Deciphera Pharmaceuticals Reports Updated Preliminary Phase 1 Clinical Study Results with DCC-2618 at the European Society of Medical Oncology (ESMO) 2018 Congress
- Preliminary Median Progression Free Survival and Disease Control Rates from the Phase 1 Study of DCC-2618 in Second- and Third-Line GIST Patients Demonstrate the Potential for Improved and Durable Clinical Outcomes in Patients with Less Advanced Disease -
- Updated Objective Response Rates and Disease Control Rates Observed in these Preliminary Results with DCC-2618 Continue to Exceed Previously Published Results of Registrational Trials for Currently Approved Therapies in Second- and Third-Line GIST Patients -
- Median Progression Free Survival in Fourth-Line and Fourth-Line-Plus GIST Patients Demonstrate the Potential for Durable Clinical Outcomes with DCC-2618 in Patients with Advanced Disease -
“We are extremely pleased with the preliminary results presented today
that we believe demonstrate the potential of DCC-2618 to provide
improved, durable clinical benefit for GIST patients from second-line
through fourth-line-plus,” said
The presentation reported preliminary results with a cutoff date of
| Line of Therapy | GIST Patients (n) | DCR at 3 Months | ORR(1) | Median Progression(5) Free Survival | ||||||||
| 2nd Line(4) | 38 | 79% | 18%(2) | 42 weeks | ||||||||
| 3rd Line(4) | 29 | 83% | 24% | 40 weeks | ||||||||
| ≥4th Line | 111 | 66% | 9%(3) | 24 weeks | ||||||||
| 2nd & 3rd Line(4) | 67 | 81% | 21% (2 & 3) | 40 weeks | ||||||||
Notes: (1) Includes nine unconfirmed responses: 2nd line (n=1), 3rd line (n=3) and ≥4th line (n=5); (2) Does not reflect one PR reported after cutoff date, which would result in an ORR in 2nd line of 21% and an ORR in 2nd line and 3rd line combined of 22%; (3) Excludes five patients due to missing data at the time of data cutoff (n=2), lack of first tumor assessment (n=1), withdrawal of consent prior to first assessment (n=1) and unrelated death at C1D4 prior to first assessment (n=1); (4) 59 of 67 combined 2nd line and 3rd line patients received 150mg once daily; and (5) Censored patients for mPFS were 2nd line (58%), 3rd line (52%), 4th line and 4th line plus (35%) and 2nd and 3rd line (55%).
“The preliminary progression free survival data and objective response
rates observed with DCC-2618 are very encouraging across all lines of
therapy presented: second-, third-, and fourth-line and beyond,” said
Highlights from the proffered paper include:
Preliminary Clinical Activity in Second-, Third-, Fourth- and Fourth-Line-Plus GIST Patients Demonstrates the Potential for Durable Clinical Outcomes with DCC-2618
- Progression Free Survival (mPFS): The mPFS values observed with DCC-2618 were 42 weeks in second-line patients and 40 weeks in third-line patients. Previously published results for approved therapies from centrally-read registrational trials reported a mPFS for sunitinib of 24 weeks in second-line patients and a mPFS for regorafenib of 21 weeks in third-line patients. In fourth- and fourth-line-plus patients, where there are currently no approved therapies, the observed mPFS with DCC-2618 was 24 weeks. Published studies have reported a mPFS of 4-6 weeks for similarly heavily pre-treated patients who did not receive an active therapy.
- Disease Control Rate (DCR): The observed DCRs at three months of 79% in second-line patients and 83% in third-line patients exceed the previously published results for approved therapies from centrally-read registrational trials of 60% for sunitinib in second-line patients and 53% for regorafenib in third-line patients. The DCR observed for DCC-2618 in fourth-line and fourth-line-plus patients was 66%.
