On September 19, 2017 Pfizer Inc. (NYSE:PFE) reported that the U.S. Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney) (Press release, Pfizer, SEP 19, 2017, View Source [SID1234520568]). The role of the Advisory Committee is to provide recommendations to the FDA. The ODAC discussions were based on the supplemental New Drug Application (sNDA) currently under review by the FDA. The FDA decision on whether or not to approve the sNDA is anticipated by January 2018.

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Approximately 75 percent of patients with clear cell RCC are non-metastatic, and 70-80 percent will have a nephrectomy with curative intent, or surgical removal of the tumor.1 High-risk patients represent approximately 15 percent of all patients with primary resected RCC and approximately 60 percent of these high-risk patients will have recurrence and develop metastatic disease within five years.2 The current treatment is surgery followed by observation. This treatment is suboptimal for patients at high risk of recurrence.

"We are encouraged by today’s productive discussion and look forward to working with the FDA over the next few weeks as they incorporate today’s discussion into their review and decision regarding SUTENT in this patient population," said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development. "SUTENT has long been a standard of care for the treatment of advanced RCC and we believe that this potential benefit can be extended into patients with high-risk of RCC recurrence, as demonstrated in the S-TRAC trial."

The sNDA under review by the FDA is based on results from the S-TRAC trial, a randomized double-blind Phase 3 trial of adjuvant SUTENT vs. placebo in 615 patients with locoregional, resected RCC at high risk of recurrence. The study met its primary endpoint of improving disease-free survival (DFS), and the results were published by The New England Journal of Medicine in October 2016.

SUTENT was first approved in the United States in 2006 for the treatment of advanced RCC, where it is the most widely prescribed first-line treatment. Now approved in 119 countries,3 more than 350,000 patients have been treated with SUTENT in its approved indications of advanced RCC, imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST) and advanced pancreatic neuroendocrine tumors (pNET).4 Use of SUTENT is not approved in the adjuvant setting. SUTENT is supported by an extensive body of evidence in scientific literature, including more than 440 publications.

The ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes recommendations to the FDA. Its vote is not binding, but is considered by the FDA in its decision making process.

As a leader in the treatment of advanced RCC, Pfizer is dedicated to meeting the unmet needs of these patients and advancing the science of RCC through research into established and novel compounds. Our near term areas of focus include expanding access of our marketed products, exploration of biomarkers to better personalize therapy and immunotherapy combinations.

About SUTENT (sunitinib malate)

SUTENT is an oral multi-kinase inhibitor that works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Two important SUTENT targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.

SUTENT Important Safety Information

Boxed Warning/Hepatotoxicity: Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. Monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. SUTENT should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution. Do not restart SUTENT if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.

Pregnancy: Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant.

Nursing mothers: Given the potential for serious adverse reactions (ARs) in nursing infants, a decision should be made whether to discontinue nursing or SUTENT.

Cardiovascular events: Cardiovascular events, including heart failure, cardiomyopathy, myocardial ischemia, and myocardial infarction, some of which were fatal, have been reported. Use SUTENT with caution in patients who are at risk for, or who have a history of, these events. Monitor patients for signs and symptoms of congestive heart failure (CHF) and, in the presence of clinical manifestations, discontinuation is recommended. Patients who presented with cardiac events, pulmonary embolism, or cerebrovascular events within the previous 12 months were excluded from clinical studies.

QT interval prolongation and Torsades de Pointes: SUTENT has been shown to prolong QT interval in a dose-dependent manner, which may lead to an increased risk for ventricular arrhythmias including Torsades de Pointes, which has been seen in <0.1% of patients. Monitoring with on-treatment electrocardiograms and electrolytes should be considered.

Hypertension: Hypertension may occur. Monitor blood pressure and treat as needed with standard antihypertensive therapy. In cases of severe hypertension, temporary suspension of SUTENT is recommended until hypertension is controlled.

Reversible posterior leukoencephalopathy syndrome (RPLS): There have been (<1%) reports, some fatal, of subjects presenting with seizures and radiological evidence of RPLS.

