Cyclopropanes

Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer

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Monday, June 28, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Orphan drugs, Drugs, Organic compounds, Antineoplastic drugs, Tyrosine kinase inhibitors, Cabozantinib, Cyclopropanes, Quinolines, Exelixis, Ipsen, Sorafenib, COSMIC-312, HCC, CABOMETYX® (cabozantinib), Ipsen, COSMIC-312, HCC, CABOMETYX® (CABOZANTINIB), IPSEN

Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).

Key Points: 
  • Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).
  • In the European Union, CABOMETYX is also approved in combination with nivolumab as first line treatment for patients living with advanced RCC.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer

Retrieved on: 
Monday, June 28, 2021
Research, FDA, Clinical trials, Other Health, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Chemical compounds, Orphan drugs, Drugs, Organic compounds, Antineoplastic drugs, Tyrosine kinase inhibitors, Cabozantinib, Cyclopropanes, Quinolines, Exelixis, Ipsen, Sorafenib, COSMIC-312, HCC, CABOMETYX® (cabozantinib), Ipsen, COSMIC-312, HCC, CABOMETYX® (CABOZANTINIB), IPSEN

Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).

Key Points: 
  • Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).
  • In the European Union, CABOMETYX is also approved in combination with nivolumab as first line treatment for patients living with advanced RCC.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

Exelixis and Ipsen Announce Detailed Results from Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Presented at ASCO 2021

Retrieved on: 
Monday, June 7, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Anatomy, Thyroid disease, Organ systems, Cyclopropanes, Orphan drugs, Organs anatomy), Cabozantinib, Quinolines, Exelixis, Thyroid cancer, Ipsen, Thyroid nodule, CABOMETYX, CABOMETYX

Exelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) today announced detailed results from the phase 3 COSMIC-311 pivotal trial of cabozantinib (CABOMETYX) in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC).

Key Points: 
  • Exelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) today announced detailed results from the phase 3 COSMIC-311 pivotal trial of cabozantinib (CABOMETYX) in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC).
  • COSMIC-311 is a global, multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that aimed to enroll approximately 300 patients at 150 sites globally.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer: The American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer.

Final Data from Calithera Biosciences’ Phase 2 CANTATA Study in Renal Cell Carcinoma Presented at 2021 ASCO Annual Meeting

Retrieved on: 
Monday, June 7, 2021
Tyrosine kinase inhibitors, Cabozantinib, Cyclopropanes, Quinolines, Medicine, Progression-free survival, Chemical substances, Health care

The findings were highlighted in an oral presentation at the virtual American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.

Key Points: 
  • The findings were highlighted in an oral presentation at the virtual American Society of Clinical Oncology (ASCO) 2021 Annual Meeting.
  • Results announced previously showed that the addition of telaglenastat to cabozantinib did not improve progression-free survival (PFS) in the study population.
  • Median progression-free survival (mPFS) in patients who received telaglenastat and cabozantinib was 9.2 months versus 9.3 months in patients who received placebo and cabozantinib.
  • The frequency and severity of adverse events in the telaglenastat-treated population were comparable to those of cabozantinib alone and remained consistent with known risks of both agents.

Exelixis and Ipsen Announce Detailed Results from Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Presented at ASCO 2021

Retrieved on: 
Monday, June 7, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Anatomy, Thyroid disease, Organ systems, Cyclopropanes, Orphan drugs, Organs anatomy), Cabozantinib, Quinolines, Exelixis, Thyroid cancer, Ipsen, Thyroid nodule, CABOMETYX, CABOMETYX

Exelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) today announced detailed results from the phase 3 COSMIC-311 pivotal trial of cabozantinib (CABOMETYX) in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC).

Key Points: 
  • Exelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) today announced detailed results from the phase 3 COSMIC-311 pivotal trial of cabozantinib (CABOMETYX) in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC).
  • COSMIC-311 is a global, multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that aimed to enroll approximately 300 patients at 150 sites globally.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer: The American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer.

Exelixis Announces Consistent Efficacy Benefits Across Subgroups of Phase 3 CheckMate -9ER Trial of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-line Treatment for Patients with Advanced Renal Cell Carcinoma

Retrieved on: 
Friday, June 4, 2021
General Health, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Clinical medicine, Drugs, Hematology, Orphan drugs, Antineoplastic drugs, Cabozantinib, Cyclopropanes, Sunitinib, Renal cell carcinoma, Venous thrombosis, Embolism, CheckMate -9ER, RCC, CABOMETYX® (cabozantinib), Exelixis, CHECKMATE -9ER, RCC, CABOMETYX® (CABOZANTINIB), EXELIXIS

CheckMate -9ER is an open-label, randomized (1:1), multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma with a clear cell component.

Key Points: 
  • CheckMate -9ER is an open-label, randomized (1:1), multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma with a clear cell component.
  • The primary efficacy analysis compares the doublet combination regimen of CABOMETYX and OPDIVO versus sunitinib in all randomized patients.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.
  • Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients.

