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.