On February 17, 2017 Ethicon, Inc. reported a definitive agreement to acquire Torax Medical, Inc., a privately held medical device company that manufactures and markets the LINX Reflux Management System, a novel minimally invasive device for the surgical treatment of GERD (Press release, Johnson & Johnson, FEB 17, 2017, View Source [SID1234517770]). The acquisition of Torax Medical will enable Ethicon to offer patients a safe and effective alternative to the anatomy-altering laparoscopic Nissen fundoplication surgical procedure.1

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This LINX Reflux Management System, a small implant comprised of interlinked titanium beads with magnetic cores which augment the body’s natural barrier function to prevent reflux. LINX is currently used by physicians in over 300 hospitals in the United States and Europe. This acquisition is consistent with Ethicon’s strategy of advancing innovation and investing in areas of unmet medical needs such as esophageal health.

Financial terms of the transaction have not been disclosed. The closing of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The transaction is expected to close during the first quarter of 2017.

On February 17, 2017 ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo reported that the METIV-HCC phase 3 study of tivantinib in hepatocellular carcinoma (HCC) did not meet its primary endpoint of improving overall survival (Press release, ArQule, FEB 17, 2017, View Source [SID1234517745]).

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METIV-HCC is a biomarker-selected, double-blind, placebo-controlled, randomized phase 3 study evaluating tivantinib (2:1) versus best supportive care in patients with MET-overexpressing, inoperable HCC intolerant to or previously-treated with systemic therapy. A total of 340 patients with MET-overexpressing HCC analyzed by a validated immunohistochemical assay were randomized in the intent-to-treat population for efficacy analysis. The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival and safety. Full results from the trial will be presented at an upcoming scientific forum.

"HCC is a disease with high unmet need, especially in the second-line setting, so these results are disappointing for the patients as well as the investigators and the companies," said Paolo Pucci, Chief Executive Officer of ArQule.

"Despite the negative outcome of this study, we remain committed to applying rigorous science to unmet needs for patients with cancer," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We would like to take this opportunity to thank all of the investigators, and especially the patients, for their participation in this study."

The ArQule investor conference call can be accessed in the "Investors and Media" section of ArQule’s website, www.arqule.com, under "Events and Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. and using the passcode 74015633. A replay will be available two hours after the completion of the call and can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events and Presentations."

About Hepatocellular Carcinoma (HCC)
Liver cancer is the sixth most common cancer globally with 782,000 new cases in 2012 and is the second most common cause of cancer-related death with 745,000 deaths in 2012.1 HCC accounts for about 90 percent of primary liver cancers.2 Cirrhosis, chronic hepatitis B and C and smoking are recognized worldwide as factors increasing the risk of HCC.2

About Tivantinib (ARQ 197)
ArQule and Daiichi Sankyo have a licensing, co-development and co-commercialization agreement for tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.

On February 18, 2107 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported encouraging results from the Phase II IMmotion150 study that compared TECENTRIQ (atezolizumab) plus Avastin (bevacizumab) and TECENTRIQ monotherapy to sunitinib alone in people with previously untreated, locally advanced or metastatic renal cell carcinoma (mRCC) (Press release, Hoffmann-La Roche, FEB 17, 2017, View Source [SID1234517752]). These results were presented at the 2017 Genitourinary Cancers Symposium taking place from February 16-18 in Florida, USA.

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IMmotion150 is the first randomised clinical trial to evaluate the combination of TECENTRIQ and Avastin in mRCC. The study was designed to inform further clinical development of this combination and these study results reinforce the potential of this combination in this setting.

The study showed that people whose disease expressed PD-L1 (programmed death-ligand 1) and were treated with TECENTRIQ plus Avastin had a 36 percent reduction in the risk of their disease worsening or death compared to people treated with sunitinib alone (median progression-free survival [mPFS]: 14.7 vs. 7.8 months; HR= 0.64; 95% CI 0.38, 1.08). No PFS advantage was observed compared to sunitinib in the intention-to-treat [ITT] population (mPFS: 11.7 vs. 8.4 months; HR = 1.00; 95% CI 0.69, 1.45). Median Duration of Response (DoR) has not yet been reached after 20.7 months of follow-up across treatment arms. Adverse events in the TECENTRIQ plus Avastin arm were consistent with those observed in previous studies of each medicine.

