Galecto Biotech Strengthens Executive Team with Appointment of Richard Marshall as Chief Medical Officer

On May 21, 2018 Galecto Biotech AB, the leading developer of galectin modulators for the treatment of severe diseases, including fibrosis and cancer, reported the appointment of Richard Marshall, MD, PhD, as Chief Medical Officer (Press release, Galecto Biotech, MAY 21, 2018, View Source [SID1234526811]). Dr Marshall joins Galecto with more than 15 years of experience across drug discovery, clinical development and business development in various positions at Glaxo Smithkline (GSK). Most recently, he was Vice-President and Head of the Fibrosis & Lung Injury Discovery Performance Unit. During his tenure at GSK, Dr Marshall led the early clinical development for NucalaTM, anti-IL-5 mAb in asthma and nasal polyposis. He is a visiting Professor at Newcastle University and an Honorary Consultant in Thoracic Medicine at Royal Brompton & Harefield NHS Foundation Trust. Dr Marshall earned his undergraduate, medical and doctorate degress at University College London.

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"Richard is a great addition to the Galecto management team as we move towards late-stage clinical studies with our lead program, TD139, a potent and selective inhibitor of galectin-3, in Idiopathic Pulmonary Fibrosis (IPF) and advance other candidates in fibrosis, inflammation and cancer through clinical development," said Hans Schambye, CEO of Galecto Biotech. "His career at GSK has seen him deliver on all aspects of drug discovery and development within the respiratory and fibrosis field, making him ideal to help take Galecto to the next level."

"Galecto’s unique approach to targeting galectin-3 has shown very promising results, so far, in clinical studies. This exciting mechanism has the potential to bring new medicines to patients, treating fibrosis and inflammation across a range of severe, often life threatening, diseases. I look forward to working with the superb team at Galecto to help steer the next stage of clinical development for Galecto’s portfolio of candidate drugs," said Dr Marshall.

ERLEADA&#8482 Significantly Reduced Risk of Prostate Specific Antigen (PSA) Progression in Patients with Non-Metastatic Castration-Resistant Prostate Cancer

On May 18, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported a post-hoc analysis from the Phase 3 SPARTAN study that showed treatment with ERLEADA (apalutamide) significantly reduced the risk of prostate specific antigen (PSA) progression in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who had a rapidly rising PSA while receiving continuous androgen deprivation therapy (ADT) (Abstract PD10-11) (Press release, Johnson & Johnson, MAY 18, 2018, View Source [SID1234526908]). These data were presented during the Prostate Cancer: Advanced (including Drug Therapy) I Oral Podium Session at the 2018 American Urological Association (AUA) Annual Meeting.

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Additionally, Janssen presented another study that assessed the association between PSA doubling time and both metastasis-free survival (MFS) and overall survival (OS) in patients with nmCRPC (Abstract PD10-04). Shorter PSA doubling time has been associated with shorter time to metastasis or death.1,2

"Patients with non-metastatic castration-resistant prostate cancer are at risk for metastases and mortality. In these patients, PSA doubling time is an important predictor of outcomes, including time to developing metastases or symptoms from their cancer," said Eric Small, M.D. FASCO, Professor of Medicine, Chief of the Division of Hematology and Oncology, and Deputy Director of the Helen Diller Comprehensive Cancer Center at the University of California, San Francisco, and co-principal investigator of the SPARTAN study. "This analysis further underscores the efficacy of apalutamide therapy and helps us understand how PSA changes in these patients are associated with clinical outcomes."

Key Findings from the SPARTAN Study

According to the data from the SPARTAN study presented at AUA 2018, ERLEADA significantly decreased the risk of PSA progression by 94 percent, compared with the placebo group (median not reached vs. 3.71 months; HR=0.06; 95% CI, 0.05-0.08; P<0.0001).3

Additionally, the median time to PSA response was 29 days in the ERLEADA plus ADT group1,2 At 12 weeks after randomization, median PSA decreased by 90 percent in the ERLEADA group and increased by 40 percent in the placebo group.1,2

Among patients treated, baseline median PSA doubling time was 4.4 and 4.5 months, and median baseline PSA was 7.78 and 7.96 ng/mL in the ERLEADA and placebo groups, respectively.3 A ≥90 percent maximum decline in PSA from baseline at any time on study was observed in 66 percent of patients in the ERLEADA group and 1 percent of patients in the placebo group.3

