On October 24, 2017 Molecular Templates, Inc., (Nasdaq:MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), reported the dosing of the first patient in a Phase 1 expansion study of MT-3724, a first-generation ETB that targets the CD20 cell surface antigen present in a variety of lymphomas and leukemias (Press release, Molecular Templates, OCT 24, 2017, View Source [SID1234521123]). Strong evidence of anti-tumor activity in heavily pre-treated patients has been observed in Part 1 of the study.

“MT-3724 has shown activity in heavily pre-treated DLBCL patients with a median of greater than four prior therapies in the dose escalation portion of this study,” said Eric E. Poma, Ph.D., Chief Executive and Chief Scientific Officer of Molecular Templates. “We are pleased to begin dosing patients in the expansion cohort, which is designed to further characterize the efficacy and response rates in these difficult to treat patients.”
The Phase 1 study is a two-part study in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma or relapsed/refractory B-cell CLL. In Part 1, patients were treated with MT-3724 given as intravenous (IV) infusions at doses ranging from 5 mcg/kg up to 100 mcg/kg. The primary outcome measures are safety and tolerability, while secondary endpoints are pharmacokinetics (PK), pharmacodynamics (PD) and tumor response. The MTD was identified as 75 mcg/kg and this was supported by a dose-dependent clearance of CD20+ peripheral B cells, which is an acknowledged surrogate marker of efficacy.

Establishment of the MTD has triggered initiation of Part 2 of the study, in which relapsed or refractory DLBCL patients without high serum levels of Rituxan will be treated with MT-3724 as a monotherapy at the MTD dose. The study has been designed to enroll up to 40 patients in total.

Part 2 of the study is being conducted at multiple centers across the United States including Memorial Sloan-Kettering Cancer Center in New York City, the MD Anderson Cancer Center in Houston, Texas, and the University of Arizona in Tucson, Arizona with data expected in the first half of 2018. Molecular Templates anticipates initiating a phase II monotherapy study in relapsed and refractory DLBCL patients in 2018 that could be pivotal in nature. The first patient was dosed at the University of Arizona. Additional information on the study, including inclusion/exclusion criteria, can be found at www.clinicaltrials.gov (NCT Identifier: NCT02715843).

About MT-3724
MT-3724, Molecular Templates’ lead drug candidate, is an immunotoxin that targets the CD20 cell surface antigen present in a variety of lymphomas and leukemias. CD20 is a non-internalizing receptor and MT-3724 is the first immunotoxin to induce internalization and destruction of CD20 positive cells to enter the clinic. MT-3724 is currently being investigated in a Phase 1 clinical trial in heavily pre-treated Diffuse Large B-cell Lymphoma (DLBCL) patients. More information is available at clinicaltrials.gov.

On October 24, 2017 Varian (NYSE: VAR) reported five patients with brain cancer became the first patients in the US to be treated using the company’s HyperArc High Definition Radiotherapy (HDRT), a new type of radiosurgery treatment, at the University of Alabama at Birmingham Comprehensive Cancer Center (Press release, InfiMed, OCT 24, 2017, View Source [SID1234521122]). HyperArc is designed to automate and simplify sophisticated treatments such as stereotactic radiosurgery (SRS) and make them available to more cancer patients around the world.

“We have been doing preclinical and clinical development of single isocenter radiosurgery for a decade,” said John Fiveash, M.D., professor and vice chair for academic programs in the UAB Department of Radiation Oncology. “Over the last five years, our radiosurgery plan quality has improved to equal or exceed our Gamma Knife. Physicians and patients preferred the frameless and highly efficient delivery on our TrueBeam and Edge systems and our Gamma Knife was decommissioned June 2017. HyperArc planning automates much of the radiosurgery treatment planning strategies that we have implemented at UAB and could enable more clinics to perform higher quality radiosurgery for more patients.”

“Working closely with leading institutions like UAB played an important role in the development of HyperArc,” said Kolleen Kennedy, president of Varian’s Oncology Systems business. “We value their continued contributions to the advancement of cancer care and we are excited that HyperArc treatments have now begun in the US.”

HyperArc capitalizes on the unique capabilities of Varian’s TrueBeam and EDGE treatment systems. HyperArc treatments allow clinicians the ability to deliver more compact radiation doses that closely conform to the size, shape, and location of tumors while sparing more surrounding healthy tissue. These advanced treatments can be delivered in a conventional treatment time slot. The treatment planning for HyperArc is supported by Varian’s Eclipse treatment planning software.

For more information on HyperArc, visit www.varian.com/hyperarc

On October 24, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the initiation of a multi-arm clinical trial evaluating PEGPH20, Halozyme’s investigational new drug, in combination with atezolizumab (TECENTRIQ), an anti-PDL1 cancer immunotherapy from Genentech, a member of the Roche Group (Press release, Halozyme, OCT 24, 2017, View Source [SID1234521121]). The combination will be tested in patients with previously treated, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancer.

The study is sponsored by and funded by Genentech as part of a clinical collaboration agreement announced last year to evaluate PEGPH20 and atezolizumab in up to eight tumor types. Genentech initiated the first study in July to evaluate the combination in patients with previously treated metastatic pancreatic ductal adenocarcinoma.

The gastric cancer study is a Phase 1b/2, open-label, multicenter, randomized clinical trial designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations compared with the standard chemotherapy regimens. It will enroll an all-comer population regardless of hyaluronan (HA) level. The overall analysis plan includes a retrospective analysis of the HA-high population identified using the Ventana HA companion diagnostic assay.

HA is a glycosaminoglycan, or chain of natural sugars in the body that can accumulate around cancer cells creating high pressure in a tumor, constricting blood flow and thereby reducing access of chemotherapy and immunotherapeutic agents. PEGPH20 is an enzyme that temporarily degrades HA, reducing tumor pressure and potentially increasing blood flow, allowing greater access for chemotherapies and immunotherapies to treat the tumor.

The study will be conducted in the U.S., as well as countries outside the U.S.

The collaboration between Halozyme and Genentech includes testing the experimental combination in MORPHEUS, Roche’s Novel Cancer Immunotherapy Development Platform. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently.

“PEGPH20 is currently under evaluation in six indications with potential across a range of difficult to treat solid tumors,” said Dr. Helen Torley, president and chief executive officer. “Our hope is to advance new treatment options for patients with each ongoing study.”

About PEGPH20 (pegvorhyaluronidase alfa)
PEGPH20 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.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track designation 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 October 24, 2017 Amgen (NASDAQ:AMGN) reported the launch of At Home with Joan, a campaign led by breast cancer survivor and advocate Joan Lunden (Press release, Amgen, OCT 24, 2017, View Source [SID1234521118]). This campaign aims to empower patients diagnosed with cancer to be active participants in their treatment plan in order to understand and navigate the risks associated with strong chemotherapy, including infection as manifested by febrile neutropenia, or a low blood cell count with fever.1

Motivated by her own cancer battle and passion for sharing valuable health information with the public, the iconic journalist traveled the country to get up close and personal with four breast cancer survivors also treated with strong chemotherapy. Together, they share their stories in order to inspire others to be an advocate and play an active role on their healthcare team. In the At Home with Joan campaign, Lunden reinforces the number one piece of advice she wished she knew before her diagnosis: that you are your own best advocate.

More than 1.6 million Americans will be diagnosed with cancer this year and among those that develop febrile neutropenia, more than 80 percent require hospitalization.2,3 According to the National Cancer Institute, patient-clinician communication plays an important role in optimizing health outcomes for patients with cancer.4

The cornerstone of the campaign is a series of videos, available at www.AtHomeWithJoan.com, which feature one-on-one, intimate conversations at home between Lunden and breast cancer survivors discussing topics such as:

The importance of educating yourself about your treatment options and having open dialogue with your doctor
Why a strong support network and partnering with your healthcare team is critical
Staying positive and maintaining a sense of control throughout the experience
Patient experiences with treatment to reduce the risk of infection associated with strong chemotherapy
“While I’ve been on thousands of assignments throughout my career, I feel that perhaps my most important one is my current mission to educate and empower others to better understand their cancer and treatment options available so that they can play an active role in their care,” said Lunden. “With so much information out there and critical decisions to make, it’s normal to feel overwhelmed. By sharing our stories, we can learn from each other. It is my hope that these heartfelt conversations with courageous, inspiring survivors will provide candid perspectives and tips on how to advocate for yourself and ask the right questions early on.”

