On May 15, 2017 Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, reported online a poster previously presented at the National Cancer Research Institute (NCRI) Cancer Conference in Liverpool that showed axalimogene filolisbac achieved durable response in a patient with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) (Press release, Advaxis, MAY 15, 2017, View Source [SID1234519112]).

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Sharad Ghamande, MD, principal investigator and Professor and Director of Gynecologic Oncology at the Georgia Cancer Center at Augusta University, discussed cervical cancer and axalimogene filolisbac in detail recently on the JENNIE Show on the News Channel ABC 6, WJBF in Augusta, GA. Also, one patient in this phase 1 study experienced an ongoing and durable partial response, and this patient was recently featured in the Augusta Chronicle, as she is being treated by Dr. Ghamande at the Georgia Cancer Center at Augusta University. Read the full Augusta Chronicle article here.

Overall, nine patients who had documented disease progression after they had received curative treatments of chemotherapy and/or radiation with or without bevacizumab were enrolled in this phase 1, open-label, dose-determining study. Axalimogene filolisbac was well-tolerated across two dose levels. The study also established a recommended phase 2 dose of 1×1010 CFU and demonstrated antitumor activity at that dose. Axalimogene filolisbac was safely administered at 5 and 10 times the dose levels previously studied, without significant toxicity.

"The best overall tumor response in eight of the nine enrolled patients is encouraging in evaluating the potential of axalimogene filolisbac," said Dr. Ghamande. "We were pleased to see a sustained and durable partial response in one patient, which is very rare for this kind of tumor that is unresponsive to chemotherapy, and survival in these patients is often less than 10 months. In addition, we could safely administer the drug at 5 and 10 times the dose levels previously studied, without any significant toxicity."

There was only one instance of dose-limiting toxicity, with that patient experiencing a grade 3 treatment related adverse event (TRAE) of hypotension at a dose of 5×109 CFU. Across all doses, eight of nine patients experienced a grade 1-2 TRAE, including chills, nausea and hypotension.

The poster on the phase 1 data, "High-dose treatment with ADXS11-001, a Listeria monocytogenes-listeriolysin O (Lm-LLO) immunotherapy, in women with cervical cancer: a phase I, dose-escalation study" (no. 58) is available at www.advaxis.com. The company is preparing to initiate a phase 3 trial in PRmCC later this year.

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This is a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.

On May 15, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its revenues and cash position for the first three months of 2017 (Press release, Innate Pharma, MAY 15, 2017, View Source [SID1234519103]).

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Cash, cash equivalents and financial assets of the Company amounted to €223.8 million* as of March 31, 2017. At the same date, financial liabilities amounted to €5.0 million.

Revenues for the first three months of 2017 amounted to €7.3 million (€5.7 million for the same period in 2016). This revenue results from the co-development and commercialization agreement with AstraZeneca, corresponding to the recognition over the period of the initial payment received in June 2015.

In 2016, revenue for the first three months also resulted mainly from the recognition over the period of the initial payment from the agreement with AstraZeneca.

At the beginning of 2017, Innate Pharma received a USD 15.0 million (€13.8 million) milestone payment from Bristol-Myers Squibb for the continued exploration of lirilumab in combination with Opdivo (nivolumab). This milestone has been recognized as revenue in its entirety in 2016 since the trigger event occurred in 2016.

Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, commented: "During the first quarter of 2017, we were thrilled by the transition by Bristol-Myers Squibb of the combination of lirilumab with nivolumab to a randomized controlled cohort in squamous cell carcinoma of the head and neck, as part of a broad expansion of the trial in solid tumors. We look forward to potential further update at an upcoming scientific conference.

With a clear strategy for growth, encouraging progress across our clinical programs, a strong financial position and several near-to-medium term read-outs on the horizon, we are well placed to deliver shareholder value and

On May 14, 2017 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported results from an analysis of data pooled from three Phase 3 studies evaluating IMBRUVICA (ibrutinib) use in patients with high-risk chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): RESONATETM, RESONATETM-2 and HELIOS (Press release, AbbVie, MAY 14, 2017, View Source [SID1234519102]).

