XL092


Associated tags: Biotechnology, Pharmaceutical, Clinical Trials, Oncology, Health, XL092

Exelixis Expands Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Include the Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Phase 1b STELLAR-002 Trial

Retrieved on: 
Tuesday, October 4, 2022

The novel triplet combination of XL092 and the fixed-dose combination of nivolumab and relatlimab has the potential to be used in multiple expansion cohorts.

Key Points: 
  • The novel triplet combination of XL092 and the fixed-dose combination of nivolumab and relatlimab has the potential to be used in multiple expansion cohorts.
  • XL092 is Exelixis next-generation oral tyrosine kinase inhibitor (TKI) that targets VEGF receptors, MET, AXL, MER and other kinases implicated in cancers growth and spread.
  • Bristol Myers Squibbs relatlimab is a lymphocyte activation gene-3 (LAG-3)-blocking antibody.
  • The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the combination therapy regimens, including XL092 and nivolumab, XL092, nivolumab and ipilimumab, and XL092 and the fixed-dose combination of nivolumab and relatlimab.

Exelixis Announces Dose-Escalation Results from the Phase 1 STELLAR-001 Trial Evaluating XL092 Alone and in Combination with an Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors at ESMO 2022

Retrieved on: 
Saturday, September 10, 2022

STELLAR-001 enrolled patients with advanced solid tumors for which standard of care did not exist or was not effective.

Key Points: 
  • STELLAR-001 enrolled patients with advanced solid tumors for which standard of care did not exist or was not effective.
  • Tumor reduction was seen in 71% of patients receiving single-agent XL092 and in 56% of patients receiving XL092 in combination with atezolizumab.
  • Confirmed partial responses were observed in four patients treated with single-agent XL092 and one patient treated with XL092 in combination with atezolizumab.
  • XL092 is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with immune checkpoint inhibitors.

Exelixis Announces Initiation of the STELLAR-303 Phase 3 Pivotal Trial Evaluating XL092 in Patients with Metastatic Colorectal Cancer

Retrieved on: 
Tuesday, June 21, 2022

Following recent promising data evaluating cabozantinib in combination with immunotherapies in colorectal cancer, we are thrilled to initiate our first phase 3 pivotal trial for XL092, our next-generation tyrosine kinase inhibitor.

Key Points: 
  • Following recent promising data evaluating cabozantinib in combination with immunotherapies in colorectal cancer, we are thrilled to initiate our first phase 3 pivotal trial for XL092, our next-generation tyrosine kinase inhibitor.
  • We look forward to learning more about how XL092 in combination with atezolizumab may benefit patients with metastatic colorectal cancer.
  • XL092 is the first internally discovered Exelixis compound to enter the clinic following the companys reinitiation of drug-discovery activities.
  • Colorectal cancer is the third most common cancer and the third-leading cause of cancer-related deaths in the U.S.

Exelixis Announces Initiation of Phase 1b Trial Evaluating XL092 in Combination with Immuno-oncology Therapies in Patients with Advanced Solid Tumors

Retrieved on: 
Wednesday, December 15, 2021

Exelixis, Inc. (Nasdaq: EXEL) today announced initiation of the dose-escalation stage of STELLAR-002, a phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced initiation of the dose-escalation stage of STELLAR-002, a phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.
  • The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the XL092 combination therapy regimens.
  • XL092 is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with immune checkpoint inhibitors.
  • XL092 is the first internally discovered Exelixis compound to enter the clinic following the companys reinitiation of drug-discovery activities.

Exelixis Announces Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Evaluate XL092 in Combination with Immuno-oncology Therapies in Advanced Solid Tumors

Retrieved on: 
Monday, June 14, 2021

Exelixis, Inc. (Nasdaq: EXEL) today announced a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.
  • Exelixis is sponsoring STELLAR-002 and Bristol Myers Squibb will provide nivolumab, ipilimumab and bempegaldesleukin for use in the trial.
  • STELLAR-002 will begin with a dose-escalation phase to determine the recommend dose for each of the XL092 combination therapies: XL092 in combination with nivolumab, XL092 in combination with nivolumab and ipilimumab and XL092 in combination with nivolumab and bempegaldesleukin.
  • XL092 is the first internally discovered Exelixis compound to enter the clinic following the companys reinitiation of drug discovery activities.

Exelixis Announces Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer to Evaluate XL092 and Avelumab in Various Forms of Locally Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, March 18, 2021

Exelixis is sponsoring the STELLAR-001 clinical trial, and Merck KGaA, Darmstadt, Germany and Pfizer will provide avelumab for use in the trial.

Key Points: 
  • Exelixis is sponsoring the STELLAR-001 clinical trial, and Merck KGaA, Darmstadt, Germany and Pfizer will provide avelumab for use in the trial.
  • Single-agent avelumab is the only ICI approved in the U.S. for maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-based chemotherapy.
  • Initiated in February 2019, the dose-escalation evaluation of XL092 in the monotherapy arm of the phase 1 trial is ongoing.
  • XL092 is the first internally discovered Exelixis compound to enter the clinic following the companys reinitiation of drug discovery activities.

Exelixis Announces First Patient Enrolled in Phase 1 Trial Cohort Evaluating XL092 in Combination with Atezolizumab in Patients with Advanced Solid Tumors

Retrieved on: 
Monday, October 26, 2020

Exelixis, Inc. (NASDAQ: EXEL) today announced enrollment of the first patient into the dose-escalation cohort of the combination arm of the phase 1 trial (NCT03845166) evaluating the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of XL092 alone and in combination with atezolizumab (TECENTRIQ) in patients with advanced solid tumors.

Key Points: 
  • Exelixis, Inc. (NASDAQ: EXEL) today announced enrollment of the first patient into the dose-escalation cohort of the combination arm of the phase 1 trial (NCT03845166) evaluating the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of XL092 alone and in combination with atezolizumab (TECENTRIQ) in patients with advanced solid tumors.
  • Initiated in February 2019, the dose-escalation evaluation of the XL092 monotherapy arm of the phase 1 trial is ongoing.
  • XL092 is the first internally discovered Exelixis compound to enter the clinic following the companys reinitiation of drug discovery activities.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

Exelixis to Present the Preclinical Profile and Initial Clinical Pharmacokinetics of XL092, Its Next-Generation Oral Tyrosine Kinase Inhibitor

Retrieved on: 
Friday, October 9, 2020

XL092 is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors, MET, AXL, MER, and other kinases implicated in cancers growth and spread.

Key Points: 
  • XL092 is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors, MET, AXL, MER, and other kinases implicated in cancers growth and spread.
  • In designing XL092, Exelixis sought to build upon the experience and target profile of cabozantinib, the companys flagship medicine, while improving key characteristics, including clinical half-life.
  • Exelixis is a member of the Standard & Poors (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.
  • For more information about Exelixis, please visit www.exelixis.com , follow @ ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.