The SPARTAN trial was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluated ERLEADA in combination with ADT in patients with nmCRPC who had a rapidly rising PSA (PSA doubling time ≤10 months). The primary endpoint was MFS. ERLEADA plus ADT improved MFS by 2 years (24.3 months) compared to placebo plus ADT (40.5 months vs. 16.2 months; HR=0.28; 95% CI, 0.23-0.35; P<0.0001).4

Key Findings from the Population-Based Study

Janssen also presented data from a population-based study designed to evaluate the association of PSA doubling time and baseline PSA levels with MFS and OS in patients with nmCRPC. The study was conducted using an integrated electronic health records and claims database.5 Specifically, PSA doubling time of ≤10 months was associated with shorter MFS and OS and was a marker for high-risk disease.5 Of the patients with evaluable PSA doubling time, 38.2 percent were defined as high-risk and 61.8 percent as low-risk, with a median MFS of 15.2 and 30.5 months, (P<0.0001) and median OS of 36.0 and 57.6 months (P=0.0092), respectively.5

"The data presented today demonstrated that a shorter PSA doubling time can result in poor outcomes for patients, supporting the benefit of ERLEADA in reducing the risk of PSA progression in patients with non-metastatic castration-resistant prostate cancer," said Marco Gottardis, Ph.D., Vice President and Prostate Cancer Disease Area Stronghold Leader for the Oncology Therapeutic Area at Janssen Research & Development, LLC. "Janssen is fully committed to the discovery and development of next-generation treatments and bringing forward data that may help physicians consider treatment options for patients with rapidly rising PSA levels who are at high-risk for metastasis."

Additionally, Janssen will present a moderated poster titled, "Patient Reported Outcomes (PROs) in SPARTAN, a Phase 3, double-blind, randomized study of apalutamide plus androgen deprivation therapy (ADT) vs. placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC)" on Sunday, May 20, from 7:00 a.m. to 9:00 a.m. PST (Abstract MP52-20).6

About Non-Metastatic Castration-Resistant Prostate Cancer

Non-metastatic castration-resistant prostate cancer refers to a disease state in which the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a total body bone scan or CT scan.7 Features include: lack of detectable metastatic disease;7 rapidly rising prostate specific antigen while on androgen deprivation therapy (ADT); and serum testosterone level below 50 ng/dL.8,9 Ninety percent of patients with nmCRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.10 The relative 5-year survival rate for patients with distant stage prostate cancer is 30 percent.11 It is critical to delay the onset of metastasis in patients with nmCRPC.

About ERLEADA

ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and was approved by the FDA on February 14, 2018 as the first approved treatment for this disease state.4 Apalutamide is the only therapy with a category 1 recommendation for non-metastatic (M0) CRPC in the NCCN Guidelines for Prostate Cancer. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer include apalutamide as a treatment option for patients with non-metastatic (M0) CRPC with a category 1 recommendation (especially for those with a PSA doubling time ≤10 months)*.12 Additionally, the AUA Guidelines for Castration-Resistant Prostate Cancer (CRPC) were recently updated to include apalutamide (ERLEADA) with continued androgen deprivation as a treatment option that clinicians should offer to patients with nmCRPC who are at high-risk for developing metastatic disease (Standard; Evidence Level Grade A)**.13

*Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

**Standard: Directive statement that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be taken based on Grade A or B evidence.

**Evidence Level: A designation indicating the certainty of the results as high, moderate, or low (A, B, or C, respectively) based on AUA nomenclature and methodology.

INDICATION

ERLEADA (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

ERLEADA IMPORTANT SAFETY INFORMATION4

CONTRAINDICATIONS

Pregnancy — ERLEADA (apalutamide) can cause fetal harm and potential loss of pregnancy.

WARNINGS AND PRECAUTIONS

Falls and Fractures — In a randomized study (SPARTAN), falls and fractures occurred in 16% and 12% of patients treated with ERLEADA compared to 9% and 7% treated with placebo, respectively. Falls were not associated with loss of consciousness or seizure. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone targeted agents.