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In this analysis, CLL/SLL patients with genomic abnormalities that typically put them at high risk for poor outcomes achieved higher complete response (CR) rates and overall response rates (ORR), as well as longer progression free survival (PFS) at 24 months and overall survival (OS) at 30 months, when treated with IMBRUVICA versus comparator-treated patients. In RESONATE, patients received IMBRUVICA or ofatumumab; in RESONATE-2, patients received IMBRUVICA or chlorambucil; and in HELIOS, patients received IMBRUVICA plus bendamustine and rituximab (BR) or placebo plus BR. The high-risk genomic abnormalities reviewed were deletion 11q (del 11q), trisomy 12, complex karyotype (CK) and unmutated immunoglobulin heavy-chain variable-region (IGHV). In IMBRUVICA-treated patients, the presence of del 11q was associated with trends of longer PFS and OS than patients without del 11q when treated with IMBRUVICA (abstract #19). These data will be presented today in an oral presentation at the 17th International Workshop on Chronic Lymphocytic Leukemia (iwCLL) biennial meeting in New York, NY.

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

"Over the past few years, we’ve seen tremendous improvements in the treatment of people with CLL and SLL. Newly introduced medications can improve the outcome of therapy, particularly for patients with high-risk prognostic markers who typically do not respond well to standard chemotherapy," said Thomas J. Kipps, M.D., Ph.D., University of California San Diego, Moores Cancer Center and lead investigator of the study.† "Analysis of the clinical data suggests an improvement in outcomes for certain high-risk CLL/SLL patients treated with IMBRUVICA."

CLL is a type of cancer that starts from cells that become certain white blood cells (called lymphocytes) in the bone marrow. The cancer (leukemia) cells start in the bone marrow but then go into the blood. There are approximately 19,000 newly diagnosed CLL patients every year.1 SLL is a slow-growing lymphoma biologically similar to CLL in which too many immature white blood cells cause lymph nodes to become larger than normal.2 CLL/SLL are predominately a disease of the elderly, with a median age of 71 at diagnosis.3 Genomic abnormalities in CLL, including del 11q, deletion 17p (del 17p), trisomy 12, CK and IGHV, are detected in up to 80 percent of patients and play an important role in disease pathogenesis and evolution, determining patient outcomes and therapeutic strategies.6

"We are encouraged by the findings from these analyses, which add to the large body of data supporting IMBRUVICA in treating CLL/SLL patients," said Danelle James, M.D., M.S., Head of Clinical Science, Pharmacyclics LLC, an AbbVie company. "We have one of the most robust databases for a single molecule in hematological oncology and more than 25,000 CLL patients have been treated in the U.S. alone with IMBRUVICA since approval in 2014. We continue to investigate the use of IMBRUVICA in high-risk patients so that ideally they too can achieve better response rates and overall outcomes to treatment."

About the Study

Abstract #19: Outcomes of Ibrutinib-Treated Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL) with High-Risk Prognostic Factors in an Integrated Analysis of 3 Randomized Phase 3 Studies

Oral presentation: Sunday, May 14, 2017, 5:00 PM ET
Data from three studies, RESONATE, RESONATE-2 and HELIOS, were pooled to analyze the outcomes of IMBRUVICA and comparator-treated patients when separated on the basis of genomic abnormality. The ORR in patients treated with IMBRUVICA was 89 percent in unmutated IGHV, 88 percent in del 11q, 86 percent in trisomy 12 and 87 percent in CK, with patients achieving a CR rate of 22 percent in unmutated IGHV, 18 percent in del 11q, 25 percent in trisomy 12 and 10 percent in CK. At 24 months, in patients treated with IMBRUVICA, PFS was 78 percent in unmutated IGHV, 82 percent in del 11q, 77 percent in trisomy 12 and 76 percent in CK. In patients treated with IMBRUVICA, at 30 months, OS was 88 percent in unmutated IGHV, 93 percent in del 11q, 89 percent in trisomy 12 and 84 percent in CK.3

In each subgroup, PFS, OS, ORR and CR rates trended higher in IMBRUVICA-treated patients versus comparator-treated patients, regardless of genomic factors. In IMBRUVICA-treated patients, unmutated IGHV, del 11q, trisomy 12 or CK were generally not associated with shorter PFS or OS, or decreased ORR or CR rate. Further, in IMBRUVICA-treated patients, del 11q was associated with a trend of longer PFS (82 percent at 24 months for those with del 11q, compared with 75 percent for those without del 11q) and OS (93 percent at 30 months for those with del 11q, compared with 86 percent for those without del 11q) and trisomy 12 with increased CR rate (25 percent for those with trisomy 12, compared with 6 percent for those without trisomy 12). In a multivariate analysis, ibrutinib-treated patient outcomes in those only having received one or more prior lines of therapy versus treatment in the first-line was associated with shorter PFS and OS.3

