– Rebastinib in Combination with Paclitaxel
Demonstrated Progression Free Survival of 9.1 months in Heavily
Pretreated Patients with Platinum-Resistant Ovarian Cancer (PROC)
–
– Pivotal Phase 3 Study of Rebastinib plus
Paclitaxel in PROC Planned to Initiate in 2022 Subject to
Regulatory Feedback –
– Updated Results for Vimseltinib Showed
Objective Response Rate of 47% in Patients with Tenosynovial Giant
Cell Tumor (TGCT) –
– Pivotal Phase 3 Study of Vimseltinib in TGCT
Expected to Initiate in the Fourth Quarter of 2021 –
– Company to Host Virtual Investor Event to
Discuss Rebastinib and Vimseltinib Results Today at 10 AM ET –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
commercial-stage biopharmaceutical company developing innovative
medicines to improve the lives of people with cancer, today
announced four e-poster presentations at the ESMO Congress 2021.
The presentations include updated preliminary results from the
ongoing Phase 1b/2 study of rebastinib in combination with
paclitaxel in patients with PROC and updated preliminary results
from the ongoing Phase 1/2 study of vimseltinib in patients with
TGCT. A long-term update on the Phase 3 INVICTUS study of QINLOCK®
(ripretinib) in patients with advanced gastrointestinal stromal
tumors (GIST), and results from the expansion phase of the Phase 1
study of ripretinib in patients with KIT-altered metastatic
melanoma will also be presented.
All e-poster presentations are now available on-demand via the
ESMO website and on the Company’s website at
www.deciphera.com/presentations-publications. Deciphera will also
host an investor event featuring key opinion leaders to discuss the
rebastinib and vimseltinib data today, September 17, 2021, at 10 AM
ET. A live webcast of the event may be accessed through the
“Investors” section of Deciphera’s website at www.deciphera.com. A
replay of the webcast will be available following the event.
“We are excited to present strong results at this year’s ESMO
Congress, which support both our plans to initiate a Phase 3
pivotal study for rebastinib pending regulatory feedback, and our
plans to initiate a Phase 3 pivotal study for vimseltinib. The
updated safety and efficacy results for rebastinib in combination
with paclitaxel show highly encouraging results, including a median
progression free survival of 9.1 months, in heavily pretreated
patients with PROC where additional treatment is heterogeneous and
single agent paclitaxel retreatment has historically shown only 3-4
months of PFS. Based on these impressive results in patients with a
significant unmet medical need, we have begun planning for a
pivotal Phase 3 study that we plan to initiate in 2022 following
regulatory feedback,” said Matthew L. Sherman, MD, Executive Vice
President and Chief Medical Officer of Deciphera. “We are equally
encouraged by the tolerability and efficacy data presented today
from the Phase 1/2 study of vimseltinib in TGCT. The data presented
today with vimseltinib in TGCT reinforce its potential to be a
best-in-class treatment for this disease. We are rapidly moving
forward with this program and we expect to initiate our Phase 3
study, MOTION, in the fourth quarter of this year.”
Dr. Sherman continued, “In addition to rebastinib and
vimseltinib, we presented positive results from the Phase 1 study
of ripretinib in patients with KIT-altered metastatic melanoma, and
a long-term update from the Phase 3 INVICTUS study of QINLOCK,
which shows further prolonged clinically meaningful median overall
survival among patients receiving QINLOCK. Finally, we look forward
to our Phase 3 INTRIGUE readout later this year in patients with
second-line GIST.”
Updated Preliminary Data from the
Ongoing Phase 1b/2 Study of Rebastinib in Combination with
Paclitaxel in PROC
The Phase 1b/2 study of rebastinib in combination with
paclitaxel is a two-part, open-label, multicenter study assessing
the safety, tolerability, anti-tumor activity, and pharmacokinetics
of rebastinib in patients with advanced or metastatic solid tumors.
The data presented today is from the second stage of Part 2 of the
Simon two-stage design in PROC.
As of the June 22, 2021 cutoff date, 38 patients with PROC
initiated treatment with rebastinib and paclitaxel and are included
in the safety population and 34 patients that met the criteria for
the modified intent-to-treat population (mITT) are included in the
efficacy analysis.