Hemorrhagic events: Hemorrhagic events, including tumor-related hemorrhage such as pulmonary hemorrhage, have occurred. Some of these events were fatal. Perform serial complete blood counts (CBCs) and physical examinations.

Tumor lysis syndrome (TLS): Cases of TLS have been reported primarily in patients with high tumor burden. Monitor these patients closely and treat as clinically indicated.

Thrombotic microangiopathy (TMA): TMA, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, sometimes leading to renal failure or a fatal outcome, has been reported in patients who received SUTENT as monotherapy and in combination with bevacizumab. Discontinue SUTENT in patients developing TMA. Reversal of the effects of TMA has been observed after treatment was discontinued.

Proteinuria: Proteinuria and nephrotic syndrome have been reported. Some of these cases have resulted in renal failure and fatal outcomes. Perform baseline and periodic urinalysis during treatment, with follow-up measurement of 24-hour urine protein as clinically indicated. Interrupt SUTENT and dose reduce if 24-hour urine protein is ≥3 g; discontinue SUTENT in cases of nephrotic syndrome or repeat episodes of urine protein ≥3 g despite dose reductions.

Dermatologic toxicities: Severe cutaneous reactions have been reported, including cases of erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), some of which were fatal. If signs or symptoms of EM, SJS, or TEN are present, SUTENT treatment should be discontinued. If a diagnosis of SJS or TEN is suspected, treatment must not be re-started. Necrotizing fasciitis, including fatal cases, has been reported, including of the perineum and secondary to fistula formation. Discontinue SUTENT in patients who develop necrotizing fasciitis.

Thyroid dysfunction: Thyroid dysfunction may occur. Monitor thyroid function in patients with signs and/or symptoms of thyroid dysfunction, including hypothyroidism, hyperthyroidism, and thyroiditis, and treat per standard medical practice.

Hypoglycemia: SUTENT has been associated with symptomatic hypoglycemia, which may result in loss of consciousness or require hospitalization. Reductions in blood glucose levels may be worse in patients with diabetes. Check blood glucose levels regularly during and after discontinuation of SUTENT. Assess whether anti-diabetic drug dosage needs to be adjusted to minimize the risk of hypoglycemia.

Osteonecrosis of the jaw (ONJ): ONJ has been reported. Consider preventive dentistry prior to treatment with SUTENT. If possible, avoid invasive dental procedures, particularly in patients receiving bisphosphonates.

Wound healing: Cases of impaired wound healing have been reported. Temporary interruption of therapy with SUTENT is recommended in patients undergoing major surgical procedures.

Adrenal function: Adrenal hemorrhage was observed in animal studies. Monitor adrenal function in case of stress such as surgery, trauma, or severe infection.

Laboratory tests: CBCs with platelet count and serum chemistries including phosphate should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.

CYP3A4 coadministration: Dose adjustments are recommended when SUTENT is administered with CYP3A4 inhibitors or inducers. During treatment with SUTENT, patients should not drink grapefruit juice, eat grapefruit, or take St John’s Wort.

Most common ARs & most common grade 3/4 ARs (advanced RCC): The most common ARs occurring in ≥20% of patients receiving SUTENT for treatment-naïve metastatic RCC (all grades, vs IFNα) were diarrhea (66% vs 21%), fatigue (62% vs 56%), nausea (58% vs 41%), anorexia (48% vs 42%), altered taste (47% vs 15%), mucositis/stomatitis (47% vs 5%), pain in extremity/limb discomfort (40% vs 30%), vomiting (39% vs 17%), bleeding, all sites (37% vs 10%), hypertension (34% vs 4%), dyspepsia (34% vs 4%), arthralgia (30% vs 19%), abdominal pain (30% vs 12%), rash (29% vs 11%), hand-foot syndrome (29% vs 1%), back pain (28% vs 14%), cough (27% vs 14%), asthenia (26% vs 22%), dyspnea (26% vs 20%), skin discoloration/yellow skin (25% vs 0%), peripheral edema (24% vs 5%), headache (23% vs 19%), constipation (23% vs 14%), dry skin (23% vs 7%), fever (22% vs 37%), and hair color changes (20% vs <1%).