In RESONATE, patients received IMBRUVICA 420 mg once daily until disease progression or ofatumumab for up to 24 weeks. In RESONATE-2, patients age 65 or older with treatment-naïve CLL/SLL, not including del 17p, received IMBRUVICA 420 mg once daily until disease progression, or chlorambucil. In HELIOS, a Janssen-sponsored, randomized, multi-center, double-blind study, previously treated CLL/SLL patients were randomized to receive IMBRUVICA or placebo, once daily continuing until disease progression or unacceptable toxicity with six cycles of BR.3

Adverse events (AEs) were similar in patients with or without genomic factors, and reflect a median treatment exposure of 19-20 months for IMBRUVICA-treated patients and 5-10 months for comparator-treated patients. Discontinuation due to AEs ranged from 8-15 percent in IMBRUVICA-treated patients and 13-17 percent in comparator-treated patients.3

P-values ranged from 0.03-0.96. To view more abstract data, including all P-values, see Table 1 and Table 2 at the end.

About IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.4,5 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.4

IMBRUVICA is FDA-approved in five distinct patient populations: CLL, SLL, WM, along with previously-treated MCL and MZL.4

IMBRUVICA was first approved for patients with MCL who have received at least one prior therapy in November 2013.
Soon after, IMBRUVICA was initially approved in CLL patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
IMBRUVICA was approved for patients with WM in January 2015.
In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for CLL/SLL patients.
In January 2017, IMBRUVICA was approved for patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.
Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.4

IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with approximately 130 ongoing clinical trials. There are total of 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and approximately 100 investigator-sponsored trials and external collaborations that are active around the world. To date, more than 65,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage – Fatal bleeding events have occurred in patients treated with IMBRUVICA. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA.

The mechanism for the bleeding events is not well understood. IMBRUVICA may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and postsurgery depending upon the type of surgery and the risk of bleeding.

Infections – Fatal and nonfatal infections have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have occurred in patients treated with IMBRUVICA. Evaluate patients for fever and infections and treat appropriately.

Cytopenias – Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 13% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, 0% to 13%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA. Monitor complete blood counts monthly.

Atrial Fibrillation – Atrial fibrillation and atrial flutter (range, 6% to 9%) have occurred in patients treated with IMBRUVICA, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines.

Hypertension – Hypertension (range, 6% to 17%) has occurred in patients treated with IMBRUVICA with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new-onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA. Adjust existing antihypertensive medications and/or initiate antihypertensive treatment as appropriate.

Second Primary Malignancies – Other malignancies (range, 3% to 16%) including non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with IMBRUVICA. The most frequent second primary malignancy was non-melanoma skin cancer (range, 2% to 13%).

Tumor Lysis Syndrome – Tumor lysis syndrome has been infrequently reported with IMBRUVICA therapy. Assess the baseline risk (eg, high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity – Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Advise men to avoid fathering a child during the same time period.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia** (61%), thrombocytopenia** (62%), diarrhea (43%), anemia** (41%), musculoskeletal pain (30%), rash (30%), nausea (29%), bruising (30%), fatigue (29%), hemorrhage (22%), and pyrexia (21%).

** Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased).

The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MCL patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin infections (5%).

The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MZL patients were pneumonia (10%), fatigue (6%), diarrhea (5%), rash (5%), and hypertension (5%).

Approximately 6% (CLL/SLL), 14% (MCL), 11% (WM) and 10% (MZL) of patients had a dose reduction due to adverse reactions. Approximately 4%-10% (CLL/SLL), 9% (MCL), and 9% (WM [6%] and MZL [13%]) of patients discontinued due to adverse reactions. Most common adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash, and neutropenia (1% each) in CLL/SLL patients and subdural hematoma (1.8%) in MCL patients. The most common adverse reactions leading to discontinuation were interstitial lung disease, diarrhea, and rash (1.6% each) in WM and MZL patients.

DRUG INTERACTIONS

CYP3A Inhibitors – Avoid coadministration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA dose.

CYP3A Inducers – Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment – Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA dose.

