STEMLINE THERAPEUTICS


Associated tags: XPO1, Patient, CD123, BPDCN, Therapy, Multiple myeloma, HER2, Woman

Locations: UNITED STATES, EUROPE, EU, US

Menarini Group Presents Updated Data from ELECTRA and ELEVATE Combination Studies of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2024 Annual Meeting

Retrieved on: 
Thursday, May 23, 2024

Both the ELECTRA and ELEVATE studies were designed to overcome different resistance mechanisms observed in estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC) and improve patient outcomes through novel oral-oral combination treatment options.

Key Points: 
  • Both the ELECTRA and ELEVATE studies were designed to overcome different resistance mechanisms observed in estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC) and improve patient outcomes through novel oral-oral combination treatment options.
  • Data will be presented at the 2024 American Society of Clinical Oncology (ASCO), on June 2 from 9 a.m. to 12 p.m. CT.
  • Phase 2 for the combination of elacestrant and abemaciclib in ER+, HER2- metastatic breast cancer, irrespective of the metastatic site, is already ongoing.
  • “The data we are presenting at ASCO highlight elacestrant’s potential to further enhance patient outcomes when combined with other compounds.”

Menarini Group and Insilico Medicine Enter Global Exclusive License Agreement for Novel KAT6 Inhibitor for Potential Breast Cancer Treatment and Other Oncology Indications

Retrieved on: 
Thursday, January 4, 2024

Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.

Key Points: 
  • Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.
  • This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties.
  • Breast cancer is the most commonly diagnosed tumor type and the leading cause of cancer death among women, globally.
  • Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer.

Menarini Group and Insilico Medicine Enter Global Exclusive License Agreement for Novel KAT6 Inhibitor for Potential Breast Cancer Treatment and Other Oncology Indications

Retrieved on: 
Thursday, January 4, 2024

Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.

Key Points: 
  • Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.
  • This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties.
  • Breast cancer is the most commonly diagnosed tumor type and the leading cause of cancer death among women, globally.
  • Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer.

Menarini Group and Insilico Medicine Enter Global Exclusive License Agreement for Novel KAT6 Inhibitor for Potential Breast Cancer Treatment and Other Oncology Indications

Retrieved on: 
Thursday, January 4, 2024

This is a significant clinical challenge and highlights the urgent need for novel therapies to help overcome treatment resistance.

Key Points: 
  • This is a significant clinical challenge and highlights the urgent need for novel therapies to help overcome treatment resistance.
  • Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer.
  • Insilico presented data on the molecule at the San Antonio Breast Cancer Symposium in early December.
  • Currently, endocrine therapy in combination with CDK4/6 inhibitors is the standard treatment for ER+/HER2- breast cancer patients with advanced or metastatic disease.

Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Monday, December 11, 2023

Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.

Key Points: 
  • Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.
  • Data was presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • The ELEVATE study is evaluating elacestrant in combination with inhibitors of the PI3K/AKT/mTOR pathway (everolimus and alpelisib) and cell-cycle pathway inhibitors (palbociclib, ribociclib, and abemaciclib).
  • Additional cohorts are currently under evaluation to assess pharmacokinetics (PK) and determine the recommended phase 2 dose (RP2D) for each combination.

Menarini Group Presents New Progression-Free Survival Data from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Clinically Relevant Subgroups of Patients with ER+, HER2- Metastatic Breast Cancer (mBC) with ESR1 Mutations at SABCS 2023

Retrieved on: 
Friday, December 8, 2023

This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.

Key Points: 
  • This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • ESR1 mutations are present in up to 40% of ER+, HER2- advanced or mBC.
  • “At Menarini Stemline our goal is to provide transformational treatments to help extend and improve the lives of people living with cancer.
  • See here for details of the Menarini Group/Stemline Therapeutics' full range of presentations at SABCS 2023.

Menarini Group Announces New Data on ORSERDU® (elacestrant) at the 2023 San Antonio Breast Cancer Symposium and on ELZONRIS® (tagraxofusp-erzs) at the 65th American Society of Hematology Annual Meeting and Exposition

Retrieved on: 
Monday, November 20, 2023

In September 2023 , ORSERDU was approved by the European Commission.

Key Points: 
  • In September 2023 , ORSERDU was approved by the European Commission.
  • Updated data, including a spotlight discussion on additional biomarker and clinical subgroup analyses from the Phase 3 EMERALD trial, along with new safety updates evaluating elacestrant in multiple combination settings, will be presented at the San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • Updated data, including an oral presentation of updated real-world results in treatment-naïve patients with BPDCN demonstrating durable outcomes and a manageable safety profile leading to prolonged survival, will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, December 9-12, 2023.
  • “The breadth of data on our novel oncology therapies, spanning solid tumors and hematologic malignancies, underscore our commitment to addressing significant unmet medical needs in difficult-to-treat cancers,” said Elcin Barker Ergun, CEO of the Menarini Group.

Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Monday, December 11, 2023

Encouraging results from phase 1 ELECTRA, evaluating ORSERDU in combination with abemaciclib regardless of metastatic sites, show a tolerable and manageable safety profile with favorable preliminary efficacy.

Key Points: 
  • Encouraging results from phase 1 ELECTRA, evaluating ORSERDU in combination with abemaciclib regardless of metastatic sites, show a tolerable and manageable safety profile with favorable preliminary efficacy.
  • Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.
  • Data was presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • "We look forward to learning more about ORSERDU's role in combination settings and its potential across the spectrum of metastatic breast cancer."

Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Monday, December 11, 2023

Encouraging results from phase 1 ELECTRA, evaluating ORSERDU in combination with abemaciclib regardless of metastatic sites, show a tolerable and manageable safety profile with favorable preliminary efficacy.

Key Points: 
  • Encouraging results from phase 1 ELECTRA, evaluating ORSERDU in combination with abemaciclib regardless of metastatic sites, show a tolerable and manageable safety profile with favorable preliminary efficacy.
  • Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.
  • Data was presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • "We look forward to learning more about ORSERDU's role in combination settings and its potential across the spectrum of metastatic breast cancer."

Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU® (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer

Retrieved on: 
Tuesday, November 7, 2023

Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.

Key Points: 
  • Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.
  • Under the Sub-Licensing agreement, SciClone will pursue the development and registration of ORSERDU in China and commercialize ORSERDU upon its regulatory approval in China.
  • “Patients living with metastatic breast cancer need effective and tolerable options,” said Elcin Barker Ergun, CEO of the Menarini Group.
  • The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations.