On June 1, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the National Institute for Health and Care Excellence (NICE) will make ZEJULA (niraparib), the first PARP inhibitor shown to be effective in patients with a BRCA mutation as well as those without a BRCA mutation, available to women in England and Wales with recurrent platinum-sensitive ovarian cancer via the Cancer Drugs Fund (CDF)1 (Press release, TESARO, JUN 1, 2018, View Source [SID1234527048]). NICE has recommended ZEJULA via the CDF for women with a BRCA mutation who have received two lines of chemotherapy and in women without a BRCA mutation who have received two or more lines of chemotherapy.

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"At TESARO, we continue to globalize our mission and bring transformative therapies to patients. We are pleased that NICE will now provide more women with recurrent ovarian cancer in England and Wales access to ZEJULA through the CDF," said Orlando Oliveira, Senior Vice President and General Manager, TESARO International. "Through close partnership with both NICE and NHS, TESARO can now offer ZEJULA as an option for second-line maintenance treatment, regardless of a patient’s BRCA status."

The CDF is a source of funding for cancer drugs in England, providing patients access to promising new oncology treatments while NHS England and NICE analyze any additionally requested data to inform a final reimbursement decision on a new treatment or indication. Overall survival data for ZEJULA are not yet available, and as a result NICE has recommended ZEJULA for use within the CDF while further data are collected2. Interim funding is provided via the CDF, giving patients access to the treatment through a managed access arrangement.

"Recurrent ovarian cancer is an aggressive form of cancer where a key goal of treatment is to keep women in remission and off chemotherapy for as long as possible – allowing them the best chance for a good quality of life," said Jonathan Ledermann, Professor of Medical Oncology at the University College London Cancer Institute. "ZEJULA offers the chance to delay this cancer from returning or progressing for months, and possibly years in some cases. It is a significant step forward. Crucially, this decision opens the door for many women who, until now, have not had the option of maintenance treatment with a PARP inhibitor."

About Ovarian Cancer
In the UK, ovarian cancer has the highest mortality rate of all gynecological cancers3. It has one of the highest incidence rates in Europe4 with survival rates among the lowest5. The rate of newly diagnosed cases of ovarian cancer in the UK is 16 per 100,000 of the population compared to the European average of 12.6 per 100,0005. Every year 4,100 women lose their lives to ovarian cancer – 11 women every day6.

The most common symptoms of ovarian cancer include abdominal or pelvic pain, bloating, difficulty eating, and urinary urgency, all of which are commonly associated with less serious conditions. 60% of women with ovarian cancer are diagnosed in an advanced stage7, when prognosis is poor. Although significant progress has been made in treatment of ovarian cancer, the disease recurs in approximately 85% of women with advanced ovarian cancer8, at which point it may be incurable9,10. Recurrent ovarian cancer is the sixth most common cause of cancer death among women and has the highest mortality rate of all gynecological cancers.

About ZEJULA (niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

ZEJULA is approved in Europe as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response (CR) or partial response (PR) to platinum-based chemotherapy. The approval was based on data from the clinically rigorous ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study of ZEJULA that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. ZEJULA is the first once-daily, oral poly (ADP-ribose) polymerase (PARP)1/2 inhibitor to be approved in Europe that does not require BRCA mutation or other biomarker testing.

The primary endpoint of the trial was progression free survival (PFS). Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by a robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients with or without germline BRCA mutations as compared to the control arm. Treatment with ZEJULA reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (hazard ration (HR) 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a PR or a CR.

The approved starting dose of ZEJULA is 300 milligrams once per day. According to the European summary of product characteristics (SmPC), in patients below 58 kilograms, a starting dose of 200 milligrams once per day may be considered. The most commonly administered dose of ZEJULA over the course of the Phase 3 NOVA clinical trial was 200 milligrams once per day, following dose modification. Further exploratory analyses of the NOVA study indicated that individual dose modification maintained efficacy and reduced the rate of new adverse events.11

ZEJULA (niraparib) Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in some clinical studies. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.

On June 1, 2018 Pfizer Inc. (NYSE:PFE) reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for TRAZIMERA, a potential biosimilar to Herceptin (trastuzumab), for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.1 (Press release, Pfizer, JUN 1, 2018, View Source [SID1234527047]).

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"Pfizer is extremely proud to offer expanded biologic treatment options for patients by bringing more affordable, life changing biosimilar medicines to market, and today’s positive recommendation from the CHMP marks one more step forward. TRAZIMERA has the potential to help many patients with HER2 overexpressing cancers across Europe and, if approved, would help address the evolving needs of healthcare systems, physicians, payers and patients, "said Amrit Ray, MD, MBA, Global President, Research & Development, Pfizer Essential Health.

