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08/13/2019 | 07:15am EDT

Item 8.01 Other Events.

Corporate Update

On August 13, 2019, Deciphera Pharmaceuticals, Inc. (the "Company" or "we")
announced positive top-line data from its INVICTUS pivotal Phase 3 clinical
study of ripretinib, a broad-spectrum KIT and PDGFR? inhibitor, in patients with
fourth-line and fourth-line plus gastrointestinal stromal tumor, or GIST. The
Company also announced positive updated data from its ongoing Phase 1 clinical
study of ripretinib.

Top-line Results from INVICTUS Phase 3 Study in Fourth-Line and Fourth-Line Plus GIST

The INVICTUS Phase 3 clinical study is a randomized, double-blind,
placebo-controlled, international, multicenter study to evaluate the safety,
tolerability, and efficacy of ripretinib compared to placebo in patients with
advanced GIST whose previous therapies have included imatinib, sunitinib, and

On August 13, 2019, we announced top-line data from the INVICTUS Phase 3
clinical study, including that the trial achieved its primary endpoint of
improved progression free survival, or PFS, compared to placebo in patients with
fourth-line and fourth-line plus GIST, as determined by blinded independent
central radiologic review using modified Response Evaluation Criteria in Solid
Tumors, or RECIST, version 1.1.

In the INVICTUS study, ripretinib demonstrated a median PFS of 6.3 months (27.6
weeks) compared to 1.0 month (4.1 weeks) in the placebo arm and significantly
reduced the risk of disease progression or death by 85% (HR of 0.15, p<0.0001)
compared to placebo.

For the key secondary endpoint of objective response rate, or ORR, as determined
by blinded independent central radiologic review using modified RECIST version
1.1, ripretinib demonstrated an ORR of 9.4% compared with 0% for placebo
(p-value=0.0504), which was not statistically significant. Ripretinib in this
study also showed a clinically meaningful improvement over placebo in terms of
the secondary endpoint of overall survival, or OS (median OS 15.1 months with
ripretinib compared to 6.6 months with placebo, HR = 0.36, nominal
p-value=0.0004). Since statistical significance was not achieved for ORR, the
hypothesis testing of OS was not formally performed. According to the
pre-specified hierarchical testing procedure of the endpoints, the hypothesis
testing of OS cannot be formally conducted unless the test of ORR is
statistically significant. The OS data for the placebo arm includes patients
taking placebo who, following progression, were crossed-over to ripretinib

Ripretinib was generally well tolerated and the adverse event results in
INVICTUS were consistent with data from previously presented Phase 1 study
results. Grade 3 or 4 treatment-emergent adverse events, or TEAEs, occurred in
42 patients (49%) on the ripretinib arm compared to 19 patients (44%) on the
placebo arm. Grade 3 or 4 TEAEs in greater than 5% of patients in the ripretinib
arm were anemia (9%; n=8), abdominal pain (7%; n=6) and hypertension (7%; n=6).
Grade 3 or 4 TEAEs in greater than 5% of patients in the placebo arm were anemia
(14%; n=6). The below table lists all TEAEs greater than 15% in the ripretinib
arm compared to the placebo arm in INVICTUS.

                          INVICTUS Phase 3 Clinical Study
                                                      Placebo    150mg Daily
       Treatment Emergent Adverse Event              (N=43)(1)    (N=85)(1)
       Any event                                     42 (98%)     84 (99%)
       Alopecia                                       2 (5%)      44 (52%)
       Fatigue                                       10 (23%)     36 (42%)
       Nausea                                         5 (12%)     33 (39%)
       Abdominal pain                                13 (30%)     31 (36%)
       Constipation                                   8 (19%)     29 (34%)
       Myalgia                                        5 (12%)     27 (32%)
       Diarrhea                                       6 (14%)     24 (28%)
       Decreased appetite                             9 (21%)     23 (27%)
       Palmar-plantar erythrodysaesthesia syndrome       0        18 (21%)
       Vomiting                                       3 (7%)      18 (21%)
       Headache                                       2 (5%)      16 (19%)
       Weight decreased                               5 (12%)     16 (19%)
       Arthralgia                                     2 (5%)      15 (18%)
       Blood bilirubin increased                         0        14 (16%)
       Oedema peripheral                              3 (7%)      14 (16%)
       Muscle spasms                                  2 (5%)      13 (15%)

