ONT-380

Odonate Therapeutics Announces Completion of Enrollment in CONTESSA, a Phase 3 Study of Tesetaxel in Patients with Metastatic Breast Cancer

Retrieved on: 
Monday, October 21, 2019
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Clinical medicine, Cancer, Medicine, Breast cancer, Metastatic breast cancer, Cancer treatments, Tyrosine kinase inhibitors, ONT-380, Apatinib, Tesetaxel, CONTESSA, Odonate Therapeutics, Inc.

In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies.

Key Points: 
  • In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies.
  • Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.
  • CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC).
  • Odonate Therapeutics, Inc. is a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer.

Seattle Genetics Announces Positive Topline Results from Pivotal Trial of Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer

Retrieved on: 
Monday, October 21, 2019
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Medicine, Clinical medicine, Cancer, Cancer treatments, Genentech, RTT, ONT-380, HER2/neu, Trastuzumab, Metastatic breast cancer, Breast cancer, Protein kinase inhibitor, HER2-Positive Breast Cancer, HER2CLIMB, Tucatinib, Seattle Genetics

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced positive topline results from the HER2CLIMB trial, a randomized, double-blind, placebo-controlled, active comparator pivotal trial evaluating tucatinib.

Key Points: 
  • Seattle Genetics, Inc. (Nasdaq:SGEN) today announced positive topline results from the HER2CLIMB trial, a randomized, double-blind, placebo-controlled, active comparator pivotal trial evaluating tucatinib.
  • The trial compared tucatinib in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.
  • Seattle Genetics management will host a conference call and webcast to discuss topline results from the HER2CLIMB clinical trial of tucatinib.
  • Tucatinib, a small molecule tyrosine kinase inhibitor, is in clinical trials for HER2-positive metastatic breast cancer and metastatic colorectal cancer.

Seattle Genetics Announces Initiation of Phase 3 Clinical Trial of Tucatinib in Combination with Ado-trastuzumab Emtansine (T-DM1, Kadcyla®) for Patients with Advanced or Metastatic HER2-Positive Breast Cancer

Retrieved on: 
Thursday, October 10, 2019
Biotechnology, Health, Pharmaceutical, Oncology, Research, Public relations, Investor relations, General Health, Communications, Science, Clinical trials, Clinical medicine, Medicine, Cancer, Cancer treatments, Genentech, ONT-380, Breast cancer, RTT, Trastuzumab emtansine, Tucatinib, HER2/neu, Metastatic breast cancer, Tucatinib, HER2-Positive Metastatic Breast Cancer, Seattle Genetics

We are pleased to advance this tucatinib clinical trial with the vision of improving combination outcomes for patients with HER2-positive metastatic breast cancer who receive T-DM1.

Key Points: 
  • We are pleased to advance this tucatinib clinical trial with the vision of improving combination outcomes for patients with HER2-positive metastatic breast cancer who receive T-DM1.
  • Tucatinib has been granted orphan drug designation by the FDA for the treatment of breast cancer patients with brain metastases.
  • Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer.
  • Moulder, S. et al., Phase 1 Trial of ONT-380, a HER2 Inhibitor, in Patients with HER2+ Advanced Solid Tumors, with an Expansion Cohort in HER2+ Metastatic Breast Cancer.

Annexon Biosciences Reports Top-line Phase 1b Results for Novel C1q Inhibitor ANX005 in Guillain-Barré Syndrome

Retrieved on: 
Monday, September 30, 2019
Biotechnology, Health, Pharmaceutical, Clinical trials, Health, Clinical research, Design of experiments, Medical research, Clinical pharmacology, Clinical trial, Pharmaceutical industry, ONT-380

We are very pleased by the tolerability profile, pharmacokinetic and biomarker activity observed in our Phase 1b trial in GBS patients.