- The median progression-free survival (PFS) was 9.1 months.
- There were 13 patients with objective responses (10 confirmed)
for an objective response rate (ORR) of 38% (confirmed and
unconfirmed) and 29% (confirmed only) with a median duration
response of 5.5 months.
- The clinical benefit rate at 16 weeks was 76%.
- A CA-125 response occurred in 19 of 26 patients (73%).
- Rebastinib in combination with paclitaxel was generally well
tolerated at 50 mg BID, and most common (≥15%) treatment-emergent
adverse events (TEAEs) were Grade 1 or 2.
- Four patients experienced serious adverse events (SAEs) at
least possibly related to rebastinib including reversible muscular
weakness (n=2), constipation (n=1), fatigue (n=1), and urinary
tract infection (n=1).
Based on the strength of these findings, the Company has begun
planning for a pivotal study in PROC that is anticipated to start
in 2022, subject to feedback from regulators.
Updated Preliminary Data from the
Ongoing Phase 1/2 Study of Vimseltinib in TGCT
The Phase 1/2 study of vimseltinib is an open-label, multicenter
study evaluating the safety, efficacy, pharmacokinetics, and
pharmacodynamics of vimseltinib in patients with solid tumors and
TGCT. The data today is from patients with TGCT in both the Phase 1
dose escalation portion of the study and from cohort A in the Phase
2 expansion portion of the study. Cohort A includes TGCT patients
with no prior anti-CSF1/CSF1R (previous therapy with imatinib or
nilotinib is allowed) and cohort B includes patients with prior
anti-CSF1/CSF1R (previous therapy with imatinib or nilotinib are
not eligible).
As of the June 7, 2021 cutoff date, 68 TGCT patients were
treated with vimseltinib and included in the safety population,
including 32 TGCT patients enrolled in the Phase 1 dose escalation
portion of the study and 36 TGCT patients enrolled in cohort A in
the Phase 2 portion of the study. Efficacy data presented today is
from 51 TGCT patients, including all 32 TGCT patients enrolled in
the Phase 1 dose escalation portion of the study and 19 TGCT
patients enrolled in cohort A in the Phase 2 portion of the study
that were evaluable for efficacy as of the cutoff date.
Dose Cohorts and Demographics:
- 32 patients enrolled in Phase 1 (dose escalation) and 36
patients enrolled in Phase 2 cohort A (expansion):
- Phase 1 cohort 5 (n=8): 30 mg loading dose daily for five days
followed by a maintenance dose of 30 mg twice a week.
- Phase 1 cohort 8 (n=12): 30 mg loading dose daily for three
days followed by a maintenance dose of 10 mg daily.
- Phase 1 cohort 9 (n=12): 20 mg loading dose daily for three
days followed by a maintenance dose of 6 mg daily.
- Phase 2 cohort A (n=36): 30 mg twice weekly (no loading
dose).
- 12 out of 32 patients (38%) in Phase 1 and 32 out of 36
patients (89%) in Phase 2 cohort A had at least one prior surgery;
five patients (16%) in Phase 1 and two patients (6%) in Phase 2
cohort A had received at least one prior systematic therapy.
- 51 patients were evaluable for efficacy by Response Evaluation
Criteria In Solid Tumors (RECIST) v1.1 at the data cutoff in Phase
1 across all dose cohorts and in Phase 2 cohort A; response data is
based on independent central radiologic review with the exception
of one patient who had a local assessment, and for whom no central
assessment was performed.
Updated Preliminary Efficacy and Duration of Treatment:
- Of the 51 efficacy-evaluable patients in Phase 1 across all
dose cohorts and in the Phase 2 cohort A, 24 patients had a
response resulting in an ORR of 47%.
- Of the 32 patients in Phase 1, 16 patients achieved an
objective response for an ORR of 50% with durable responses
observed across all dose cohorts, including one complete response
in cohort 5. The median duration of treatment for all patients was
10.1 months. 72% of patients remain active in the study as of the
data cutoff date.
