On August 13, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported positive top-line data from the INVICTUS pivotal Phase 3 clinical study of ripretinib, a broad-spectrum KIT and PDGFRα inhibitor, in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST) (Press release, Deciphera Pharmaceuticals, AUG 13, 2019, View Source [SID1234538651]).

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"There is a dire unmet need for new therapies that can deliver effective disease control for patients with advanced GIST who have failed currently approved treatment options," said Margaret von Mehren, MD, Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania. "These top-line data from a Phase 3, randomized, placebo-controlled study are highly impressive and suggest that ripretinib’s approach of targeting the broad spectrum of KIT and PDGFRα mutations known to drive GIST can significantly improve progression free survival in the most heavily pretreated patients. Particularly notable is the magnitude of benefit observed for overall survival in this study."

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 ripretinib compared to placebo in 129 patients with advanced GIST whose previous therapies have included at least imatinib, sunitinib, and regorafenib. The INVICTUS study achieved its primary endpoint of improved PFS as determined by blinded independent central radiologic review using modified Response Evaluation Criteria in Solid Tumors (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 (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 overall survival (OS) (median OS 15.1 months vs. 6.6 months, 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 treatment.

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 (TEAEs) occurred in 42 (49%) patients on the ripretinib arm compared to 19 (44%) on the placebo arm. Grade 3 or 4 TEAEs >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 >5% of patients in the placebo arm were anemia (14%; n=6). The below table lists TEAEs >15% in the ripretinib arm compared to placebo.

INVICTUS Phase 3 Clinical Study

Treatment Emergent Adverse Event

Placebo

Ripretinib

(N=43)(1)

150mg
Daily

(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

%)

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

"Today’s announcement represents a significant milestone in our mission to deliver important new medicines for the treatment of cancer," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "On behalf of the entire Deciphera team, I would like to thank the patients, their caregivers and the healthcare professionals who participated in the INVICTUS study. The data from INVICTUS reinforce our belief that ripretinib has the potential to transform the treatment of GIST, and our focus now turns to working closely with the FDA as they evaluate ripretinib for those patients with GIST who, having failed all currently approved therapies, are in desperate need of a treatment option."

Based on the positive INVICTUS data, the Company expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 2020.

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

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss the results of the INVICTUS Phase 3 clinical study today, August 13, 2019 at 8:00 AM ET. To access the live call by phone please dial 866-930-5479 (domestic) or 409-216-0603 (international); the conference ID is 8859018. A live audio webcast of the event and accompanying slides may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

About the INVICTUS Phase 3 Study

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 regorafenib. This study was designed to provide evidence of clinical benefit in fourth-line and fourth-line plus patients with GIST that would be required to secure a regulatory approval. Patients were randomized 2:1 to either 150 mg of ripretinib or placebo once daily. The primary efficacy endpoint is progression-free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR), Time to Tumor Progression (TTP) and Overall Survival (OS). See www.clinicaltrials.gov for further information (NCT03353753).

About GIST

Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST is the most common sarcoma of the gastrointestinal tract, with approximately 4,000 to 6,000 new GIST cases each year in the United States and a similar incidence rate in European and other countries. Most cases of GIST are driven by a spectrum of mutations. The most common primary mutations are in KIT kinase, representing approximately 75% to 80% of cases, or in PDGFRα kinase, representing approximately 5% to 10% of cases. Current therapies are unable to inhibit the full spectrum of primary and secondary mutations, which drives resistance and disease progression. Estimates for 5-year survival range from 48% to 90%, depending on the stage of the disease at diagnosis.

About Ripretinib

Ripretinib is an investigational 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 other cancers. Ripretinib was specifically designed to improve the treatment of patients with GIST by inhibiting a broad spectrum of mutations in KIT and PDGFRα. Ripretinib is a KIT and PDGFRα inhibitor that inhibits 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. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST. In June 2019, the U.S. FDA granted Fast Track Designation to ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.

