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Myriad Genetics to Highlight New Clinical Outcomes Data on myPath(R) Melanoma at the American Society of Dermatopathology Annual Meeting

On October 8, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that new clinical outcomes and clinical utility data for myPath Melanoma will be featured at the American Society of Dermatopathology (ASDP) 52nd meeting being held Oct. 8 to 11, 2015 in San Francisco, Calif (Press release, Myriad Genetics, OCT 8, 2015, View Source [SID:1234507671]). The findings add to the growing body of knowledge for myPath Melanoma and will support the Company’s clinical reimbursement dossier for the product.

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"The accurate diagnosis of melanoma can be challenging based on histologic findings alone and there are potentially severe consequences of a misdiagnosis, including the under-treatment or overtreatment of patients," said Loren Clarke, M.D., vice president, Medical Affairs for Dermatology, Myriad Genetic Laboratories. "Our studies show that myPath Melanoma accurately differentiates malignant melanoma from benign skin lesions and helps physicians deliver a more objective and confident diagnosis for their patients."

A list of the myPath Melanoma presentations at ASDP (#ASDP2015) follows.

Podium Presentation

Title: Correlation of myPath Melanoma gene expression score with clinical outcome on a series of melanocytic lesions.

Date: Saturday, Oct. 10, 2015: 3:00 p.m. PT.

Location: Hilton Union Square, Continental 4-6.

Eugen Minca, M.D., department of Pathology, Cleveland Clinic, will present a study that correlates myPath Melanoma test results with clinical outcomes data (e.g., recurrence, sentinel lymph node metastases and distant metastases) from 127 patients with melanocytic lesions. Of these cases, 65 lesions were melanomas and 62 were benign lesions, according to the pathology diagnosis. The myPath Melanoma test scores were reviewed in conjunction with the diagnosis and clinical outcome. Of the 65 melanomas, 14 developed metastases and 51 had no adverse events after 47 months of follow up and myPath Melanoma diagnosed malignancy in all 14 cases with adverse outcomes, which represents a 100 percent sensitivity rate in these metastatic cases. There were no adverse events associated with the 62 benign lesions after an average follow up of 30 months. Of these, the myPath Melanoma test produced a benign score in 48 cases, an indeterminate score in seven cases and a malignant score in seven cases. Importantly, after myPath testing and upon expert histologic review, three of the seven cases with a malignant score were reclassified as melanomas. This is the first study with clinical outcome data and supports previous validation studies demonstrating that the myPath Melanoma test provides additional insight into difficult-to-diagnose lesions, supporting its use as an ancillary diagnostic test.

Poster Presentation

Title: A retrospective study of the influence of a gene expression signature on the treatment of melanocytic tumors.

Date: Thursday, Oct. 8 from 1:00 p.m. PT to Oct. 11 at 11:00 a.m. PT.

Location: Golden Gate, Ballroom.

In this study, 632 difficult-to-diagnose melanocytic lesions were analyzed using the myPath Melanoma diagnostic test. Retrospective chart reviews were conducted for 315 of the cases to document the actual treatment carried out for each patient. Of these, 214 patients received a benign myPath Melanoma test result, 92 received a malignant result and nine received an indeterminate result. The percentage change was measured from the treatment recommendations of the expert dermatopathologists to the actual treatment provided by dermatologists. The results show that excisions were reduced by 33.1 percent in patients who received a benign myPath Melanoma test result. Conversely, the use of additional treatment, such as surgery, increased by 36.2 percent in patients who received a malignant myPath Melanoma test result. These data support the integration of the myPath Melanoma test into medical practice to improve patient care by allowing more definitive diagnoses by dermatopathologists and optimized treatment decisions by dermatologists.

About myPath Melanoma

myPath Melanoma is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. Myriad myPath Melanoma is a unique test of 23 genes that provides valuable, additive diagnostic information unavailable from any other method – information that can help physicians deliver a more confident diagnosis.

Melanoma is the most serious type of skin cancer. According to the American Cancer Society, about 76,000 new melanomas are diagnosed each year and more than 9,000 people die from the disease annually. Each year in the United States, there are approximately 1.5 million skin biopsies performed specifically for the diagnosis of melanoma, and approximately 14 percent or 210,000 biopsies are classified as indeterminate, meaning that the dermatopathologist cannot confidently determine whether the cells are benign or malignant. For more information visit: www.mypath.myriad.com and www.mypathmelanoma.com.

Delcath Announces National Reimbursement Coverage For CHEMOSAT Procedures In Germany

On October 8, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported the establishment of a national reimbursement code for procedures performed with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) in Germany (Press release, Delcath Systems, OCT 8, 2015, View Source;p=RssLanding&cat=news&id=2095411 [SID:1234507669]). The German Institute for the Hospital Remuneration System (InEK) issued a ZE diagnostic-related group (DRG) code, which permits hospitals in Germany to obtain reimbursement for CHEMOSAT procedures beginning in 2016. This new nationwide code replaces the previous Neue Untersuchungs und Behandlungsmethoden (NUB) procedure that required patients in Germany to apply individually for reimbursement of their CHEMOSAT treatment. The decision represents the first national reimbursement mechanism for CHEMOSAT procedures in Europe.

