[{"orgOrder":0,"company":"Oncolytics Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Oncolytics Biotech\u00ae Updates Clinical Development and Operations Activities During the COVID-19 Pandemic","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Oncolytics Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Oncolytics Biotech\u00ae to Present Clinical Findings of Pelareorep-Induced Immune Response in Breast Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Kisqali Receives Highest Rating of any CDK4\/6 Inhibitor on the ESMO Magnitude of Clinical Benefit Scale","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Penelope-B Trial of Ibrance\u00ae (palbociclib) in Early Breast Cancer Did Not Meet Primary Endpoint","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small 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Kisqali\u00ae Data Showing Longest Median Overall Survival Ever Reported in HR+\/HER2- Advanced Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NEJM Publication of Novartis Kisqali\u00ae Data Shows Longest Median Overall Survival Ever Reported in HR+\/HER2- Advanced Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pfizer Presents Positive Real-World Evidence for First-Line IBRANCE\u00ae (palbociclib) Combination Therapy in HR+, HER2- Metastatic Breast Cancer at ESMO Breast Cancer 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Data at ASCO and EHA Showcase Latest Oncology Research and Innovation, Including in Breast and Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Avenzo Therapeutics","sponsor":"New Enterprise Associates","pharmaFlowCategory":"D","amount":"$150.0 million","upfrontCash":"Undisclosed","newsHeadline":"Avenzo Therapeutics Announces $150 Million Oversubscribed Financing To Advance Emerging Oncology Pipeline","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sanofi Provides Update on Amcenestrant Clinical Development Program","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Onconova Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Onconova Therapeutics Doses First Patient in Phase 1\/2a Trial of Narazaciclib Combined with Letrozole in Endometrial Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Prestwick2_001025
Amcenestrant (SAR439859) is an orally bioavailable SERD that demonstrates pure ER antagonism in vivo. Compared with other SERD agents, amcenestrant provides optimal ER antagonism and degradation.
The net proceeds will be used to advance Avenzo’s ARTS-021 (AVZO-021), a potentially best-in-class CDK2 selective inhibitor being studied in an ongoing U.S.-based Phase 1 clinical study for the treatment of HR+/HER2- metastatic breast cancer and other advanced solid tumors.
ON123300 (narazaciclib) is a multi-kinase inhibitor targeting CDK 4, CDK 6, and other kinases important for cell proliferation and motility. It is being investigated in combination with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC).
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.
Latest in HR+/HER2- metastatic breast cancer, including data on CDK recycling with Kisqali® plus endocrine therapy, further MONALEESA-2 quality of life and overall survival analyses, and a new biomarker analysis of Piqray® plus fulvestrant.
After balancing for baseline demographic and clinical characteristics, median OS (95% CI) was significantly longer in Ibrance (palbociclib) group versus AI group (49.1 [45.2–57.7] vs 43.2 [37.6–48.0] months; hazard ratio (HR) = 0.76 [95% CI, 0.65–0.87]; P=0.0001).
MONALEESA-2 results show a statistically significant more than one-year increase in survival for women with HR+/HER2- postmenopausal aBC when using Kisqali plus letrozole compared to letrozole alone as first-line therapy.
MONALEESA-2 final analysis showed Kisqali, a CDK4/6 inhibitor in combination with letrozole has reported statistically significant overall survival benefit with aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in first-line (1L) setting.
Abstract, titled “Utility of the 70-gene MammaPrint assay for prediction of benefit from extended letrozole therapy in the NRG Oncology/NSABP B-42 trial” detailed a retrospective evaluation of 1,866 samples representing entire cohort.
Kisqali plus endocrine therapy had a median OS of nearly five years (58.7 months), the longest ever reported for premenopausal women with HR+/HER2- metastatic breast cancer (MBC), after a median of 53.5 months follow-up.