Seizure — In a randomized study (SPARTAN), 2 patients (0.2%) treated with ERLEADA experienced a seizure. Permanently discontinue ERLEADA in patients who develop a seizure during treatment. It is unknown whether anti-epileptic medications will prevent seizures with ERLEADA. Advise patients of the risk of developing a seizure while receiving ERLEADA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others.

ADVERSE REACTIONS

Adverse Reactions — The most common adverse reactions (≥10%) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, fall, hot flush, decreased appetite, fracture, and peripheral edema.

Laboratory Abnormalities — All Grades (Grade 3-4)

Hematology — anemia ERLEADA 70% (0.4%), placebo 64% (0.5%); leukopenia ERLEADA 47% (0.3%), placebo 29% (0%); lymphopenia ERLEADA 41% (2%), placebo 21% (2%)
Chemistry — hypercholesterolemia ERLEADA 76% (0.1%), placebo 46% (0%); hyperglycemia ERLEADA 70% (2%), placebo 59% (1%); hypertriglyceridemia ERLEADA 67% (2%), placebo 49% (0.8%); hyperkalemia ERLEADA 32% (2%), placebo 22% (0.5%)
Rash — Rash was most commonly described as macular or maculo-papular. Adverse reactions were 24% with ERLEADA versus 6% with placebo. Grade 3 rashes (defined as covering > 30% body surface area [BSA]) were reported with ERLEADA treatment (5%) versus placebo (0.3%).

The onset of rash occurred at a median of 82 days. Rash resolved in 81% of patients within a median of 60 days (range: 2 to 709 days) from onset of rash. Four percent of patients treated with

ERLEADA received systemic corticosteroids. Rash recurred in approximately half of patients who were re-challenged with ERLEADA.

Hypothyroidism was reported for 8% of patients treated with ERLEADA and 2% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Elevated TSH occurred in 25% of patients treated with ERLEADA and 7% of patients treated with placebo. The median onset was day 113. There were no Grade 3 or 4 adverse reactions. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted.

DRUG INTERACTIONS

Effect of Other Drugs on ERLEADA — Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties. No initial dose adjustment is necessary; however, reduce the ERLEADA dose based on tolerability [see Dosage and Administration (2.2)].

Effect of ERLEADA on Other Drugs — ERLEADA is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans. Concomitant use of ERLEADA with medications that are primarily metabolized by CYP3A4, CYP2C19, or CYP2C9 can result in lower exposure to these medications. Substitution for these medications is recommended when possible or evaluate for loss of activity if medication is continued. Concomitant administration of ERLEADA with medications that are substrates of UDP-glucuronosyl transferase (UGT) can result in decreased exposure. Use caution if substrates of UGT must be co-administered with ERLEADA and evaluate for loss of activity.

P-gp, BCRP or OATP1B1 substrates — Apalutamide is a weak inducer of P-glycoprotein (P- gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically. Concomitant use of ERLEADA with medications that are substrates of P-gp, BCRP, or OATP1B1 can result in lower exposure of these medications. Use caution if substrates of P-gp, BCRP or OATP1B1 must be co-administered with ERLEADA and evaluate for loss of activity if medication is continued.

Dendreon Initiates Large-Scale Clinical Trial to Investigate PROVENGE® (sipuleucel-T) in Men with Early-Stage Prostate Cancer on Active Surveillance

On May 18, 2018 Dendreon Pharmaceuticals LLC, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported it will conduct a large-scale, placebo-controlled clinical trial evaluating the effectiveness of PROVENGE (sipuleucel-T) in reducing disease progression in men with prostate cancer on active surveillance (AS) (Press release, Dendreon, MAY 18, 2018, View Source [SID1234526806]). PROVENGE was the first U.S. Food and Drug Administration (FDA)-approved immunotherapy made from a patient’s own immune cells and remains the only immunotherapy treatment for prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

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"Dendreon led the way with PROVENGE, the first active cellular immunotherapy approved by the FDA," said Jim Caggiano, chief executive officer of Dendreon. "We have already established that PROVENGE helps mCRPC patients live longer, and physicians have prescribed it to over 30,000 men. With this trial, Dendreon is taking another leadership position in the treatment of prostate cancer; if successful, it could again revolutionize the way the disease is treated."

