Pharmaceutical Technology

AUGUST 8, 2022

According to the trial data, Enhertu lowered disease progression or mortality risk by 50% compared with chemotherapy according to the physician’s choice in HER2-low metastatic breast cancer patients with hormone receptor (HR)-positive disease or HR-negative disease. months compared with 5.1 months for the chemotherapy arm.

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FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

JULY 8, 2022

The company claimed that the utmost benefit is reported in hormone-receptor positive (HR+) women and those who commence treatment with Nerlynx within a year of receiving trastuzumab-based therapy. In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3%

FDA Approval 246

FDA Approval HR Drugs Hormones 246

Pharmaceutical Technology

MARCH 6, 2023

Verzenio along with endocrine therapy (ET) has received approval as an adjuvant treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) adult patients who are at a high recurrence risk.

FDA Approval 130

FDA Approval HR Hormones Clinical Trials 130

Pharmaceutical Technology

JUNE 2, 2023

Data from Novartis ’ Phase III NATALEE trial show that adding Kisqali to endocrine therapy lowered the risk of cancer recurrence by 25% in patients with hormone receptor-positive (HR+)/HER2- early-stage breast cancer (EBC).

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HR Hormones Trials Drugs 130

Pharmaceutical Technology

SEPTEMBER 26, 2022

The 'life-extending' drug combination is recommended for usage in adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received hormone therapy.

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HR Drugs Hormones Medicine 130

The Pharma Data

SEPTEMBER 21, 2020

New data has been unveiled for the combination of Novartis’ Piqray (alpelisib) with AstraZeneca’s Faslodex (fulvestrant) in the treatment of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer in patients whose tumours are PIK3CA positive. months compared to 14.8

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HR Hormones Trials 52

Scienmag

SEPTEMBER 19, 2021

Lugano, Switzerland, 19 September 2021 – Adding a CDK 4/6 inhibitor to first-line hormonal treatment prolongs survival by one year for postmenopausal women with hormone receptor (HR) positive, HER2 negative advanced breast cancer, according to late breaking results of the MONALEESA-2 trial presented at the ESMO Congress 2021. (1)

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HR Hormones Trials 52

Medical Xpress

DECEMBER 6, 2022

Non-Hispanic Black women with hormone receptor (HR)-positive/HER2-negative, lymph node-positive breast cancer had worse outcomes compared to non-Hispanic whites, Asians, and Hispanics, despite similar 21-gene recurrence scores, according to a study presented at the 2022 San Antonio Breast Cancer Symposium, held December 6-10, 2022.

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HR Hormones Genetics Gene 71

BioTech 365

OCTOBER 5, 2020

NASDAQ: PBYI), a biopharmaceutical company, announced that efficacy results of neratinib in HER2-positive, hormone receptor-positive (HR+), early stage breast cancer (eBC) from the Phase III ExteNET trial were … Continue reading →

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The Pharma Data

MARCH 25, 2021

months with letrozole alone (HR 0.58: 95% CI, 0.49 months among patients in the letrozole group (HR 0.66: 95% CI, 0.53 This real-world cohort includes more than 1,400 women with HR+, HER2- mBC with any extent of visceral disease. months with IBRANCE plus letrozole versus 11.9 to 0.82; P=0.0002). in the IBRANCE group and 68.0%

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Pharmaceutical Technology

JULY 25, 2022

AstraZeneca noted that the sBLA is based on findings from the randomised, open-label Phase III DESTINY-Breast04 clinical trial of Enhertu in priorly treated subjects with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease.

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HR Hormones Licensing Licensing 130

Scienmag

MARCH 9, 2022

A study led by researchers from The University of Texas MD Anderson Cancer Center showed a significant overall survival benefit with ribociclib plus endocrine therapy for postmenopausal patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer.

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HR Hormones Medicine Research 62

Scienmag

SEPTEMBER 29, 2020

20-year research breakthrough offers new hope for high risk patients with HR+ breast cancer A new treatment for breast cancer patients with hormone receptor (HR+) early stage disease who are at a high risk of recurrence has been shown to reduce the risk by 25%, according to a study led by The Royal Marsden NHS […].

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HR Hormones Research Clinical Trials 61

pharmaphorum

AUGUST 15, 2022

At this year’s ASCO congress, the Trop2-targeting antibody-drug conjugate (ADC) was found to improve progression-free survival significantly in in patients with hormone receptor-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment.

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HR Hormones Sales Antibody 90

XTalks

FEBRUARY 7, 2024

The approval of Truqap was the first-in-class approval for AstraZeneca.

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Life Science HR Hormones Marketing 59

Drug Discovery World

DECEMBER 14, 2023

Antibody drug conjugate MBRC-101 MBrace Therapeutics presented preclinical data demonstrating the potential of its novel antibody drug conjugate MBRC-101 for the treatment of solid tumours including hormone receptor-positive (HR+) and triple negative breast cancers. months of additional follow-up and 78.3% The results show a 25.1%

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The Pharma Data

FEBRUARY 21, 2022

1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. 4 Currently, chemotherapy remains the only treatment option both for patients with HR-positive tumours following progression on endocrine (hormone) therapy, and for those who are HR-negative.5.

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HR Trials Hormones Antibody 52

The Pharma Data

MARCH 27, 2023

“The positive topline results from NATALEE represent a major milestone in our ambition to expand the benefits of Kisqali to patients with earlier stages of breast cancer, building on the heritage of this effective treatment in HR+/HER2- metastatic breast cancer,” said Shreeram Aradhye, M.D.,

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pharmaphorum

MARCH 14, 2022

The phase 2 AMEERA-3 trial was testing amcenestrant in women aged 18 and over with hormone receptor-positive, HER2-negative advanced breast cancer, and showed no benefit in progression-free survival for the drug compared to physician’s choice endocrine therapy.