Deciphera Pharmaceuticals has an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization of ripretinib in Greater China (Mainland China, Hong Kong, Macau and Taiwan). Deciphera Pharmaceuticals retains development and commercial rights for ripretinib in the rest of the world.

On August 13, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported financial results for the second quarter ended June 30, 2019 (Press release, Alpine Immune Sciences, AUG 13, 2019, View Source [SID1234538631]).

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"I am proud of the progress Alpine has made in the first six months of the year and the momentum we’ve built heading into a potentially transformative year ahead," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "The Phase I trial of ALPN-101 in healthy volunteers has advanced through the single-ascending dose cohorts, enabling initiation of the multiple-ascending dose cohorts. This is an important milestone for our first-in-class dual ICOS/CD28 blocker which we believe has the potential to deliver meaningful remissions in inflammatory diseases. We expect to have completed the critical portions of the Phase 1 trial of ALPN-101 by the end of 2019 and look forward to initiating our studies in acute GVHD and Psoriatic Arthritis."

Recent Pipeline and Company Highlights

ALPN-101 Update:

Phase I Trial Successfully Progresses Through the Single-Ascending Dose (SAD) Cohorts: Dosing of all planned SAD cohorts in the Phase I healthy volunteer study has been successfully completed. Enrollment has begun on the multiple-ascending dose cohorts.
"The safety, pharmacokinetic and pharmacodynamic data so far have been encouraging and we believe this study, once complete, will allow us to select an appropriate dose(s) for Phase II studies," said Stanford Peng, MD, PhD, Alpine’s President and Head of Research and Development. "We expect to have these data before the end of the year and hope to present the data publicly in the first half of 2020."

Trials in patients with GVHD and Psoriatic Arthritis are on track to begin following completion of the Phase I healthy volunteer study.
Alpine plans to present additional preclinical data supporting the potential role of ALPN-101 in additional indications at an upcoming scientific conference in the fourth quarter of 2019, supporting the potential broad utility of ALPN-101.
ALPN-202 Update:

Alpine anticipates submitting for regulatory authorization to begin clinical trials by the end of 2019. Alpine believes ALPN-202 will be the first clinical trial of a conditional T-cell agonist targeting CD28 while also providing checkpoint blockade.
Alpine expects to present new mechanistic data in the fourth quarter of 2019 supporting the unique mechanism of action of ALPN-202.
Corporate Update:

Initiated New Collaboration with Adaptimmune: Alpine entered into a collaboration and license agreement with Adaptimmune Therapeutics (NASDAQ:ADAP) in May 2019. The new partnership aims to utilize Alpine’s secreted and transmembrane immunomodulatory protein (termed SIP and TIP) technology in an effort to further enhance the design and development of Adaptimmune’s next-generation SPEAR T-cell therapies.
Expanded Management Team:

Alpine announced the addition of Wayne Gombotz, PhD as Chief Technology Officer of Alpine. With over 30 years of biotechnology and pharmaceutical experience, most recently as Chief Development Officer at Immune Design, Dr. Gombotz will help advance Alpine’s programs into and through each stage of clinical development.

Remy Durand, PhD was also appointed as Vice President, Business Development during the second quarter of 2019. Remy brings with him deep experience in biotechnology strategy, company formation, and investor relations. Prior to joining Alpine, Remy was a Vice President on the investment team at Frazier Healthcare Partners. He received his PhD from Stanford University in Bioengineering.

Financial Results for Second Quarter and First Six Months of 2019

As of June 30, 2019, Alpine had cash, cash equivalents, and short-term investments totaling $55.6 million compared to $52.3 million as of December 31, 2018. Alpine recorded a net loss of $11.9 million and $7.9 million for the three months ended June 30, 2019 and 2018, respectively, and $24.2 million and $13.2 million for the six months ended June 30, 2019 and 2018, respectively.

