On December 6, 2017 Amgen (NASDAQ:AMGN) reported that it will host a webcast call for the investment community at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition on Saturday, Dec. 9, 2017, at 11:30 a.m. ET (Press release, Amgen, DEC 6, 2017, View Source;p=RssLanding&cat=news&id=2321467 [SID1234522402]). David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen, together with other members of Amgen’s management team and a clinical investigator, will participate to discuss the Company’s oncology program, including our BiTE immunotherapy platform.

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Live audio of the investor call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On December 6, 2017 Cellectar Biosciences (Nasdaq: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that the company will increase the targeted patient enrollment in the relapsed/refractory (R/R) multiple myeloma (MM) cohort of its currently enrolling Phase 2 clinical trial of CLR 131. Data from the MM cohort of the study demonstrated that the treatment exceeded pre-specified criteria for clinically meaningful benefit (Press release, Cellectar Biosciences, DEC 6, 2017, View Source [SID1234522403]). As a result, the cohort will be expanded up to as many as 40 patients.

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"The initial results from the multiple myeloma arm of this Phase 2 study underscore the potential for CLR 131 to benefit these heavily pre-treated and relapsed patients. We continue to see clinical benefit with CLR 131 in both our Phase 1 and Phase 2 clinical studies and look forward to reporting additional data from the both of these clinical studies next year.," stated James Caruso, president and chief executive officer of Cellectar Biosciences. "Furthermore, we are pleased to have achieved this key clinical milestone within our projected timelines" added Mr. Caruso.

On December 6, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported that its WP1066 drug will receive $2 million in private grant funding for its recently announced Investigational New Drug ("IND") clearance for a physician-sponsored Phase I trial of Moleculin’s drug WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma (Press release, Moleculin, DEC 6, 2017, View Source [SID1234522405]).

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"On the heels of our recent IND announcement, we are honored to now announce that a significant private grant has been awarded to help cover the costs of the upcoming brain tumor trial at MD Anderson," commented Walter Klemp, Chairman and CEO of Moleculin. "We should emphasize that this $2 million grant is in addition to two prestigious SPORE grants awarded by the National Cancer Institute ("NCI")."

Mr. Klemp added, "The Specialized Programs of Research Excellence ("SPORE") program was established by NCI to enable the rapid and efficient movement of basic scientific findings into clinical settings and it is now considered a highly prestigious award for promising anticancer technologies. Due to the highly competitive nature of such grants and their and external review processes, we believe they provide further validation of our program and the approach to the treatment of brain cancer and cancer metastasis to the brain. Overall, the combination of all of these funding sources not only allows this trial to begin to move forward, we believe it signals strong support for the development of this class of potential drugs and more specifically, significant enthusiasm for the potential of WP1066 to shut down unwanted cell signaling and to empower the immune system to fight cancer."

The grants described here do not flow through Moleculin’s financial statements, but instead are applied to the cost of preclinical and clinical activities at and conducted by MD Anderson.

On December 6, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease) (Press release, Hoffmann-La Roche, DEC 6, 2017, View Source [SID1234522404]). Avastin was previously granted provisional approval in this setting under the FDA’s accelerated approval program.

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"Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "Delaying disease progression and reducing the need for corticosteroids over the course of treatment are considered important goals for those impacted by this devastating disease where patients have limited treatment options."
This conversion to full approval was based on the totality of evidence of Avastin in glioblastoma, including data from the Phase III EORTC 26101 study. Avastin is now approved in the United States for nine distinct uses across six different types of cancer.

About the EORTC 26101 Study

EORTC 26101 is an independent Phase III, multicenter, randomized, open-label trial, conducted by the European Organization for Research and Treatment of Cancer (EORTC), which evaluated the addition of Avastin to lomustine chemotherapy in 432 patients with previously treated glioblastoma. The primary endpoint of the study was overall survival (OS), and progression-free survival (PFS) as assessed by investigator and overall response rate (ORR) were key secondary endpoints. Results showed the following:

There was no significant increase in OS with Avastin-based treatment (HR=0.91, p=0.4578).
As the primary endpoint was not met, all secondary endpoints should be considered descriptive only.

Avastin-based treatment increased the time to disease progression or death compared to chemotherapy alone (median PFS: 4.2 months vs. 1.5 months, HR=0.52, 95% CI: 0.41-0.64).

Among people taking corticosteroids at baseline (50 percent), more people were able to completely stop intake of corticosteroids while on treatment in the Avastin arm compared to the control arm (23 percent vs. 12 percent).

In the Avastin with lomustine arm, 22 percent of people discontinued treatment due to adverse reactions compared with 10 percent of people in the lomustine arm.

Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications.

