On November 16, 2015 Private clinical swelling dedicated to the development of new cancer therapies The cancer research company Tragara Pharmaceuticals (Tragara Pharmaceuticals, Inc., hereinafter referred to as "Tragara") reported that Li China Cancer Medical Co., Ltd. (hereinafter referred to as "Li’s Pharmaceutical Factory") subsidiary of China Cancer Medical Co., Ltd. (China) Oncology Focus Limited) has obtained the TG02 concession for oral multi-kinase inhibitors granted by Tragara (Press release, Lee’s Pharmaceutical, NOV 17, 2015, View Source [SID1234532913]). Lee’s Pharmaceutical Factory Is a biopharmaceutical company listed on the main board of the Hong Kong Stock Exchange (stock code: 950), with more than 20 in the Chinese pharmaceutical industry. Year of operation history.

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Under the terms of the agreement, Lee’s Pharmaceuticals acquired exclusive rights to develop and sell TG02 in the following countries, including: China Mainland, Hong Kong, Macau, Taiwan, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Myanmar, Philippines Bin, Singapore, Thailand and Vietnam. Tragara will receive upfront payments for prepaid cash, related potential periodic payments and The tiered royalties for net sales. Lee’s Pharmaceuticals will be responsible for the development, registration and commercialization of TG02 within its scope of license. Industrialization related expenses. In the early stages, Lee’s Pharmaceuticals will focus on the clinical development of TG02 for hepatocellular carcinoma treatment. both sides Research and development results and related data will be shared.

In the United States, TG02 is currently being combined with the new-generation protease inhibitor carfilzomib for phase 1b clinical trials in patients with multiple myeloma. Research stage. The concept has been validated in this study and Tragara will continue to recruit more patients to participate in the study. For MYC- The first phase of over-expressed solid tumors is in the planning stage.

Tragara also announced today that the company recently completed a $13 million Series C private placement financing. Lee’s Pharmaceutical Factory and Existing investors have participated in the financing, including investors in Domain Associates Ventures, Morgan Taylor Venture capital firms (Morgenthaler Ventures), ProQuest Investments investment companies and RusnanoMedInvest Investment Company.

"We are honored to work with Tragara to develop TG02 in Greater China and Southeast Asia. I believe TG02 will be very A new treatment option for patients with multiple hepatocellular carcinoma (HCC)." Dr. Li Xiaoyu, Chief Executive Officer and Executive Director of Lee’s Pharmaceuticals "We are currently developing a PD-L1 monoclonal antibody, an oncolytic virus and a proprietary chemical, plus one Targeted therapeutics, which will give our group a dominant position in the field of cancer treatment, and successfully self-developed combined drugs. "

"We are very pleased to work with Lee’s Pharmaceuticals to develop and accelerate the development of TG02 on a global scale. This collaboration is not only About the development of TG02 for the treatment of hepatocellular carcinoma (HCC), and will also serve as a platform to establish an over-expression table for MYC oncogenes Clinical proof of solid tumors. We are full of expectations for cooperation with Lee’s Pharmaceuticals. President and head of Tragara Executive Officer Thomas M. Estok said.

On November 17, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it will present eight posters at the 2015 San Antonio Breast Cancer Symposium (SABCS) being held Dec. 8 to 12, 2015 in San Antonio, Texas (Press release, Myriad Genetics, NOV 17, 2015, View Source [SID:1234508272]).

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"Myriad is committed to bringing transformative molecular diagnostics to people with cancer. Our data at SABCS showcase our expanding portfolio of companion diagnostics and their potential to help personalize treatments for people with breast cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "We’re also excited about several new studies that highlight the ability of our myRisk Hereditary Cancer test to identify patients at risk for hereditary cancers."

A list of the Myriad presentations at SABCS is below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS15.

myChoice HRD Poster Presentations

Title: The role of germline BRCA status and Homologous Recombination Deficiency and response to neoadjuvant weekly paclitaxel followed by anthracycline-based chemotherapy.
Date: Thursday, Dec. 10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-29.

Title: Homologous recombination deficiency (HRD) as a predictive biomarker of response to preoperative systemic therapy (PST) in TBCRC008 comprising a platinum in HER2-negative primary operable breast cancer.
Date: Thursday, Dec. 10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-13.

Title: Homologous recombination deficiency (HRD) as a predictive biomarker of response to neoadjuvant platinum-based therapy in patients with triple negative breast cancer (TNBC); A pooled analysis.
Date: Thursday, Dec. 10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-12.
myRisk Hereditary Cancer Poster Presentations

Title: Predisposing germline mutations in an unselected academic breast cancer (BC) cohort.
Date: Wednesday, Dec. 9, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P1-08-07.

