Incyte this morning teed up a fresh look at data from its early-stage study of its closely watched IDO1 drug epacadostat combined with Merck’s PD-1 checkpoint therapy Keytruda. And the update — a little more than week after the first preliminary data were reported — is encouraging some analysts to anticipate a success for its pivotal trial of the immunotherapy duo, which is now underway.
In the lead up to the big ESMO meeting this weekend, investigators for Incyte $INCY say that they tracked progression-free survival rates of 74 percent and 57 percent after 6 months and 12 months. The study has not yet matured enough for the researchers to pin down a median PFS rate. But the complete response rate has increased slightly to 26%.
In a statement, Incyte noted:
The objective response rate (ORR) and disease control rate (DCR) remained consistent with the previously published abstract data, at 58 percent (12 months) and 74 percent (6 months), respectively. All responses are confirmed and ongoing (median follow-up among responders 56 plus [range of 46 to 90 plus] weeks).
RBC’s Simos Simeonidis offered a quick thumbs up on the results this morning, noting that the data look good compared to rival combinations. He ticked off reasons for optimism:
1) after three more months of follow-up, since the March 28th data cutoff of the abstract, the PFS was not reached; this increases our confidence that the combo of epacadostat+pembro will end up with mPFS that will be superior of the ipi+nivo combo (mPFS 11.5 months); 2) the 12- and 6-month PFS discussed in the poster of 57% and 74%, respectively, compare favorably with the respective PFS of results from trials of other immunotherapy regimens; 3) the response rate remained robust and steady, including an additional patient whose PR became a CR; all this while the responses remained durable; 4) 83% (5/6) of melanoma patients treated with 100mg or more of epacadostat were responders; 5) the safety of the combination remained benign, both in terms of numbers (19% G3/4) and in terms of types of TEAEs. There are data in the poster about responses in additional tumors, including lung and kidney; however, we have a harder time having as strong an opinion on them, given the small number of patients tested in each tumor type. Our key takeaway is that epacadostat is a very active and safe agent in melanoma and this data presentation appears to confirm/reinforce the company’s decision to move into the Phase III setting.
Incyte has been running Phase I and Phase II studies of the combo in a range of tumor types. It launched the Phase III pivotal trial in June, with plans to report data in 2018.
These kinds of combination studies involving checkpoint drugs have become all the rage in the oncology field. Incyte in particular, though, has been busily partnering with a variety of drugs, spurring high hopes that it’s getting closer to the market with a leading IDO1 drug. The therapy targets a mechanism used by cancer cells to avoid an immune system attack, and a combo with a checkpoint would seem to offer a one-two punch allowing a full-on immune response to cancer cells.
“We are excited to share further data with additional follow-up from the Phase 1 portion of the ECHO-202 study,” said Steven Stein, Incyte’s chief medical officer, in a statement. “The durable responses seen in patients with treatment-naïve advanced or metastatic melanoma reaffirm the activity of this immunotherapy combination, and we look forward to the read-out of ECHO-301, the ongoing, pivotal Phase III trial.”
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