On June 2, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported that presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in a virtual format from June 4 to 8, 2021 (Press release, Blue Earth Diagnostics, JUN 2, 2021, View Source [SID1234583374]). The two abstracts outlined the launch of studies investigating the use of Axumin (fluciclovine F 18, also known as FACBC) PET in the management of oligometastatic, recurrent prostate cancer, and its role, as assessed by the impact on radiographic progression-free survival, in guiding radiotherapy planning for patients with recurrent disease. Details of the presentations to be given by Blue Earth Diagnostics’ collaborators are listed below.

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NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a registered trademark of Blue Earth Diagnostics, Ltd., or its related companies. All other marks are the property of their respective owners.

Highlighted Axumin (Fluciclovine F 18) Scientific Presentations

All ASCO (Free ASCO Whitepaper) presentations are available beginning Friday, June 4, 2021, at 9:00 a.m. ET.

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Subtrack: Prostate Cancer – Local-Regional Disease

Title: The fluciclovine (FACBC) PET/CT site-directed therapy of oligometastatic prostate cancer (Flu-BLAST-PC) trial

Author(s): Risa Liang Wong, Sarah K Holt, Jing Zeng, Laura Graham, Rachel Kang, Nathan Conrad, Andrea Toulouse, Zoya Bauer, Michael Lai, Todd Yezefski, Jonathan L. Wright, Emily Steinberger Weg, Andrew Caleb Hsieh, Heather H. Cheng, Jean H Lee, Delphine L. Chen, Daniel W. Lin, Evan Y. Yu

Session: Poster session

Abstract: TPS5099

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Subtrack: Prostate Cancer – Local-Regional Disease

Title: Phase III study of local or systemic therapy INtensification DIrected by PET in prostate

CAncer patients with post-prostaTEctomy biochemical recurrence (INDICATE): ECOGACRIN EA8191

Author(s): Neha Vapiwala, Yu-Hui Chen, Steve Y. Cho, Fenghai Duan, Christos Kyriakopoulos, Daniel H. Shevrin, Rana R. McKay, Bridget F. Koontz, Evan Y. Yu, Volkan Beylergil, David A. Mankoff, Jonathan McConathy, Glenn Liu, Terence Z. Wong, Michael Anthony Carducci

Session: Poster session

Abstract: TPS5098

Blue Earth Diagnostics invites participants at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting to attend the above presentations and to learn more about the Company at www.blueearthdiagnostics.com. For full session details and scientific presentation listings, please see the ASCO (Free ASCO Whitepaper) online program here.

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION ABOUT AXUMIN
INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full U.S. Axumin prescribing information is available at:

View Source
About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including in neuro-oncology.

On June 2, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the appointment of industry veteran Zelanna Goldberg, M.D., M.A.S. as its Chief Medical Officer (Press release, Alpine Immune Sciences, JUN 2, 2021, View Source [SID1234583373]). Dr. Goldberg joins Alpine from Iovance Biotherapeutics, where she was Senior Vice President, Clinical Science.

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"We are very enthusiastic about the addition of Zelanna to the Alpine team, particularly as we pursue an expanding scope of clinical development activities across oncology and inflammatory disease indications," said Stanford Peng, M.D., Ph.D., President and Head of Research and Development at Alpine. "Zelanna is an experienced clinical development executive with a commitment to helping patients with life-threatening and debilitating diseases."

"I am thrilled to join Alpine and lead the clinical strategy and development of the company’s extremely promising pipeline, including ALPN-101, ALPN-202, and ALPN-303," said Dr. Goldberg. "I look forward to integrating within the research and development team to continue to advance these unique therapies and those that are coming next from Alpine’s directed evolution platform to meaningfully improve the lives of patients with cancer and life-threatening auto-immune diseases."

Dr. Goldberg brings over 20 years of industry and clinical practice experience, including strategic and/or operational responsibility for multiple therapeutic products such as dacomitinib (Vizimpro), palbociclib (Ibrance), and avelumab (Bavencio). Most recently, Dr. Goldberg was Senior Vice President, Clinical Sciences at Iovance Biotherapeutics, where she oversaw multiple aspects of the clinical development program of lifileucel (LN-145). Prior to Iovance, Dr. Goldberg held roles of increasing responsibility at Sunesis, Oxigene and Pfizer, where she was the global clinical lead for multiple assets. Prior to entering industry, Dr. Goldberg was an Associate Professor in the Department of Radiation Oncology at the University of California, Davis Medical Center.

