On April 18, 2017 FierceBiotech reported in an article that Celgene is licensing rights to develop its TORC1/2 inhibitor CC-223 in East and Southeast Asia to Antengene (Article, FierceBiotech, APR 18, 2017, View Source [SID1234520281]). CRO Tigermed will help the latter with clinical development.

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On April 18, 2017 Amgen (NASDAQ: AMGN) reported the launch of Neulasta (pegfilgrastim) Onpro NARRATIVES, an online media resource about the value of a cancer care team that provides comprehensive support for patients receiving strong chemotherapy (Press release, Amgen, APR 18, 2017, View Source(pegfilgrastim)&text=Neulasta%20is%20administered%20by%20manual,on%2Dbody%20injector%20for%20Neulasta [SID1234563973]). Intended to support conversations between cancer patients undergoing strong chemotherapy and their healthcare team about potential risk for infection due to a low white blood cell count, Neulasta Onpro NARRATIVES shares personal cancer stories as well as educational materials.

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"Getting the breast cancer diagnosis was terrifying and unbelievable," said Natalie M., a breast cancer patient from Huntington Beach, Calif. "But once I got over the shock, I made sure I had the right team around me, including an oncologist and nursing staff I trusted to help guide me through my cancer journey."

After identifying Natalie was at risk for infection due to strong chemotherapy, her oncologist, Dr. John S. Link in Orange County, Calif., recommended she take Neulasta. When discussing options for Neulasta delivery, her nurse – Linda Buck, MSN, ANP-C, OCN – suggested Natalie try Neulasta Onpro because it could be applied the same day as her chemotherapy treatment and was designed to automatically deliver the dose of Neulasta the next day.1

On Neulasta Onpro NARRATIVES, Dr. Link and Nurse Buck share their personal experience working together to care for people going through strong chemotherapy and identify those who may be at risk for infection, and specifically describe how they cared for Natalie through her very personal cancer journey.

In addition to the personal stories, Neulasta Onpro NARRATIVES provides tips for initiating the important discussion between patients and their cancer care team, along with other educational resources. Resources on Neulasta Onpro NARRATIVES are intended to help raise awareness of the risk for infection due to strong chemotherapy and encourage patients to discuss the potential risk with their healthcare professional.

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 FDA 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.

On April 17, 2017 Novocure (NASDAQ:NVCR) reported that data from a post hoc analysis of the EF-14 pivotal phase 3 clinical trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) have been published in CNS Oncology (Press release, NovoCure, APR 17, 2017, View Source [SID1234518587]). The objective of the pre-specified post hoc analysis was to evaluate the efficacy and safety of Optune when added to physician’s best choice second-line treatment after first disease recurrence among patients enrolled in the EF-14 trial.

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The analysis shows that the median overall survival of patients treated with Optune in combination with physician’s best choice second line chemotherapy increased by 28 percent compared to patients treated with physician’s best choice second line chemotherapy alone from 9.2 months to 11.8 months (HR= 0.70, p= 0.049). Bevacizumab, alone or in combination with chemotherapy, was the most frequently used second-line treatment. The analysis also shows that the median overall survival of patients treated with Optune in combination with bevacizumab increased by 31 percent compared to patients treated with bevacizumab alone from 9.0 months to 11.8 months (HR=0.61, p= 0.043).

"Taken in conjunction with the previously reported benefits with TTFields for newly diagnosed GBM in the EF-14 interim analysis, these results support the early initiation and continued use of Optune in combination with standard systemic therapies for the treatment of GBM," said Santosh Kesari, a trial investigator and Chair of Translational Neurosciences and Neurotherapeutics at John Wayne Cancer Institute and Director of Neuro-oncology at the Pacific Neuroscience Institute at Providence Saint John’s Health Center in Santa Monica, California. "The publication of these data adds to the growing body of evidence around Optune’s efficacy and supports the incorporation of Optune as a combination treatment for patients with glioblastoma."