Research and development expenses for the second quarter ended June 30, 2019 were $10.2 million compared to $5.7 million for the second quarter ended June 30, 2018. For the six months ended June 30, 2019 and 2018, research and development expenses were $20.5 million and $9.5 million, respectively. The company expects a continued increase to research and development activities to support the clinical advancement of its ALPN-101 and ALPN-202 programs.

General and administrative expenses for the second quarter ended June 30, 2019 were $2.6 million compared to $1.9 million for the second quarter ended June 30, 2018. For the six months ended June 30, 2019 and 2018, general and administration expenses were $4.9 million and $4.0 million, respectively. The increase was primarily attributable to professional and legal fees, in addition to personnel-related expenses and the costs associated with expanding the company’s operations as we continue to increase development and clinical activities.

Cash Guidance

Alpine expects to have sufficient cash to fund operations and drive the clinical advancement of Alpine’s lead programs, ALPN-101 in autoimmune/inflammatory diseases and ALPN-202 in oncology, into 2021.

On August 13, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported updated data from its ongoing Phase 1 clinical study of ripretinib, a broad-spectrum KIT and PDGFRα inhibitor, in patients with second-line through fourth-line plus gastrointestinal stromal tumors (GIST) (Press release, Deciphera Pharmaceuticals, AUG 13, 2019, View Source [SID1234538652]).

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In a separate press release issued today, Deciphera announced positive top-line results from its INVICTUS pivotal Phase 3 clinical study supporting a potential new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib. In addition to the INVICTUS data, Deciphera will also be submitting in its NDA supportive data from the ongoing Phase 1 clinical study, which will include the updated data from GIST patients at doses of >100mg of ripretinib. Additional results from the Phase 1 clinical study in these patients are expected to be presented at an upcoming medical meeting.

"We believe the updated data from our ongoing Phase 1 clinical study, with the additional six months of maturity from our last Phase 1 data cut-off, continue to support ripretinib’s potential across the broad range of KIT and PDGFRα mutations known to occur in patients with GIST following therapy with imatinib," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "In the updated data from the second-line cohort, we believe ripretinib has demonstrated encouraging clinical benefit based on the objective response rate, disease control rate and median progression free survival rates observed. These results strengthen our confidence in the INTRIGUE pivotal Phase 3 clinical study comparing ripretinib to sunitinib, the standard of care for patients receiving second-line treatment for GIST."

Updated Phase 1 Data

Updated data from 178 GIST patients receiving ripretinib at doses of >100mg daily are noted in the table below as of March 1, 2019. The table includes investigator-assessed objective response rate (ORR) by best response, disease control rate (DCR) and median progression free survival (mPFS), all of which were determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Line of Therapy(1)

Objective Response Rate by Best Response

Includes Unconfirmed

(Confirmed Only)

Disease Control Rate

at 3 Months

Median Progression Free Survival (mPFS)

Censored Patients for mPFS

Mean Treatment 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

≥Fourth-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 (Free ESMO Whitepaper) 2018; based on additional data cleaning, one patient from each of 2nd line and 4th/≥4th line were reclassified as 3rd line patients; (2) Median treatment durations were: 2nd line = 44 weeks, 3rd line = 48 weeks, 4th line = 46 weeks and ≥4th 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.

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 treatment-emergent adverse events (TEAEs) in >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.

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement, as well as results from the INVICTUS Phase 3 clinical study, today, August 13, 2019 at 8:00 AM ET. To access the live call by phone please dial 866-930-5479 (domestic) or 409-216-0603 (international); the conference ID is 8859018. A live audio webcast of the event and accompanying slides may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

About GIST

Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST is the most common sarcoma of the gastrointestinal tract, with approximately 4,000 to 6,000 new GIST cases each year in the United States and a similar incidence rate in European and other countries. Most cases of GIST are driven by a spectrum of mutations. The most common primary mutations are in KIT kinase, representing approximately 75% to 80% of cases, or in PDGFRα kinase, representing approximately 5% to 10% of cases. Current therapies are unable to inhibit the full spectrum of primary and secondary mutations, which drives resistance and disease progression. Estimates for 5-year survival range from 48% to 90%, depending on the stage of the disease at diagnosis.