Exelixis Announces Quality-Adjusted Survival Benefit Demonstrated in Analysis of Phase 3 CheckMate -9ER Trial of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) in Patients with Previously Untreated Advanced Renal Cell Carcinoma

Retrieved on: 
Friday, June 4, 2021
General Health, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Drugs, Cancer treatments, Antineoplastic drugs, Orphan drugs, Cabozantinib, Cyclopropanes, Quinolines, Sunitinib, Renal cell carcinoma, Nivolumab, Toni Choueiri, CheckMate -9ER, RCC, CABOMETYX® (cabozantinib), Exelixis, CHECKMATE -9ER, RCC, CABOMETYX® (CABOZANTINIB), EXELIXIS

This analysis shows that the overall survival benefit demonstrated in the phase 3 CheckMate -9ER trial results in clinically important gains in quality-adjusted survival.

Key Points: 
  • This analysis shows that the overall survival benefit demonstrated in the phase 3 CheckMate -9ER trial results in clinically important gains in quality-adjusted survival.
  • CheckMate -9ER is an open-label, randomized (1:1), multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma with a clear cell component.
  • The primary efficacy analysis compares the doublet combination regimen of CABOMETYX and OPDIVO versus sunitinib in all randomized patients.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

Sinovant Sciences and Nabriva Therapeutics Announce Positive Topline Results from Phase 3 Trial of Lefamulin in Chinese Adults with Community Acquired Bacterial Pneumonia (CABP)

Retrieved on: 
Tuesday, May 25, 2021
Chemical compounds, Drugs, Cyclopropanes, Moxifloxacin, Health care, Antibiotic, Pneumonia, Empiric

Subjects were randomized 2:1 to lefamulin and moxifloxacin and stratified by prior antibiotic exposure, pneumonia severity index (PSI) risk class, and renal impairment.

Key Points: 
  • Subjects were randomized 2:1 to lefamulin and moxifloxacin and stratified by prior antibiotic exposure, pneumonia severity index (PSI) risk class, and renal impairment.
  • These results are similar to those observed in the global Phase 3 LEAP 1 and LEAP 2 clinical trials conducted by Nabriva.
  • We are delighted with the results of this trial, said Dr. Rae Yuan, CEO of Sinovant.
  • These data strongly support the use of lefamulin as an empiric monotherapy for CABP, a disease that affects millions of Chinese patients annually.

Exelixis Announces Phase 1b Results from Cohort 6 of COSMIC-021 Trial in Patients with Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Monday, May 24, 2021
Oncology, Health, General Health, Radiology, Clinical trials, Pharmaceutical, Biotechnology, Orphan drugs, Chemical compounds, Drugs, Cancer treatments, Cabozantinib, Cyclopropanes, Quinolines, Exelixis, Prostate cancer, Atezolizumab, CRPC, Nicholas J. Vogelzang, the COSMIC-021 Study, CRPC, CABOMETYX® (cabozantinib), Exelixis, THE COSMIC-021 STUDY, CRPC, CABOMETYX® (CABOZANTINIB), EXELIXIS

Exelixis, Inc. (NASDAQ: EXEL) today announced results from the metastatic castration-resistant prostate cancer (CRPC) cohort 6 of COSMIC-021, the phase 1b trial of cabozantinib (CABOMETYX) in combination with atezolizumab in patients with locally advanced or metastatic solid tumors.

Key Points: 
  • Exelixis, Inc. (NASDAQ: EXEL) today announced results from the metastatic castration-resistant prostate cancer (CRPC) cohort 6 of COSMIC-021, the phase 1b trial of cabozantinib (CABOMETYX) in combination with atezolizumab in patients with locally advanced or metastatic solid tumors.
  • Many patients with metastatic castration-resistant prostate cancer who have progressed on a novel hormonal therapy wish to avoid or delay chemotherapy.
  • We look forward to building on these results with the phase 3 CONTACT-02 trial in our continued effort to bring cabozantinib to many more patients in need.
  • COSMIC-021 is a multicenter, phase 1b, open-label study that is divided into two parts: a dose-escalation phase and an expansion cohort phase.

PhaseBio Highlights Real-World Healthcare Cost and Bleeding Cost Data Featured at the International Society for Pharmacoeconomic and Outcomes Research (ISPOR) Virtual 2021 Conference

Retrieved on: 
Thursday, May 20, 2021
Science, Cardiology, Biotechnology, Insurance, Research, Pharmaceutical, Health, Professional services, Health sciences, Health, Alcohols, Cyclopropanes, Ticagrelor, Clinical research, Design of experiments, Drugs, Clinical trial

All patients were required to present \xe2\x89\xa51 year of continuous insurance coverage prior to initiating their therapy, and outcomes were measured while patients remained on therapy.

Key Points: 
  • All patients were required to present \xe2\x89\xa51 year of continuous insurance coverage prior to initiating their therapy, and outcomes were measured while patients remained on therapy.
  • The Phase 1 clinical trial of bentracimab in healthy volunteers was published in the New England Journal of Medicine in March 2019.
  • Additionally, the Phase 2a trial investigated a bentracimab regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects.
  • These results are consistent with the results observed in healthy younger subjects treated with ticagrelor in the previously published Phase 1 trial.