Key Points: 
  • We are very pleased by the tolerability profile, pharmacokinetic and biomarker activity observed in our Phase 1b trial in GBS patients.
  • Based on these promising results, we look forward to advancing ANX005 into later-stage clinical trials.
  • A Phase 1b placebo controlled, dose escalation trial of ANX005 was conducted in 31 patients with Guillain-Barr syndrome (GBS).
  • Annexon has completed a Phase 1b clinical trial of ANX005 and plans to advance ANX005 into later-stage clinical trials in Guillain-Barr Syndrome (GBS).

Initial Results from MOUNTAINEER Trial Show Antitumor Activity of Tucatinib Combination in HER2-Positive Metastatic Colorectal Cancer

Retrieved on: 
Sunday, September 29, 2019
Research, Clinical trials, Biotechnology, Pharmaceutical, Health, Oncology, Science, Medicine, Clinical medicine, Drugs, Genentech, Cancer treatments, Antineoplastic drugs, Immunology, RTT, Trastuzumab, HER2/neu, ONT-380, Trastuzumab emtansine, MOUNTAINEER, Tucatinib, Colorectal Cancer, Seattle Genetics

Tucatinib is a potent and selective inhibitor of HER2, and the combination of tucatinib and trastuzumab demonstrated significant activity for heavily pre-treated patients with HER2-positive metastatic colorectal cancer, said John H. Strickler, M.D., Duke University Medical Center.

Key Points: 
  • Tucatinib is a potent and selective inhibitor of HER2, and the combination of tucatinib and trastuzumab demonstrated significant activity for heavily pre-treated patients with HER2-positive metastatic colorectal cancer, said John H. Strickler, M.D., Duke University Medical Center.
  • The trial demonstrated that tucatinib has the potential to play a role in the treatment of colorectal cancer.
  • We look forward to developing tucatinib in combination with trastuzumab and other therapies for the treatment of HER2-positive metastatic colorectal cancer.
  • MOUNTAINEER is a multi-center, open label, single-arm phase 2 clinical trial of tucatinib in combination with trastuzumab in patients with HER2-positive, RAS wildtype metastatic or unresectable colorectal cancer.

FDA Grants Orphan Drug Designation to Puma Biotechnology’s NERLYNX® for the Treatment of Breast Cancer Patients with Brain Metastases

Retrieved on: 
Tuesday, September 3, 2019
Oncology, FDA, Health, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Clinical medicine, Cancer treatments, HER2/neu, Neratinib, Brain metastasis, Breast cancer, ONT-380, Tucatinib, HER2-Positive Breast Cancer, Puma Biotechnology

Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX (neratinib) for the treatment of breast cancer patients with brain metastases.

Key Points: 
  • Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX (neratinib) for the treatment of breast cancer patients with brain metastases.
  • Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer, said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma.
  • Despite expanded treatment options for HER2-positive breast cancer, brain metastases in these patients represent a significant clinical challenge, as well as sources of morbidity and mortality for most of these patients.
  • HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.

RemeGen, Ltd. Announces Positive Results from RC48 Clinical Trial in HER2-Positive Metastatic or Unresectable Urothelial Cancer

Retrieved on: 
Tuesday, June 4, 2019
Medicine, Clinical medicine, Cancer treatments, Antineoplastic drugs, Immunology, Antibody-drug conjugates, Genentech, HER2/neu, Investigational New Drug, Trastuzumab emtansine, ONT-380

YANTAI,China, June 4, 2019 /PRNewswire/ --RemeGen, Ltd. today announcedpositive topline results for a Phase II clinical trial of RC48.

Key Points: 
  • YANTAI,China, June 4, 2019 /PRNewswire/ --RemeGen, Ltd. today announcedpositive topline results for a Phase II clinical trial of RC48.
  • The HER2-targeting antibody-drug conjugate (ADC) and potential new medicine was evaluated in patients with HER2-positive metastatic or unresectable urothelial cancer who have received previous treatment with chemotherapies and had visceral metastasis.
  • These results are expected to support a global late stage clinical trial, including an Investigational New Drug Application (IND), with the US Food and Drug Administration (FDA) anticipated in the second half of 2019.
  • RC48 was the first ADC drug approved for human clinical trials inChinaand an excellent safety profile has been observed in clinical trials.

