AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 3, 2024

Navigating regulatory affairs in the biopharma industry requires a skilled talent pool, according to Benjamin James, HR Leader, Asia-Pacific, Cytiva Lifesciences – a global life sciences (biopharma) company. in 2021 to 5.60 […]

HR 130

HR Life Science Clinical Trials Clinical Trials 130

BioTech 365

SEPTEMBER 28, 2021

This HR+/HER2-VE Breast … Continue reading →

HR 40

HR Clinical Trials Clinical Trials Trials 40

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. months compared with 5.1 months for the chemotherapy arm. months compared with 16.8

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

JANUARY 27, 2023

It is also based on the data obtained from the DESTINY-Breast04 Phase III trial, which assessed Enhertu’s safety and efficacy against the physician’s choice of chemotherapy. The European Commission’s approval comes after the positive opinion of the Committee for Medicinal Products for Human Use.

HR 235

HR Engineer Antibody Medicine 235

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

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 Real-world evidence is woven into the fabric of how we innovate and advance care for patients with breast cancer, supporting our randomized clinical trials,” said Chris Boshoff, M.D., to 0.82; P=0.0002).

HR 52

HR Clinical Trials Clinical Trials Trials 52

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.

HR 52

HR Hormones Trials 52

Scienmag

SEPTEMBER 20, 2020

Data from latest research presented at the ESMO Virtual Congress 2020 Lugano, Switzerland, 20 September 2020 – Adding abemaciclib to hormonal therapy reduces the risk of cancer recurrence by 25% in patients with high-risk early hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer, according to (..)

HR 45

HR Hormones Drugs Research 45

Pharmaceutical Technology

JUNE 9, 2023

The subunit antigen in the vaccine has been based on the structure of the targeting S-RBD and HR proteins of the XBB and BA.5 Trials demonstrated that the vaccine induced a high titer of neutralising antibodies against several subvariants, including Omicron subvariants XBB.1.5, 5 subvariants. XBB1.16, XBB1.9.1,

Vaccination 269

Vaccination Vaccine HR Protein 269

The Pharma Data

FEBRUARY 21, 2022

All patients in the trial received a HER2 test, and the results were centrally confirmed. 1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. The trial met the key secondary endpoint of PFS in patients with HER2-low metastatic breast cancer regardless of HR status (HR-positive or HR-negative).

HR 52

HR Trials Hormones Antibody 52

pharmaphorum

AUGUST 17, 2022

Sanofi has called time on breast cancer candidate amcenestrant – at one time one of its top pipeline prospects – after it missed the mark in another clinical trial. The post End of the line for Sanofi’s SERD amcenestrant as it fails first-line trial appeared first on.

Trials 52

Trials HR Hormones Development 52

Pharmaceutical Technology

JUNE 4, 2023

in the placebo arm (hazard ratio [HR]: 0.58). months in the placebo arm (HR: 0.73). The 1-year EFS rate in the Phase III AEGEAN trial, which also recruited stage II-IIIB patients, was 73.4%, highly comparable to Keytruda’s 73.2% At a median duration of follow-up of 25.2 months, the two-year event-free survival (EFS) was 62.4%

HR 189

HR FDA Approval Trials Marketing 189

The Pharma Data

MARCH 27, 2023

The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met. “There is a critical need for new, well-tolerated options that keep patients cancer-free without disrupting quality of life.

HR 40

HR Trials Hormones Research 40

Drug Discovery World

NOVEMBER 1, 2023

Durvalumab and olaparib, AstraZeneca A primary analysis of the DUO-E Phase III trial investigating durvalumab and olaparib in advanced or recurrent endometrial cancer showed an improvement in PFS compared to chemotherapy, reducing the risk-of disease progression or death by 45%. Median PFS was 13.8 months compared to 4.9 compared to 22.9%.

Clinical Trials 59

Clinical Trials Clinical Trials Trials HR 59

pharmaphorum

APRIL 25, 2022

Roche revealed in its first-quarter results statement that giredestrant missed the mark in the phase 2 acelERA trial in advanced breast cancer, in what appears to be another blow to the emerging oral selective oestrogen receptor degrader (SERD) class.

Trials 69

Trials Hormones HR Sales 69

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.

HR 130

HR Hormones Clinical Trials Clinical Trials 130

pharmaphorum

MARCH 14, 2022

Shares in Sanofi were on the slide this morning after the drugmaker revealed that one of its top pipeline prospects – selective oestrogen receptor degrader (SERD) amcenestrant – stumbled in a mid-stage breast cancer trial. The post Sanofi takes a hit as hotly tipped breast cancer drug fails trial appeared first on.