   (1) Safety population includes 128 patients. One patient was randomized to
                    placebo but did not receive study drug.

Based on the positive INVICTUS data, the Company expects to submit a New Drug
Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for
ripretinib for the treatment of patients with advanced GIST who have received
prior treatment with imatinib, sunitinib and regorafenib in the first quarter of

Additional results from the INVICTUS Phase 3 clinical study are expected to be presented at an upcoming medical meeting.

Updated Data from Ongoing Phase 1 Study in GIST Patients

We are studying ripretinib in an ongoing Phase 1 trial in patients with advanced
malignancies, including, without limitation, GIST. On August 13, 2019, we
announced an update to the results from our ongoing Phase 1 study of ripretinib
in 178 GIST patients who received at least one dose at or above 100 mg
of ripretinib daily, with a cut-off date of March 1, 2019, with data based on
investigator assessment. We observed an ORR by best response, which is the
proportion of patients with either complete responses, or CRs, or partial
responses, or PRs, by RECIST version 1.1, in each line of GIST as summarized

In addition, we observed a disease control rate, or DCR, defined as the
proportion of patients with either stable disease or a PR at a point in time, at
three months in each line of patients as summarized below. Disease control
includes stable disease, PRs and CRs, measured by computerized tomography, or
CT scan, or magnetic resonance imaging, or MRI scan, and assessed locally by
RECIST. We also observed median progression free survival, or mPFS, and
treatment duration.

Updated interim results, including those announced on August 13, 2019, are summarized in the below table.

                                       Objective Response
                                          Rate by Best                              Median
                                       Response Includes        Disease           Progression          Censored               Mean
                                          Unconfirmed        Control Rate        Free Survival       Patients for          Treatment
Line of Therapy(1)                      (Confirmed Only)      at 3 Months           (mPFS)               mPFS            Duration(2)(3)
Second-Line (n=37)                         30% (22%)                   81%             42 weeks                38%              43 weeks
Third-Line (n=31)                          23% (13%)                   80%             40 weeks                32%              48 weeks
Fourth-Line (n=60)                          15% (8%)                   73%             30 weeks                30%              49 weeks
³Fourth-Line (n=110)(4)                     11% (7%)                   66%             24 weeks                22%              41 weeks

(1) Overall number of patients (n=178) remains the same as prior data presented
at ESMO 2018; based on additional data cleaning, one patient from each of 2nd
line and 4th/³4th line were reclassified as 3rd line patients; (2) Median
treatment durations were: 2ndline = 44 weeks, 3rd line = 48 weeks, 4th line = 46
weeks and ³4th line = 29 weeks; (3) Includes 60 patients who elected for
intra-patient dose escalation from 150 mg QD to 150 mg BID; (4) Number of
patients includes 60 patients from 4th line.


In the Phase 1 study, ripretinib was generally well tolerated and the updated
adverse events were consistent with previously presented Phase 1 data in
patients with GIST. Grade 3 or 4 TEAEs in greater than 5% of patients were
lipase increased (18%; n=33), anemia (11%; n=20), hypertension (7%; n=13) and
abdominal pain (6%; n=11). 13% of patients (n=24) experienced TEAEs leading to
study treatment discontinuation, 17% of patients (n=31) experienced TEAEs
leading to dose reduction and 49% of patients (n=88) had TEAEs leading to study
drug interruption. The TEAEs in greater than 10% of GIST patients at or above
100 mg daily (n=179) by Grades 1/2 and Grades 3/4 are summarized in the table

