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.

On June 1, 2018 Celgene Corporation (NASDAQ:CELG) and bluebird bio, Inc. (NASDAQ:BLUE) reported updated results from the ongoing CRB-401 phase I clinical study of bb2121, an investigational anti-B-cell maturation antigen (BCMA) CAR T cell therapy, in 43 patients with late-stage relapsed/refractory multiple myeloma (Press release, bluebird bio, JUN 1, 2018, View Source [SID1234527043]). These data were the subject of an oral presentation by Noopur Raje, M.D. at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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"We are encouraged by the continuing deep and durable responses seen in this study and look forward to the results of our pivotal study, KarMMa, which is currently enrolling," said Jay Backstrom, Chief Medical Officer for Celgene. "We continue to see BCMA as an excellent target in multiple myeloma and we believe bb2121 has the potential to have a significant impact on the treatment approach and outcomes for these patients. We and our partners at bluebird bio are fully committed to the continued rapid clinical development of bb2121 and the evaluation of its potential in the treatment of patients with relapsed and refractory multiple myeloma."

"To see a median PFS of 11.8 months in this heavily pretreated patient population is very encouraging," said David Davidson, M.D., Chief Medical Officer, bluebird bio. "As the data from this program continue to mature, bb2121 has set a high bar as the leading investigational anti-BCMA CAR T cell candidate for relapsed and refractory multiple myeloma. In addition, the deep MRD-negative responses, the activity seen across myeloma with high and low levels of BCMA expression, as well as adverse events observed support the evaluation of bb2121 in earlier lines of multiple myeloma, where patients may experience more durable outcomes."

The open-label phase I CRB-401 study (NCT02658929) is evaluating the preliminary safety and efficacy of bb2121 anti-BCMA CAR T cell therapy in patients with relapsed/refractory multiple myeloma.

Patients in the study were heavily pre-treated, with a median of seven prior myeloma treatment regimens (min, max: 3,14) in the dose escalation cohort (n=21) and eight prior regimens (min, max: 3, 23) in the dose expansion cohort (n=22). More than 90% of patients had received prior treatment with two IMiD therapies, two proteasome inhibitors, daratumumab and an autologous stem cell transplant.

As of the March 29, 2018 data cut-off, 43 patients had been enrolled and dosed in either the dose-escalation cohort of the study, at four dose levels (50 x 106, 150 x 106, 450 x 106 and 800 x 106 CAR+ T cells), or in the dose expansion cohort in a dose range between 150-450 x 106 CAR+ T cells.

Patients received a lymphodepleting conditioning regimen of fludarabine and cyclophosphamide, followed by an infusion of bb2121 anti-BCMA CAR T cells. The CAR T cells were produced from each patient’s own blood cells, which were modified using a proprietary lentiviral vector encoding the anti-BCMA CAR.

Responses were dose-related and observed for both low and high BCMA expression levels. In patients treated with 450 x 106 CAR+ T cells whose myeloma cells expressed low levels of BCMA (0 to 50% of cells BCMA positive), 8 of 8 had a response. In those expressing high BCMA (≥50% BCMA positive), 10 of 11 had a response.

The median progression-free survival (PFS) estimate for patients in the dose-escalation phase treated at active doses (≥150 x 106 CAR+ T cells) was 11.8 months (95% CI 8.8, NE), while patients receiving 50 x 106 CAR+ T cells had a median PFS of 2.7 months (95% CI 1.0, 2.9).

In the dose-escalation and expansion phase of the study, all patients who responded and were evaluable for minimal residual disease (MRD as measured by adaptive next-generation sequencing assay) (n=16) were MRD negative at one or more time points. Additionally, two patients who did not have a response and were evaluated for MRD were MRD positive at month one. The median PFS estimate in MRD negative responders was 17.7 months (95% CI: 5.8, NE).

Among all infused patients (n=43), 63% had cytokine release syndrome (CRS), mostly Grade 1 & 2, with 2 patients experiencing Grade 3 CRS (5%). Nine patients (21%) received tocilizumab, including 4 patients (9%) who also received steroids and the median duration of CRS was 6 days (1,32). For patients receiving 150 x 106 CAR+ T cells (n=18), the rate of CRS was 39% with no grade 3 cases. For patients receiving ≥150 x 106 CAR+ T cells (n=22), the rate of CRS was 82% with 9.1% of patients experiencing grade 3 events. Also among all infused patients, there were 14 patients (33%) who experienced neurotoxicity, with one patient experiencing a grade 3 or higher event. Other frequent Grade 3/4 AEs included cytopenias commonly associated with lymphodepleting chemotherapy such as neutropenia (79%), thrombocytopenia (51%) and anemia (44%), as well as infection (any grade) with a frequency of 61% overall and 23% in the first month. Grade 3 or higher infection occurred with a frequency of 21% overall and 5% in the first month.

"The continuing high, durable response rates and MRD-negative results in this heavily pre-treated population of multiple myeloma patients further illustrates BCMA as a promising target in this incurable disease and bb2121 as an investigational therapy of great potential in patients with relapsed and refractory multiple myeloma with both high and low BCMA expression," said Dr. Raje., Professor of Medicine at Harvard Medical School and Director of the Multiple Myeloma Center at Massachusetts General Hospital. "We will continue to evaluate the long-term effect of bb2121 as we learn more about the potential for this investigational therapy."

bb2121 is an investigational compound that is not approved for any use in any country. bb2121 received Breakthrough Therapy Designation from the U.S. FDA and PRIME eligibility from the EMA. Celgene has also sponsored an open-label, single-arm, pivotal, phase 2 study (KarMMa), which is recruiting in North America and Europe, to evaluate bb2121 further in patients with relapsed and refractory multiple myeloma (NCT03361748).