- Of the 36 patients enrolled in Phase 2 cohort A, 19 patients
were evaluable for efficacy, of which there were eight patients
with an objective response for an ORR of 42%. Of the 19 patients,
10 had more than one follow-up imaging assessment and two responses
occurred at later scans. The median duration of treatment for all
patients was 1.9 months. The study is ongoing and follow-up
evaluation is continuing with 83% of patients remaining active as
of the data cutoff date.
Safety and Tolerability:
- In both Phase 1 and Phase 2 cohort A, treatment with
vimseltinib was generally well tolerated in patients with TGCT. Two
patients (6%) discontinued treatment due to a TEAE in Phase 1 and
one patient (3%) discontinued treatment due to an TEAE in Phase 2
cohort A.
- Two patients experienced SAEs at least possibly related to
vimseltinib, including metabolic encephalopathy and vaginal
hemorrhage in Phase 1; no treatment-related SAEs were reported in
Phase 2 cohort A.
- The majority of the common (≥15%) TEAEs were Grade 2 or
lower.
- Observed transaminase, pancreatic, and creatine phosphokinase
enzyme elevations were mostly low grade, asymptomatic, and
consistent with mechanism of action of CSF1R inhibitors.
- No abnormalities in bilirubin levels were reported.
Phase 3 MOTION Study
Based on the positive results of the ongoing Phase 1/2 study,
the Company plans to advance vimseltinib into a pivotal Phase 3
study in patients with TGCT. The MOTION study is two-part,
randomized, double-blind, placebo-controlled study of vimseltinib
to assess the efficacy and safety in patients with symptomatic TGCT
who are not amenable to surgery. In Part 1 of the study, eligible
study participants will be assigned to receive either vimseltinib
or matching placebo for 24 weeks. Participants assigned to placebo
in Part 1 will have the option to receive vimseltinib for Part 2 of
the study. Part 2 is a long-term treatment phase in which all
participants receive open-label vimseltinib. The primary endpoint
of the study is ORR at 25 weeks as measured by RECIST v1.1 by
blinded independent central review. The Company expects to initiate
the MOTION study in the fourth quarter of this year.
Long-term Update from Phase 3 INVICTUS
Study of QINLOCK in Patients with Advanced GIST
The INVICTUS Phase 3 clinical study is a randomized (2:1),
double-blind, placebo-controlled, international, multicenter study
to evaluate the safety, tolerability, and efficacy of QINLOCK
compared to placebo in patients with advanced GIST whose previous
therapies have included at least imatinib, sunitinib, and
regorafenib. The Company previously reported primary results from
the randomized portion of the INVICTUS study, in which QINLOCK
significantly improved PFS and showed a clinically meaningful
overall survival (OS) benefit.
An exploratory evaluation of primary and secondary endpoints in
the Phase 3 INVICTUS study, with a cutoff date of January 15, 2021,
an additional 19 months after the primary analysis, demonstrates
consistent PFS with no change since the primary data cut off, and
improved median OS among patients receiving ripretinib.
- Median PFS was 6.3 months with QINLOCK compared to 1.0 month
with placebo.
- Median OS was 18.2 months with QINLOCK compared to 6.3 months
with placebo.
- Median OS was 10 months in placebo patients who crossed over to
QINLOCK.
- Median ORR was 11.8% with QINLOCK compared to 0% with
placebo.
- Median duration of response with QINLOCK was 14.5 months.
Safety findings were consistent with the primary analysis
results and most TEAEs were Grade 1 or 2. Increases in TEAEs and
TEAEs leading to dose modifications in the additional 19 months of
follow up were minimal.
These more mature results continue to support the clinically
meaningful benefit in PFS and OS for QINLOCK with an acceptable
safety profile in patients with advanced GIST treated with three or
more prior lines of therapy.