Nearly 165,000 men are diagnosed with prostate cancer every year.1 Approximately 30 to 40 percent opt for AS2 – which includes regular monitoring to ensure the cancer is not growing or spreading – instead of choosing more aggressive treatment options. AS can allow men to delay – or even avoid – surgery and radiation, which often result in life-altering side effects.3 To date, no anti-cancer drug has been proven to prevent the disease from progressing during AS.

"The large body of data collected on PROVENGE has proven it has a significant impact on increasing overall survival in men with mCRPC," said Bruce A. Brown, M.D., senior vice president, medical, at Dendreon. "With the ProVent trial, our aim is to determine if PROVENGE can reduce prostate cancer disease progression in men on AS and potentially provide an alternative to choosing a treatment that can negatively impact quality of life."3

The ProVent clinical trial will assess the efficacy of PROVENGE in reducing histopathologic disease progression in men on AS, with a targeted enrollment of 450 participants. Men age 18 or older who have histologically-proven adenocarcinoma of the prostate diagnosed within 12 months of randomization are eligible to enroll. Study enrollment is expected to begin in late 2018, with topline results expected in 2023.

About the ProVent Trial

The randomized, double-blind, placebo-controlled, multicenter ProVent trial will be conducted at approximately 50 sites across the United States. Study participants will be randomized 2:1 to receive PROVENGE or placebo. The primary objective of the trial is to assess the efficacy of PROVENGE in reducing histopathologic disease progression in men on AS.

The primary endpoint is histological upgrade from ISUP Grade Group 1 to Grade Group 2 or higher, or Grade Group 2 upgraded to Grade Group 3 or higher. Secondary endpoints include the number of study participants with subsequent prostate cancer treatment (e.g., surgery, radiation, hormone therapy), the percentage of participants with a negative biopsy, and safety. Exploratory objectives will evaluate the association of immunologic responses with efficacy and patient quality of life outcomes.

About Active Surveillance (AS)

During AS, prostate tumors are not treated, but are regularly monitored via biopsies (every 1-2 years) and regular prostate-specific antigen (PSA) testing to determine disease progression. AS reduces the risk of overtreatment of clinically-insignificant prostate cancer, while retaining the option of definitive therapy.

AS is increasingly accepted as a treatment option for certain categories of prostate cancer.4 It is included in treatment guidelines from organizations including the American Urological Association, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and National Comprehensive Cancer Network.

About PROVENGE (sipuleucel-T)

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Janssen to Present New Data in Urothelial, Haematologic and Prostate Cancers at ASCO 2018, including Best of ASCO Selections

On May 18, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson, reported 21 company-sponsored abstracts will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 1-5 (Press release, Johnson & Johnson, MAY 18, 2018, View Source [SID1234526805]). New data analyses in support of a portfolio of products, including the investigational treatments erdafitinib and apalutamide, as well as approved treatments Imbruvica (ibrutinib), Darzalex (daratumumab), and Zytiga (abiraterone acetate) will be highlighted across urothelial, haematologic and prostate cancers.

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Notably, Phase 2 trial results for the investigational compound erdafitinib, which received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation, will be presented during an oral presentation on Sunday, June 3 (Abstract #4503).1,2 For haematologic cancers, Phase 3 data from the iNNOVATE study will provide the first look at ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory Waldenström’s macroglobulinemia (WM) (Abstract #8003).3 In addition, Phase 2 data from the CAPTIVATE study will be presented evaluating ibrutinib plus venetoclax in first-line chronic lymphocytic leukaemia (CLL) (Abstract #7502).4 Oral presentations for erdafitinib and ibrutinib have been selected to be featured at the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings, which highlight cutting-edge science and reflect the leading research in oncology.

"The breadth of new data from our portfolio shows our commitment to finding solutions for patients living with cancer according to their specific treatment needs," said Dr Ivo Winiger-Candolfi, Oncology Therapeutic Area Lead, Janssen Europe, Middle East and Africa. "It reinforces our dedication to work with our partners and move a step closer to making cancer a preventable, chronic or curable disease."