About Ripretinib

Ripretinib is an investigational 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 other cancers. Ripretinib was specifically designed to improve the treatment of patients with GIST by inhibiting a broad spectrum of mutations in KIT and PDGFRα. Ripretinib is a KIT and PDGFRα inhibitor that inhibits 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. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST. In June 2019, the U.S. FDA granted Fast Track Designation to ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.

Deciphera Pharmaceuticals has an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization of ripretinib in Greater China (Mainland China, Hong Kong, Macau and Taiwan). Deciphera Pharmaceuticals retains development and commercial rights for ripretinib in the rest of the world.

About the INTRIGUE Phase 3 Study

The INTRIGUE Phase 3 clinical study is an interventional, randomized, global, multicenter, open-label study to evaluate the safety, tolerability and efficacy of ripretinib compared to sunitinib in patients with GIST previously treated with imatinib. This study was designed to provide evidence of clinical benefit to support regulatory approvals in second-line GIST patients in the United States, Europe and other major markets. Patients will be randomized 1:1 to either 150 mg of ripretinib once daily or 50 mg of sunitinib once daily for four weeks followed by two weeks without sunitinib. The primary efficacy endpoint is median progression-free survival (mPFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). See www.clinicaltrials.gov for further information (NCT03673501).

On August 13, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported financial results for its fiscal fourth-quarter and full-year 2019, reported an update on recent business highlights and provided fiscal year and first-quarter 2020 financial guidance (Press release, Myriad Genetics, AUG 13, 2019, View Source [SID1234538763]).

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"Fiscal year 2019 revenue increased 14 percent with earnings up 18 percent. Unfortunately, revenue in the fourth quarter was two percent below expectations largely due to lower reimbursement for our expanded carrier screening test," said Mark C. Capone, president and CEO, Myriad Genetics. "Looking ahead to fiscal year 2020, with stabilized pricing, growing new product volumes and recent reimbursement advances with GeneSight, we are highly optimistic about our ability to deliver an inflection in revenue and earnings as we transition through the fiscal year."

Recent Business Highlights

Hereditary Cancer

Hereditary cancer revenue returned to year-over-year growth in fiscal year 2019 representing the first time hereditary cancer revenue has grown in the last five fiscal years.

Presented data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting from the Women’s Health Initiative study that evaluated mutation rates in 2,195 post-menopausal women with breast cancer. The study found that women with post-menopausal breast cancer had a high rate of inherited mutations in a range of cancer causing genes and this mutation rate did not diminish with age. This along with other studies have shown that

current hereditary breast cancer testing guidelines miss approximately 50 percent of mutation carriers.

GeneSight

Announced coverage decision from UnitedHealth, the largest commercial payer in the United States, covering GeneSight for patients that have a diagnosis of major depressive disorder or anxiety and have failed at least one prior medication.

Announced coverage decision for GeneSight by Kroger Prescription Plans. As part of the agreement, Kroger initiated an early access program at 500 Kroger pharmacies where GeneSight testing will be facilitated by the Kroger Health pharmacist.

Presented data at the Clinical Pharmacogenomics Implementation Consortium annual meeting showing GeneSight had more than double the predictive power for drug blood levels compared to single gene pharmacogenomics tests.

Completed a Medicare Coverage Advisory Committee meeting reviewing potential expansion of the GeneSight LCD to primary care physicians. During the meeting, Medicare’s selected subject matter experts unanimously agreed that pharmacogenomics testing should be available to primary care physicians.

Prolaris

Published data from a large study of 1,062 men with newly diagnosed localized prostate cancer to evaluate the ability of the Prolaris test to predict risk of metastases. The study found that Prolaris was the strongest independent predictor of progression to metastatic disease, and men were approximately three times more likely to develop metastatic disease with each unit increase in the Prolaris test score (HR: 2.93; p=1.8×10-11).

