On September 28, 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 that data from two EU treatment centers supporting treatment of patients with liver metastases from ocular melanoma with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) will be presented as a poster at the European Cancer Congress (ECCO) annual meeting, being held in Vienna, Austria from September 25-29, 2015 (Press release, Delcath Systems, SEP 28, 2015, View Source;p=RssLanding&cat=news&id=2090858 [SID:1234507586]).

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The study entitled, "Treating Unresectable Liver Metastases of Uveal Melanoma with (Percutaneous) Isolated Hepatic Perfusion with Melphalan: Results from Two Experienced Centers," by E.M. De Leede, M.C. Burgmans, et al., was a retrospective study conducted by investigators at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC) in the Netherlands. Investigators compared patients with uveal (ocular) melanoma liver metastases treated with isolated hepatic perfusion (IHP), an open surgical procedure that can be performed only once, with patients treated with repeatable percutaneous hepatic perfusion (PHP) using the CHEMOSAT system with an aim to treat patients twice with a six week interval. Treatment characteristics, complications, toxicity, progression free and overall survival of both therapeutic approaches were analyzed. Both IHP and PHP treatments were performed with melphalan.

In the IHP cohort (30 patients treated between March 1999 and April 2009) progression free survival was 6 months and recurrence was mainly in the liver, and overall survival was 10 months. In the PHP cohort (9 patients who received 15 PHP treatments since February 2014), the maximum follow-up period was 14 months. Eight patients are still alive, seven without progression of disease. A decrease in red and white blood cell count and thrombocytes after the procedure was observed, and 3 patients needed blood transfusions or platelet infusion. Treatment was overall well tolerated. Investigators concluded that "percutaneous hepatic perfusion appears to be an effective and safe procedure in selected patients with unresectable liver metastases of colorectal cancer or uveal melanoma and can be repeated."

"With eight out of nine patients still alive at 14 months in this retrospective analysis, this is an encouraging signal for PHP and we look forward to seeing the final data," said Jennifer Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "This study is the first of several scheduled posters on the clinical merits of CHEMOSAT to be presented at major medical meetings this fall. We expect this growing body of clinical data will advance the continued adoption of CHEMOSAT in Europe and will support our ongoing reimbursement efforts in those territories."

The abstract of this study is available on the ECCO 2015 website.

On September 28, 2015 Array BioPharma’s (Nasdaq: ARRY) reported clinical trial results from its wholly-owned MEK inhibitor, binimetinib, and BRAF inhibitor, encorafenib, this weekend at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)’s (ESMO) (Free ESMO Whitepaper) annual European Cancer Conference (ECC) (Press release, Array BioPharma, SEP 28, 2015, View Source;p=RssLanding&cat=news&id=2090805 [SID:1234507585]). At the meeting, preliminary data were shared from both a Phase 2 combination trial of binimetinib and encorafenib in BRAF-mutant melanoma patients (LOGIC2) and a Phase 1b/2 combination trial of binimetinib and ribociclib (Novartis, LEE011), a CDK4/6 inhibitor in NRAS-mutant melanoma patients.

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BRAF-mutant Melanoma Preliminary Results

LOGIC2 is an ongoing 140-patient, two-part study designed to explore the safety and activity of novel triplet combinations in BRAF-mutant melanoma. In part 1, patients are treated with the combination of binimetinib and encorafenib until disease progression. Based on the results of molecular profiling at that time, each patient is assigned to one of four arms containing a triplet combination of binimetinib, encorafenib and a third targeted therapy. Results from part 1 of the study are reported separately for patients who have previously received a BRAF and/or MEK inhibitor versus those who were initially naive to BRAF and MEK inhibitor treatment.

In part 1, patients are treated with binimetinib 45 mg twice daily (BID) and encorafenib 450 mg once daily (QD), the same doses evaluated in the ongoing Phase 3 COLUMBUS trial. In the BRAF/MEK-naive group (n=40), the interim overall response rate (confirmed and unconfirmed complete response or partial response) was 68%, with a 6-month progression-free survival estimate of 79%. Of note, 96% of patients in this group continued to receive study treatment as of the data cutoff. Preliminary data from all patients in the study (n=89) also indicate that the combination of binimetinib and encorafenib showed good tolerability with a 12% incidence of pyrexia and little to no rash or photosensitivity. These results indicate that the combination of binimetinib and encorafenib show encouraging clinical activity and an emerging differentiated tolerability profile relative to other MEK/BRAF inhibitor combinations.