Title: The patient experience in a prospective trial of multiple-gene panel testing for cancer risk.
Date: Thursday, Dec. 10, 2015: 7:30 to 9:00 a.m. CT.
Location: Poster P2-09-07.

Title: Interim analysis of multiplex gene panel testing for inherited susceptibility to breast cancer.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-01.

Title: Multiplex Identification of genetic etiologies among women with bilateral breast cancer using a 25-gene hereditary cancer panel.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-02.

Title: Characterization of Li-Fraumeni syndrome diagnosed using a 25-gene hereditary cancer panel.
Date: Friday, Dec. 11, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster Discussion PD7-03.

For more information about these presentations, please visit the SABCS website at View Source

On November 17, 2015 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that data investigating the use of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in advanced non-small cell lung cancer, melanoma, classical Hodgkin lymphoma, multiple myeloma, and ER-positive/HER2-negative breast cancer will be presented at four medical congresses through the end of this year (Press release, Merck & Co, NOV 17, 2015, View Source [SID:1234508270]). In total, data from more than 30 abstracts will be presented at the Society for Melanoma Research (SMR) 2015 Congress in San Francisco, Nov. 18 – 21; the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, Dec. 5 – 8; the San Antonio Breast Cancer Symposium (SABCS), Dec. 8 – 12; and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia 2015 Congress in Singapore, Dec. 18 – 21. By the end of 2015, data on the anti-tumor activity of KEYTRUDA will have been presented across more than 20 tumor types.

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"The field of immuno-oncology holds great potential across a broad spectrum of cancers," said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. "Data for KEYTRUDA being presented at these scientific meetings include a first-time comparison to chemotherapy in advanced non-small cell lung cancer, novel combination data in advanced melanoma as well as first-time data in two additional tumor types, namely multiple myeloma and hormone receptor positive breast cancer, further demonstrating our deep commitment to advancing cancer treatment."

The KEYTRUDA clinical development program to date includes patients with more than 30 tumor types in more than 160 clinical trials, including more than 80 trials that combine KEYTRUDA with other cancer treatments.

A select list of KEYTRUDA data to be presented at these meetings includes:

SMR (data to be presented include three late breaking oral presentations and multiple posters on KEYTRUDA monotherapy)

Late Breaker Oral Presentation: Preliminary Data From a Phase 1/2 Study of Epacadostat (INCB024360) with Pembrolizumab as First-Line Treatment in Patients with Advanced/Metastatic Melanoma. O. Hamid. Saturday, Nov. 21, 2:50 p.m. PST. Location: Salon 9-15 (San Francisco Marriott Marquis).

Late Breaker Oral Presentation: Primary Analysis of MASTERKEY-265 Phase 1b Study of Talimogene Laherparepvec (T-VEC) and Pembrolizumab (pembro) for Unresectable Stage IIIB-IV Melanoma. G. Long. Saturday, Nov. 21, 3:20 p.m. PST. Location: Salon 9-15 (San Francisco Marriott Marquis).

Late Breaker Oral Presentation: KEYNOTE-029: Pembrolizumab (pembro) + Low-Dose Ipilimumab (ipi) For Advanced Melanoma. G. Long. Saturday, Nov. 21, 2:00 p.m. PST. Location: Salon 9-15 (San Francisco Marriott Marquis).
For more information about this congress, including a complete list of abstract titles, please visit the SMR 2015 website at www.melanomacongress.com.

ASH (data to be presented include four oral presentations and one poster presentation, including updated findings in classical Hodgkin lymphoma and first-time findings in multiple myeloma)

(Abstract #505) Oral Presentation: Pembrolizumab in Combination with Lenalidomide and Low-Dose Dexamethasone for Relapsed/Refractory Multiple Myeloma (RRMM): Keynote-023. J. San Miguel. Monday, Dec. 7, 7:00 a.m. EST. Location: Hall E1 (Orange County Convention Center).

(Abstract #584) Oral Presentation: PD-1 Blockade With Pembrolizumab in Patients With Classical Hodgkin Lymphoma After Brentuximab Vedotin Failure: Safety, Efficacy, and Biomarker Assessment. P. Armand. Monday, Dec. 7, 10:45 a.m. EST. Location: Hall E2 (Orange County Convention Center).

For more information about this congress, including a complete list of abstract titles, please visit the ASH (Free ASH Whitepaper) Annual Meeting website at www.hematology.org/Annual-Meeting.