Phase 1 Study of Ripretinib in Patients
with KIT-altered Metastatic Melanoma
As part of the expansion phase of the Phase 1 study, 26 patients
with KIT-altered metastatic melanoma were treated with ripretinib
at the recommended Phase 2 dose of 150 mg daily in repeated 28-day
cycles. Tumor progression was assessed by the investigator using
computed tomography/magnetic resonance imaging according to RECIST
v1.1 on day 1 of cycles 3, 5, 7, and every three cycles thereafter,
and a final study visit. ORR was confirmed with follow-up imaging
approximately 28 days later. Patients who had disease progression
at ripretinib 150 mg daily were allowed to dose escalate to 150 mg
twice daily.
- Ripretinib demonstrated encouraging efficacy in patients with
KIT-altered metastatic melanoma with a confirmed ORR of 23%, median
duration of response of 9.1 months, and median PFS of 7.3 months.
In addition, there were two unconfirmed partial responses resulting
in an ORR of 31% (confirmed and unconfirmed).
- Tyrosine kinase inhibitor (TKI)-naïve patients had a greater
response (confirmed ORR of 29% and median PFS of 10.2 months) to
ripretinib than those with prior TKI treatment (confirmed ORR of
11% and median PFS of 2.9 months).
- Ripretinib had an acceptable safety profile in KIT-altered
metastatic melanoma consistent with the approved indication in
GIST.
About Deciphera Pharmaceuticals
Deciphera is a biopharmaceutical company focused on discovering,
developing and commercializing important new medicines to improve
the lives of people with cancer. We are leveraging our proprietary
switch-control kinase inhibitor platform and deep expertise in
kinase biology to develop a broad portfolio of innovative
medicines. In addition to advancing multiple product candidates
from our platform in clinical studies, QINLOCK® is Deciphera’s
FDA-approved switch-control kinase inhibitor for the treatment of
fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also
approved for fourth-line GIST in Australia, Canada, China, Hong
Kong, and Taiwan. For more information, visit www.deciphera.com and
follow us on LinkedIn and Twitter (@Deciphera).
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, our expectations
and timing regarding top-line data from our Phase 3 INTRIGUE study
in second-line GIST, pivotal study plans and timing of study
initiation for vimseltinib in TGCT patients and for the
rebastinib/paclitaxel combination in platinum-resistant ovarian
cancer patients, subject to feedback from regulators, and the
potential for vimseltinib to be a best-in-class treatment for TGCT.
The words “may,” “will,” “could,” “would,” “should,” “expect,”
“plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “seek,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a 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 severity and
duration of the impact of COVID-19 on our business and operations,
our ability to successfully demonstrate the efficacy and safety of
our drug candidates and in additional indications for our existing
drug, the preclinical or clinical results for our product
candidates, which may not support further development of such
product candidates, our ability to manage our reliance on
sole-source third parties such as our third party drug substance
and drug product contract manufacturers, comments, feedback and
actions of regulatory agencies, our ability to commercialize
QINLOCK and execute on our marketing plans for any drugs or
indications that may be approved in the future, our ability to
build and scale our operations to support growth in additional
geographies, the inherent uncertainty in estimates of patient
populations, competition from other products, our ability to obtain
and maintain reimbursement for any approved product and the extent
to which patient assistance programs are utilized, our ability to
comply with healthcare regulations and laws, our ability to obtain,
maintain and enforce our intellectual property rights, any or all
of which may affect the initiation, timing and progress of clinical
studies and the timing of and our ability to obtain additional
regulatory approvals, and other risks identified in our Securities
and Exchange Commission (SEC) filings, including our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2021, and
subsequent filings with the SEC. We caution you not to place undue
reliance on any forward-looking statements, which speak only as of
the date they are made. We disclaim any obligation to publicly
update or revise any such statements to reflect any change in
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements
contained in this press release represent our views only as of the
date hereof and should not be relied upon as representing our views
as of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
QINLOCK and the QINLOCK logo are registered trademarks, and
Deciphera and the Deciphera logo are trademarks, of Deciphera
Pharmaceuticals, LLC.
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version on businesswire.com: https://www.businesswire.com/news/home/20210917005090/en/
Investor Relations: Jen Robinson Deciphera Pharmaceuticals, Inc.
jrobinson@deciphera.com 781-906-1112
Media: David Rosen Argot Partners
David.Rosen@argotpartners.com 212-600-1902
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