The most common grade 3/4 ARs (occurring in ≥5% of patients with RCC receiving SUTENT vs IFNα) were fatigue (15% vs 15%), hypertension (13% vs <1%), asthenia (11% vs 6%), diarrhea (10% vs <1%), hand-foot syndrome (8% vs 0%), dyspnea (6% vs 4%), nausea (6% vs 2%), back pain (5% vs 2%), pain in extremity/limb discomfort (5% vs 2%), vomiting (5% vs 1%), and abdominal pain (5% vs 1%).

Most common grade 3/4 lab abnormalities (advanced RCC): The most common grade 3/4 lab abnormalities (occurring in ≥5% of patients with RCC receiving SUTENT vs IFNα) included lymphocytes (18% vs 26%), lipase (18% vs 8%), neutrophils (17% vs 9%), uric acid (14% vs 8%), platelets (9% vs 1%), hemoglobin (8% vs 5%), sodium decreased (8% vs 4%), leukocytes (8% vs 2%), glucose increased (6% vs 6%), phosphorus (6% vs 6%), and amylase (6% vs 3%).

Most common ARs & most common grade 3/4 ARs (imatinib-resistant or -intolerant GIST): The most common ARs occurring in ≥20% of patients with GIST and more commonly with SUTENT than placebo (all grades, vs placebo) were diarrhea (40% vs 27%), anorexia (33% vs 29%), skin discoloration (30% vs 23%), mucositis/stomatitis (29% vs 18%), asthenia (22% vs 11%), altered taste (21% vs 12%), and constipation (20% vs 14%). The most common grade 3/4 ARs (occurring in ≥4% of patients with GIST receiving SUTENT vs placebo) were asthenia (5% vs 3%), hand-foot syndrome (4% vs 3%), diarrhea (4% vs 0%), and hypertension (4% vs 0%).

Most common grade 3/4 lab abnormalities (imatinib-resistant or -intolerant GIST): The most common grade 3/4 lab abnormalities (occurring in ≥5% of patients with GIST receiving SUTENT vs placebo) included lipase (10% vs 7%), neutrophils (10% vs 0%), amylase (5% vs 3%), and platelets (5% vs 0%).

Most common ARs & most common grade 3/4 ARs (advanced pNET): The most common ARs occurring in ≥20% of patients with advanced pNET and more commonly with SUTENT than placebo (all grades, vs placebo) were diarrhea (59% vs 39%), stomatitis/oral syndromes (48% vs 18%), nausea (45% vs 29%), abdominal pain (39% vs 34%), vomiting (34% vs 31%), asthenia (34% vs 27%), fatigue (33% vs 27%), hair color changes (29% vs 1%), hypertension (27% vs 5%), hand-foot syndrome (23% vs 2%), bleeding events (22% vs 10%), epistaxis (21% vs 5%), and dysgeusia (21% vs 5%). The most commonly reported grade 3/4 ARs (occurring in ≥5% of patients with advanced pNET receiving SUTENT vs placebo) were hypertension (10% vs 1%), hand-foot syndrome (6% vs 0%), stomatitis/oral syndromes (6% vs 0%), abdominal pain (5% vs 10%), fatigue (5% vs 9%), asthenia (5% vs 4%), and diarrhea (5% vs 2%).

Most common grade 3/4 lab abnormalities (advanced pNET): The most common grade 3/4 lab abnormalities (occurring in ≥5% of patients with advanced pNET receiving SUTENT vs placebo) included decreased neutrophils (16% vs 0%), increased glucose (12% vs 18%), increased alkaline phosphatase (10% vs 11%), decreased phosphorus (7% vs 5%), decreased lymphocytes (7% vs 4%), increased creatinine (5% vs 5%), increased lipase (5% vs 4%), increased AST (5% vs 3%), and decreased platelets (5% vs 0%).

Please see full Prescribing Information, including BOXED WARNING and Medication Guide, for SUTENT (sunitinib malate) at www.SUTENT.com.