"The receipt of ZE reimbursement represents an important step towards increased commercialization of CHEMOSAT and highlights the role our therapy has been playing in Germany for the treatment of patients with cancers in the liver," said Jennifer K. Simpson, Ph.D., MSN, CRNP, CEO & President of Delcath Systems, Inc. "The application for coverage under the ZE scheme was made by the German Radiology Society and has been widely supported by major German cancer hospitals, which also speaks to the confidence the German clinical community has in the therapy. With a ZE DRG code established, an application under the annual NUB process is no longer required. We look forward to supporting participating hospitals in their negotiations with insurers in the coming year and are pleased that this new reimbursement will make CHEMOSAT treatment more easily accessible to patients in Germany suffering with cancers in the liver."

ZE is a national reimbursement code that augments existing DRG codes until a specific new DRG code can be created. With the establishment of a ZE code for CHEMOSAT, the procedure is now permanently represented in the DRG catalog in Germany. The establishment of ZE coverage by InEK was made in response to an application made by the German Radiology Society for CHEMOSAT in March 2015.

Agios to Webcast R&D Day on October 16, 2015

On October 8, 2015 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic metabolic disorders, reported that the company will webcast presentations from its Research and Development (R&D) Day on Friday, October 16, 2015 starting at 9:00 a.m. ET in New York City (Press release, Agios Pharmaceuticals, OCT 8, 2015, View Source;p=RssLanding&cat=news&id=2095350 [SID:1234507668]).

Presentations will include a review of Agios’ research approach and clinical development strategy for the company’s lead cancer metabolism and rare genetic metabolic disorders programs. Along with the Agios team, external speakers will review the reported clinical data from these programs and the diseases that these investigational medicines aim to treat, including acute myeloid leukemia, advanced solid tumors and pyruvate kinase deficiency.

Agios speakers scheduled to present include:

David Schenkein, M.D., Chief Executive Officer
Scott Biller, Ph.D., Chief Scientific Officer
Chris Bowden, M.D., Chief Medical Officer
Sam Agresta, M.D., Vice President, Head of Clinical Development
Ann Barbier, M.D., Ph.D., Vice President, Clinical Development, Rare Genetic Diseases
External speakers:

Timothy Cloughesy, M.D., Director, UCLA Neuro-Oncology Program and Professor, Ronald Reagan UCLA Medical Center
Courtney DiNardo, M.D., MSCE, Assistant Professor, Department of Leukemia, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center
Agios invites the public and media to listen to the presentations via a live webcast that can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at agios.com. The presentations are scheduled to begin at approximately 9:00 a.m. ET. A replay of the webcast will be archived on the Agios website for approximately 30 days following the presentation.

Aduro Biotech Receives Milestone Payment From Janssen for Submission of Investigational New Drug Application for ADU-214 in Lung Cancer

On October 08, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported that it has received a milestone payment from Janssen Biotech, Inc. for Aduro’s submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for ADU-214, a LADD immunotherapy in development for the treatment of non-small cell lung cancer (Press release, Aduro BioTech, OCT 8, 2015, View Source [SID:1234507677]).

The IND will enable Janssen, Aduro’s license partner for ADU-214, to initiate a multi-center Phase 1 trial to evaluate the safety and immunogenicity of intravenous administration of ADU-214.

"We are pleased to support Janssen in their advancement of ADU-214 into clinical trials in non-small cell lung cancer," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We believe there is tremendous potential with our LADD immunotherapy platform and our partnerships, like this one with Janssen, supplement our own efforts and provide additional resources to evaluate the clinical value of our technology in multiple tumor types."

Janssen expects to initiate a Phase 1 trial by the end of 2015 to evaluate the safety and immunogenicity of intravenous administration of ADU-214 in patients with non-small lung cancer.

In October 2014, Aduro entered into its second agreement with Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, granting an exclusive, worldwide license to ADU-214 and other product candidates engineered for the treatment of lung cancer and certain other cancers based on its novel LADD immunotherapy platform. Under the agreement facilitated by the Johnson & Johnson Innovation center in California, Aduro received a $30 million up-front payment and a milestone payment associated with submission of the IND, and is eligible to receive future development, regulatory and commercialization milestone payments up to a potential total of $786.5 million. In addition, Aduro is eligible to receive royalties at a rate ranging from high single-digits to low teens on worldwide net sales upon successful launch and commercialization.

About LADD

LADD is Aduro’s proprietary platform of live-attenuated double-deleted Listeria monocytogenes strains that have been engineered to induce a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity.