"MEK and BRAF combination therapy is now established as the optimal molecularly targeted approach for BRAF mutant melanoma patients," said Reinhard Dummer, M.D., investigator, University Hospital Zurich. "In this study, the combination of encorafenib and binimetinib demonstrated robust clinical activity, consistent with results from other BRAF/MEK inhibitor combinations, but with a potentially improved and differentiated safety profile."

NRAS-mutant Melanoma Interim Results

A Phase 1b/2 study of binimetinib in combination with ribociclib showed promising preliminary antitumor activity in NRAS-mutant melanoma patients. Results were shared from 45 patients enrolled in the dose escalation portion of the study, which included two dosing schedules (28-day or 21-day cycles). For the 28-day dosing schedule, patients received continuous twice daily dosing of binimetinib while receiving ribociclib for 21 days per 28 day cycle. For the 21-day schedule, both agents were delivered for 14 days of a 21 day cycle.

For patients receiving the combination on a 28-day cycle (n=22), the Objective Response Rate (ORR, confirmed and unconfirmed complete or partial responses) was 41%, the Disease Control Rate (DCR, confirmed and unconfirmed complete or partial responses and stable disease) was 82% with a median Progression Free Survival (mPFS) of 6.7 months. Furthermore, the ORR was 56% (n=9) for patients receiving dose level 1 of the 28-day schedule consisting of binimetinib 45 mg BID and the lowest dose of ribociclib (200 mg QD), indicating that robust activity can be achieved with this dose and schedule. Common treatment-related adverse events included elevated creatine phosphokinase (CPK), skin and gastrointestinal events. Investigation of an alternative 21-day schedule is ongoing.

"Among metastatic melanoma patients, the presence of an NRAS-mutation is a predictor of poor prognosis, and for this subgroup of patients, there are currently no approved targeted therapies," said Carla van Herpen, M.D., Ph.D., Radboud University Medical Center, Nijmegen, The Netherlands. "Simultaneous inhibition of MEK and CDK4/6 protein kinases could suppress the activation of two major signaling pathways associated with NRAS mutations and may provide additive, or synergistic, activity versus single-agent therapy."

About Melanoma

Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the United States, with almost 74,000 new cases and nearly 10,000 deaths from the disease projected in 2015. BRAF and NRAS mutations occur in approximately 40% to 60% and 15% to 20%, respectively, of patients with melanoma. When melanoma is diagnosed early, it is generally a curable disease. However, when it spreads to other parts of the body, it is the deadliest and most aggressive form of skin cancer. A person with metastatic melanoma typically has a short life expectancy with only approximately 15% of patients surviving for five years following diagnosis of metastatic disease.

About BRAF, MEK, Binimetinib and Encorafenib

Raf and MEK are key protein kinases in the RAS/RAF/MEK/ERK pathway, which regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal and thyroid cancers. Binimetinib is a small molecule MEK inhibitor and encorafenib is a small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Three Phase 3 trials in advanced cancer patients continue to advance: NRAS-mutant melanoma (NEMO, with binimetinib), low-grade serous ovarian cancer (MILO, with binimetinib) and BRAF-mutant melanoma (COLUMBUS, with binimetinib and encorafenib). The NEMO and COLUMBUS Part 1 studies completed enrollment in April 2015. NRAS-mutant melanoma represents the first potential indication for binimetinib, with a projected regulatory filing estimated in the first half of 2016. Array also projects a regulatory filing of binimetinib in combination with encorafenib in BRAF melanoma in 2016.

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On September 28, 2015 ArQule, Inc. (NASDAQ:ARQL) reported preliminary results for the ongoing phase 1b expansion study in oncology for ARQ 092, an orally available selective pan-AKT inhibitor (Press release, ArQule, SEP 28, 2015, View Source [SID:1234507584]). The results were presented at the 2015 ESMO (Free ESMO Whitepaper) European Cancer Congress on September 27th, 2015.

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Thus far 25 patients have been treated in the study, and four partial responses (PRs) have been observed. These include two patients with the AKT1 E17K mutation and one patient with the PIK3CA H1047R mutation. Mutation status for a fourth patient could not be determined. Of the four PRs, two were observed in follicular lymphoma, one in breast cancer and one in endometrial cancer. The poster presentation can be accessed in the "Investor and Media" section of our website, www.arqule.com, under "Recent Data Presentations."

