Quantum Pharmaceuticals is developing small molecule PFKFB3 inhibitors for the treatment of solid tumors, including colon cancer, pancreatic cancer, TNBC and HCC (Presentation, Quantum Pharmaceuticals, JUN 2, 2014, View Source; width="640" height="480" [SID:1234500571]).

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On June 1, 2014 GlaxoSmithKline plc reported that the Phase III study of two anti-HER2 agents, lapatinib (Tykerb/Tyverb) and trastuzumab, did not meet the primary endpoint of improved disease free survival (DFS) compared to single agent therapy with trastuzumab as adjuvant treatment for HER2 positive early breast cancer (Press release, GlaxoSmithKline, JUN 1, 2014, View Source [SID:1234510054]). The safety profile was consistent with the established safety profile of the study drugs, with no new safety signals observed.

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These results were presented today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois.

"While it is disappointing that ALTTO did not meet its primary endpoint, we now have a tremendous amount of information that will help to further our knowledge of the biology of this disease and inform future studies in HER2 positive breast cancer in the adjuvant setting. Further analysis of these data will continue over the coming months," said Dr. Rafael Amado, Senior Vice President Oncology R&D at GSK. "We are most grateful to the more than 8,000 patients across the world who participated in ALTTO—their generous contribution to the scientific community will facilitate a greater understanding of this aggressive disease."

The primary analysis of the study tested for superiority (p≤0.025) between the combination arm and trastuzumab alone with respect to DFS; the trastuzumab followed by lapatinib arm was tested for non-inferiority (p≤0.025). The results showed that at four years, 88 percent of women lived without their disease returning (4-year DFS) in the lapatinib plus trastuzumab arm and 86 percent in the trastuzumab arm [HR 0.84 (97.5% CI, 0.70-1.02; p=0.048)]. The 4-year DFS rate for the trastuzumab followed by lapatinib arm was 87 percent compared to 86 percent in the trastuzumab arm [HR 0.96 (97.5% CI, 0.80-1.15; p=0.061)].

Adverse events (AEs) more frequently reported in the lapatinib plus trastuzumab arm compared to the trastuzumab arm were diarrhoea (75% vs. 20%), rash (55% vs. 20%) and hepatobiliary (23% vs. 16%). Diarrhoea, grade 3 or higher, was increased in all lapatinib containing treatment arms (5-15%), compared to trastuzumab alone (1%). The incidence of febrile neutropenia was <1% across treatment arms and primary cardiac endpoints were <1% in all arms. Overall, fatal AEs were consistent between treatment groups (<1%), with no clear pattern to the reported events. AEs leading to discontinuation were higher in the lapatinib containing arms (23% in the combination arm) compared with the trastuzumab arm (8%).

On June 2, 2014 Bayer reported that it has entered into a global agreement with Orion for the development and commercialization of the compound ODM-201, an investigational novel oral androgen receptor inhibitor (Press release Orion Pharma, JUN 1, 2014, View Source [SID:1234500614]). ODM-201 is in clinical development for the treatment of patients with prostate cancer. Bayer and Orion plan to start jointly the clinical Phase III program to further evaluate the efficacy and safety of ODM-201 in patients with non-metastatic castration-resistant prostate cancer (nm-CRPC) in 2014. These patients are at high risk of developing metastatic disease and can be identified due to rapid Prostate Specific Antigen (PSA) increases.

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"We see in ODM-201 a potential new treatment for patients with high risk non-metastatic castration-resistant prostate cancer and are looking forward to developing this promising compound," said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "Bayer’s oncology portfolio currently includes Xofigo which has been shown to prolong life in patients with castrate resistant prostate cancer with symptomatic bone metastases, and no known visceral metastases. From a clinical perspective, ODM-201 has the potential to complement our portfolio in prostate cancer and enables us to deliver new treatment options for patients who desperately need them."

"Joining forces with Bayer, I believe that we have again achieved a collaboration that represents the best of all worlds," said Dr. Reijo Salonen, SVP R&D and Chief Medical Officer for Orion. "Bayer has recently committed to developing therapies in Oncology, particularly for prostate cancer. At Orion, we continue our track record of inventing innovative molecules. And most importantly, for patients with prostate cancer, this partnership will bring a medicine that will make an important difference to their lives."

Under the terms of the agreement, Bayer and Orion will jointly develop ODM-201, with Bayer contributing a major share of the costs of future development. Bayer will commercialize ODM-201 globally and Orion has the option to co-promote ODM-201 in Europe. Orion will be responsible for the manufacturing of the product. Orion will receive an upfront payment of EUR 50 million and is eligible to receive cash payments from Bayer upon achievement of certain development, tech transfer and commercialization milestones, as well as tiered double-digit royalties on future global net sales. Orion will use the majority of the up-front payment this year against the costs of the Phase III study to be started this year.