On April 17, 2017 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported top-line results from the company’s randomized 145-patient Phase 2 PINNACLE clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) in combination with etoposide plus either cisplatin or carboplatin chemotherapy ("chemotherapy") in previously untreated patients with extensive-stage small cell lung cancer (Press release, OncoMed, APR 17, 2017, View Source [SID1234518580]). Results for the combination of tarextumab plus chemotherapy were undifferentiated from those of chemotherapy plus placebo, and therefore the trial did not meet its primary endpoint of progression-free survival or secondary endpoints of overall survival and biomarkers reflective of Notch pathway gene activation.

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"Small cell lung cancer is a very difficult-to-treat disease and unfortunately, tarextumab did not show benefit over placebo in this Phase 2 trial," said Paul J. Hastings, OncoMed’s Chairman and CEO. "We deeply appreciate the participation by the investigators and staff, patients and caregivers who all contributed to the conduct and completion of this Phase 2 clinical trial."

OncoMed also announced today that it will discontinue enrollment in the Phase 1b clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) in combination with trifluridine/tipiracil (Lonsurf) in third-line colorectal cancer patients. The combination of brontictuzumab plus chemotherapy was not tolerable in this patient population.

"Based on the events of today and last week, we will be undertaking a comprehensive portfolio prioritization review immediately," continued Mr. Hastings. "The immediate task ahead is to thoroughly examine the available data, our resources and the opportunities to re-focus our efforts. We ended the first quarter of 2017 with $156.9 million in cash and short-term investments."

The median progression-free survival (mPFS) for tarextumab plus chemotherapy was 5.6 months versus 5.5 months for chemotherapy plus placebo (HR=0.969). The median overall survival (mOS) analysis did not show a benefit for tarextumab in combination with chemotherapy (mOS=9.3 months) compared to the chemotherapy plus placebo arm (10.3 months; HR=1.01). Five individual Notch biomarkers (Hes1, Hes6, Hey1, Hey2 and Notch3) failed to identify a definitive subset of patients with a treatment effect on either mPFS or mOS. Overall response rates were 68.5% and 70.8% in the tarextumab and placebo arms respectively. The combination of tarextumab plus chemotherapy was well tolerated. The safety profile appeared to be similar between the two groups except for diarrhea and thrombocytopenia, which were more prevalent in the tarextumab treatment arm, and constipation, which was more prevalent in the placebo arm.

OncoMed management will host a conference call today at 8:30 a.m. ET/5:30 a.m. PT to discuss the PINNACLE clinical trial data. OncoMed plans to present full study findings, including results from the biomarker analyses, at a future scientific conference.

About the Phase 2 PINNACLE Trial
Patients enrolled in the randomized, double-blinded, multi-center PINNACLE clinical trial were randomized into two study arms and received either 15mg/kg of tarextumab every three weeks in combination with six cycles of etoposide and either cisplatin or carboplatin chemotherapy followed by tarextumab maintenance to progression or six cycles of chemotherapy and a placebo. The primary endpoint of the trial was progression-free survival. Secondary endpoints included overall survival and overall response rate, pharmacokinetics, safety and biomarker analyses. Overall survival, progression-free survival and overall response rates are also being assessed against elevated tumor expression of the Notch pathway genes Hes1, Hes6, Hey1, Hey2 and Notch3 as a secondary endpoint. The PINNACLE trial was conducted at 36 sites in the United States.

About Tarextumab (anti-Notch2/3, OMP-59R5)
Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK).

About Small Cell Lung Cancer
According to the American Cancer Society, lung cancer (both small cell and non-small cell) is the second most common cancer in men and women and is by far the leading cause of cancer death. Small cell lung cancer is expected to make up about 10%-15% of the 224,390 newly diagnosed lung cancer cases and the 158,080 deaths estimated to occur in the U.S. in 2016. Small cell lung cancer tends to grow and spread quickly, and is typically not discovered until it has metastasized to other parts of the body (extensive stage). The current standard of care in treating small cell lung cancer is the chemotherapeutic etoposide in combination with either cisplatin or carboplatin. In spite of a high sensitivity to chemotherapy and remission rates of up to 80% following initial treatment, the median overall survival is less than one year for patients with extensive stage disease1.

Oncbiomune has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, OncBioMune Pharmaceuticals, 2017, APR 17, 2017, View Source [SID1234522113]).

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