"These Phase II results support the scientific rationale for potentially combining TECENTRIQ and Avastin in people with this type of kidney cancer," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "There is a significant need for new treatment options for people living with advanced RCC, a disease where currently only about one in 10 people are alive beyond five years following diagnosis."

Roche is also evaluating TECENTRIQ plus Avastin vs sunitinib in a Phase III study (IMmotion151; NCT02420821) in people with previously untreated, locally advanced or metastatic RCC. A study of TECENTRIQ as adjuvant treatment for RCC began enrolling earlier this year.

About the IMmotion150 study
IMmotion150 is a global, multicentre, open-label, randomised Phase II study that was designed to evaluate the efficacy and safety of TECENTRIQ plus Avastin (Arm A), TECENTRIQ alone (Arm B) or sunitinib alone (Arm C) in 305 patients with previously untreated, locally advanced or metastatic RCC. People in Arm A received TECENTRIQ administered intravenously at 1200 mg every 3 weeks (6-week cycles) plus Avastin intravenously at 15 mg until disease progression or lack of clinical benefit. People in Arm B received TECENTRIQ alone (until disease progression or lack of clinical benefit), and people in Arm C received sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks rest until disease progression.

The co-primary endpoints were PFS per RECIST v.1.1 via Independent Review Facility (IRF) assessment in all randomised patients (ITT population) and in the PD-L1 selected (IC1/2/3) subgroup. PD-L1 expression was assessed on tumour-infiltrating immune cells (IC) with an investigational immunohistochemistry (IHC) test based on the SP142 antibody being developed by Roche Tissue Diagnostics. Secondary endpoints included IRF-assessed overall response rate (ORR) and duration of response (DoR), investigator-assessed PFS, ORR, DoR and safety, and overall survival (OS). A summary of the efficacy data from Arms A, B and C of the IMmotion150 study is included below.

IMmotion150 was designed with planned crossover. Over three quarters (78 percent) of sunitinib patients (Arm C) who progressed subsequently received TECENTRIQ plus Avastin (Arm A) OS results were immature at time of analysis with only 35 percent of events having occurred.

Safety in the TECENTRIQ plus Avastin arm appeared consistent with the known safety profile of the individual medicines. No new safety signals were identified. Frequency of all-grade treatment-related adverse events was similar between arms. The most common AE’s occurring in more than 20% of patients receiving Tecentriq plus Avastin and with a greater than 5% increase when compared to sunitinib included: arthralgia (38%), proteinuria (36%), epistaxis (28%), and pruritus (22%). Frequency of grade 3-4 AEs regardless of relationship to treatment were similar between patients treated with TECENTRIQ plus Avastin (63%) and sunitinib (69%). Treatment-related grade 3-4 events reported in 40% of TECENTRIQ plus Avastin treated patients and 57% of sunitinib treated patients. One person who was treated with TECENTRIQ plus Avastin experienced intracranial haemorrhage that led to death. Fifteen of 101 patients (15%) treated with TECENTRIQ plus Avastin discontinued treatment for adverse events.

About renal cell carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer and forms when abnormal cells develop in the small tubes (known as renal tubules) in the kidneys. Each year about 338,000 people are diagnosed with kidney cancer globally accounting for nearly 145,000 deaths worldwide.1 The disease is more prevalent in males and people aged 55–74 years.2 Currently there is a significant need for more effective treatments with only about one in ten people alive five years post diagnosis.2

About TECENTRIQ (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1), which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this interaction, TECENTRIQ may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.

About Avastin
With the initial approval 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 across the world through its proven survival benefit (overall survival and/or progression free survival) in several types of cancer, including colorectal cancer, non-small cell lung cancer, kidney cancer, breast cancer, ovarian cancer, cervical cancer, and glioblastoma. Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today with over 2.4 million patients treated with this medicine so far. With one of the largest clinical development programmes ever seen in oncology, Avastin will continue to transform how patients are treated as ongoing studies seek to understand the full potential of this medicine and its combinations with the most cutting edge therapies in development.

