Abemaciclib

On the Road to Halving Cancer: The 2023 Biotech Advancements Igniting Hope

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Wednesday, September 20, 2023
US Foods, Mantle cell lymphoma, IMGN, Congress, Prednisone, Patient, AstraZeneca, Risk, Prostate cancer, Propel, Eli Lilly and Company, Merck, Merck & Co., News, NYSE, Disease, White House, Monarchism in Iran, MRK, Hope, Mutation, ONC, TSX, FDA, Death, Prednisolone, Oncolytics Biotech, Eye, Cancer, ImmunoGen, PFS, BTK, Cancer Moonshot, BRCA, Ovarian cancer, ORR, Progression-free survival, RBC Capital Markets, OS, Paclitaxel, Quality of life, Pelareorep, MCL, Food, Breast cancer, Pharmaceutical industry, Birth control, Vaccine, Abemaciclib, Pirtobrutinib

VANCOUVER, British Columbia , Sept. 20, 2023 /PRNewswire/ -- USA News Group - Earlier this year, the US White House requested over $2.8 billion in funding from Congress for their  "Cancer Moonshot" initiative, an ambitious plan to slash cancer rates in half within the next quarter-century. Already, 2023 is brimming with encouraging progress in the biotech sector that is boosting our hope in the battle against cancer. Simplifying the jargon, this includes major breakthroughs in treatments that are prolonging the time before cancer worsens (known as progression-free survival or PFS) and increasing the rate at which patients respond positively to treatment (overall response rate or ORR). This inspiring progress has been led by companies like from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Eli Lilly and Company, ImmunoGen, Inc. (NASDAQ: IMGN), Merck &Co., Inc. (NYSE: MRK), and AstraZeneca PLC (NASDAQ: AZN).

Key Points: 
  • Already, 2023 is brimming with encouraging progress in the biotech sector that is boosting our hope in the battle against cancer.
  • The trial, known as BRACELET-1, tested a therapy that combines the company's drug, pelareorep, with a common cancer treatment, paclitaxel.
  • In fact, the risk of the disease getting worse was reduced by an impressive 71% compared to paclitaxel alone, through its progression-free survival (PFS).
  • For patients, this could mean more time to enjoy life without the burden of worsening symptoms.

On the Road to Halving Cancer: The 2023 Biotech Advancements Igniting Hope

Retrieved on: 
Wednesday, September 20, 2023
US Foods, Mantle cell lymphoma, IMGN, Congress, Prednisone, Patient, AstraZeneca, Risk, Prostate cancer, Propel, Eli Lilly and Company, Merck, Merck & Co., News, NYSE, Disease, White House, Monarchism in Iran, MRK, Hope, Mutation, ONC, TSX, FDA, Death, Prednisolone, Oncolytics Biotech, Eye, Cancer, ImmunoGen, PFS, BTK, Cancer Moonshot, BRCA, Ovarian cancer, ORR, Progression-free survival, RBC Capital Markets, OS, Paclitaxel, Quality of life, Pelareorep, MCL, Food, Breast cancer, Pharmaceutical industry, Birth control, Vaccine, Abemaciclib, Pirtobrutinib

VANCOUVER, British Columbia, Sept. 20, 2023 /PRNewswire/ -- USA News Group - Earlier this year, the US White House requested over $2.8 billion in funding from Congress for their  "Cancer Moonshot" initiative, an ambitious plan to slash cancer rates in half within the next quarter-century. Already, 2023 is brimming with encouraging progress in the biotech sector that is boosting our hope in the battle against cancer. Simplifying the jargon, this includes major breakthroughs in treatments that are prolonging the time before cancer worsens (known as progression-free survival or PFS) and increasing the rate at which patients respond positively to treatment (overall response rate or ORR). This inspiring progress has been led by companies like from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Eli Lilly and Company, ImmunoGen, Inc. (NASDAQ: IMGN), Merck &Co., Inc. (NYSE: MRK), and AstraZeneca PLC (NASDAQ: AZN).

Key Points: 
  • Already, 2023 is brimming with encouraging progress in the biotech sector that is boosting our hope in the battle against cancer.
  • The trial, known as BRACELET-1, tested a therapy that combines the company's drug, pelareorep, with a common cancer treatment, paclitaxel.
  • In fact, the risk of the disease getting worse was reduced by an impressive 71% compared to paclitaxel alone, through its progression-free survival (PFS).
  • For patients, this could mean more time to enjoy life without the burden of worsening symptoms.