The regulatory submission is supported with a comprehensive data package and totality of evidence demonstrating a high degree of similarity to the originator product. This includes results from the primary REFLECTIONS B327-02 clinical comparative study, which demonstrated clinical equivalence and found no clinically meaningful differences between TRAZIMERA and Herceptin in patients with first line HER2 overexpressing metastatic breast cancer. As part of the REFLECTIONS clinical trial program for the proposed biosimilar trastuzumab, TRAZIMERA has been studied in nearly 500 patients and across more than 20 countries to date.2,3,4

"Many patients with breast and gastric cancers have an HER2 overexpression, which can correlate with poor outcomes and aggressive disease," said Dr. Mark Pegram, associate director for clinical research at the Stanford Comprehensive Cancer Institute, and director of the Breast Oncology Program at the Stanford Women’s Cancer Center.5,6 "With the availability of biosimilars like TRAZIMERA in Europe, oncologists will have additional treatment options to choose from, which potentially helps our patients have greater access to these medicines."

TRAZIMERA is Pfizer’s fourth7,8,9 biosimilar and first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA. Pfizer’s biosimilars pipeline is progressing and consists of 11 distinct Pfizer and legacy Hospira biosimilar molecules in various stages of development.

Working together for a healthier world

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of June 1, 2018. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about TRAZIMERA, Pfizer’s proposed trastuzumab biosimilar, including its potential benefits, that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for TRAZIMERA may be filed in any other jurisdictions; whether and when the European Commission may approve the pending application for TRAZIMERA in the EU and whether and when any such other applications for TRAZIMERA that may be pending (including the application pending with the FDA, for which the company received a complete response letter) or filed may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether TRAZIMERA will be commercially successful; intellectual property and/or litigation implications; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of TRAZIMERA; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

On June 1, 2018 LabCorp (NYSE: LH), a leading global life sciences company, and Unilabs, a leading European provider of clinical laboratory testing and medical diagnostic imaging services, reported a strategic collaboration to provide expanded global development and delivery of companion diagnostics (Press release, LabCorp, JUN 1, 2018, View Source;p=RssLanding&cat=news&id=2352738 [SID1234527046]). This collaboration broadens the network of laboratories used by biopharmaceutical companies to support companion diagnostic development and commercialization. The purpose of the collaboration is to expand access to commercialization channels for companion diagnostics in North America and Europe, and accelerate the adoption of companion diagnostics. The companies will use globally harmonized processes to simplify the technical, regulatory and clinical complexities associated with these critical assays. The companies expect the first application of these processes will be in oncology, particularly immuno-oncology.

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This press release features multimedia. View the full release here: View Source

LabCorp, an established leader in the development and commercialization of companion diagnostics, processes more than 2.5 million patient specimens per week, collected from clinician offices and hospitals and via its own network of nearly 2,000 patient service centers, more than 5,000 in-office phlebotomists and a growing retail presence. Unilabs, a European leader, has more than 230 laboratories in 15 countries and 350 customer service locations, and processes more than 188 million diagnostic tests each year.

The collaboration will initially focus on the commercial availability of assays that have been developed and validated both analytically and clinically by LabCorp and Covance, LabCorp’s drug development business. Terms of the agreement have not been disclosed.

"Companion diagnostics are an essential component of precision medicine, enabling physicians to identify the patients who are most likely to benefit from targeted and novel therapies," said David P. King, LabCorp chairman and CEO. "With this collaboration, we are capitalizing on the scientific and operational strengths of two leaders in companion diagnostics to benefit biopharmaceutical clients who need global solutions for precision medicine, with the ultimate goal of improving health and improving lives for patients around the world."

"Our collaboration with LabCorp addresses the need for global harmonization and combined capabilities, including scientific expertise, operational excellence and timely availability of high-quality companion diagnostic services," said Unilabs CEO, Jos Lamers. "With our extensive laboratory network and geographical footprint, we enable clients to accelerate their precision medicine development and commercialization efforts. Our combined ability to bridge the time gaps between development phase and drug approval, and to national reimbursement, by offering a centralized laboratory testing facility, gives our respective customers the advantage of early adoption of their drug. The intimate knowledge of local testing standards, regulatory and quality requirements and navigating logistical challenges will ensure instant access to high-quality testing. This facilitates embracing of a new test in the clinic thereby removing critical barriers for a new treatment."

On June 1, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported it will present data evaluating certain biomarkers as potential predictors of survival in patients with previously untreated metastatic pancreatic ductal adenocarcinoma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which takes place June 1-5 in Chicago (Press release, Halozyme, JUN 1, 2018, View Source [SID1234527045]). In addition, Halozyme partner Janssen will present five posters of clinical studies involving subcutaneous daratumumab using Halozyme ENHANZE technology.