At Home with Joan also features conversations between Lunden and Edward George, M.D., medical oncologist, and Tina Pryor, RN, oncology nurse, which focus on what to expect from treatment with strong chemotherapy, tips for doctors’ appointments including what questions to ask, what to wear to treatments, coping with hair loss and ways to reduce the frequency of clinic visits by helping to protect yourself from infection right from home.

Like Lunden and the At Home with Joan participants, many newly diagnosed cancer patients will undergo strong chemotherapy and may be unaware of the potential risks associated with this type of treatment, including infection, as manifested by febrile neutropenia, and the important questions to ask their care team.

“While strong chemotherapy targets tumor cells that are rapidly dividing, what many patients don’t realize is it can also affect other cells, including blood cells,” said Dr. George. “As an oncologist, a reduction of white blood cell count is one of my biggest concerns because it can leave patients susceptible to infection and hospitalization. This is a serious topic that patients need to be aware of so they can speak to their doctor about treatment options to help prevent it.”

“My hope as an oncology nurse is that each patient’s healthcare team has discussed treatment options that help reduce the risk of infection, including Neulasta (pegfilgrastim) Onpro, which is applied the same day as a patient’s chemotherapy appointment, so they can spend more time at home with their families,” said Pryor. “These patients want to get back to their normal life and recover in the comfort of their own home. As a member of their support team, I want patients to know there are treatment options to help bring back that normalcy and comfort that frequent clinic and hospital visits interrupt.”

To view the eight-part video series and learn more about upcoming community events featuring Lunden, fellow survivors and cancer experts, visit www.AtHomeWithJoan.com. Additional resources include a printable Doctor Discussion guide for patients to bring to their appointments with important questions to ask about treatment.

About Joan Lunden
As the longest running female host ever on early morning television, Joan Lunden was the co-host of Good Morning America for nearly two decades. Lunden is an award-winning journalist, bestselling author, health and wellness advocate, international speaker, and a mom of seven children. After being diagnosed with breast cancer in June of 2014, Lunden made it her mission to educate and inspire others about breast cancer prevention, treatment, and survival. Lunden speaks all over the country about her breast cancer journey, health & wellness, inspiration, and success.

About Neulasta (pegfilgrastim)
Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. In a pivotal clinical trial, in patients with nonmyeloid malignancies undergoing myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia, treatment with Neulasta was shown to significantly reduce the incidence of febrile neutropenia.

Neulasta is administered by manual injection and is also available via the Neulasta Onpro kit, which was approved by the U.S. Food and Drug Administration in 2014 and includes a specially designed, single-use prefilled syringe co-packaged with an on-body injector for Neulasta.

For more information about Neulasta, visit www.Neulasta.com and www.NeulastaHCP.com.

Important Safety Information Regarding Neulasta
Contraindication
Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Splenic Rupture
Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta for ARDS. Discontinue Neulasta in patients with ARDS.

Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions.

Allergies to Acrylics
The on-body injector for Neulasta uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

Use in Patients with Sickle Cell Disorders
Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

Glomerulonephritis
Glomerulonephritis has been reported in patients receiving Neulasta. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after withdrawal of Neulasta. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose‐reduction or interruption of Neulasta.

Leukocytosis
White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim. Monitoring of CBCs during pegfilgrastim therapy is recommended.

Capillary Leak Syndrome
Capillary leak syndrome has been reported after granulocyte colony‐stimulating factor (G‐CSF) administration, including Neulasta, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life‐threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells
The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded. The most common adverse reactions (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.

Please see additional Neulasta Safety Information, by visiting www.amgen.com/medpro/products.html.

Please see the Neulasta Full Prescribing Information by clicking here

On October 24, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it has submitted BRACAnalysis CDx in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by Ministry of Health, Labor and Welfare as a companion diagnostic to olaparib for use in HER2- metastatic breast cancer patients (Press release, Myriad Genetics, OCT 24, 2017, View Source [SID1234521116]).

“This regulatory submission as a companion diagnostic for a PARP inhibitor outside the United States reflects another important major milestone as Myriad seeks to become a global leader in personalized medicine,” said Mark C. Capone, president and chief executive officer, Myriad Genetics. “We believe there is broad applicability across all healthcare systems for our suite of companion diagnostics tests to improve the quality of care and lower healthcare costs.”

Myriad estimates there are greater than 10,000 cases of HER2- metastatic breast cancer per year in Japan which would be eligible for testing with BRACAnalysis CDx. Myriad will support testing in the Japanese market through its United States FDA approved laboratory.