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Pfizer and the Union for International Cancer Control Award 20 Grants Totaling $760,000 to Address the Needs of Metastatic Breast Cancer Patients Worldwide

On October 13, 2015 Pfizer reported that this Breast Cancer Awareness Month, it and the Union for International Cancer Control (UICC) are proud to announce the recipients from the Seeding Progress and Resources for theCancer Community: Metastatic Breast Cancer Challenge (SPARC MBC Challenge), a first-of-its-kind initiative to address the unique challenges facing women with metastatic breast cancer worldwide (Press release, Pfizer, OCT 13, 2015, View Source [SID:1234507711]). In total, 20 organizations from 18 countries have been selected to receive grants amounting to $760,000 (USD) in funding provided by Pfizer.

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Launched on World Cancer Day in February 2015, the SPARC MBC Challenge received significant interest with over 80 applications submitted by organizations in 46 countries, reflecting the urgent need for improved services and support for women with metastatic breast cancer. Due to this high level of interest, Pfizer increased its funding of the initiative from $500,000 (USD) to $760,000 (USD) to support additional projects.

The SPARC MBC Challenge aims to empower advocacy groups, hospital networks, support groups and other organizations worldwide as they initiate projects to close the gap in information, support, awareness and policy between metastatic breast cancer and early disease, as well as help reduce the number of women diagnosed at the metastatic stage of breast cancer.

"Globally, there are wide disparities in the diagnosis, management and care of metastatic breast cancer, a disease that is clinically complex, emotionally burdensome and socially misunderstood," said Professor Sanchia Aranda, president-elect, UICC. "We are hopeful this program will help us to fulfill our mission of promoting greater equity in access to comprehensive breast cancer services, and we are thrilled with the community’s response to the SPARC MBC Challenge and the number of applications submitted to support projects that can greatly impact the lives of women living with this diagnosis."

Awardees were selected through a competitive application process overseen by an external, multidisciplinary selection committee formed by UICC and chaired by Dr. Fatima Cardoso, director of the Breast Unit of the Champalimaud Cancer Center in Lisbon, Portugal.

Each awardee will receive either a campaign grant ($20,000 USD) or a network grant ($60,000 USD). These grants will be used to fund projects in support of women with metastatic breast cancer worldwide, including projects in low-income countries, such as Uganda and Haiti, where women are frequently diagnosed at a more advanced stage of breast cancer than women in developed nations.1,2

"Our partnership with UICC on this initiative represents our commitment to the hundreds of thousands of women worldwide who are living with metastatic breast cancer," said Liz Barrett, global president and general manager, Pfizer Oncology. "This initiative helps bring us one step closer to the day when metastatic breast cancer patients around the world may have access to the care and support they need, regardless of their location or socio-economic status."

"One particularly valuable component of the SPARC MBC Challenge is that it will also provide mentorship support to the awardees and enable networking and sharing of best practices among the organizations," said Professor Aranda. "We look forward to following the progress and results of all awarded projects that were selected to address the challenges facing the MBC community globally."

Among the awardees is Associação Mama Help, an organization based in Portugal that will be creating an online resource center in the Portuguese language to provide information and support to women living with metastatic breast cancer. Additionally, Uganda Women’s Cancer Support Organisation (UWOCAO), will implement a project in partnership with the Uganda Cancer Institute to identify the challenges faced by women with advanced breast cancer in Uganda and help increase awareness of their unique needs among advocates, caregivers and policymakers. Based on this understanding, the organization will seek to develop new tools, services and policies to address their needs and to ultimately help increase access to supportive care and improve quality of life for women with metastatic breast cancer.

New Study Published in Cell Reports Highlights Indoximod, Demonstrates the Key Role of IDO in Both Local and Systemic Immunosuppression

On October 13, 2015 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer, reported that a peer-reviewed article in Cell Reports offers new insight demonstrating that the tumor indoleamine 2,3-dioxygenase (IDO) pathway is a central regulator of both local and systemic immunosuppression and resistance to immunotherapy in melanoma (Press release, NewLink Genetics, OCT 13, 2015, View Source [SID:1234507710]).

The paper also reports that indoximod, NewLink Genetics’ wholly owned IDO pathway inhibitor, reversed tumor-associated immunosuppression in pre-clinical melanoma models and that there is a "strong rationale" for therapeutic targeting of IDO as one of the central regulators of immune suppression. The paper, titled Tumor-Expressed IDO Recruits and Activates MDSCs in a Treg-Dependent Manner and authored by Rikke B. Holmgaard, Dmitriy Zamarin, Yanyun Li, Billel Gasmi, David H. Munn, James P. Allison, Taha Merghoub, and Jedd D. Wolchok, was published on line and appears today in the October 13, 2015 issue of Cell Reports.