About Glioblastoma

Glioma (cancer of the glial cells) is the most common type of malignant primary brain tumor (a tumor that originates in the brain), and represents nearly one-fourth of all primary brain tumors and three-fourths of all malignant tumors1. Glioblastoma (or glioblastoma multiforme) is the most common and the most aggressive type of glioma, accounting for more than half of all gliomas. It is estimated that more than 12,300 people will be diagnosed with glioblastoma in the United States in 20171.

About Avastin

With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and recurrent, platinum-resistant and platinum-sensitive ovarian cancer. In addition, Avastin is approved over 70 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal cancer, non-small cell lung cancer, cervical cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over 2.7 million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 300 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

On December 6, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported results from a ground-breaking validation study to better define the risk of breast cancer in women of European ancestry who test negative for a hereditary cancer mutation with the myRisk Hereditary Cancer test (Press release, Myriad Genetics, DEC 6, 2017, View Source [SID1234522406]). The results are being featured in a Spotlight presentation today at the 2017 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

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"Myriad Genetics is the first to bring to market a comprehensive approach to lifetime breast cancer risk assessment that includes 28 genes, family history evaluation, and well-validated SNPs through riskScore," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "This comprehensive approach delivers the most precise tool in the industry to help physicians assess a patient’s breast cancer risk and empower choices that may prevent a patient’s breast cancer from ever happening."

A summary of this study appears below and more information about the company’s presentation can be found at: View Source Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS17.

myRisk Hereditary Cancer with riskScore Spotlight Presentation
Title: Development and Validation of a Combined Residual Risk Score to Predict Breast Cancer Risk in Unaffected Women Negative for Mutations on a Multi-Gene Hereditary Cancer Panel.
Presenter: Elisha Hughes, Ph.D.
Date: Wednesday, Dec. 6, 2017, 5:00—7:00 p.m.
Location: Poster Discussion, PD1-08

This study was designed to validate the new riskScore test’s ability to predict the 5-year and lifetime risk of breast cancer compared to the Tyrer-Cuzick model alone. riskScore is a novel test that combines data from the Tyrer-Cuzick model with 86 genetic markers, called single nucleotide polymorphisms (SNPs), to comprise a combined risk score that accounts for clinical, familial and genetic variables.

The validation study included 1,617 women: 990 women with breast cancer and 627 controls. The results show that riskScore is a highly statistically significant predictor of the 5-year and lifetime risk of breast cancer (p=5.2×10-39 and p=4.1×10-35, respectively). Moreover, riskScore was statistically significantly superior to Tyrer-Cuzick alone for both 5-year and lifetime risk of breast cancer (1.0×10-12 and 8.3×10-13, respectively), underscoring the important contribution of the SNPs to the test.

"The combination of the SNP panel with Tyrer-Cuzick provides even greater precision than previously demonstrated from family history models," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. "As a result, we believe our myRisk Hereditary Cancer test, now enhanced with riskScore, provides the most comprehensive breast cancer risk assessment available today."

In a separate analysis, the riskScore test was applied to a real-world cohort of 6,479 women who tested negative for mutations in 11 genes associated with hereditary breast cancer to determine their remaining lifetime risk of developing breast cancer. The results show that riskScore remaining lifetime risk estimates ranged from 0.88 percent to 66.4 percent (Graph 1). Additionally, 38.2 percent of patients tested with riskScore had a lifetime risk >20 percent and 7.4 percent had a lifetime risk >3 times the general population (35 percent).

"These data confirm the important contribution of SNPs to breast cancer risk assessment in unaffected women who test negative for mutations in hereditary breast cancer genes with a precise measure of breast cancer risk," said Lanchbury. "The addition of the SNP data appears to be especially helpful in identifying those patients at higher risk for developing breast cancer."

Graph 1: View Source

"Patients who are above 20 percent lifetime risk are candidates for additional screening based on U.S. Preventive Services Task Force recommendations and those above 35 percent may be candidates for more aggressive medical interventions," said Lancaster. "Importantly, these data show that riskScore identifies a larger number of high-risk patients than either BRCA1 or BRCA2 testing and represents the next major epoch in hereditary cancer risk assessment and patient care."

About riskScore
riskScore is a new clinically validated personalized medicine tool that enhances Myriad’s myRisk Hereditary Cancer test. riskScore helps to further predict a women’s lifetime risk of developing breast cancer using clinical risk factors and genetic-markers throughout the genome. The test incorporates data from greater than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was validated in our laboratory to predict breast cancer risk in women of European descent. This data is then combined with a best-in-class family and personal history algorithm, the Tyrer-Cuzick model, to provide every patient with individualized breast cancer risk.

About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 28 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.