Ribociclib

Olema Oncology Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Corporate Update

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Monday, March 11, 2024
Breast cancer, SAN, Cancer, Investigational New Drug, Woman, ESMO, Biomedical Research, FDA, Everolimus, Corporation, Ribociclib, GAAP, SVB, Patient, Clinical trial, Novartis, Congress, Silicon Valley Bank, Oncology, Initiate, IND, Trial of the century, Research, Pharmaceutical industry

“In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.

Key Points: 
  • “In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.
  • Presented palazestrant monotherapy Phase 2 clinical results at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, as an oral presentation demonstrating compelling activity in both wild-type and ESR1-mutant tumor types.
  • Non-GAAP G&A expenses were $3.1 million and $13.3 million for the quarter and year ended December 31, 2023, respectively, excluding $1.4 million and $5.5 million non-cash stock-based compensation expense respectively.
  • A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

Arvinas Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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Tuesday, February 27, 2024
CDK4, ESPP, Research, BCL6, Sale, Exercise, LRRK2, ARVN, CDK7, ATM, HER2, Genentech, European Medicines Agency, Congress, Development, Breast cancer, Pfizer, CBR, ESMO, Everolimus, Greyhawk, ESR1, Oncology, Enrollment, Investment, Insurance, Prostate cancer, PFS, Food, Ribociclib, Bayer, Administration, Patient, Neutropenia, Pharmaceutical industry

NEW HAVEN, Conn., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Median PFS of 11.1 and 11.0 months in patients with ESR1 wild-type and ESR1 mutant tumors, respectively.
  • Announced the appointment of Randy Teel, Ph.D., Arvinas’ current senior vice president of corporate and business development, to the role of interim chief financial officer and treasurer.
  • The Arvinas Board of Directors has launched a formal search process to identify Mr. Cassidy’s permanent replacement.
  • Revenues: Revenue was $78.5 million and $(43.1) million for the year and quarter ended December 31, 2023 as compared with $131.4 million and $38.0 million for the year and quarter ended December 31, 2022.

Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions

Retrieved on: 
Friday, December 8, 2023
Quality of life, Food, Risk, Aes, Breast cancer, QT, Neutropenia, Oncology, MD Anderson Cancer Center, MD, Recurrence, Ribociclib, Novartis, RFS, European Medicines Agency, Patient, Safety, University, FACP, Pharmaceutical industry

“As clinicians, we know that patients diagnosed with HR+/HER2- early breast cancer remain at risk of recurrence for decades, despite adjuvant endocrine therapy.

Key Points: 
  • “As clinicians, we know that patients diagnosed with HR+/HER2- early breast cancer remain at risk of recurrence for decades, despite adjuvant endocrine therapy.
  • With fewer than 4% of events in both treatment arms (3.3% in the Kisqali-ET arm and 3.4% in the ET only arm), overall survival (OS) results will continue to evolve in the longer term1,2.
  • The safety profile of Kisqali at the 400 mg dose remained consistent with previously reported results, with generally low-grade adverse events (AEs), other than laboratory abnormalities.
  • AEs of special interest (grade 3 or higher) were neutropenia (44.3%), liver-related AEs (e.g., elevated transaminases) (8.6%), and QT interval prolongation (1.0%)1,2.

Olema Oncology Announces Palazestrant Demonstrates Attractive Combinability with CDK4/6 Inhibitors Ribociclib and Palbociclib in Phase 1b/2 Studies

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Tuesday, December 5, 2023
CBR, Master of Medicine, Hollywood Private Hospital, ESR1, Metabolism, Breast cancer, FDA, Ribociclib, Incidence, SAN, Disclosure, Partial, Mutation, Curtin University, Toxicity, CDK, Webcast, Patient, Safety, Pharmaceutical industry

However, on December 5, 2023, the 2023 San Antonio Breast Cancer Symposium (SABCS) published the posters ahead of schedule.

Key Points: 
  • However, on December 5, 2023, the 2023 San Antonio Breast Cancer Symposium (SABCS) published the posters ahead of schedule.
  • “OPERA-01, our Phase 3 monotherapy pivotal trial of palazestrant, has initiated, with multiple trial sites now activated and patient dosing started.
  • Palazestrant did not affect ribociclib drug exposure in patients, and ribociclib had no clinically meaningful effect on palazestrant drug exposure.
  • There was no observed drug-drug interaction between palazestrant and palbociclib, and there was no induced metabolism or increase in exposure of either palbociclib or palazestrant when administered in combination.

Olema Oncology to Present New Palazestrant Clinical Data in Combination with CDK4/6 Inhibitors at the 2023 San Antonio Breast Cancer Symposium (SABCS)

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Tuesday, November 28, 2023
Patient, Ribociclib, SAN, Pharmaceutical industry

SAN FRANCISCO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced that it will be presenting new Phase 1b/2 clinical data of palazestrant (OP-1250) in combination with CDK4/6 inhibitor ribociclib, a Poster Spotlight Session on Phase 2 clinical data of palazestrant in combination with palbociclib, and a trial-in-progress poster for the OPERA-01 monotherapy Phase 3 pivotal trial at the upcoming San Antonio Breast Cancer Symposium (SABCS) being held December 5-9, 2023, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.  