On September 19, 2017 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported that the European Commission has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy (Press release, Ipsen, SEP 19, 2017, View Source [SID1234520567]). This approval allows for the marketing of Xermelo (telotristat ethyl) in the above indication in all 28 member states of the European Union, Norway and Iceland.

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David Meek, Chief Executive Officer, Ipsen stated: "We are delighted to provide patients suffering from inadequately controlled carcinoid syndrome with a new treatment option in combination with a somatostatin analogue that demonstrates both efficacy and safety in particularly improving diarrhea, a most debilitating symptom. Xermelo complements our strategy for neuroendocrine tumors aiming to deliver clinical benefits along every step of the patient treatment journey."

"As a physician involved in the management of patients living with carcinoid syndrome, I am encouraged by the European approval of Xermelo as a new therapeutic option for this difficult-to-treat condition" said Professor Dieter Hörsch MD PhD, ENETS Center of Excellence for Neuroendocrine Tumors in Bad Berka, Germany. He added: "Thanks to our experience with Xermelo in clinical trials we observed profound improvement of quality of life and well-being of our patients. The positive safety and efficacy data prompted its rapid integration in clinical practice guidelines."

According to Teodora Kolarova, Executive Director of the International Neuroendocrine Cancer Alliance (INCA)[1] "The severe and unpredictable diarrhea associated with carcinoid syndrome has significant negative impact on patients’ lives. The majority of patients affected by this condition see it interfere severely with their physical and emotional health, social role and lifestyle. Access to new treatments, more information and support is warranted."

The approval is based on the results of two randomized Phase 3 trials, TELESTAR and TELECAST.

About the TELESTAR Phase 3 Pivotal Trial

The efficacy and safety of telotristat ethyl 250 mg taken tid were established in a 12-week double-blind, placebo-controlled, randomised, multicentre phase 3 trial. The study included a 36-week open-label extension period during which all patients were treated with a higher dose of telotristat ethyl. A total of 135 patients were recruited in 12 countries (AU, BE, CA, FR, DE, IL, IT, NL, ES, SE, UK, USA). The mean age was 64 years (range 37 to 88 years) and 52% were male. All patients had well-differentiated metastatic neuroendocrine tumours with documented history of carcinoid syndrome, and were treated with stable-dose SSAs for ≥ 3 months before enrolment. Patients had an average of four or more bowel movements (BM) per day: at baseline, mean daily BM frequency averaged over the baseline period were 5.2 and 6.1 counts/day in the placebo and telotristat ethyl 250 mg groups, respectively. The study included a 12-week double-blind treatment (DBT) period, in which patients initially received placebo (n=45) or telotristat ethyl 250 mg (n=45) or a higher dose (telotristat ethyl 500 mg; n=45) three times daily. During the study, patients were allowed to use rescue medication (short-acting SSA therapy) and anti-diarrheals for symptomatic relief but were required to be on stable-dose of long-acting SSA therapy for the duration of the double-blind period.

The primary endpoint was the mean change from baseline in daily BM frequency averaged over the 12-week double blind period. Estimated difference in BM frequency per day versus placebo averaged over 12 weeks was -0.81 for telotristat ethyl 250mg (p<0.001).

A substantially greater proportion of patients on telotristat ethyl 250 mg tid achieved a durable response, defined as at least a 30 percent reduction in daily bowel movements over at least half the days of the 12-week DBT period: 44 percent on telotristat ethyl, as compared to 20 percent on placebo (p<0.040). When the full effect of telotristat ethyl is observed (during the last 6 weeks of the DBT period) the proportion of responders with at least 30% BM reduction was 51% (23/45) in the 250 mg group versus 22% (10/45) in the placebo group (post-hoc analysis).

Telotristat ethyl significantly reduced the percent change from baseline in urinary 5-hydroxyindole acetic acid (u-5HIAA) versus placebo at week 12 (p< 0.001).

About the TELECAST Phase 3 Trial

The Phase 3 TELECAST study was designed similarly to TELESTAR study as a companion to this pivotal Phase 3 study to provide additional efficacy and safety information in patients with carcinoid syndrome.

A total of 76 patients were evaluated for efficacy. The mean age was 63 years (range 35 to 84 years) and 55% were male. All patients had well-differentiated metastatic neuroendocrine tumour with carcinoid syndrome. Most patients (92.1%) had fewer than 4 BM per day and all except 9 were treated by SSA therapy.

The primary endpoints were the percent change from Baseline in u5-HIAA at Week 12 and incidence of treatment emergent adverse events (TEAEs). The mean u5-HIAA excretion at baseline was 69.1 mg/24hours in the telotristat ethyl 250 mg tid group (n=17) and 84.8 mg/24hours in the placebo group (n=22). The percent change from baseline in u5-HIAA excretion at week 12 was +97.7% in the placebo group versus -33.2% in the telotristat ethyl 250 mg tid group.

Notably, 40% of patients in the telotristat ethyl 250 mg tid treatment arm achieved a ≥30% reduction in BM frequency for at least 50% of the days in the double-blind treatment period, while there were no responders in the placebo arm (p=0.001).

Safety information about Xermelo in TELESTAR AND TELECAST clinical trials

In clinical trials, over 230 patients with carcinoid syndrome were treated with Xermelo. The placebo-controlled safety analyses were focused on the integrated data from the 12-week placebo-controlled double-blind periods from the two phase 3 randomized clinical trials. For this safety analysis, 71 patients received placebo and 70 patients received Xermelo 250 mg three times daily. The most commonly reported adverse reactions in patients treated with telotristat ethyl were abdominal pain (26%), gamma-glutamyl transferase increased (11%) and fatigue (10%). They were generally of mild or moderate intensity. The most frequently reported adverse reaction leading to discontinuation of telotristat ethyl was abdominal pain in 7.1% of patients (5/70).

About carcinoid syndrome (CS)

Well-differentiated neuroendocrine tumor (NET) is a relatively rare tumor type that arises from cells of the neuroendocrine system. Carcinoid syndrome (CS) occurs when well-differentiated NETs secrete large amounts of serotonin and other vasoactive products into the systemic circulation. Classically, symptoms associated with CS include cutaneous flushing, diarrhea, wheezing, abdominal pain, and in the long-term, valvular heart disease.

Somatostatin analogues (SSA) are the cornerstone of therapy for the relief of CS and tumor control. SSA inhibit the release of serotonin by NETs and have become first-line therapy for CS.

Due to the severe morbidity of CS and the lack of established treatment options, the population of patients with CS needing further control in addition to their SSA therapy is one with a high unmet medical need.

ABOUT XERMELO (TELOTRISTAT ETHYL)

Xermelo is a novel, orally administered, inhibitor of the enzyme tryptophan hydroxylase (TPH). Through inhibition of TPH, the rate-limiting step in the synthesis of serotonin, Xermelo was designed to reduce the production of serotonin within neuroendocrine tumors.

On 22 October 2014, Ipsen and Lexicon announced that they had entered into an exclusive licensing agreement for Ipsen to commercialize Xermelo (telotristat ethyl) in all territories excluding the United States and Japan, where Lexicon retains the rights. On 28 February 2017, Lexicon received U.S. Food and Drug Administration (FDA) approval for Xermelo as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

On 20 July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xermelo, intended for the treatment of carcinoid syndrome diarrhoea in combination with a somatostatin analogue.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the European Medicines Agency website and made available in all official European Union languages.

For all common and uncommon adverse reactions, please refer to full SmPC. For more information, see the regularly updated registered product information on the European Medicine Agency website: www.ema.europa.eu

On September 19, 2017 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the results of a single institution study were presented at the Cardiology and Interventional Radiology of Europe (CIRSE) annual meeting, held in Copenhagen, Denmark on September 16-20, 2017 (Press release, Delcath Systems, SEP 19, 2017, View Source [SID1234520566]).

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The study, Prospective Clinical and Pharmacological Evaluation of the Delcath System’s Second Generation (GEN2) Hemofiltration System in Patients Undergoing Percutaneous Hepatic Perfusion (PHP) with Melphalan, was conducted by a team at the Leiden University Medical Center (LUMC) in Leiden, The Netherlands and presented by T.S. Meijer, MD. The study prospectively evaluated filtration efficiency and hematologic side effects in seven patients who received a total of ten PHP procedures with the GEN2 CHEMOSAT system. Pharmacokinetic sampling was conducted at several points during the PHP procedure, and filtration efficiency was calculated at several discrete points. Blood tests were conducted following each procedure to determine hematologic side effect Grade Levels until the blood values normalized.

Results of the study showed the GEN2 CHEMOSAT system had an overall efficiency of 86%, with efficiency highest at the time of highest concentration of melphalan in the blood and declining as melphalan blood concentration declined. Peak efficiency was 95.4% in samples taken after 10 minutes of filtration, 85.9% at the end of the drug infusion period, and 77.5% at the end of the saline washout period. Researchers noted these results were superior to and more consistent than prior experience published with the first generation CHEMOSAT system. Hematologic side effects were mainly Grade 1 and 2 with some Grade 3 and 4 side effects emerging post-procedure, including 40% of treatment cycles showing Grade 4 thrombocytopenia, 80% showing Grade 3 or 4 leucopenia, and 70% showing lymphocytopenia. All patients were asymptomatic and all lab results normalized in three weeks. Other adverse events were managed, and there was no mortality, no severe bleeding complications, and no hypotensive cardiac or cerebral events. Researchers concluded that the GEN2 CHEMOSAT system appears to have higher melphalan filter efficiency, more consistent performance, and appears safe but needs further validation.

Commenting on the study, Dr. Jennifer K. Simpson, President & CEO of Delcath Systems, said, "This study provides good external confirmation of the filtration efficiency capability and consistent performance seen with the GEN2 CHEMOSAT, and is consistent with what we are seeing in the commercial setting. This study also indicates that the hematologic side effects of treatment with CHEMOAT are manageable. We look forward to validating these observations in our registration trials, which include robust evaluation of the pharmacokinetic characteristics of the PHP procedure."

On September 19, 2017 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported two abstracts were selected for presentation at the 32nd annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting (Press release, Advaxis, SEP 19, 2017, View Source [SID1234520564]). The conference is renowned for its scientific exchange, education and mission to improve patient outcomes through advancement of science and the cancer immunotherapy field.

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Both poster presentations feature Advaxis’ proprietary Listeria monocytogenes (Lm)-based technology. The first presentation, "ADXS-PSA immunotherapy increases the magnitude and quality of prostate cancer antigen-specific T cell responses in patients with metastatic castration-resistant prostate cancer," will feature data from Advaxis’ clinical trial with ADXS-PSA. The presentation examines the frequency and functionality of the T cell response not only specific to its target antigen, but to other prostate cancer antigens.

This data builds on what was presented at CICON 2017 and is the first time that an Lm-based vector targeting a self protein – PSA – can increase the frequency and functionality of T cells reactive to PSA as well as to other prostate cancer antigens. As one of Advaxis’ four focus franchises, prostate cancer could be a significant value creator to expand the Lm platform into new tumor types. The data will be presented by Sandy Hayes, Ph.D., senior director of research and biomarker lead at Advaxis.

The second poster presentation, "Listeria monocytogenes-based immunotherapies alter the suppressive phenotype of intratumoral regulatory T cells," spotlights preclinical data pointing to a potential key mechanism for inducing and sustaining infiltration of tumor-specific T cell effectors. The data will be presented by Rachelle E. Kosoff, Ph.D., senior scientist of research at Advaxis.

"We’re grateful to be sharing these meaningful findings with the rest of the immunotherapy community," said Dr. Robert Petit, chief scientific officer at Advaxis. "Each poster presentation allows members of our field to discuss new findings and approaches, with the goal of bringing improved treatment options to patients."

SITC takes place at Maryland’s National Harbor in the Gaylord National Hotel and Convention Center from Nov. 8 – 12, 2017. The conference focuses on improving outcomes for current and future patients with cancer by incorporating strategies based on basic and applied immunotherapy.

To learn more about Advaxis and its immunotherapy clinical programs, visit www.advaxis.com/clinical-trials.