Dr. Goldberg received her M.D. degree from University of Toronto Faculty of Medicine. Dr. Goldberg completed her residency in Radiation Oncology at Ontario Cancer Institute/Princess Margaret Hospital-University of Toronto, and her post-doctoral training in radiosensitizing drugs at Stanford University.

Disclosure of Inducement Grant under Nasdaq Listing Rules

The compensation committee of Alpine’s board of directors granted Dr. Goldberg an option to purchase 160,000 shares of common stock. The option will vest with respect to 25% of the shares underlying the option on the one-year anniversary of Dr. Goldberg’s employment start date of June 1, 2021, and the remaining 75% of the shares underlying the option will vest in equal monthly installments over the 36-month period following the one-year anniversary of Dr. Goldberg’s employment start date, subject to her continued service to Alpine through each relevant vesting date. In addition, pursuant to the terms of Alpine’s change of control and severance policy, if there is a change of control and, upon or during the 12 months after the change of control, Dr. Goldberg’s employment is terminated either (i) by Alpine without cause or (ii) by Dr. Goldberg for good reason, the option will become fully vested and exercisable. The option has a ten-year term and an exercise price of $10.29, equal to the per share closing price of Alpine’s common stock as reported by Nasdaq on June 1, 2021.

The stock options were granted outside Alpine’s 2018 Equity Incentive Plan as an inducement material to Dr. Goldberg entering into employment with Alpine in accordance with Nasdaq Listing Rule 5635(c)(4). The terms and conditions of the option are generally consistent with those in Alpine’s 2018 Equity Incentive Plan.

On June 2, 2021 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that Michael Amoroso, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 10:30 a.m. ET (Press release, Abeona Therapeutics, JUN 2, 2021, View Source [SID1234583372]).

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A live and archived webcast of the presentation will be available on the investor section of the Abeona Therapeutics website at www.abeonatherapeutics.com.

On June 2, 2021 Novartis reported updated median overall survival (OS) results for Kisqali (ribociclib) in combination with fulvestrant in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (Press release, Novartis, JUN 2, 2021, View Source [SID1234583369]). The exploratory analysis of OS after an additional 16.9 months of follow-up of the Phase III MONALEESA-3 trial evaluated Kisqali plus fulvestrant as first- or second-line treatment compared to fulvestrant alone in postmenopausal women with HR+/HER2- metastatic breast cancer1. The analysis found that with extended follow-up of more than four years, Kisqali in combination with fulvestrant continued to demonstrate a clinically relevant OS benefit of more than a year compared with fulvestrant alone1. These updated median OS data (Abstract #1001) will be presented in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"Successfully demonstrating overall survival improvements in an incurable disease like metastatic breast cancer is a significant achievement, and is what we ultimately strive for in most clinical trials," said Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center. "When the MONALEESA-7 trial achieved median OS of nearly five years at SABCS 2020, it was the first time we saw a median survival this long with a CDK4/6 inhibitor in the metastatic setting. It is encouraging to see median OS results of nearly 4.5 years in the MONALEESA-3 study, underscoring that ribociclib offers hope for patients to have a longer life while preserving quality of life."

After a median follow-up of 56.3 months, median OS for patients taking Kisqali in combination with fulvestrant was 53.7 months vs. 41.5 months for fulvestrant alone (HR=0.73; 95% CI: 0.59-0.90)1. Additionally, Kisqali plus fulvestrant had prolonged OS in the first-line (median, not reached vs. 51.8 months; HR=0.64; 95% CI: 0.46-0.88) and second-line (median, 39.7 vs. 33.7 months; HR=0.78; 95% CI: 0.59-1.04) treatment subgroups1. This exploratory ad hoc analysis follows the previously reported MONALEESA-3 OS analysis presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019 and published in the New England Journal of Medicine, which demonstrated statistically significant OS results for Kisqali in combination with fulvestrant with a 28% reduction in the risk of death (HR=0.72; 95% CI: 0.568-0.924; p=0.00455)6,7. Results from the subgroup analyses were consistent with the survival data seen with the intent-to-treat (ITT) population1.