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On May 13, 2017 Dendreon reported findings from a new analysis of its PROCEED registry, which followed men with metastatic castrate-resistant (hormone-refractory) prostate cancer (mCRPC) treated with PROVENGE (sipuleucel-T) in a real-world treatment setting (Press release, Dendreon, MAY 13, 2017, View Source [SID1234519101]). The analysis found that African-American patients demonstrated an additional median OS benefit of 9.3 months compared with Caucasian patients (37.3 months vs 28.0 months, respectively).i Among the group of patients below the median prostate specific antigen (PSA) levels at the time of PROVENGE treatment, African-American patients demonstrated an additional OS benefit of nearly two additional years (20.9 months) compared with Caucasian patients (54.3 months vs. 33.4 months, respectively).i

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"These new PROCEED registry data suggest that patients with asymptomatic or minimally symptomatic mCRPC may benefit the most with early use of PROVENGE and provide a rationale for immunotherapy as an early treatment strategy in sequencing algorithms for mCRPC"
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These compelling results were presented today in an oral podium presentation at the 112th American Urological Association (AUA) Annual Meeting in Boston by lead author A. Oliver Sartor, M.D., the Laborde Professor of Cancer Research in the Departments of Medicine and Urology at Tulane University School of Medicine. PROVENGE is the first and only U.S. Food and Drug Administration (FDA)-approved autologous cellular immunotherapy on the market.

"These new findings are very encouraging given that African-American men with prostate cancer have a mortality rate more than twice as high as Caucasian men and historically have presented with aggressive disease and have had worse outcomes in both real-world settings and controlled clinical trials," said Dr. Sartor. "The fact that we saw an even greater benefit in African-American patients within the lower PSA quartile ranges is also important and provides further evidence that PROVENGE should be used as early as possible within its labeled indication."

The PROCEED registry enrolled more than 1,900 patients with mCRPC who received PROVENGE between 2011 and 2013 in everyday treatment settings.i Of these, approximately 12 percent were African-American.i The analysis presented at the AUA meeting compared OS in a subset of African-American patients (n=210) and Caucasian patients (n=420) matched by baseline PSA.i

The analysis showed that the median OS was significantly greater in the African-American patients than in the Caucasian patients (37.3 months vs 28 months, p<0.001).i African-American patients also had better outcomes than Caucasian patients when OS was assessed based on the median PSA level (26.8 ng/mL) and by PSA quartiles.i Among those with a PSA level below the median, the OS was 54.3 months for African-American patients vs. 33.4 months for Caucasian patients – a difference of 20.9 months (p<0.001).i A multivariate analysis found that African-American race was an independent baseline predictor of improved OS (p<0.001) following treatment with PROVENGE.

The findings from the PROCEED analysis regarding the full population are consistent with an analysis of the Phase 3 IMPACT registration trial of PROVENGE published in Urology in 2013. In that analysis, a lower baseline PSA level was associated with a greater overall survival benefit with PROVENGE. Among patients with a baseline PSA ≤22.1 ng/mL, the median OS was 41.3 months for those treated with PROVENGE vs. 28.3 months for those in the control arm – an improvement of 13 months.ii

"These new PROCEED registry data suggest that patients with asymptomatic or minimally symptomatic mCRPC may benefit the most with early use of PROVENGE and provide a rationale for immunotherapy as an early treatment strategy in sequencing algorithms for mCRPC," said James Caggiano, president of Dendreon. "We are pleased to be able to provide this new clinical data about how metastatic prostate cancer patients respond to and benefit from PROVENGE in everyday clinical practice. It should be useful to urologists and oncologists in supporting treatment decisions for their patients, especially their African-American patients, who typically are more likely to be diagnosed with advanced disease and to have higher mortality."

About Prostate Cancer in African-American Men

Prostate cancer is the most frequently occurring non-cutaneous cancer among men in the United States and is second only to lung cancer among the leading causes of cancer-related deaths.iii

Prostate cancer is also the most commonly diagnosed cancer in African-American men, representing 31 percent of all cancers.iv It is estimated that in 2016, one in six African-American men were diagnosed with prostate cancer – an estimated 29,530 new cases – and one in 23 had a lifetime probability of dying from their disease.v The incidence of prostate cancer is 60 percent higher among African-American than Caucasian men, and the mortality rate is more than twice as high,vi which prostate cancer incidence patterns from population modeling suggest is likely due to a higher incidence of preclinical disease and higher risk of progression to metastatic disease before clinical diagnosis among African-American men compared with the general population.vii Based on this modeling, African-American men are more likely to be diagnosed with prostate cancer at a younger age and a higher stage and to have their disease progress after treatment compared with Caucasian men.vi The lifetime probability of an African-American man dying of prostate cancer is almost double that of a Caucasian man (4.4 percent vs. 2.4 percent).iv

About PROVENGE (sipuleucel-T)

PROVENGE (sipuleucel-T) 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.

For full Prescribing Information, please visit View Source