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DCPH > AACR update on DCC-2618...

Deciphera Pharmaceuticals, Inc. Reports Updated Data from Ongoing Phase 1 Clinical Trial of DCC-2618 at AACR

Deciphera Pharmaceuticals, Inc. Reports Updated Data from Ongoing Phase 1 Clinical Trial of DCC-2618 at 2018 American Association for Cancer Research (AACR) Annual Meeting

“The data presented at AACR provides a robust assessment of the safety and tolerability profile of DCC-2618 in GIST patients at the 150 mg QD dose selected for the INVICTUS pivotal Phase 3 study in fourth-line and fourth line plus GIST, which we initiated in January 2018,” said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera.

“If successful, the INVICTUS study could serve as the basis for a New Drug Application (NDA), providing a much-needed therapeutic option for these patients for whom there are no approved treatment options. We also plan to initiate a second Phase 3 registration study later this year, evaluating DCC-2618 in second-line GIST patients who have progressed, or are intolerant to front-line therapy with imatinib.”

The poster presentation includes the following highlights:

Safety and tolerability of DCC-2618 on 100 GIST patients treated at the 150 mg QD dose out of the total of 169 patients treated with DCC-2618, as of the cut-off date of January 18, 2018.

As of March 19, 2018, 81 of 137 GIST patients enrolled at the cut-off date and treated at 100 mg or more per day, remained on study treatment.

In addition, 46 patients were treated for more than 6 months, including 10 patients who were treated for more than 12 months.

Employing a population pharmacokinetic (PK) model based on steady state exposure to DCC-2618 and the active metabolite, DP-5439, increasing doses of DCC-2618 resulted in dose proportional increases in the combined exposure.

Preliminary data from the 12 GIST patients dose escalated from 150 mg QD to 150 mg BID following progression by RECIST (Response Evaluation Criteria in Solid Tumors) are immature and do not currently support a conclusion regarding a benefit from intra-patient dose escalation.

Based on the 100 GIST patients treated at the RP2D dose of 150 mg QD, DCC-2618 was well-tolerated, supporting the use of this dose in the pivotal, randomized Phase 3 trial, INVICTUS (NCT03353753).