Trials 64

Trials Hormones HR Drugs 64

pharmaphorum

OCTOBER 11, 2020

Pfizer already makes big revenues from its breast cancer drug Ibrance, but a late-stage trial failure has set back its hopes of even loftier sales – and set up a challenge from Eli Lilly’s rival drug Verzenio. The post Ibrance trial failure dashes Pfizer’s growth hopes for the drug appeared first on.

Trials 52

Trials HR Hormones Drugs 52

Medical Xpress

DECEMBER 8, 2022

In patients with hormone receptor (HR)-positive, HER2-negative tumors resistant to aromatase inhibitors, addition of the investigational AKT inhibitor capivasertib to fulvestrant (Faslodex) doubled the median progression-free survival compared with placebo plus fulvestrant in the phase III CAPItello-291 clinical trial, according to results presented (..)

Hormones 73

Hormones HR Clinical Trials Clinical Trials 73

Pharmaceutical Technology

MARCH 6, 2023

JUPITER-02 is a Phase III randomised trial with sites in China, Singapore and Taiwan that randomised 289 patients with NPC to receive either Tuoyi + cisplatin/gemcitabine or cisplatin/gemcitabine only. months for the chemotherapy arm (hazard ratio [HR]: 0.52). At a median follow-up of 22.1 months, the PFS for the Tuoyi arm was 21.4

HR 130

HR FDA Approval Licensing Licensing 130

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 in heavily pre-treated patients. “We

HR 52

HR Hormones Trials In-Vivo 52

Drug Discovery World

MARCH 24, 2023

Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA). The Phase III will have overall survival as the primary objective and may include a specific patient population.

Trials 52

Trials Immune Response HR Clinical Development 52

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.

HR 52

HR Trials Protein Medicine 52

Drug Discovery World

JUNE 7, 2023

Positive primary endpoint data from Novartis’ pivotal Phase III NATALEE trial has been presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

HR 52

HR Drugs 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)

HR 52

HR Hormones Trials 52

pharmaphorum

OCTOBER 26, 2022

AstraZeneca seems to have dodged the problems besetting other developers of oral selective oestrogen receptor degrader (SERD) drugs with a phase 2 win for its candidate camizestrant in a phase 2 trial. It’s worth noting that the trial has a different design to those conducted by Sanofi and Roche. Capivasertib trial also positive.

HR 52

HR Trials Drugs Hormones 52

The Pharma Data

MARCH 22, 2023

positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma Two statistically significant Phase 3 trials, GLOW and SPOTLIGHT, to serve as the basis for global regulatory submissions Astellas Pharma Inc. In both trials, approximately 38% of these patients had CLDN18.2-positive

Trials 40

Trials HR Development Clinical Development 40

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 →

Hormones 52

Hormones HR Trials 52

pharmaphorum

SEPTEMBER 15, 2020

Accelerated approvals are granted based on earlier trial data, with the expectation that manufacturers will supply full efficacy and safety data from a larger trial. The post Gilead pays $21bn for Immunomedics ahead of breast cancer trial readout appeared first on.

Trials 77

Trials HR Drugs Sales 77

The Pharma Data

APRIL 8, 2022

NYSE: PFE) announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Pfizer Inc.

Trials 52

Trials HR Development Medicine 52

The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. maturity, HR of 0.81, 95% CI 0.67-1.00; 0.43) and OS (HR of 0.29, 95% CI, 0.14-0.56). 0.94), and a modest trend for OS (HR of 0.91, 95% CI, 0.73-1.13).

HR 40

HR Trials Medicine Clinical Trials 40

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.

HR 52

HR Hormones Trials Sales 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])

FDA Approval 52

FDA Approval HR Trials Hormones 52

Pharmaceutical Technology

MAY 26, 2023

Paxlovid’s approval was based on results from the Phase III EPIC-HR clinical trial (NCT04960202). However, other studies found that the relapse in symptoms occurs in patients independent of Paxlovid use. In response to the approval news, some pointed concerns about long-term safety.

HR 147

HR Clinical Trials Clinical Trials Drugs 147

XTalks

NOVEMBER 8, 2021

After co-developing one of the world’s most widely used COVID-19 vaccines, Pfizer announced positive trial results on Friday for its investigational antiviral pill, revealing that the pill could cut the risk of hospitalization and death by 89 percent. The EPIC-HR study began enrolling participants in July 2021.

HR 98

HR Trials Drugs Development 98

pharmaphorum

JUNE 6, 2022

In February, AstraZeneca and Daiichi Sankyo teased the results of their pivotal trial of Enhertu in HER2-low breast cancer, and, at ASCO, they finally revealed the data – with the numbers every bit as good as hoped. months, with consistent results across all patient subgroups. months, with consistent results across all patient subgroups.

HR 105

HR Sales Trials Doctors 105