On May 21, 2018 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported it has raised USD$300 million in an oversubscribed Series C financing (Press release, Grail, MAY 21, 2018, View Source [SID1234526850]). The financing is led by Ally Bridge Group, co-led by Hillhouse Capital Group and 6 Dimensions Capital, and includes Blue Pool Capital, China Merchant Securities International, CRF Investment, HuangPu River Capital (HPR), ICBC International, Sequoia Capital China, and WuXi NextCODE.

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Since early 2016, GRAIL has raised more than $1.5 billion in three rounds of equity financing to pursue its vision of transforming the way cancer is diagnosed and reducing global cancer mortality. The Series C funding will add to the company’s balance sheet and support ongoing development and validation of products for the early detection of cancer in GRAIL’s clinical research program.

"GRAIL has continued to execute at a rapid pace towards its goal of saving lives through early detection of cancer. We have enrolled more than 73,000 participants in our population-scale clinical studies, CCGA and STRIVE, and are on-track to complete enrollment in both studies this year," said Jennifer Cook, Chief Executive Officer of GRAIL. "We recently reported data supporting the potential for development of a highly specific and sensitive blood test, and are now continuing our development programs to optimize and validate a product for early detection of multiple cancer types."

"We are fortunate to partner with new international investors who share our vision of delivering early detection products to people globally," said Ken Drazan, President of GRAIL. "Many of our new investors have a focus in Asia, which we believe is a natural fit as we plan to grow our capabilities and operations in the region, following the planned launch of our first product for early detection of nasopharyngeal cancer in Hong Kong this year."

"We are very impressed with the scientific, clinical, and software engineering achievements the team at GRAIL has made in just over two years. Our significant investment in GRAIL aligns well with Ally Bridge’s strong focus on investing in some of the world’s most innovative life science technologies and enhancing value-creation across geographies," said Frank Yu, Founder and Chief Executive Officer, Ally Bridge Group.

On May 21, 2018 Verastem, Inc. (NASDAQ: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing drugs to improve the survival and quality of life of cancer patients, reported that Jonathan Pachter, PhD, the Company’s Chief Scientific Officer, will give an oral presentation and moderate a roundtable discussion at the 3rd Annual Advances in Immuno-Oncology Congress being held May 24-25, 2018 in London, UK (Press release, Verastem, MAY 21, 2018, View Source;p=RssLanding&cat=news&id=2350086 [SID1234526826]).

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"The data that will be presented at the Immuno-Oncology Congress demonstrate the unique potential of duvelisib, as a dual inhibitor of PI3K-delta and PI3K-gamma, to enhance the efficacy of immune checkpoint and co-stimulatory antibodies in preclinical models of both hematological malignancies and solid tumors," said Dr. Pachter. "These results support continued research and lend particular importance as we move toward the commercialization of duvelisib, Verastem’s lead candidate an oral, dual inhibitor of PI3K-delta and PI3K-gamma. The duvelisib New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma. I will also give an update on the scientific rationale and clinical progress of our FAK inhibitor defactinib in combination with PD-1 and PD-L1 inhibitors in solid tumors."

Details for the presentation and round table discussion at the Congress are as follows:

Oral Presentation Title: Immunological Effects of Clinical Stage FAK & PI3K-Delta/Gamma Inhibitors
Session: Translational Immuno-Oncology
Date and time: Thursday, May 24, 2018 at 5:40 – 6:10 PM BST

Round Table Discussion Title: Novel Checkpoint Pathways & Strategies for Combined Modality Treatment
Date and time: Friday, May 25, 2018 at 7:30 – 8:00 AM BST

A copy of the oral presentation will be available following the presentation.

About Duvelisib
Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Defactinib
Defactinib is an investigational inhibitor of focal adhesion kinase (FAK), a non-receptor tyrosine kinase that mediates oncogenic signaling in response to cellular adhesion and growth factors.7 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity.8,9 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov.

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.

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

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.