EndoPredict

Published data in the journal Clinical Cancer Research demonstrating that the EndoPredict test identifies women with early-stage breast cancer who can safely forgo extended endocrine therapy five years after diagnosis.

Published the results of the first comprehensive cost-effectiveness analysis of the EndoPredict test compared to other breast cancer assays. The study found that the EndoPredict test was more than twice as cost effective as Oncotype DX.

Companion Diagnostics

Announced that the BRACAnalysis CDx companion diagnostic test effectively identified patients with metastatic pancreatic cancer who benefitted from treatment with Lynparza

(olaparib) in the Phase III POLO study. Patients in the study with a germline mutation had a clinically-meaningful and statistically-significant improvement in progression-free survival (PFS) of 7.4 months when treated with Lynparza compared to 3.8 months for placebo (HR 0.53; p=0.004).

Received approval from the Japanese Ministry of Health, Labour, and Welfare for Myriad’s BRACAnalysis Diagnostic System as a companion for Lynparza in women with ovarian cancer.

Announced that BRACAnalysis CDx effectively identified patients with castrate resistant, metastatic prostate cancer who benefitted from treatment with Lynparza in the PROfound study. Results from the study showed a statistically-significant and clinically-meaningful improvement in radiographic progression-free survival in patients who received Lynparza vs. enzalutamide or abiraterone and had deleterious mutations in the BRCA1/2 genes.

myPath Melanoma

Received a positive final local coverage decision from Noridian Healthcare Solutions for myPath Melanoma.

German Clinic Sale

Announced planned sale of the Privatklinik Dr. Robert Schindlbeck GmbH & Co. KG (the "Clinic"), which is expected to occur around the middle of fiscal year 2020.

Fiscal Year 2020 and Fiscal First-Quarter 2020 Financial Guidance

Myriad’s fiscal year 2020 and first-quarter 2020 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss the fiscal fourth-quarter financial results and fiscal year 2020 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, August 13, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal fourth-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-763-5615. International callers may dial 1-212-231-2936. All callers will be asked to reference reservation number 21927089. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On August 13, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission (EC) has approved variations to broaden the use of Imbruvica (ibrutinib) in two indications (Press release, Johnson & Johnson, AUG 13, 2019, View Source [SID1234538653]). This includes the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and the use of ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). The approval follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 28 June 2019.

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"The data supporting both the CLL and WM approvals show significant improvements in progression free survival with the use of ibrutinib-based therapy versus the standard of care study comparators respectively," said Dr Alessandra Tedeschi, Medical Director, Department of Hematology, Niguarda Hospital, Milan, Italy, and investigator in both the iNNOVATE and iLLUMINATE studies. "These approvals therefore provide healthcare professionals with new chemotherapy-free options for patients with these complex blood cancers."

The approval in CLL was based on results from the Phase 3 iLLUMINATE (PCYC-1130) study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with previously untreated CLL.1

In WM, the decision was based on data from the Phase 3 iNNOVATE (PCYC-1127) study, published in the New England Journal of Medicine.2 The study evaluated the efficacy and safety of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3

Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).4,5

"With five European Commission approvals in five years, this latest EC decision further extends the potential reach and impact ibrutinib can have for patients," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "We remain committed to a comprehensive clinical development programme for ibrutinib, including exploring its use in other combinations, to address the needs of more and more patients with B-cell malignancies."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

Dr Alessandra Tedeschi is co-investigator in both the iNNOVATE and iLLUMINATE studies. She was not compensated for any media work.

#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.6 By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.7

Ibrutinib is currently approved in Europe for:8

Chronic lymphocytic leukaemia (CLL): As a single agent or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL
Waldenström’s macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients
Ibrutinib is approved in more than 95 countries, and, to date, has been used to treat more than 158,000 patients worldwide across its approved indications.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.8

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.9 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.10 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.11

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).12 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.13 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.14 The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.12,14