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"Our goal at Halozyme is to develop new therapies for cancer patients, while minimizing the burden and impact of treatment on their lives," said Helen Torley, president and chief executive officer. "The exploratory plasma biomarker data may support efforts to identify patients who benefit from our investigational drug, PEGPH20, through a simple blood draw rather than a needle biopsy.

"Our ENHANZE technology allows certain drugs to be given subcutaneously in a shorter, simpler injection than when the drug is delivered intravenously, thereby reducing the treatment burden for patients. We are delighted that Janssen will be presenting five posters on their exploration of a subcutaneous version of daratumumab that can be given in 5 minutes or less using our ENHANZE technology."

The Halozyme research of peptide biomarkers measured maturation and degradation of type III collagen, a key component of the extracellular matrix, using baseline plasma samples from patients in Halozyme’s HALO-202 Phase 2 clinical study of PEGPH20 (pegvorhyaluronidase alfa) in combination with ABRAXANE (nab-paclitaxel) and gemcitabine (PAG arm) as compared to ABRAXANE and gemcitabine only (AG arm).

Highlights from the Halozyme biomarker analysis include:

In the Discovery cohort (Stage 1), median progression-free survival (PFS) was 8.0 months in the PAG arm versus 5.3 months in the AG arm for patients whose biomarker scores were equal or above a specific cut-off value. The proportion of this patient population to all subjects tested in Stage 1 is 50 percent.
In the Validation cohort (Stage 2), patients whose biomarker scores were equal to or above the cut-off value derived from the Discovery cohort experienced a median PFS of 8.8 months in the PAG arm versus 3.4 in the AG arm, as well as overall survival of 13.8 months in the PAG arm versus 8.5 months in the AG arm. The proportion of this patient population to all subjects tested in Stage 2 is 47 percent.
PEGPH20 is a proprietary enzyme that targets and degrades hyaluronan (HA), a glycosaminoglycan or naturally occurring sugar in the body. HA accumulates in higher concentrations around many solid tumors, potentially constricting blood vessels, impeding the immune response and the access of other therapies.

Janssen’s daratumumab
Janssen (Janssen Research & Development, LLC) presentations will highlight development of subcutaneous daratumumab using Halozyme ENHANZE technology. Results from the Phase 1b PAVO study of patients with relapsed or refractory multiple myeloma showed daratumumab co-formulated with ENHANZE enabled dosing in 3 to 5 minutes and was well tolerated with low infusion-related reactions.

Additional Updates and Presentations at ASCO (Free ASCO Whitepaper)
In an update on the HALO-101 Lung/Gastric Phase 1b study, Halozyme said that in light of the evolution in the standard of care in first-line non-small-cell lung cancer, it is closing enrollment in the lung cohort in the study. Investigators are being given the option to continue treatment of ongoing patients, and data will be submitted to medical forum later this year.

Halozyme’s ASCO (Free ASCO Whitepaper) abstracts include:

Extracellular matrix (ECM) circulating peptide biomarkers as potential predictors of survival in patients (pts) with untreated pancreatic ductal adenocarcinoma (mPDA) receiving pegvorhyaluronidase alfa (PEPGH20), nab-paclitaxel (A), and gemcitabine (G). Abstract 12030. Monday, June 4, 1:15 to 4:45 p.m. CT.

Tumor hyaluronan (HA) as a novel biomarker to taxane therapy in non-small cell lung cancer (NSCLC). Publication only.

A Pilot study of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma: Interim Safety and Efficacy Analysis. Publication only.

Pegvorhyaluronidase alfa (PEPGH20) enhances FOLFIRINOX efficacy in a preclinical model of human pancreatic ductal adenocarcinoma. Publication only.

Affinity histochemical evaluation of hyaluronan accumulation in solid malignancies of the digestive system. Publication only.

About PEGPH20
PEGPH20 (pegvorhyaluronidase alfa) is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies. In January, Halozyme announced the positive topline results as of December 2016 of its randomized phase 2 HALO-202 study of PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and gemcitabine chemotherapy in metastatic pancreatic cancer. In the study, PEGPH20 met key endpoints, including in the targeted HA-High patient population.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.

On June 1, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that Chief Executive Officer Rachel King will provide a company overview at the Jefferies Annual Health Care Conference in New York, on Thursday, June 7, 2018, at 11:30 a.m. ET (Press release, GlycoMimetics, JUN 1, 2018, View Source [SID1234527044]).

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To access the live webcast and subsequent archived recordings for the presentation, please visit the GlycoMimetics website at www.glycomimetics.com.