On March 21, 2019 Samsung Bioepis Co., Ltd. reported findings of a three-year follow-up study comparing biosimilar ONTRUZANT (trastuzumab) and reference medicine trastuzumab in early or locally advanced HER2-positive breast cancer (Press release, Samsung Bioepis, MAR 21, 2019, View Source [SID1234534530]). The data, which show comparable overall survival and cardiac safety, were presented today at the 16th St. Gallen International Breast Cancer Conference 2019 taking place in Vienna, Austria.

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"With the development of our biosimilar trastuzumab, we aimed to make one of the mainstays of modern cancer therapy more accessible for more people more quickly, and these long-term data underline the importance of that aim," said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges."

Participants enrolled in an initial Phase III study received eight cycles of the biosimilar trastuzumab or the reference medicine concurrently with chemotherapy in the neoadjuvant setting. Following surgery, they received additional 10 cycles of the biosimilar trastuzumab or the reference medicine. After completion of therapy, 367 of these participants (186 in the biosimilar trastuzumab group and 181 in the reference medicine group) were enrolled in the follow-up study. Median follow-up from initiation of study treatment was 40.8 months in the biosimilar trastuzumab group and 40.5 months in the reference medicine group.

Overall survival was 97% in the biosimilar trastuzumab group and 93.6% in the reference medicine group (HR 0.39, 95% CI, 0.14-1.12). Event-free survival was 92.5% in the biosimilar trastuzumab group and 86.3% in the reference medicine group (HR 0.49, 95% CI, 0.26-0.91). The incidence of cardiac events was rare for both treatment groups throughout the three-year follow-up period. There were three cases of asymptomatic significant left ventricular ejection fraction (LVEF) decrease (biosimilar trastuzumab, n=1; reference medicine, n=2), with all patients recovering with LVEF ≥ 50%. There were no cases of symptomatic congestive heart failure, cardiac death or other significant cardiac conditions reported in either group.

The poster of this study will be exhibited at the 16th St. Gallen International Breast Cancer Conference 2019, as follows:

[P156] 3-YEAR FOLLOW-UP OF A PHASE III STUDY COMPARING SB3 (TRASTUZUMB BIOSIMILAR) AND REFERENCE TRASTUZUMAB IN HER2 POSITIVE EARLY OR LOCALLY ADVANCED BREAST CANCER IN NEOADJUVANT SETTING [POSTER SESSION I, MARCH 21, 2019]
ONTRUZANT (trastuzumab) 150 mg was granted the European Commission (EC) Marketing Authorization in November 2017 and was approved by the U.S. Food and Drug Administration in January 2019. In February 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a 420 mg vial presentation of ONTRUZANT.iii With the adoption of CHMP’s positive opinion for ONTRUZANT 420 mg vial presentation, ONTRUZANT will be available in two vial sizes in Europe, providing clinics with greater convenience and flexibility than the 150 mg vial presentation alone.

On March 21, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that its 2018 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy have been posted to shareholders (Press release, Hutchison China MediTech, MAR 21, 2019, View Source [SID1234534549]). The documents can be accessed from the website of Chi-Med (www.chi-med.com).

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On March 21, 2019 Modra Pharmaceuticals B.V. ("Modra") reported that the first patients have been treated in its Phase IIa study in patients with recurrent or metastatic HER-2 negative breast cancer (Press release, Modra Pharmaceuticals, MAR 21, 2019, View Source [SID1234534531]). The trial will evaluate the efficacy and safety of Modra’s lead product, ModraDoc006/r, a proprietary oral therapeutic based on the standard intravenous taxane chemotherapy, docetaxel. In addition to enabling patients to take their chemotherapy at home, the novel approach has, in prior pre-clinical and clinical testing, demonstrated the potential to reduce toxicity and increase the efficacy of the treatment. As the lead program in the Company’s pipeline, ModraDoc006/r has successfully completed Phase I clinical trials in patients with solid tumors and specifically in patients with prostate cancer.

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"Chemotherapy remains a fundamental component of many modern cancer treatment regimens, including for patients with breast or prostate cancer, and ModraDoc006/r has been designed to improve the therapeutic outcomes and quality-of-life of patients as it offers a potentially safer and more efficacious solution that can be taken at home," commented Colin Freund, CEO of Modra Pharmaceuticals. "The swift start of this trial represents an important development milestone for Modra, and, together with our planned Phase IIb clinical trial in metastatic castration resistant prostate cancer, which recently received IND approval from the FDA, builds momentum for our global clinical development strategy."

The Phase IIa international multi-center study will determine the efficacy and tolerability of ModraDoc006/r in patients with recurrent or metastatic HER-2 negative breast cancer. For this trial, up to 24 evaluable patients will be treated. All patients will be given tablets of ModraDoc006/r twice daily, one day per week. The primary endpoint is objective response rate according to response evaluation criteria in solid tumors (RECIST). The secondary endpoints include progression-free survival and safety assessments. An additional exploratory objective is to determine whether ModraDoc006/r can be utilized safely in frail patients.

About Metastatic Breast Cancer

Breast cancer is the most common type of cancer in women. Once breast cancer becomes metastatic it is rarely curable, and it is widely accepted that women with metastatic disease should receive a form of systemic chemotherapy at some time during the course of their disease. Docetaxel has proven to be clinically effective in multiple tumor types including breast cancer.

About ModraDoc006/r

ModraDoc006 is a proprietary tablet form of the taxane chemotherapy drug, docetaxel. ModraDoc006 is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile and enhanced efficacy, as compared to standard intravenously-administered docetaxel.

On March 21, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that interim clinical data from its Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the primary treatment of primary choroidal melanoma, will be highlighted in an oral presentation at the International Society of Ocular Oncology (ISOO) 2019 Annual Meeting being held March 22-26, 2019, in Los Angeles (Press release, Aura Biosciences, MAR 21, 2019, View Source [SID1234534532]).

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"These 18-month safety and efficacy data demonstrate that light-activated AU-011 is well-tolerated, including with multiple administrations, and has shown initial evidence of tumor control and preservation of visual acuity even in high risk patients whose tumors are close to the fovea and optic disk," said Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology, Harvard Medical School, and lead author of the presentation.

"Light-activated AU-011 continues to show a compelling degree of tumor control, tolerability and vision preservation as a potential first line treatment option for patients with small choroidal melanoma and indeterminate lesions, especially given the lack of targeted treatment options for these patients," commented Cadmus Rich, M.D., Chief Medical Officer of Aura. "It is also remarkable that no drug-related severe adverse events, serious adverse events or dose limiting toxicities have been observed in the study to date. We are excited to share these data with the medical community at ISOO this year."

This open-label, multicenter trial is designed to investigate single and multiple ascending doses of light-activated AU-011 in approximately 52 adult subjects with clinically diagnosed primary choroidal melanoma. The details for the ISOO 2019 presentation are as follows:

Title: Eighteen Month Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma
Date and time: Sunday, March 24, 2019; 11:10-11:15am PT
Location: The Ritz-Carlton Marina del Rey

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

On March 21, 2019 Galera Therapeutics, Inc., a clinical-stage biotechnology company focused on the development of drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported data from its Phase 2b clinical trial of lead product candidate avasopasem manganese for the treatment of severe oral mucositis (SOM) in patients with head and neck cancer will be presented at the 2019 National Comprehensive Cancer Network (NCCN) Annual Conference (Press release, Galera Therapeutics, MAR 21, 2019, View Source [SID1234534553]). The meeting will take place March 21-23, 2019, at the Rosen Shingle Creek in Orlando, Fla.

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Details of the presentation are as follows:

Title: Reducing the duration, incidence and severity of mucosal injury due to cancer radiation therapy (RT); positive randomized Phase 2b trial results with GC4419 (avasopasem manganese), a small molecule superoxide (SO) dismutase (SOD) mimetic

Session: General Poster Session Two
Date/Time: Friday, March 22, 2019, 12:25-1:40 p.m. EDT
Presenter: Jon T. Holmlund, M.D., Chief Medical Officer, Galera

As one of the top five scoring abstracts, the data will also be shared in an oral presentation during a breakfast session from 7-8 a.m. EDT on Saturday, March 23, 2019, and published in the Journal of the National Comprehensive Cancer Network print and online editions.

The 2019 NCCN Annual Conference: Improving the Quality, Effectiveness, and Efficiency of Cancer Care, brings together cancer researchers, providers and other care professionals to share the latest cancer therapies and provide updates on selected NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the data upon which the NCCN Guidelines are based, and quality initiatives in oncology. For more information, visit View Source

About Avasopasem Manganese

Avasopasem manganese (GC4419) is a highly selective and potent small molecule dismutase mimetic that closely mimics the activity of human superoxide dismutase enzymes. It works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. Conversion of elevated superoxide to hydrogen peroxide, which is selectively more toxic to cancer cells, can also enhance the effect of radiation on tumors, particularly with stereotactic body radiation therapy (SBRT), which produces high levels of superoxide.

Avasopasem manganese is being studied in the Phase 3 ROMAN trial of patients with head and neck cancer, its lead indication, for its ability to reduce the incidence and severity of radiation-induced severe oral mucositis. In Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial, avasopasem manganese demonstrated the ability to dramatically reduce the duration of SOM from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, while demonstrating acceptable safety when added to a standard radiotherapy regimen. Avasopasem manganese is also currently being studied in combination with SBRT for its anti-tumor effect in a Phase 1/2 trial of patients with locally advanced pancreatic cancer. In addition, in multiple preclinical studies, it demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy and Fast Track designations to avasopasem manganese for the reduction of SOM in patients with head and neck cancer.