"As overall survival data mature, we’re proud that Kisqali continues to distinguish itself, offering more life for both younger and older women living with metastatic breast cancer," said Susanne Schaffert, Ph.D., President, Novartis Oncology. "These data confirming the sustained efficacy of Kisqali for a broad range of people with HR+/HER2- metastatic breast cancer regardless of line of therapy are unique and inspiring. Our exploration of the benefits of Kisqali continues as we evaluate its potential in the adjuvant setting."

The need for chemotherapy was delayed to 4 years (48.1 months) in patients taking Kisqali in combination with fulvestrant and 28.8 months in the patients taking fulvestrant alone (HR=0.70; 95% CI: 0.57-0.88). Adverse events were consistent with previously reported Phase III trial results1.

"Breast cancer has recently emerged as the most common cancer among females worldwide. The decrease in screenings due to COVID-19 creates a potential threat to improvements in breast cancer survival," said Jean A. Sachs, MSS, MLSP, CEO of Living Beyond Breast Cancer. "What gives me hope is the continued focus on driving science for our community, and to see progress being made in metastatic breast cancer research as we work toward cures."

Visit View Source for the latest information from Novartis, including our commitment to the Oncology community, and access to our ASCO (Free ASCO Whitepaper)21 Virtual Scientific Program data presentations (for registered participants).

About Kisqali (ribociclib)
Kisqali was initially approved by the US Food and Drug Administration (FDA) in March 2017 and by the European Commission (EC) in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial. Kisqali in combination with an aromatase inhibitor was approved for the treatment of pre-, peri- or postmenopausal women as initial endocrine-based therapy, and also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the FDA in July 2018 and by the EC in December 2018. Regulatory filings are underway with other health authorities worldwide.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Important Safety Information from the Kisqali EU SmPC
Kisqali (ribociclib) is a prescription medicine approved in combination with an aromatase inhibitor as initial endocrine-based therapy in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is not known if Kisqali is safe and effective in children or adolescents. Kisqali can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Kisqali is not indicated for concomitant use with tamoxifen due to an increased risk of QT prolongation. Patients should tell their health care provider right away if they have a change in their heartbeat (a fast or irregular heartbeat), or if they feel dizzy or faint. Kisqali can cause serious liver problems. Patients should tell their health care provider right away if they get any of the following signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark or brown (tea-colored) urine, feeling very tired, loss of appetite, pain on the upper right side of the stomach area (abdomen), and bleeding or bruising more easily than normal. Low white blood cell counts are very common when taking Kisqali and may result in infections that may be severe. Patients should tell their health care provider right away if they have signs and symptoms of low white blood cell counts or infections such as fever and chills. Before taking Kisqali, patients should tell their health care provider if they are pregnant, or plan to become pregnant as Kisqali can harm an unborn baby. Females who are able to become pregnant and who take Kisqali should use highly effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali. Do not breastfeed during treatment with Kisqali and for at least 3 weeks after the last dose of Kisqali. Patients should tell their health care provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements since they may interact with Kisqali. Patients should avoid grapefruit or grapefruit juice while taking Kisqali. The most common side effects (incidence >=20%) include infections, white blood cell count decreases, headache, cough, nausea, tiredness, diarrhea, vomiting, constipation, hair loss and rash. The most common Grade 3/4 side effects (incidence >5%) were infections, low neutrophils, low leukocytes, low red blood cells, abnormal liver function tests, low lymphocytes, low phosphate levels and vomiting. Abnormalities were observed in hematology and clinical chemistry laboratory tests.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.com.

About Novartis in Advanced Breast Cancer
Novartis tackles breast cancer with superior science, collaboration and a passion for transforming patient care. We’ve taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.

On June 2, 2021 Seagen Inc. (Nasdaq: SGEN) reported that management will participate in a fireside chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on Wednesday, June 9, 2021 at 2:10 p.m. Eastern Time (Press release, Seagen, JUN 2, 2021, View Source [SID1234583368]). The presentation will be webcast live and available for replay from Seagen’s website at www.seagen.com in the Investors section.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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