Lilly Highlights Verzenio® (abemaciclib) and Jaypirca™ (pirtobrutinib) Data at 2023 ASCO® Annual Meeting

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Friday, June 2, 2023
Breast Cancer Research, Monarch butterfly migration, TP53, Diarrhea, American Journal of Clinical Oncology, Progression-free survival, Hematology, Lymphoid leukemia, Atrial fibrillation, Grade 3, DOR, Aes, COVID-19, Survival, Clinical trial, Quality of life, BTK, PFS, Rated R, Cough, Fatigue, Back pain, LLY, RDI, Bruise, ET, Journal, EBC, Patient, Breast cancer, Risk, Data, Breast, Annual general meeting, Triple-negative breast cancer, Periodic breathing, Eli Lilly and Company, MCL, Chronic lymphocytic leukemia, Research, Recurrence, Abstract, Society, NYSE, ORR, Safety, Sarah Cannon Research Institute, Pharmaceutical industry, Pirtobrutinib, Abemaciclib

INDIANAPOLIS, June 2, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced Verzenio® (abemaciclib; CDK4/6 inhibitor) and Jaypirca™ (pirtobrutinib; non-covalent (reversible) BTK inhibitor) data to be presented at the 2023 ASCO® Annual Meeting in Chicago, June 2 – 6, 2023. Presentations include new analyses from the Phase 3 monarchE trial of two years of Verzenio treatment in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high risk early breast cancer (EBC) and updated data from the Phase 1/2 BRUIN trial for an approved use of Jaypirca in patients with covalent BTK inhibitor pre-treated relapsed or refractory mantle cell lymphoma (MCL).

Key Points: 
  • In this analysis, patients were classified into three equal-sized subgroups according to their relative dose intensity (RDI) of Verzenio.
  • The dataset includes the first 90 MCL patients enrolled who had received a prior covalent Bruton's tyrosine kinase (BTK) inhibitor.
  • These safety data, based on longer-term Jaypirca therapy, are consistent with the overall safety profile, without evidence of new or worsening toxicity signals.
  • Both Jaypirca data presentations will be discussed on June 5 from 1:15 – 2:45 p.m. CT during the Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia poster discussion session.

Lilly Announces Details of Presentations at 2023 American Association for Cancer Research (AACR) Annual Meeting

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Tuesday, March 14, 2023
Dehydration, Breast cancer, Patient, HER2, Infection, Tamoxifen, Loperamide, Toxicity, Hospital, Febrile neutropenia, Recurrence, Grade 2, Fulvestrant, HIV disease progression rates, Diarrhea, Pharmaceutical industry, Neutropenia, Abemaciclib

Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio.

Key Points: 
  • Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio.
  • A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio.
  • Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
  • Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors.

U.S. FDA Broadens Indication for Verzenio® (abemaciclib) in HR+, HER2-, Node-Positive, High Risk Early Breast Cancer

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Friday, March 3, 2023
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INDIANAPOLIS, March 3, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio® (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence. High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3).1 This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.

Key Points: 
  • The addition of Verzenio to ET reduced the risk of recurrence by 35% compared to ET alone (HR=0.653 [95% CI: 0.567-0.753]).
  • "Our goal in intensifying treatment for early breast cancer is to maintain remission and prevent the recurrence of cancer.
  • "A significant number of women and men have HR+, HER2- early breast cancer at high risk of returning.
  • We're pleased Verzenio will now be available to more people with this type of early breast cancer."

Lilly Announces Updated Data from the Verzenio® (abemaciclib) Phase 3 monarchE Trial Presented at SABCS and Simultaneously Published in The Lancet Oncology

Retrieved on: 
Tuesday, December 6, 2022
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INDIANAPOLIS, Dec. 6, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced updated results from the pivotal Phase 3 monarchE trial of adjuvant Verzenio® (abemaciclib) in combination with standard endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high risk early breast cancer (EBC). These data, which include results for investigational uses in the intent-to-treat (ITT) and Cohort 1 populations, were presented today as an oral presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS) and simultaneously published in The Lancet Oncology.

Key Points: 
  • The monarchE trial (N=5,637) included women and men with HR+, HER2-, node-positive EBC with a high risk of disease recurrence.
  • Adjuvant Verzenio also reduced the risk of developing metastatic disease by 34.1% (HR=0.659, 95% CI: 0.567, 0.767; nominal p
  • Data presented at SABCS also included efficacy outcomes in the FDA-approved population, as well as the Cohort 1 population.
  • Nearly twice as many patients in the control arm have developed and are living with metastatic disease compared to those receiving Verzenio.

Big Developments Set to be Unveiled at This Year's San Antonio Breast Cancer Symposium (SABCS)

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Wednesday, November 30, 2022
MOA, NEO, HER2, Epitope, Recurrence, Chain reaction, SD, LLY, TSX, 2021 Essex County Council election, EMBER, Breast cancer classification, DNA, Poster, Radar, Circulating tumor DNA, Therapy, Health, MBA, Patient, Data, Polymerase, Eli Lilly and Company, Progression-free survival, Neoplasm, Fulvestrant, Tumor microenvironment, Eli Lilly, Research, Norwich Pharma Services, TNBC, US, PCR, ONC, G1 Therapeutics, NeoGenomics, NYSE, Oncolytics Biotech, The Monarch School, MRD, News, Woman, Breast cancer, Survival, ER, Paclitaxel, Pharmaceutical industry, Medical imaging, Vaccine, Abemaciclib, Trilaciclib