Rikke B. Holmgaard, Ph.D., lead author of the paper and Research Associate, Memorial Sloan Kettering Cancer Center, said, "We learned that IDO mediates local and systemic immune suppression in murine tumor models by means of other immunosuppressive cells, such as MDSCs and Tregs, and by upregulating other immunosuppressive mechanisms mediated by MDSCs, such as arginase 1, iNOS, and immunosuppressive cytokines. In so doing, IDO makes tumors grow faster and become less responsive to immune checkpoint therapy, such as PD1/CTLA4. Thus, adding IDO inhibition may be one of the key elements of combination therapies for strong, durable anti-tumor responses."

Jedd D. Wolchok, M.D., Ph.D., Chief of Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center, Associate Professor of Immunology and Microbial Pathogenesis at Weill Cornell Medical College, and co-author of the article, added, "This data further demonstrate IDO as one of the key immune checkpoint targets and show that indoximod can block the expansion of suppressive myeloid cells and recruitment of MDSCs to the tumor microenvironment that mediate local immune suppression. It prevents activation of Tregs that mediate systemic immune suppression in a mouse model and enhances the antitumor activity of combination anti-CTLA4 and anti-PD1."

David H. Munn, M.D., Professor of Pediatric Hematology and Oncology at Georgia Regents University and co-author of the article in Cell Reports, added, "This research not only sheds additional light on the mechanism of IDO expression in tumors but also shows how indoximod can enhance anti-tumor responses when combined with other checkpoint inhibitors."

"This important work, both in animal studies and in analyses of human melanoma samples, by leading scientists in immuno-oncology validates our view of the central role IDO inhibition and indoximod may play in tumor immunosuppression," said Charles Link, M.D., CEO and Chief Scientific Officer of NewLink Genetics. "It also points to the potential for IDO inhibitors like indoximod to overcome that immunosuppression and enhance anti-tumor responses."

Indoximod is in Phase 2 clinical trials for breast cancer, prostate cancer, melanoma and glioblastoma multiforme as well as in Phase 1b/2 clinical trials for pancreatic cancer.

The authors’ analysis of tumor samples from 36 melanoma patients found that myeloid-derived suppressor cells (MDSCs) were increased in IDO+ tumors. This suggests that IDO recruits and activates such cells through activation of regulatory T cells (Tregs). The authors found greater tumor growth, as well as resistance to immune checkpoint blockade, in the tumors overexpressing IDO. Treatment of the mice bearing tumors overexpressing IDO with the IDO pathway inhibitor indoximod reversed this tumor-associated immunosuppression by decreasing the number of MDSCs and Tregs and stopping their suppressive capability.

Johnson & Johnson Reports 2015 Third-Quarter Results:

On October 13, 2015 Johnson & Johnson (NYSE: JNJ) reported sales of $17.1 billion for the third quarter of 2015, a decrease of 7.4% as compared to the third quarter of 2014 (Press release, Johnson & Johnson, OCT 13, 2015, View Source [SID:1234507708]). Operational sales results increased 0.8% and the negative impact of currency was 8.2%. Domestic sales decreased 0.6%. International sales decreased 13.7%, reflecting operational growth of 2.1% and a negative currency impact of 15.8%. Excluding the net impact of acquisitions, divestitures and hepatitis C sales, on an operational basis, worldwide sales increased 5.6%, domestic sales increased 7.7% and international sales increased 3.8%.* Earlier today, the Company also announced its Board of Directors has approved the repurchase of up to $10 billion of the company’s common stock.

Net earnings and diluted earnings per share for the third quarter of 2015 were $3.4 billion and $1.20, respectively. Third quarter 2015 net earnings included after-tax intangible amortization expense of approximately $0.4 billion and a charge for after-tax special items of approximately $0.4 billion. Third quarter 2014 net earnings included after-tax intangible amortization expense of approximately $0.3 billion and a net gain for after-tax special items of approximately $0.4 billion. A reconciliation of non-GAAP financial measures is included as an accompanying schedule. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.2 billion and adjusted diluted earnings per share were $1.49, representing decreases of 9.4% and 7.5%, respectively, as compared to the same period in 2014.* On an operational basis, adjusted diluted earnings per share increased 1.2%.*

"New and core products drove solid underlying growth for Johnson & Johnson in the quarter," said Alex Gorsky, Chairman and Chief Executive Officer. "Consistent with the plans we’ve laid out for the year, we’re focusing our portfolio and are advancing our innovation agenda to expand our leadership position in key categories while seeking new opportunities for growth. Our dedicated employees are committed to improving healthcare and making a difference in the lives of patients and consumers worldwide."