On February 17, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported new findings from the OlympiAD study that show its BRACAnalysis CDx test successfully identified patients with HER2-negative metastatic breast cancer who have BRCA mutations and who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor (Press release, Myriad Genetics, FEB 17, 2017, View Source [SID1234517753]).

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The high level results — announced earlier today from AstraZeneca — are the first reported clinical data from the OlympiAD study (NCT02000622), which assessed the efficacy and safety of olaparib monotherapy versus physicians’ choice of chemotherapy (i.e., capecitabine, vinorelbine or eribulin) in the treatment of metastatic breast cancer. Of the 302 patients in the study, 98 percent (297/302) tested positive for germline BRCA1/2 mutations as determined by Myriad’s FDA-approved BRACAnalysis CDx test. The results demonstrated a statistically-significant improvement of progression-free survival (PFS) among BRCA-mutated patients treated with olaparib compared to those treated with physicians’ choice.

"We believe the results of the OlympiAD trial support use of the BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing," said Johnathan Lancaster, M.D., Ph.D., chief medical officer of Myriad Genetic Laboratories. "This study underscores Myriad’s commitment to our pharmaceutical partners and to advancing the field of personalized medicine so that new effective treatment options are available to patients."

It is estimated there are approximately 60,000 patients with metastatic breast cancer, two thirds of whom are not currently eligible for BRCA testing based upon family and personal history alone or current testing criteria. If approved as a new indication this would triple the number of patients with metastatic breast cancer who would benefit from BRCA testing.

The ongoing collaboration between Myriad and AstraZeneca to develop a novel companion diagnostic test to identify candidates for treatment with olaparib began in 2007. In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic and was the first-ever laboratory developed test reviewed and approved by the FDA.

About BRACAnalysis CDx
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparza (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.

About Lynparza
Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DNA damage response (DDR) mechanisms in cancer cells. Lynparza is currently approved by regulatory health authorities in the EU for use as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. It is also approved in the US as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-
test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Lynparza is currently being investigated in another separate non-metastatic breast cancer Phase III study called OLYMPIA. This study is still open and recruiting patients internationally.

On February 17, 2017 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), reported that it presented a poster of its immunological data from its 94-patient Phase 2 trial evaluating vesigenurtacel-L (HS-410) either alone or in combination with BCG in patients with non-muscle invasive bladder cancer (NMIBC) at the 2017 Genitourinary (GU) Cancers Symposium (Press release, Heat Biologics, FEB 17, 2017, View Source [SID1234517757]). Researchers reported that HS-410, in combination with BCG, continues to be generally well-tolerated, that HS-410 activates CD8+ T cells and that these immune responders appear to have a lower recurrence rate than non-immune responders. Taken together, these data strengthen support for the vaccine mechanism of action and clinical proof-of-concept of immune activation.

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Patients were also evaluated based on their levels of tumor infiltrating lymphocytes (TIL) at the start of treatment. In the placebo arm, patients with low TIL levels at baseline had a higher incidence of disease recurrence than patients with high TIL levels at baseline. However, in the vaccine-treated group, recurrence levels were essentially the same between the high and low TIL subgroups, at 25% and 29%, respectively. The fact that these two groups of patients saw clinical outcomes that were roughly identical may warrant further evaluation.

"These data continue to support our hypothesized vaccine mechanism of action," said Jeff Hutchins, Ph.D., Heat’s Chief Scientific Officer and Senior Vice President of Preclinical Development. "Furthermore, we believe this vaccine treatment strategy could be evaluated in more advanced bladder patient populations, where immunotherapy has been shown to be effective, but where not all patients respond to therapy, likely due to insufficient T cell activation and proliferation."

As previously reported, vaccine arms did not show a statistical improvement over the placebo arm in the primary endpoint (1-year recurrence free survival). However, in keeping with clinical trial guidance, Heat continues to monitor all patients enrolled in the study for a 2-year duration.

The poster will be uploaded to the publications section of Heat’s corporate website in line with the conference’s embargo policy.