VANCOUVER, British Colombia, Nov. 30, 2022 /PRNewswire/ -- USA News Group  -  A new study has revealed that women diagnosed with benign breast disease through screening have an almost double risk of acquiring breast cancer. The findings come ahead of this year's San Antonio Breast Cancer Symposium (SABCS), known as one of the largest breast cancer symposiums in the world. This year's SABCS is already shaping up to contain some big developments, including data and presentations from biotech companies such as Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Eli Lilly and Company (NYSE: LLY), NeoGenomics, Inc. (NASDAQ: NEO), Zymeworks Inc. (NYSE: ZYME), and G1 Therapeutics, Inc. (NASDAQ: GTHX).

Key Points: 
  • The findings come ahead of this year's San Antonio Breast Cancer Symposium (SABCS), known as one of the largest breast cancer symposiums in the world .
  • The second poster will include data from a collaboration with SOLTI-Innovative Cancer Research from the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.
  • In addition, pharmacodynamic data from the preoperative EMBER-2 trial evaluating imlunestrant in ER+, HER2- early breast cancer will be provided.
  • Preclinical data with LOXO-783 in combination with standard-of-care breast cancer agents will also be presented at the meeting.

Big Developments Set to be Unveiled at This Year's San Antonio Breast Cancer Symposium (SABCS)

Retrieved on: 
Wednesday, November 30, 2022
MOA, NEO, HER2, Epitope, Recurrence, Chain reaction, SD, LLY, TSX, 2021 Essex County Council election, EMBER, Breast cancer classification, DNA, Poster, Radar, Circulating tumor DNA, Therapy, Health, MBA, Patient, Data, Polymerase, Eli Lilly and Company, Progression-free survival, Neoplasm, Fulvestrant, Tumor microenvironment, Eli Lilly, Research, Norwich Pharma Services, TNBC, US, PCR, ONC, G1 Therapeutics, NeoGenomics, NYSE, Oncolytics Biotech, The Monarch School, MRD, News, Woman, Breast cancer, Survival, ER, Paclitaxel, Pharmaceutical industry, Medical imaging, Vaccine, Abemaciclib, Trilaciclib

VANCOUVER, British Colombia , Nov. 30, 2022 /PRNewswire/ -- USA News Group  -  A new study has revealed that women diagnosed with benign breast disease through screening have an almost double risk of acquiring breast cancer. The findings come ahead of this year's San Antonio Breast Cancer Symposium (SABCS), known as one of the largest breast cancer symposiums in the world. This year's SABCS is already shaping up to contain some big developments, including data and presentations from biotech companies such as Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Eli Lilly and Company (NYSE: LLY), NeoGenomics, Inc. (NASDAQ: NEO), Zymeworks Inc. (NYSE: ZYME), and G1 Therapeutics, Inc. (NASDAQ: GTHX).

Key Points: 
  • The findings come ahead of this year's San Antonio Breast Cancer Symposium (SABCS), known as one of the largest breast cancer symposiums in the world .
  • The second poster will include data from a collaboration with SOLTI-Innovative Cancer Research from the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.
  • In addition, pharmacodynamic data from the preoperative EMBER-2 trial evaluating imlunestrant in ER+, HER2- early breast cancer will be provided.
  • Preclinical data with LOXO-783 in combination with standard-of-care breast cancer agents will also be presented at the meeting.

Lilly Announces Details of Presentations at 2022 San Antonio Breast Cancer Symposium

Retrieved on: 
Monday, November 21, 2022
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INDIANAPOLIS, Nov. 21, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)today announced that study investigators will present data from its breast cancer portfolio and pipeline at the 2022 San Antonio Breast Cancer Symposium (SABCS), to be held December 6-10, 2022, in San Antonio, Texas, and virtually.

Key Points: 
  • INDIANAPOLIS, Nov. 21, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)today announced that study investigators will present data from its breast cancer portfolio and pipeline at the 2022 San Antonio Breast Cancer Symposium (SABCS), to be held December 6-10, 2022, in San Antonio, Texas, and virtually.
  • In addition, pharmacodynamic data from the preoperative EMBER-2 trial evaluating imlunestrant in ER+, HER2- early breast cancer will be provided.
  • Preclinical data with LOXO-783 in combination with standard-of-care breast cancer agents will also be presented at the meeting.
  • In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.

Lilly Announces Details of Presentations at ESMO Congress 2022

Retrieved on: 
Wednesday, September 7, 2022
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A Grade 3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio.

Key Points: 
  • A Grade 3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio.
  • Lilly unites caring with discovery to create medicines that make life better for people around the world.
  • P-LLY
    Verzenio and Retevmo are trademarks owned by or licensed toEli Lilly and Company, its subsidiaries, or affiliates.
  • Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.