                            GIST PATIENTS @ ³ 100 MG DAILY
                    Treatment Emergent Adverse Events (TEAEs) >10%
                                                GRADE 1-2    GRADE 3-4    GRADE 1-4
  Treatment Emergent Adverse Event              (N=179)(1)   (N=179)(1)   (N=179)(1)
  Alopecia                                      102 (57%)      0 (0%)     102 (57%)
  Fatigue                                        94 (53%)      4 (2%)      98 (55%)
  Myalgia                                        79 (44%)      0 (0%)      79 (44%)
  Nausea                                         77 (43%)      1 (1%)      78 (44%)
  Palmar-plantar erythrodysaesthesia syndrome    71 (40%)      1 (1%)      72 (40%)
  Constipation                                   67 (37%)      0 (0%)      67 (37%)
  Decreased appetite                             60 (34%)      2 (1%)      62 (35%)
  Diarrhea                                       50 (28%)      3 (2%)      53 (30%)
  Weight decreased                               51 (29%)      1 (1%)      52 (29%)
  Lipase increased                               18 (10%)     33 (18%)     51 (29%)
  Muscle spasms                                  47 (26%)      0 (0%)      47 (26%)
  Abdominal pain                                 33 (18%)     11 (6%)      44 (25%)
  Vomiting                                       42 (24%)      2 (1%)      44 (25%)
  Arthralgia                                     40 (22%)      0 (0%)      40 (22%)
  Anemia                                         18 (10%)     20 (11%)     38 (21%)
  Hypertension                                   25 (14%)     13 (7%)      38 (21%)
  Cough                                          37 (21%)      0 (0%)      37 (21%)
  Dry skin                                       37 (21%)      0 (0%)      37 (21%)
  Dyspnea                                        32 (18%)      4 (2%)      36 (20%)
  Headache                                       33 (18%)      1 (1%)      34 (19%)
  Back Pain                                      30 (17%)      2 (1%)      32 (18%)
  Dizziness                                      29 (16%)      0 (0%)      29 (16%)
  Rash                                           27 (15%)      0 (0%)      27 (15%)
  Hypokalaemia                                   21 (12%)      5 (3%)      26 (15%)
  Hypophosphataemia                              17 (10%)      8 (5%)      25 (14%)
  Actinic keratosis                              25 (14%)      0 (0%)      25 (14%)
  Blood bilirubin increase                       16 (9%)       5 (3%)      21 (12%)
  Amylase increased                              19 (11%)      2 (1%)      21 (12%)
  Insomnia                                       21 (12%)      0 (0%)      21 (12%)
  Seborrhoeic keratosis(2)                       21 (12%)      0 (0%)      21 (12%)
  Urinary tract infection                        16 (9%)       4 (2%)      20 (11%)
  Dysgeusia                                      20 (11%)      0 (0%)      20 (11%)
  Pain in extremity                              18 (10%)      1 (1%)      19 (11%)

Blood creatine phosphokinase increased 13 (7%) 5 (3%) 18 (10%)

  Upper respiratory tract infection              18 (10%)      0 (0%)      18 (10%)
  Rash maculo-papular                            18 (10%)      0 (0%)      18 (10%)
  Hypomagnesaemia                                18 (10%)      0 (0%)      18 (10%)
  Pruritus                                       18 (10%)      0 (0%)      18 (10%)
  Skin papilloma(2)                              17 (10%)      0 (0%)      17 (10%)
  Vision blurred                                 17 (10%)      0 (0%)      17 (10%)

(1) Includes one patient that only participated in the food effect portion of the

Phase 1 study; (2) Dermatology skin exams were implemented to better evaluate

    skin lesions.



Additional results from the Phase 1 clinical study in these patients are expected to be presented at an upcoming medical meeting.