Selected data presentations include:

Erdafitinib: Results from the primary analysis of the Phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients with metastatic or unresectable urothelial carcinoma (mUC) and Fibroblast Growth Factor Receptor alterations (FGFRalt).
These data will be featured in an oral presentation from 9:00 – 9:12 a.m. CDT on Sunday, June 3 (Abstract #4503)1 and have been selected for the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings.
Ibrutinib: Findings from the Phase 3 placebo-controlled iNNOVATE study will be presented, assessing ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory WM.*
These data will be featured in an oral presentation from 3:45 – 3:57 p.m. CDT on Friday, June 1 (Abstract #8003)3 and have been selected for the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings.
Ibrutinib: Early results from the Phase 2 CAPTIVATE study will be presented, evaluating ibrutinib in combination with venetoclax in first-line CLL.*
These data will be featured in an oral presentation from 10:09 – 10:21 a.m. CDT on Sunday, June 3 (Abstract #7502) and have been selected for the Best of ASCO (Free ASCO Whitepaper) 2018 Meetings.4
Daratumumab: Phase 1 data from the MMY1001 study will report on the efficacy and safety of daratumumab in combination with carfilzomib and dexamethasone in lenalidomide-refractory patients with relapsed multiple myeloma.
These data will be presented in an oral presentation from 3:09 – 3:21 p.m. CDT on Friday, June 1 (Abstract #8002).5
Daratumumab: Follow-up efficacy and safety data from the pivotal Phase 3 ALCYONE study will be presented for daratumumab in combination with bortezomib, melphalan and prednisone in patients with newly diagnosed multiple myeloma who are transplant ineligible.
These data will be presented in a poster presentation from 8:00 – 11:30 a.m. CDT on Monday, June 4 (Abstract #8031).6
Daratumumab: Safety run-in results from the Phase 3 ANDROMEDA study will be presented evaluating the subcutaneous use of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone in patients with newly diagnosed amyloid light chain (AL) amyloidosis.7 Amyloidosis is an incurable disease in which cells that normally produce antibodies make an abnormal protein that deposits in and causes damage to organs such as the heart and kidneys.8
These data will be presented in a poster discussion presentation from 3:00 – 4:15 p.m. CDT on Monday, June 4 (Abstract #8011).
Apalutamide: New analyses from the pivotal Phase 3 SPARTAN clinical trial will be presented examining the relationship between time to metastasis (TTM) and site of metastases in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
These data will be presented in a poster presentation from 1:15 – 4:45 p.m. CDT on Saturday, June 2 (Abstract #5033).9
Abiraterone acetate: New findings from the pivotal Phase 3 LATITUDE clinical trial in patients with metastatic high-risk castration-sensitive prostate cancer (CSPC) will be presented.
These data will be presented in a poster presentation from 1:15 – 4:45 p.m. CDT on Saturday, June 2 (Abstract #5028).10
Prostate Cancer: New analysis exploring the association between metastasis-free survival (MFS) and overall survival (OS) will be presented in nmCRPC for the first time.
These data will be presented in a poster presentation from 1:15 – 4:45 p.m. CDT on Saturday, June 2 (Abstract #5032).11
For more information on the abstracts presented by Janssen, please click here.

*Abstracts were submitted by ibrutinib co-developer partner, Pharmacyclics, an AbbVie company.

#ENDS#

About erdafitinib

Erdafitinib is an investigational, once-daily pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor being evaluated by Janssen Research and Development in Phase 2 and 3 clinical trials in patients with advanced urothelial cancer and other solid tumours. FGFRs are a family of receptor tyrosine kinases which may be upregulated in various tumour cell types and may be involved in tumour cell differentiation and proliferation, tumour angiogenesis, and tumour cell survival.12 In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Therapeutics Ltd. to develop and commercialise erdafitinib.

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.13 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.14

Ibrutinib is currently approved in Europe for the following uses:15

Chronic lymphocytic leukaemia (CLL): As a single agent 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): Adult patients with relapsed or refractory mantle cell MCL.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.15

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.15

About daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.16,17,18 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.19 A subset of myeloid derived suppressor cells (MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.19 Daratumumab is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.20,21,22,23,24,25,26,27,28 Additional studies are ongoing or planned to assess its potential for a solid tumour indication and in other malignant and pre-malignant diseases in which CD38 is expressed, such as smouldering myeloma.29,30,31,32 For more information, please see www.clinicaltrials.gov.