The phase 1b study follows completion of the phase 1a dose escalation portion of the trial that enrolled 82 patients and tested various dosages and dose regimens. In the phase 1a trial after one PR was observed in a patient with chronic lymphocytic lymphoma, the study was expanded to phase 1b with a focus on lymphoma, endometrial cancer and tumors harboring AKT (AKT1 E17K) or PI3K (PIK3CA H1047R) mutations.

"The preliminary results of the phase 1b expansion cohort are very encouraging," said Dr. Brian Schwartz, Head of Research and Development and Chief Medical Officer at ArQule. "The observation of four PRs in the 25 patients we have enrolled thus far validate our strategy to focus the trial on specific cancers with the AKT and PI3K mutations. We will continue to explore ARQ 092 in both cancer and rare diseases harboring these mutations."

ArQule continues to enroll patients in the phase 1b study while assessing next steps for ARQ 092 in oncology. In parallel, ArQule collaborators at the National Institute of Health (NIH) received approval of the Investigational New Drug (IND) application to begin a phase 1 trial with ARQ 092 in Proteus syndrome, a rare disease that is caused by a mutation of the AKT1 gene.

About ARQ 092 and the AKT Pathway

ARQ 092 is an orally available, selective small molecule inhibitor of the AKT kinase. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications.

ARQ 092, the lead compound in ArQule’s AKT program, has completed Phase 1a clinical testing and has advanced into Phase 1b expansion testing in cohorts of patients with endometrial cancer, lymphoma and tumors harboring either AKT or PI3K mutations. A number of next-generation compounds in the Company’s AKT program are in early to late stages of pre-clinical development.

On September 28, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the commercial availability in countries that accept the CE mark1 of the cobas EGFR Mutation Test v2, the first oncology assay from Roche that utilises either plasma or tumour tissue as a sample (Press release, Hoffmann-La Roche , SEP 28, 2015, View Source [SID:1234507568]). The test identifies 42 mutations in the epidermal growth factor receptor (EGFR) gene, the most of any In-vitro Diagnostic (IVD) on the market, and can also be used as an aid in selecting eligible patients with non-small cell lung cancer (NSCLC) for therapy with an EGFR tyrosine kinase inhibitor (TKI).

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"As more targeted therapies become available, it is critical that we provide innovative molecular testing methods that make it easier for patients to get tested, regardless of the surgery risks or tumour tissue availability," said Roland Diggelmann, COO, Roche Diagnostics. "By investing in liquid biopsy research and developing the cobas EGFR Mutation Test v2 for use with either plasma or tissue samples, Roche is helping to remove these common barriers from molecular testing."

According to a recent survey of more than 550 oncologists, EGFR genetic testing is not being conducted in about 25 percent of patients with NSCLC2,3. Some of the reasons for not testing included lack of diagnostic material and cases where a patient was deemed unfit to undergo biopsy. With the cobas EGFR Mutation Test v2 being validated with both tissue and plasma sample types, patients who previously did not qualify for biopsy now have the opportunity to receive a result from a simple plasma test to guide the corresponding therapy.

The cobas EGFR Mutation Test v2 is available now in countries that accept the CE mark1. For more information, please visit www.cobas-egfrtestv2.com.

About the cobas EGFR Mutation Test v2
The cobas EGFR Mutation Test v2 is a real-time PCR test that identifies 42 mutations in exons 18-21, including L858R, exon 19 deletions, L861Q and the TKI-resistance mutation, T790M. It is designed to enable testing of either tissue or plasma specimens with one kit, and allows labs to mix-batch tissue and plasma on the same plate. Additionally, Roche has developed a cell-free DNA (cfDNA) sample preparation kit that is optimised for extracting the DNA from plasma.

When testing plasma with the cobas EGFR Mutation Test v2, a new feature called the Semi-Quantitative Index (SQI) is included in the report. This number is designed to reflect a trend in the amount of mutant cfDNA in the sample. When frequently testing for the EGFR mutation using the test, tracking the SQI value and identifying a trend may lead to understanding tumour progression.
The cobas EGFR Mutation Test v2 is designed to run on the cobas 4800 System, v2.1 or higher. The system can also be used for the detection of mutations in the KRAS and BRAF gene of tumour samples.