SpringWorks Therapeutics Announces Initiation of Phase 1b Clinical Trial of MEK Inhibitor PD-0325901 in Combination with BeiGene’s RAF Dimer Inhibitor Lifirafenib in Advanced or Refractory Solid Tumors

Retrieved on: 
Monday, May 6, 2019
Health, Biotechnology, Clinical trials, Oncology, Pharmaceutical, Other Health, Enzymes, Tyrosine kinase receptors, Protein kinases, Signal transduction, Tyrosine kinase inhibitors, BRAF, Oncogenes, Mitogen-activated protein kinase, C-Met, Vemurafenib, ONT-380

The Phase 1b trial is a multicenter, open label, dose-escalation trial of PD-0325901 in combination with lifirafenib in adult patients with advanced or metastatic, unresectable tumors harboring K-RAS/N-RAS or B-RAF mutations, or any other MAPK pathway aberration.

Key Points: 
  • The Phase 1b trial is a multicenter, open label, dose-escalation trial of PD-0325901 in combination with lifirafenib in adult patients with advanced or metastatic, unresectable tumors harboring K-RAS/N-RAS or B-RAF mutations, or any other MAPK pathway aberration.
  • The trial is being conducted under a global clinical collaboration agreement between SpringWorks Therapeutics and BeiGene, which was entered into in September 2018.
  • PD-0325901 has been tested in several Phase 1 and Phase 2 clinical trials, and approximately 260 subjects have been exposed to treatment.
  • Lifirafenib was discovered in BeiGenes research facilities in Beijing, China, and is an investigational small molecule kinase inhibitor with RAF monomer and dimer inhibition activities.

Odonate Therapeutics Announces Initiation of CONTESSA 2, a Phase 2 Study of Tesetaxel in Patients with Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

Retrieved on: 
Monday, March 4, 2019
Health, Clinical trials, Oncology, Pharmaceutical, Organic compounds, Chemistry, Organic chemistry, Pyridines, Breast cancer, Metastatic breast cancer, Tesetaxel, Trastuzumab emtansine, ONT-380

CONTESSA 2 is designed to complement CONTESSA, a Phase 3 study in taxane-experienced patients, by investigating the same tesetaxel-containing regimen in patients who have not previously received a taxane.

Key Points: 
  • CONTESSA 2 is designed to complement CONTESSA, a Phase 3 study in taxane-experienced patients, by investigating the same tesetaxel-containing regimen in patients who have not previously received a taxane.
  • In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies.
  • CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC).
  • CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/MBC).

Daiichi Sankyo Presents Updated Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Expressing Advanced Colorectal Cancer at 2018 European Society for Medical Oncology (ESMO) Congress

Retrieved on: 
Sunday, October 21, 2018
Medicine, Clinical medicine, Cancer treatments, Health, Immunology, RTT, Trastuzumab, HER2/neu, Daiichi Sankyo, ONT-380

"These initial findings support further evaluation of [fam-] trastuzumab deruxtecan in this specific type of colorectal cancer."

Key Points: 
  • "These initial findings support further evaluation of [fam-] trastuzumab deruxtecan in this specific type of colorectal cancer."
  • "Patient enrollment is underway into our global phase 2 study evaluating safety and efficacy of [fam-] trastuzumab deruxtecan in patients with HER2 expressing advanced colorectal cancer."
  • Any reported cases of ILD/pneumonitis in the [fam-] trastuzumab deruxtecan clinical development program are evaluated by an independent adjudication committee.
  • [Fam-] trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in U.S. only; trastuzumab deruxtecan in other regions of world) is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise.