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Modra Pharmaceuticals Announces First Patients Treated in Phase IIa Metastatic Breast Cancer Trial

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.

Samsung Bioepis Announces Three-year Follow-up Data for Biosimilar ONTRUZANT® (trastuzumab) in Early or Locally Advanced HER2-positive Breast Cancer

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.

"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.

Provectus Provides Update on Metastatic Uveal Melanoma Clinical Development Program for Investigational Drug PV-10

On March 21, 2019 Provectus (OTCQB: PVCT) reported that updates on the Company’s metastatic uveal melanoma drug development program for its lead investigational cancer agent PV-10 (Press release, Provectus Biopharmaceuticals, MAR 21, 2019, View Source [SID1234534529]). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells1-4, which may lead to a functional recruitment of the immune system.

Update #1. Presentations about PV-10 treatment of metastatic uveal melanoma will be given by Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine of The University of Texas MD Anderson Cancer Center at:

The International Society of Ocular Oncology (ISOO) Biennial Conference in Los Angeles, California from March 22-26, entitled "Percutaneous oncolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastasis." ISOO is a non-profit corporation with the specific and primary purpose to advance and promote the practice of ocular oncology, and

The spring meeting of the Ophthalmic Oncology Group (OOG) in London, England from April 11-13, entitled "A Phase 1 Study of Percutaneous Oncolytic Rose Bengal Disodium (PV10) for Metastatic Uveal Melanoma to the Liver." OOG is an independent scientific group devoted to clinical ophthalmic oncology and related basic-science research.
Update #2. The Company will host a round table involving metastatic uveal melanoma patients at CURE OM’s Eyes on a Cure: Patient & Caregiver Symposium in Raleigh, North Carolina from April 5-7. The Community United for Research and Education of Ocular Melanoma (CURE OM) is the Melanoma Research Foundation’s initiative to increase awareness, education, and research funding for ocular melanoma, while improving the lives of people affected by this disease.

Ocular melanoma is a general category of melanoma disease affecting the eye and orbit. Its most common form, uveal melanoma, is an intraocular affliction originating in melanocytes in the iris, ciliary body, or choroid. Together with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of ocular melanoma patients develop metastatic disease despite successful treatment of their primary tumors. Metastatic disease has historically been, and remains, generally fatal.

About Metastatic Uveal Melanoma

Uveal melanoma is a rare disease that is biologically and clinically distinct from cutaneous melanoma.5,6 Nearly 50% of uveal melanoma patients develop metastatic disease, with 80-90% of them presenting with liver as the first site of disease involvement.5,6,7 Outcomes of metastatic uveal melanoma are poor, with a median overall survival of 12 months.8

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers. In February 2019, orphan drug designation status was granted to PV-10 by the U.S. Food and Drug Administration for the treatment of ocular melanoma.

BioLineRx to Report Annual 2018 Results on March 28, 2019

On March 21, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported it will release its audited annual financial results for the year ended December 31, 2018 on Thursday, March 28, 2019, before the US markets open (Press release, BioLineRx, MAR 21, 2019, View Source;p=irol-newsArticle&ID=2391959 [SID1234534528]).

The Company will host a conference call on Thursday, March 28, 2019 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-866-229-7198 from the U.S. or +972-3-918-0664 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until March 30, 2019; please dial +1-888-295-2634 from the U.S. or +972-3-925-5938 internationally

Heat Biologics to Present at the Chinese Society for Clinical Oncology Conference on Immunotherapy

On March 21, 2019 Heat Biologics,Inc. (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported an oral presentation to be held at the Chinese Society for Clinical Oncology (CSCO) Conference on Immunotherapy, endorsed by the American Association for Cancer Research (AACR) (Free AACR Whitepaper), taking place in Shanghai, China (Press release, Heat Biologics, MAR 21, 2019, View Source [SID1234534527]). The oral session will be held on March 22, 2019 from 17:00 China Standard Time. Management will present the interim results of the Phase 2 Lung Cancer Data on HS-110 + Nivolumab that were presented at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium on February 28, 2019.

Details of the presentation are as follows:

Title: Viagenpumatucel-L (HS-110) plus nivolumab in patients with advanced non-small cell lung cancer (NSCLC)

Oral Session: March 22, 2019; 17:00 China Standard Time (March 22, 2019; 2:00 Pacific Time)

Location: Main Conference Room (Powerlong Ballroom), Le Meridien Shanghai Minhang Hotel, Shanghai, China

The AACR (Free AACR Whitepaper) is proud to work with the Chinese Society for Clinical Oncology (CSCO) and endorse this conference, which will take place on March 22-23, 2019, in Shanghai, China. The program will bring together researchers from the United States, China, and around the world to share the latest developments focusing on translational to clinical applications of immunotherapy with an emphasis on cancers with high incidence in the region. Each session will feature speakers from both China and abroad and offer ample opportunity to foster international scientific exchange.