Key Points: 
  • Presentations detailing initial Phase 1b clinical data for palazestrant in combination with ribociclib, a Poster Spotlight Session on Phase 2 clinical data for palazestrant in combination with palbociclib, and the OPERA-01 Phase 3 clinical trial in progress will be presented on Dec. 7, 2023
    Olema will host an investor conference call at 8:00 a.m.
  • ET on Dec. 8, 2023
    SAN FRANCISCO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. ( “Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced that it will be presenting new Phase 1b/2 clinical data of palazestrant (OP-1250) in combination with CDK4/6 inhibitor ribociclib, a Poster Spotlight Session on Phase 2 clinical data of palazestrant in combination with palbociclib, and a trial-in-progress poster for the OPERA-01 monotherapy Phase 3 pivotal trial at the upcoming San Antonio Breast Cancer Symposium (SABCS) being held December 5-9, 2023, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.
  • Details of the SABCS 2023 poster presentations are:
    A Phase 1b/2 study of palazestrant (OP-1250) in combination with ribociclib in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced and/or 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
Oncology, Health, Diabetes, Infectious Diseases, Clinical Trials, Pharmaceutical, Cardiology, Medicine, Observation, Research, Safety, Therapy, Toxicity, Cohort, University, Everolimus, Learning, Brain, Patient, Ribociclib, Division, Pharmacokinetics, Hematology, Neutropenia, Diarrhea, Nausea, Cancer, Financial toxicity, Menarini, Traffic barrier, Pharmaceutical industry, MD

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 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
Medicine, Observation, Research, Safety, CDK, Therapy, Toxicity, Cohort, University, Disease, Everolimus, Learning, Brain, Patient, Ribociclib, Division, Pharmacokinetics, Hematology, Neutropenia, Menarini, Diarrhea, Nausea, Cancer, Toxic leukoencephalopathy, Traffic barrier, Pharmaceutical industry, MD

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
Medicine, Observation, Research, Safety, CDK, Therapy, Toxicity, Cohort, University, Disease, Everolimus, Learning, Brain, Patient, Ribociclib, Division, Pharmacokinetics, Hematology, Neutropenia, Menarini, Diarrhea, Nausea, Cancer, Toxic leukoencephalopathy, Traffic barrier, Pharmaceutical industry, MD

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."

Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions

Retrieved on: 
Friday, December 8, 2023
Safety, FACP, Food, European Medicines Agency, University, Aes, Risk, Breast cancer, Patient, QT, RFS, Neutropenia, Novartis, Ribociclib, MD, Yahalom (IDF), MD Anderson Cancer Center, Recurrence, Quality of life, Oncology, Pharmaceutical industry

"As clinicians, we know that patients diagnosed with HR+/HER2- early breast cancer remain at risk of recurrence for decades, despite adjuvant endocrine therapy.

Key Points: 
  • "As clinicians, we know that patients diagnosed with HR+/HER2- early breast cancer remain at risk of recurrence for decades, despite adjuvant endocrine therapy.
  • "The updated NATALEE results reinforce the potential of ribociclib to help address these needs for the broader at-risk population with no added disruptions to patients' quality of life compared to endocrine therapy alone."
  • Kisqali data across all secondary efficacy endpoints was also consistent, including distant disease-free survival (DDFS) (25.1% risk reduction) and recurrence-free survival (RFS) (27.3% risk reduction).
  • Novartis submitted NATALEE data to the European Medicines Agency and plans to finalize submission to the U.S. Food and Drug Administration by end of year.

Olema Oncology Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
Novartis Institute for Tropical Diseases, Trial of the century, AACR, ESMO, Progression-free survival, Biomedical Research, Congress, European Society for Medical Oncology, PFS, Conference, GAAP, Research, R, Ribociclib, ESR1, Novartis, Clinical trial, Silicon Valley Bank, Cancer, Oncology, CBR, Table, Patient, Breast, SAN, Pharmaceutical industry, Cryptocurrency, Medical imaging, G&A

Presented palazestrant Phase 2 monotherapy clinical study results as an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 22, 2023.

Key Points: 
  • Presented palazestrant Phase 2 monotherapy clinical study results as an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 22, 2023.
  • Non-GAAP R&D expenses were $16.7 million for the quarter ended September 30, 2023, excluding $2.8 million non-cash stock-based compensation expense.
  • Non-GAAP G&A expenses were $2.6 million for the quarter ended September 30, 2023, excluding $1.3 million non-cash stock-based compensation expense.
  • Non-GAAP G&A expenses were $4.1 million for the quarter ended September 30, 2022, excluding $1.5 million non-cash stock-based compensation expense.