On September 28, 2015 Bristol-Myers Squibb reported that actor Jack Huston, a star of the hit television show Boardwalk Empire and the upcoming remake of Ben Hur, took on an important new role as lung cancer advocate as he challenged Europeans to A.C.T. – be Aware, get Checked, and Talk with their doctor about lung cancer. After losing his grandfather to lung disease and his best friend and mentor, Peter Blythe, to lung cancer, Huston was motivated to take action by partnering with Bristol-Myers Squibb Company (NYSE:BMY) and leading advocacy group Lung Cancer Europe (LuCE) to ask the public, particularly those at high risk, what’s their Next Lung Cancer A.C.T.?

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Lung cancer is the number one cancer killer in Europe with an estimated 353,000 deaths each year – more than breast cancer, colorectal and prostate cancers combined. In Europe, lung cancer is the third most common cancer among women. Despite the growing prevalence, a new survey conducted among more than 8,200 participants in nine European countries showed that lung cancer knowledge is very low, with nearly six in 10 people (57%) surveyed saying that they are not knowledgeable about the disease. Further, one in five people (20%) could not identify the symptoms of lung cancer, including persistent cough, and one in 10 people (10%) do not know the risk factors, such as exposure to cigarette smoking.

Huston, along with lung cancer advocates and oncologists, unveiled the survey results at the European Cancer Congress (ECC) 2015 in Vienna, as well as a short film highlighting the personal stories of lung cancer patients.

"Like many Europeans, I know firsthand the devastating impact cancer can have on a family," said Huston. "I’ve joined The Next Lung Cancer A.C.T. in hopes of encouraging others to be mindful of the risk factors and symptoms of lung cancer and the importance of taking action now."

Key findings of the survey showed:

Six in 10 respondents (62%) believe lung cancer is a smoker’s disease, although smoking is only one risk factor for lung cancer
45 percent believe that breast cancer is the leading cause of death among women as compared to 8 percent who responded lung cancer

Nearly half of all respondents (46%) said they are not concerned about getting lung cancer, including 43 percent who have experience with lung cancer and 36 percent who are daily smokers
Eight in 10 people (83%) have never spoken to their doctor about lung cancer; an equal number of smokers (77%) also report this behavior

Following the survey, the majority of respondents (90%) expressed a willingness to take action to reduce their risk of lung cancer, including reducing their exposure to carcinogen (cancer-causing substances or agents) (50%), limit exposure to secondhand smoke (48%), and talking to their doctor (43%)

"It’s a pivotal time for lung cancer – the disease remains an enormous public threat in Europe but we are seeing promising research in the lung cancer space," said LuCE board member and lung cancer survivor, Regine Deniel Ihlen. "That is why now is the time for people to act by being aware, taking steps to get checked and having an ongoing dialogue with their physicians."

"At ECCO we are committed to helping people understand the signs that indicate that they may have cancer, as well as recognizing ways in which the disease may be prevented," said Professor Martine Piccart, President of the European CanCer Organization (ECCO). "That is why we are happy to be hosting the launch of this campaign, and we wish it every success."

"At Bristol-Myers Squibb, we are committed to fighting lung cancer through our research in oncology and by supporting the global lung cancer community," said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb. "The Next Lung Cancer A.C.T. represents our ongoing dedication to helping to empower those with cancer by providing them with knowledge to better understand the risks of lung cancer and how to take action."

About The Next Lung Cancer A.C.T.

The Next Lung Cancer A.C.T. is a public awareness campaign designed to encourage the public, particularly those at high risk of lung cancer, to take ACTion against the disease by being Aware, getting Checked and Talking to their doctor. The Next Lung Cancer A.C.T. is sponsored by Bristol-Myers Squibb, in collaboration with Lung Cancer Europe (LuCE). For more information on the campaign please visit www.TheNextLungCancerACT.eu.

About the Survey and TNS

TNS conducted the survey. TNS, the world’s largest custom research agency, is a well-recognized research group for their quality and authoritative research.

Participants in the 12-question, self-administered online omnibus survey were 8,263 Europeans, ages 16-54 across nine different countries in Europe: Austria, Denmark, Germany, Great Britain, Italy, Netherlands, Spain, Switzerland and Turkey. The survey was conducted between July 30, 2015 and August 7, 2015. The results were tested at 95% significant. At 95% confidence level, if the study were repeated, the results would not fluctuate more than 3.0-3.4 percentage points in either direction for the population surveyed in each country.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year, according to the World Health Organization (WHO). In Europe alone, lung cancer is responsible for an estimated 353,000 deaths from the disease every year – more than breast cancer, colorectal and prostate cancers combined. It has the highest economic burden of all cancers in the European Union, costing an estimated €18.8 billion or 15 percent of overall cancer costs.