On June 1, 2014 (Taipei) TS-1 Capsule (Taiwan Capsule), a chemotherapeutic drug from Taiwan’s Toyo Pharmaceutical (4105: TW), reported that it has recently been listed in the "National Health Insurance Drug Benefits Project" after receiving an indication for advanced pancreatic cancer in August 2013 (Press release, TTY Biopharm, JUN 1, 2014, View Source;ai-si-mo—-huo-wan-ji-yi-zang-ai-zhi-jian-bao-gei-fu [SID1234526668]). The payment standard jointly drafted the resolution of the meeting and agreed to include the national health insurance drug payment. The payment was made to patients who were unable to undergo surgical resection or metastatic pancreatic cancer in the late stage of treatment, and took effect on June 1, 2014. TS-1 Capsule was originally developed by Japan Dapeng Pharmaceutical Industry Co., Ltd. and was authorized to develop and market this drug in Taiwan’s Toyo Pharmaceuticals in Taiwan.

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Taiwanese pancreatic cancer has shown significant growth in recent years. According to the latest data released by the Department of Health and Welfare, there were 1,827 new patients with pancreatic cancer in the 100 years of the Republic of China, and 1,607 patients died of pancreatic cancer, which ranks among the top ten causes of cancer in the country. Eight people ranked a little more than 99 years ago in the Republic of China, showing that the current treatment is not effective. Most pancreatic cancers are diagnosed at the late stage when the tumor cannot be surgically removed. The patient needs to receive systemic chemotherapy. However, the survival time of advanced pancreatic cancer is extremely short, and the choice of drugs is limited, and patients need urgently more effective treatment options.

Mr. Lin Rongjin, General Manager of Taiwan’s Toyo Pharmaceutical Co., Ltd., said: "Continuously cultivating medicines in the field of cancer has always been the goal of Taiwan’s East Sample. This breakthrough will benefit more cancer patients. It is a good news." Taiwan’s Toyo Pharmaceutical Co., Ltd. and Japan’s Dapeng Pharmaceutical Co., Ltd. Phase III clinical trials of pancreatic cancer in Taiwan and Japan are the largest clinical studies of pancreatic cancer in Asia at present. They include Taiwan University, Chang Gung, Wing, Ma, China, Changji, Chengda, Chi Mei , Gao Yi attached medical doctors have joined this clinical study. The results of this study confirm that oral TS-1 (Evans) has comparable efficacy to current standard gemcitabine in the treatment of advanced pancreatic cancer and has lower blood side effects; if combined with gemcitabine treatment, it can prolong the time of disease progression and can be effective. Reduce the tumor and relieve the clinical symptoms caused by the tumor. This research result of advanced pancreatic cancer was published in May 2013 in the internationally renowned journal Journal of Clinical Oncology. Taiwan now offers advanced and effective new treatment options for patients with advanced pancreatic cancer. Each year, it benefits about 1,500 patients with advanced pancreatic cancer.

On May 31, 2014 Roche reported results from a Phase I open-label study that showed the investigational cancer immunotherapy MPDL3280A (anti-PDL1) shrank tumours (overall response rate) in 43 percent (13/30) of people previously treated for metastatic urothelial bladder cancer (UBC) whose tumours were characterised as PD-L1 (Programed Death Ligand-1) positive by a test being developed by Roche (Press release Hoffmann-La Roche, MAY 31, 2014, View Source [SID:1234500672]). Adverse events (AEs) were consistent with what has been previously reported for MPDL3280A. There were no severe (Grade 4-5) treatment related AEs.

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The FDA has granted MPDL3280A Breakthrough Therapy Designation. This designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.

"Bladder cancer is the ninth most common cancer worldwide, for which there have been no new treatment advances in nearly 30 years, so we are pleased the FDA has granted breakthrough designation for MPDL3280A in metastatic bladder cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We are evaluating MPDL3280A in a broad range of tumours, and have begun pivotal studies that include a companion diagnostic test in lung and bladder cancers."

Full results of the study will be presented today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) by Thomas Powles, M.D., clinical professor of Genitourinary Oncology, Barts Cancer Institute at the Queen Mary University of London, UK (Abstract #5011, Saturday, May 31, 3:36–3:48 P.M. Central Time).

About the Phase I MPDL3280A Study
The Phase I study is a single-arm, multi-center, open-label trial with a cohort of 68 people with previously treated, metastatic bladder cancer.
The study included 30 patients who were identified as PD-L1 positive (immunohistochemistry [IHC] 2/3) using an investigational PD-L1 diagnostic test being developed by Roche.
After six weeks of follow-up, the objective response rate (ORR) as measured by RECIST criteria was 43 percent (13/30), and after 12 weeks, ORR was 52 percent (13/25) in people with PD-L1-positive tumours.
A complete response (no radiographic evidence of tumour) was observed in 7 percent of PD-L1-positive patients (2/30).
The ORR was 11 percent (4/35) in people whose tumours were identified as PD-L1-negative (IHC 0/1) by our investigational test.
People in the study experienced a median time to response of 42 days.
Treatment-related Grade 3 AEs occurred in 4 percent (3/68) of people in the study and included weakness (asthenia; 2 percent), low platelet count (thrombocytopenia; 2 percent) and low phosphate levels (blood phosphorus decrease; 2 percent).
The most common AEs observed to date occurring in more than 5 percent of patients were decreased appetite (12 percent), fatigue (12 percent), nausea (12 percent), fever (pyrexia; 9 percent) and weakness (asthenia; 7 percent).