Daratumumab is currently approved in Europe for the following uses:19

As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
The most common adverse reactions seen with daratumumab include infusion reactions, fatigue, nausea, diarrhoea, muscle spasms, pyrexia, cough, dyspnoea, neutropenia, thrombocytopenia and upper respiratory tract infection. In addition, in combination with bortezomib, peripheral oedema and peripheral sensory neuropathy were frequently reported.19

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using daratumumab please refer to the Summary of Product Characteristics.19

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab.33

About apalutamide

Apalutamide is an investigational, next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signalling pathway in prostate cancer cells.34 Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.34 Apalutamide received US FDA approval on February 14, 2018 for the treatment of non-metastatic CRPC.35 On February 9, 2018 Janssen submitted a Marketing Authorisation Application to the European Medicines Agency (EMA).36

About abiraterone acetate

Abiraterone acetate plus prednisone / prednisolone is the only approved therapy in mCRPC that inhibits production of androgens (which fuel prostate cancer growth) at all three sources that are important in prostate cancer – the testes, adrenals and the tumour itself.37,38

Abiraterone acetate with prednisone / prednisolone is currently approved in Europe for the following uses:37

The treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).
The treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
The treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
The most common adverse reactions seen with abiraterone acetate plus prednisone / prednisolone include urinary tract infection, hypokalemia, hypertension, and peripheral oedema.37

For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using abiraterone acetate plus prednisone / prednisolone please refer to the Summary of Product Characteristics.37

Stemline Therapeutics Announces Three SL-401 Clinical Presentations, Including an Oral Presentation, at the Upcoming EHA Congress

On May 18, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that SL-401 will be the subject of three clinical presentations, including an oral presentation on the pivotal BPDCN program (Press release, Stemline Therapeutics, MAY 18, 2018, View Source [SID1234526804]). Updated data from the ongoing Phase 2 trial in chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF) will also be presented. Presentations will be delivered at the upcoming 23rdCongress of the European Hematology Association (EHA) (Free EHA Whitepaper), to be held from June 14-17, 2018, in Stockholm, Sweden. Abstracts are now available on the EHA (Free EHA Whitepaper) congress website.

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Details on the presentations are as follows:

Results of Pivotal Phase 2 Trial of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm
• Abstract: S116
• Session: Miscellaneous Treatments in AML
• Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
• Oral Presentation: Friday, June 15; 11:45 – 12:00 CEST (5:45 AM – 6:00 AM ET)
• Location: Room A4

Results from Ongoing Phase 1/2 Trial of SL-401 in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis
• Abstract: PF618
• Session: Myeloproliferative neoplasms – Clinical
• Poster Presentation: Friday, June 15; 17:30 – 19:00 CEST (11:30 AM – 1 PM ET)
• Location: Poster Area

Results from Ongoing Phase 1/2 Trial of SL-401 in Patients with Relapsed/Refractory CMML
• Abstract: PF626
• Session: Myeloproliferative neoplasms – Clinical
• Poster Presentation: Friday, June 15; 17:30 – 19:00 CEST (11:30 AM – 1 PM ET)
• Location: Poster Area
Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "We are honored to be showcasing, via oral presentation, the results of our SL-401 pivotal trial in BPDCN to a European audience via the EHA (Free EHA Whitepaper) Congress. We believe this selection underscores SL-401’s robust clinical data and increased global awareness of BPDCN, a devastating malignancy of high unmet medical need. In the U.S., we remain on track to complete our rolling Biologics License Application (BLA) submission this quarter. In Europe, we anticipate feedback later this year from the European Medicines Agency (EMA) regarding the timing of a potential regulatory filing in the European Union. In addition, we and our investigators continue to report encouraging signs of clinical activity and safety in indications beyond BPDCN, including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), and we look forward to presenting updated data from these indications at the conference."

Following each presentation at the conference, the data presented will be available on Stemline’s website (www.stemline.com) under the Scientific Presentations tab.

About BPDCN
Please visit the BPDCN disease awareness booth (#4125) at ASCO (Free ASCO Whitepaper) 2018 and www.bpdcninfo.com.