This document contains forward-looking statements, which reflect our current
views with respect to, among other things, our operations and financial
performance. All statements other than statements of historical facts contained
in this document, including statements regarding our strategy, future
operations, future financial position, future revenue, projected costs,
prospects, plan, objectives of management and expected market growth are
forward-looking statements. You can identify these forward-looking statements by
the use of words such as "outlook," "believes," "expects," "potential,"
"continues," "may," "will," "should," "seeks," "approximately," "predicts,"
"intends," "plans," "estimates," "anticipates" or the negative version of these
words or other comparable words. Such forward-looking statements are subject to
various risks and uncertainties. Accordingly, there are or will be important
factors that could cause actual outcomes or results to differ materially from
those indicated in these statements. We believe these factors include but are
not limited to those described under "Risk Factors" and include, among other

• the success, cost and timing of our product development activities and

clinical trials, including the timing of our ongoing Phase 3 trials and

          results therefrom;

     •    our ability to obtain and maintain regulatory approval for
          ripretinib (DCC-2618) or any of our other current or future drug

candidates, and any related restrictions, limitations, and/or warnings in

          the label of an approved drug candidate;

     •    preliminary or "top-line" data from our clinical trials based on a
          preliminary analysis of then-available top-line data in a summary format
          being perceived differently from additional data disclosed at a later
          time due to more patient data becoming available or audit and

verification procedures resulting in material changes in the final data;

     •    the timing and release of additional results from our clinical trials,
          including from the INVICTUS Phase 3 clinical study, and their



• acceptance by the public or regulatory agencies of our assumptions,

          estimates, calculations, conclusions or analyses of our data, and
          differences in interpretation or weight of importance of our data;

• our expectations regarding the size of target patient populations for our

drug candidates, if approved for commercial use, and any additional drug

          candidates we may develop;

  •   our ability to obtain funding for our operations;

     •    our ability to manufacture or obtain sufficient quantities of our drug
          candidates, including, without limitation, ripretinib, to support our
          planned clinical trials and, if approved, commercialization;

  •   the commercialization of our drug candidates, if approved;

• our plans to research, develop and commercialize our drug candidates,

          including the timing of our ongoing Phase 3 trials and the timing of
          investigational new drug, or IND, applications, including, without
          limitation, the success of IND-enabling studies for, and the expected
          timing of, an IND application for our DCC-3116 program;

• the performance and experience of our licensee, Zai Lab (Shanghai) Co.,

Ltd., or Zai, to successfully develop and, if approved, commercialize

          ripretinib in Greater China under the terms and conditions of our license

• our ability to attract additional licensees and/or collaborators with

          development, regulatory and commercialization expertise;

• our expectations regarding our ability to obtain, maintain, enforce and

defend our intellectual property protection for our drug candidates;

     •    future agreements with third parties in connection with the
          commercialization of ripretinib, or any of our other current or future
          drug candidates;

• the size and growth potential of the markets for our drug candidates, and

          our ability to serve those markets;

• the rate and degree of market acceptance of our drug candidates, as well

          as the reimbursement coverage for our drug candidates;

     •    regulatory and legal developments in the United States and foreign

     •    the performance and experience of our third-party suppliers and

     •    the success and timing of competing therapies that are or may become

• our ability to attract and retain key scientific or management personnel;

• the accuracy of our estimates regarding expenses, future revenues,

          capital requirements and needs for additional financing;

     •    our expectations regarding the period during which we qualify as an
          emerging growth company under the JOBS Act; and

• our expectations related to the use of proceeds from our public offerings.

These factors should not be construed as exhaustive and should be read in
conjunction with the other cautionary statements that are included elsewhere in
our filings with the SEC. The forward-looking statements contained in this
document are made as of the date of this document, and we undertake no
obligation to publicly update or review any forward-looking statement, whether
as a result of new information, future developments or otherwise.



© Edgar Online, source Glimpses

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