OncoGenex Announces EMA Support for Phase 3 AFFINITY Trial Protocol Amendment

On October 8, 2015 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported that the European Medicines Agency (EMA) has completed its review of the proposed amendment to the company’s Phase 3 AFFINITY protocol and statistical analysis plan (Press release, OncoGenex Pharmaceuticals, OCT 8, 2015, http://oncogenex.com/oncogenex-announces-ema-support-phase-3-affinity-trial-protocol-amendment [SID:1234507674]).

The amendment, which was agreed to by the U.S. Food and Drug Administration (FDA) earlier this year, includes the addition of a co-primary endpoint designed to prospectively evaluate the survival benefit of custirsen in men who are at increased risk for poor outcomes when treated with cabazitaxel for metastatic castrate-resistant prostate cancer (mCRPC). The EMA supported plans for prospectively defining a poor prognostic subpopulation in the Phase 3 AFFINITY trial and suggested additional supportive analyses to show benefit for the po or prognostic subpopulation beyond the broader AFFINITY trial population. Following support from the FDA and EMA, the company is proceeding with its planned protocol amendment globally.

"We are pleased that we now have feedback from both U.S. and European regulatory authorities on our plan to prospectively evaluate this group of mCRPC patients wo have increased risk factors for poor outcomes and who therefore are more likely to have shorter survival times," said Cindy Jacobs, PhD, MD, Chief Medical Officer and Executive Vice President of OncoGenex. "As we continue to gather insights from the SYNERGY trial, we are gaining a better understanding of the role clusterin plays in this vulnerable patient group and how custirsen may provide a survival benefit."

OncoGenex, in collaboration with study investigators, has defined a simple five-criteria characterization for poor prognostic patients with prostate cancer to be treated with custirsen based on the Phase 3 SYNERGY trial, which includes: 1) poor performance status, 2) elevated prostate specific antigen (PSA), 3) elevated lactate dehyrdogenase (LDH), 4) decreased hemoglobin and 5) the presence of liver metastasis. AFFINITY patients with poor prognosis will be identified as having two or more of these five well-recognized high-risk criteria. The proposed change for AFFINITY is also consistent with custirsen’s mechanism of action, as custirsen was designed to address treatment resistance which may be more prevalent in this subpopulation.

In the revised statistical analysis plan for the AFFINITY trial, the hypothesized hazard ratio (HR) for the poor prognosis subpopulation is specified to be 0.69 with the critical HR ≤ 0.778. The hypothesized HR for intent-to-treat patients (ITT population) remains unchanged as 0.75 with the critical HR ≤ 0.820.

Timing for the final analysis of the poor prognosis subpopulation is projected to occur by the end of 2015, while the final analysis of the ITT population is projected to occur in the second half of 2016. An interim analysis of the ITT population will coincide with the final analysis of the poor prognosis subpopulation. This interim analysis will have both futility and early efficacy criteria defined for the ITT population. If the final analysis of the poor prognostic subpopulation shows a survival benefit for custirsen, OncoGenex may initiate a regulatory submission.

A retrospective analysis of data from the Phase 3 SYNERGY trial presented earlier this year showed a benefit with custirsen therapy when added to first-line docetaxel chemotherapy in men with mCRPC who had a poor prognosis. The analysis showed that over 40 percent of men in the SYNERGY trial had at least two of the five common risk factors for poor prognosis as stated above. In these men, the analysis found a 27 percent lower risk of death when custirsen was used in combination with first-line docetaxel compared to docetaxel alone.

In addition, exploratory SYNERGY data analyses recently presented at the 2015 European Cancer Congress (ECC 2015) demonstrated that custirsen treatment significantly lowered serum clusterin (sCLU) levels from baseline in men with mCRPC. In addition, these data showed that sCLU reductions after custirsen treatment resulted in higher two-year survival rates in patients who were at increased risk for poor outcomes. Of those patients with lower sCLU levels, the data also showed a correlation to an overall survival benefit for custirsen-treated patients who were at increased risk for poor outcomes.

AFFINITY is being conducted at 95 global clinical trial sites. Earlier this year, the IDMC recommended the trial continue following the completion of an interim futility analysis. The trial is fully accrued and the protocol amendment does not affect the conduct of the study. Custirsen has Fast Track designation by the FDA for the poor prognosis and overall AFFINITY trial populations, as well as non-small cell lung cancer (NSCLC).

About Clusterin

A major barrier to extending survival in patients with advanced cancer is treatment failure due to the ability of tumor cells to exploit fundamental cellular mechanisms that allow them to evade destruction by anti-cancer therapies. The production of the protein clusterin is a fundamental cellular repair mechanism that tumor cells exploit to evade destruction by anti-cancer therapies. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration in patients.

About Custirsen

Custirsen is a highly specific clusterin inhibitor designed to improve survival in patients with advanced cancer by disabling a fundamental cellular repair mechanism used by tumor cells. Custirsen binds to clusterin mRNA to block the production of clusterin protein and has enhanced the tumor cell destructive effects of multiple anti-cancer therapies across a variety of tumor models. By inhibiting clusterin, custirsen is designed to alter tumor dynamics by slowing tumor growth and inhibiting tumor resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.