Ribociclib

Celcuity Inc. Announces Plan to Initiate a Phase 3 Clinical Trial for Gedatolisib as First-Line Treatment for HR+/HER2- Advanced Breast Cancer and Secures Approximately $62 Million Debt Financing

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четверг, мая 30, 2024
Ribociclib, Patient, Fulvestrant, CELC, Type, Food, Clinical trial, FDA, PFS, Disease, PIK3CA, Arm, Safety, Breast cancer, RECIST, MD, Letrozole, ABC, Pharmaceutical industry

“We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer.

Key Points: 
  • “We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer.
  • In our Phase 1b trial that evaluated gedatolisib in combination with palbociclib and letrozole, median progression free survival was 48.6 months, and the ORR was 79%.
  • Therefore, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib combined with ribociclib and fulvestrant.
  • At the closing of this amendment to the debt financing agreement, Celcuity will receive $61.7 million and will have $100 million of total debt outstanding.

Olema Oncology Announces Promising New Data for Palazestrant in Combination with Ribociclib Presented at the 2024 ESMO Breast Cancer Congress

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среда, мая 15, 2024
Ribociclib, Half-life, Neutropenia, Pharmacokinetics, MTD, DNA, Plasma, Data, Toxicity, Index, Circulating tumor DNA, Safety, QT interval, Breast cancer, Neoplasm, Congress, Incidence, Partial, ESR1, Poster, Woman, Fatigue, CBR, Breast, Webcast, Pharmaceutical industry

These results, as of the data cut-off of March 13, 2024, will be presented on May 16, 2024, in a poster session at the 2024 ESMO Breast Cancer Annual Congress in Berlin, Germany (ESMO Breast).

Key Points: 
  • These results, as of the data cut-off of March 13, 2024, will be presented on May 16, 2024, in a poster session at the 2024 ESMO Breast Cancer Annual Congress in Berlin, Germany (ESMO Breast).
  • Palazestrant did not affect ribociclib drug exposure and ribociclib had no clinically meaningful effect on palazestrant drug exposure.
  • Findings from this study support the continued clinical development of palazestrant in combination with ribociclib for the first-line treatment of ER+/HER2- advanced or metastatic breast cancer.
  • Olema will host a webcast and conference call for analysts and investors to review the data being presented at ESMO Breast Cancer Annual Congress 2024 today, Wednesday, May 15, 2024, at 8:00 a.m.

Arvinas Reports First Quarter 2024 Financial Results and Provides Corporate Update

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вторник, мая 7, 2024
Corporation, Sale, Greyhawk, License, Ribociclib, Palsy, HER2, General counsel, NVS, Food, ARVN, Research, Quantum Leap, Business development, Genentech, Development, Administration, Arm, Prostate cancer, Exercise, CDK7, Senior, Patient, Bayer, EOP, CDK4, Interim, PROTAC, LRRK2, Pharmaceutical industry

NEW HAVEN, Conn., May 07, 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 first quarter ended March 31, 2024 and provided a corporate update.

Key Points: 
  • Announced the resignation of Chief Financial Officer and Treasurer, Sean Cassidy, effective February 29, 2024.
  • Research and Development Expenses: Research and development expenses were $84.3 million for the quarter ended March 31, 2024, as compared with $95.3 million for the quarter ended March 31, 2023.
  • General and Administrative Expenses: General and administrative expenses were $24.3 million for the quarter ended March 31, 2024, as compared with $24.9 million for the quarter ended March 31, 2023.
  • Revenues: Revenues were $25.3 million for the quarter ended March 31, 2024 as compared with $32.5 million for the quarter ended March 31, 2023.

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

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понедельник, марта 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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вторник, февраля 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

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пятница, декабря 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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вторник, декабря 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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вторник, ноября 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

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понедельник, декабря 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

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понедельник, декабря 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."