The Company increased its adjusted earnings guidance for full-year 2015 to $6.15 – $6.20 per share. The Company’s guidance excludes the impact of after-tax intangible amortization expense and special items.

Worldwide Consumer sales of $3.3 billion for the third quarter represented a decrease of 7.7% versus the prior year, consisting of an operational increase of 3.1% and a negative impact from currency of 10.8%. Domestic sales increased 8.9%; international sales decreased 15.7%, which reflected an operational increase of 0.4% and a negative currency impact of 16.1%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 4.0%, domestic sales increased 8.9% and international sales increased 1.5%.*

Positive contributors to Consumer operational results were sales of over-the-counter products including TYLENOL and MOTRIN analgesics and ZYRTEC allergy medications; international feminine protection products; AVEENO and NEUTROGENA skin care products; and LISTERINE oral care products.

During the quarter, the divestiture of the SPLENDA low calorie sweetener brand to Heartland Food Products Group was completed. This completes the divestiture of products within the nutritionals business.

Worldwide Pharmaceutical sales of $7.7 billion for the third quarter represented a decrease of 7.4% versus the prior year with an operational decrease of 0.3% and a negative impact from currency of 7.1%. Domestic sales decreased 4.5%; international sales decreased 11.1%, which reflected an operational increase of 5.5% and a negative currency impact of 16.6%. Excluding the net impact of acquisitions, divestitures and hepatitis C sales, on an operational basis, worldwide sales increased 10.1%, domestic sales increased 11.5% and international sales increased 8.5%.*

Worldwide operational sales growth was driven by new products and the strength of core products. New product sales growth was negatively impacted by lower sales of OLYSIO/SOVRIAD (simeprevir) due to competitive entrants. Strong growth in new products include INVOKANA/INVOKAMET (canagliflozin), for the treatment of adults with type 2 diabetes; IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, or blood cancers; XARELTO (rivaroxaban), an oral anticoagulant; and ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer.

Additional contributors to operational sales growth were SIMPONI/SIMPONI ARIA (golimumab), biologics approved for the treatment of a number of immune-mediated inflammatory diseases; STELARA (ustekinumab), a biologic approved for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis; INVEGA SUSTENNA/XEPLION (paliperidone palmitate), a once-monthly, long-acting, injectable atypical antipsychotic for the treatment of schizophrenia in adults; CONCERTA (methylphenidate HCI), for the treatment of attention deficit hyperactivity disorder; and PREZCOBIX/REZOLSTA (darunavir/cobicistat) for the treatment of human immunodeficiency virus (HIV-1).

During the quarter, the U.S. Food and Drug Administration (FDA) granted Priority Review for the Biologic License Application for daratumumab for the treatment of double refractory multiple myeloma. Additionally, the FDA approved EDURANT (rilpirivine), in combination with other anti-retroviral agents, for treatment-naïve adolescent patients aged 12 to 18 years with human immunodeficiency virus-1 (HIV-1) infection, as well as an update to the SIMPONI ARIA (golimumab for infusion) label to include improvement in both physical and emotional measures of health when treating moderately to severely active rheumatoid arthritis. In the U.S., a supplemental new drug application was submitted to the FDA for IMBRUVICA (ibrutinib) for use in treatment-naïve patients with chronic lymphocytic leukemia. In addition, Marketing Authorization Applications were submitted to the European Medicines Agency for paliperidone palmitate once-every-three-months formulation for the treatment of schizophrenia and daratumumab for the treatment of patients with relapsed and refractory multiple myeloma. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted an accelerated assessment of the daratumumab Marketing Authorization Application.

Worldwide Medical Devices sales of $6.1 billion for the third quarter represented a decrease of 7.3% versus the prior year consisting of an operational increase of 0.9% and a negative currency impact of 8.2%. Domestic sales increased 2.0%; international sales decreased 14.8%, which reflected an operational increase of 0.1% and a negative currency impact of 14.9%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.3%, domestic sales increased 2.0% and international sales increased 0.8%.*

Primary contributors to operational growth were sales of ACUVUE contact lenses in the Vision Care business; endocutters in the Surgical Care business; sales of biosurgicals and international energy products in the Specialty Surgery business; and electrophysiology products in the Cardiovascular Care business.