SABCS (data to be presented include one oral presentation and three poster presentations, including first-time findings in ER-positive/HER2-negative breast cancer)

(Abstract #S5-07) Oral Presentation: Preliminary Efficacy and Safety of Pembrolizumab (MK-3475) in Patients with PD-L1–positive, Estrogen Receptor-positive (ER+)/HER2-negative Advanced Breast Cancer Enrolled in KEYNOTE-028. H. Rugo. Friday, Dec. 11, 11:00 a.m. CST. Location: Hall D (Henry B. Gonzalez Convention Center).
For more information about this congress, including a complete list of abstract titles, please visit the SABCS website at www.sabcs.org.

ESMO Asia (data to be presented include one oral presentation featured in the Presidential Symposium, one proffered paper presentation and seven poster presentations, including data comparing KEYTRUDA to chemotherapy in advanced non-small cell lung cancer)

(Abstract #LBA3) Presidential Symposium: KEYNOTE-010: Phase 2/3 Study of Pembrolizumab (MK-3475) vs Docetaxel for PD-L1–Positive NSCLC After Platinum-Based Therapy. R. Herbst. Sunday, Dec. 20, 5:00 p.m. SGT. Location: Hall 406 (Suntec Convention & Exhibition Centre).

(Abstract #315O) Proffered Paper Presentation: Antitumor Activity and Safety of Pembrolizumab in Patients with PD-L1-positive Nasopharyngeal Carcinoma: Interim Results From a Phase 1b Study. C. Hsu. Friday, Dec. 18, 2:50 p.m. SGT. Location: Hall 332 (Suntec Convention & Exhibition Centre).

For more information about this congress, including a complete list of abstract titles, please visit the ESMO (Free ESMO Whitepaper) Asia 2015 congress website at View Source

About KEYTRUDA (pembrolizumab) Injection 100 mg

KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is also indicated at the same dosing for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. These indications are approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Pneumonitis, including fatal cases, occurred in patients receiving KEYTRUDA. Pneumonitis occurred in 12 (2.9%) of 411 melanoma patients, including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Pneumonitis occurred in 19 (3.5%) of 550 patients with NSCLC, including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis in patients, receiving KEYTRUDA. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients with melanoma, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients, respectively, receiving KEYTRUDA. Colitis occurred in 4 (0.7 %) of 550 patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Hepatitis occurred in patients receiving KEYTRUDA. Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients with melanoma, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hypophysitis occurred in 2 (0.5%) of 411 patients with melanoma, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Hypophysitis occurred in 1 (0.2 %) of 550 patients with NSCLC, which was Grade 3 in severity. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or Grade 4 hypophysitis.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients with melanoma, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients with melanoma, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Hyperthyroidism occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2 (0.7%) or 3 (0.3%). Hypothyroidism occurred in 38 (6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3 (0.2%). Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 hyperthyroidism.

Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in patients receiving KEYTRUDA. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer anti-hyperglycemics in patients with severe hyperglycemia.

Nephritis occurred in patients receiving KEYTRUDA. Nephritis occurred in 3 (0.7%) patients with melanoma, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.

Other clinically important immune-mediated adverse reactions can occur. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following steroid taper. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

Across clinical studies with KEYTRUDA, the following clinically significant, immune-mediated adverse reactions have occurred: bullous pemphigoid and Guillain-Barré syndrome. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of patients with melanoma treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of 550 patients with NSCLC treated with KEYTRUDA: rash, vasculitis, hemolytic anemia, serum sickness, and myasthenia gravis.

Infusion-related reactions, including severe and life-threatening reactions, have occurred in patients receiving KEYTRUDA. Monitor patients for signs and symptoms of infusion related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For severe or life-threatening reactions, stop infusion and permanently discontinue KEYTRUDA.

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.

Among the 411 patients with metastatic melanoma, KEYTRUDA was discontinued for adverse reactions in 9% of 411 patients. Adverse reactions, reported in at least two patients, that led to discontinuation of KEYTRUDA were: pneumonitis, renal failure, and pain. Serious adverse reactions occurred in 36% of patients. The most frequent serious adverse reactions, reported in 2% or more of patients, were renal failure, dyspnea, pneumonia, and cellulitis. The most common adverse reactions (reported in at least 20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).

Among the 550 patients with metastatic NSCLC, KEYTRUDA was discontinued due to adverse reactions in 14% of patients. Serious adverse reactions occurred in 38% of patients. The most frequent serious adverse reactions reported in 2% or more of patients were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis. The most common adverse reactions (reported in at least 20% of patients) were fatigue (44%), decreased appetite (25%), dyspnea (23%), and cough (29%).

No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA.

It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.

Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.