t reached as of this abstract release, with a median follow-up of 42 weeks (10.5 months), suggests epacadostat+pembro is likely to compare favorably to the current SOC.”
It’s particularly encouraging, he adds, that the safety profile looks better than what’s now available, though it certainly isn’t free of SAEs.
“Though more mature data broken out by specific indication will be necessary to better contextualize potential treatment benefits, this hints that the PFS may be extending beyond 10 months, which would be superior than the low-end 6-month clinical efficacy bar for single-agent pembro and approaching the 11.5-month high-end bar for combo nivo+ipi in melanoma,” writes Jefferies’ Brian Abrahams.
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