In October, subsequent to the third quarter, the Company announced the completion of the divestiture of its Cordis business to Cardinal Health for an approximate value of $2 billion.

Incyte and Merck Expand Clinical Collaboration to Include Phase 3 Study Investigating the Combination of Epacadostat with Keytruda® (pembrolizumab) as First-line Treatment for Advanced Melanoma

On October 13, 2015 Incyte Corporation (Nasdaq: INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported the expansion of the companies’ ongoing clinical collaboration to include a Phase 3 study evaluating the combination of epacadostat, Incyte’s investigational selective IDO1 inhibitor, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment for patients with advanced or metastatic melanoma (Press release, Incyte, OCT 13, 2015, View Source;p=RssLanding&cat=news&id=2096400 [SID:1234507707]). The Phase 3 study, which is expected to begin in the first half of 2016, will be co-funded by Incyte and Merck.

This Smart News Release features multimedia. View the full release here: View Source

"We are very pleased to expand our collaboration with Merck and to move the clinical development program for epacadostat in combination with Keytruda into Phase 3," said Hervé Hoppenot, President and Chief Executive Officer of Incyte. "We believe the combination of these two immunotherapies shows promise and, if successfully developed, may help to improve clinical outcomes for patients with metastatic melanoma."

"The initiation of this large Phase 3 study with Incyte in the first-line advanced melanoma treatment setting is an important addition to our robust immunotherapy clinical development program for Keytruda," said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "We continue to explore the benefit that Keytruda brings to patients suffering from advanced melanoma when used alone, and we are pleased to be able to add this important combination study with epacadostat to our Keytruda development program."

Under the terms of the agreement Incyte and Merck have also agreed, for a period of two years, not to initiate new pivotal studies of an IDO1 inhibitor in combination with a PD-1/PD-L1 antagonist as first-line therapy in advanced or metastatic melanoma with any third party. During this time, the companies will each offer the other the opportunity to collaborate on any new pivotal study involving an IDO1 inhibitor in combination with a PD-1/PD-L1 antagonist for types of melanoma and lines of therapy outside of the current collaboration agreement.

The agreement is between Incyte and certain subsidiaries and Merck through its subsidiaries.

Epacadostat and Keytruda are part of a class of cancer treatments known as immunotherapies that are designed to enhance the body’s own defenses in fighting cancer; the two therapies target distinct regulatory components of the immune system. IDO1 is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Preclinical evidence suggests that the combination of these two agents may lead to an enhanced anti-tumor immune response compared with either agent alone.

Safety and efficacy data from the ongoing Phase 1/2 study evaluating the combination of epacadostat with Keytruda in patients with advanced malignancies is scheduled to be highlighted as a late-breaking oral presentation (Abstract #142) at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting & Associated Programs, November 4–8, 2015 at the Gaylord National Resort & Convention Center in National Harbor, MD.

Metastatic Melanoma

Melanoma, the most serious form of skin cancer, strikes adults of all ages and accounts for approximately five percent of all new cases of cancer in the United States each year. The number of new cases of melanoma continues to rise by almost three percent each year which translates to 76,000 new cases yearly in the U.S. alone.1 The 5-year survival rate for late-stage or metastatic disease is 15 percent.2

About Epacadostat (INCB024360)

Indoleamine 2,3-dioxygenase 1 (IDO1) is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. Epacadostat is an orally bioavailable small molecule inhibitor of IDO1 that has nanomolar potency in both biochemical and cellular assays and has demonstrated potent activity in enhancing T lymphocyte, dendritic cell and natural killer cell responses in vitro, with a high degree of selectivity. Epacadostat has shown proof-of-concept clinical data in patients with unresectable or metastatic melanoma in combination with the CTLA-4 inhibitor ipilimumab, and is currently in four proof-of-concept clinical trials with PD-1 and PD-L1 immune checkpoint inhibitors in a variety of cancer histologies.

About Keytruda (pembrolizumab) Injection 100mg In Melanoma

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, Keytruda releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. Keytruda is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for Keytruda in Melanoma Trials

Pneumonitis occurred in 12 (2.9%) of 411 patients, including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving Keytruda. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold Keytruda for Grade 2; permanently discontinue Keytruda for Grade 3 or 4 pneumonitis.

Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients, respectively, receiving Keytruda. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold Keytruda for Grade 2 or 3; permanently discontinue Keytruda for Grade 4 colitis.

Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients, including a Grade 4 case in 1 (0.2%) patient, receiving Keytruda. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue Keytruda.

Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving Keytruda. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold Keytruda for Grade 2; withhold or discontinue for Grade 3; and permanently discontinue Keytruda for Grade 4 hypophysitis.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving Keytruda. Hypothyroidism occurred in 34 (8.3%) of 411 patients, including a Grade 3 case in 1 (0.2%) patient, receiving Keytruda. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer corticosteroids for Grade 3 or greater hyperthyroidism. Withhold Keytruda for Grade 3; permanently discontinue Keytruda for Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.

Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving Keytruda. Monitor patients for hyperglycemia and other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold Keytruda in cases of severe hyperglycemia until metabolic control is achieved.

Nephritis occurred in 3 (0.7%) patients, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold Keytruda for Grade 2; permanently discontinue Keytruda for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. The following clinically significant immune-mediated adverse reactions occurred in patients treated with Keytruda: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, severe dermatitis including bullous pemphigoid, myasthenic syndrome, optic neuritis, and rhabdomyolysis.

For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold Keytruda and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Restart Keytruda if the adverse reaction remains at Grade 1 or less. Permanently discontinue Keytruda for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving Keytruda. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue Keytruda.

Based on its mechanism of action, Keytruda may cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of Keytruda.

Keytruda was discontinued for adverse reactions in 9% of 411 patients. Adverse reactions, reported in at least two patients, that led to discontinuation of Keytruda were: pneumonitis, renal failure, and pain. Serious adverse reactions occurred in 36% of patients. The most frequent serious adverse reactions, reported in 2% or more of patients, were renal failure, dyspnea, pneumonia, and cellulitis.

The most common adverse reactions (reported in at least 20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

No formal pharmacokinetic drug interaction studies have been conducted with Keytruda.

It is not known whether Keytruda is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with Keytruda.

The recommended dose of Keytruda (pembrolizumab) is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with Keytruda. It is not known whether Keytruda is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with Keytruda. Safety and effectiveness of Keytruda have not been established in pediatric patients.

Advaxis’s Cancer Immunotherapies to be Featured in Three Poster Presentations at the 2015 SITC Annual Meeting

On October 13, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported that three abstracts featuring Advaxis’s Lm Technology cancer immunotherapies have been selected for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting & Associated Programs, November 6-8, 2015, at Gaylord National Hotel & Convention Center in National Harbor, Md (Press release, Advaxis, OCT 13, 2015, View Source [SID:1234507706]).

The poster presentations featuring Advaxis immunotherapies at SITC (Free SITC Whitepaper) 2015 include:

Cohen et al., Phase I/II study of ADXS11-001 or MEDI4736 immunotherapies alone and in combination, in patients with recurrent/metastatic cervical or human papillomavirus (HPV)-positive head and neck cancer.

Haas et al., Phase 1-2 study of ADXS31-142 alone and in combination with pembrolizumab in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC): The KEYNOTE-046 trial.

Ghamande et al., High-dose treatment with ADXS11-001, a Listeria monocytogenes (Lm)-listeriolysin O (LLO) immunotherapy, in women with cervical cancer.

The first poster will feature an ongoing Phase 1/2 clinical trial of Advaxis’s lead immunotherapy candidate axalimogene filolisbac (ADXS-HPV) in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), for the treatment of patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

The second poster will feature an ongoing Phase 1/2 clinical trial (KEYNOTE-046) evaluating the combination of ADXS-PSA and Merck’s PD-1 checkpoint inhibitor KEYTRUDA (pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). The KEYNOTE-046 trial is the first-in-human study of ADXS-PSA and the second study initiated to evaluate the use of KEYTRUDA in advanced prostate cancer.

Data from preclinical studies suggest that Advaxis’s Lm Technology immunotherapies in combination with a checkpoint inhibitor, such as durvalumab or KEYTRUDA, may lead to an enhanced anti-tumor immune response. Results from these two studies will determine the future clinical development program for both combinations.

The third poster will include preliminary data from an ongoing Phase 1/2 clinical trial of axalimogene filolisbac at a high dose in patients with recurrent or refractory cervical cancer. Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.

About ADXS-PSA

ADXS-PSA is an Lm Technology immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).