- Objective Response Rate (ORR): The observed ORRs of 18% in second-line patients and 24% in third-line patients continue to exceed the previously published results for approved therapies from centrally-read registrational trials of 7% for sunitinib in second-line patients and 5% for regorafenib in third-line patients. These values do not include a partial response in one second-line patient that was observed after the cutoff date, which would result in an ORR in second-line patients of 21%. The ORR observed for DCC-2618 in fourth-line and fourth-line-plus patients was 9%.
Prolonged Treatment Duration in GIST Patients Receiving DCC-2618 –
Cutoff Date of
- In the second-line cohort, as of the cutoff date, 17 patients received DCC-2618 at doses of ≥100mg daily for >6 months with 65% (11 of 17) of these patients remaining on study.
- In the third-line cohort, as of the cutoff date, 20 patients received DCC-2618 at doses of ≥100mg daily for >6 months with 75% (15 of 20) of these patients remaining on study.
- In the fourth-line and fourth-line-plus patients, as of the cutoff date, 46 patients received DCC-2618 at doses of ≥100mg daily for >6 months with 74% (34 of 46) of these patients remaining on study.
Updated Safety Data Continue to Demonstrate a Favorable Tolerability Profile for DCC-2618
- For 178 GIST patients treated at doses above ≥100mg daily, DCC-2618 was generally well tolerated.
- Among the treatment-emergent adverse events (TEAEs) reported by investigators (>10%), regardless of relationship to DCC-2618, the most common were: alopecia (50%), myalgia (44%), fatigue (43%), constipation (34%), hand-foot skin reaction (32%), nausea (30%), decreased appetite (28%), weight decreased (24%), abdominal pain (23%), diarrhea (23%) and lipase increase (23%).
- Among the 178 GIST patients treated at doses above ≥100mg daily:
- 14% (24) patients experienced dose reductions due to TEAE.
- 11% (19) experienced treatment discontinuations due to TEAE.
A copy of the proffered paper will be available on the
About DCC-2618
DCC-2618 is a KIT and PDGFRα kinase switch
control inhibitor in clinical development for the treatment of KIT
and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors,
or GIST, systemic mastocytosis, or SM, and glioblastoma multiforme.
DCC-2618 was specifically designed to improve the treatment of GIST
patients by inhibiting a broad spectrum of mutations in KIT and PDGFRα.
DCC-2618 is a KIT and PDGFRα inhibitor that blocks initiating and
secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in
GIST as well as the primary D816V exon 17 mutation involved in SM.
DCC-2618 also inhibits primary PDGFRα mutations in exons 12, 14 and 18,
including the exon 18 D842V mutation, involved in a subset of GIST.
About
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and others should note that
Cautionary Note Regarding Forward-Looking Statements
This
press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, statements regarding the planned
initiation later this year of our Phase 3 trial, INTRIGUE, in second
line GIST patients; the need for a broad-spectrum KIT inhibitor in all
post-imatinib lines of therapy; potential for DCC-2618 as an effective
and well tolerated therapy to treat a wide range of patients with GIST;
statements regarding the potential benefits to patients of DCC-2618;
statements regarding plans and timelines for the clinical development of
DCC-2618; and Deciphera Pharmaceuticals’ strategy, business plans and
focus. The words “designed to,” "may," "will," "could," "would,"
"should," "expect," "plan," “approximate,” "anticipate," "intend,"
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forward-looking statements contain these identifying words. Any
forward-looking statements in this press release are based on
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number of risks, uncertainties and important factors that may cause
actual events or results to differ materially from those expressed or
implied by any forward-looking statements contained in this press
release, including, without limitation, risks and uncertainties related
to the delay of any current or planned clinical trials or the
development of our drug candidates, including DCC-2618, our ability to
successfully demonstrate the efficacy and safety of our drug candidates,
the preclinical and clinical results for our drug candidates, which may
not support further development of such drug candidates, actions of
regulatory agencies, which may affect the initiation, timing and
progress of clinical trials and other risks identified in our
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