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Trials Hormones HR Drugs 64

pharmaphorum

APRIL 25, 2022

The Swiss pharma said in its update that the acelERA trial comparing giredestrant to physician’s choice of endocrine therapy for previously-treated hormone receptor (HR)-positive, HER2-negative breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

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Trials Hormones HR Sales 69

pharmaphorum

OCTOBER 11, 2020

When added to standard treatment with hormone-based drugs, Ibrance (palbociclib) was unable to achieve better iDFS than hormone therapy alone in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early-stage breast cancer.

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Trials HR Hormones Drugs 52

Drug Discovery World

JUNE 7, 2023

in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer. Data showed that Kisqali (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2%

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HR Drugs Hormones Trials 52

pharmaphorum

JANUARY 26, 2023

In Europe, approximately 531,000 breast cancer patients are diagnosed annually, with around 141,000 deaths, and around half of all cases would fall under the HER2-low classification, split between patients with both hormone receptor (HR) positive and HR negative disease.

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The Pharma Data

APRIL 27, 2022

1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease. 6 Currently chemotherapy remains the only treatment option for patients with HR-positive tumours following progression on endocrine (hormone) therapy. 7 Few targeted options are available for those who are HR-negative.

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pharmaphorum

SEPTEMBER 9, 2022

Prospects for Gilead Sciences’ Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer continue to improve as data from the TROPiCs-02 trial strengthen, but the jury is still out on what that might mean for the drug commercially.

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HR Hormones Trials Sales 52

pharmaphorum

OCTOBER 26, 2022

Results from the SERENA-2 study have shown that camizestrant met its primary objective of improving progression-free survival (PFS) compared to Faslodex (fulvestrant) in patients with hormone receptor-positive advanced breast cancer previously treated with endocrine therapy.

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HR Trials Drugs Hormones 52

pharmaphorum

OCTOBER 12, 2022

Gilead Sciences will hear back from the FDA in February next year about its marketing application for Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer, billed by the drugmaker as a key new indication for the drug.

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pharmaphorum

AUGUST 17, 2022

It was comparing the drug to letrozole – both given on top of Pfizer’s Ibrance (palbociclib) – as first-line therapy for patients with HR-positive/HER2-negative advanced breast cancer.

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Trials HR Hormones Development 52

The Pharma Data

JUNE 2, 2023

“These additional data on Verzenio and Jaypirca build on the evidence supporting the role each of these medicines play in improving the treatment paradigms for patients with node-positive, high risk early breast cancer and covalent BTK inhibitor pre-treated relapsed or refractory MCL, respectively,” said David Hyman, M.D.,

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HR Hormones Medicine Trials 52

The Pharma Data

DECEMBER 7, 2020

Overall, 75 and 87 percent of Black and White patients, respectively, had hormone receptor-positive (HR+) tumors. No intergroup differences were seen for women with HR+/human epidermal growth factor receptor 2-negative tumors regarding type of surgery, chemotherapy regimen, radiation, or endocrine treatment.

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HR Hormones Research 52

pharmaphorum

AUGUST 8, 2022

Enhertu can also be prescribed to patients regardless of their hormone receptor (HR) status, so is an option for HR-positive as well as potentially some triple-negative breast cancer (TNBC) patients, with the potential to encroach on Gilead Sciences’ ADC Trodelvy (sacituzumab govitecan) in those settings.

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HR Hormones Sales Antibody 52

The Pharma Data

JUNE 2, 2023

This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59]) In the U.S.,

FDA Approval 52

FDA Approval HR Trials Hormones 52

pharmaphorum

SEPTEMBER 17, 2021

The Swiss drugmaker presented results from its coopERA trial of giredestrant in post-menopausal women with hormone receptor (HR)-positive, HER2-negative early breast cancer at the ESMO congress today which suggest its programme is on track.

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HR Hormones Trials Sales 52

pharmaphorum

SEPTEMBER 23, 2022

The cost-effectiveness agency has said that Ibrance (palbociclib) plus fulvestrant can be used routinely on the NHS as a second-line therapy for patients with advanced hormone receptor-positive, HER2-negative breast cancer who have already been treated with hormonal drugs.

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Hormones HR Medicine Drugs 52

The Pharma Data

JUNE 26, 2021

Basel, June 23, 2021 — VISION data published today in The New England Journal of Medicine (NEJM) shows that 177 Lu-PSMA-617 plus standard of care (SOC) significantly improved both overall survival (HR = 0.62 [95% CI: 0.52?0.74]; months) and imaging-based progression-free survival (HR = 0.40 [99.2% 0.74]; P<0.001; median 15.3

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Medicine HR Hormones Protein 52

The Pharma Data

JUNE 19, 2023

Food and Drug Administration has approved three drugs to inhibit CDK4 and 6 (Palbociclib, Ribociclib and Abemaciclib), including for the most common subtype of breast cancer, known as HR+ HER2- (hormone receptor-positive, ERBB2-negative metastatic cancer).

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The Pharma Data

JULY 22, 2021

Despite advancements in oncology in recent years, considerable unmet need persists in the treatment of HR+ breast cancer. ER is the primary driver of hormone receptor (HR) positive breast cancer, which is the most common breast cancer subtype. Chief Scientific Officer for Oncology Research and Development at Pfizer.

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Protein Development HR Hormones 52