Clinical Development, HR and Protein - Clinical Research Informer

ARVINAS AND PFIZER ANNOUNCE GLOBAL COLLABORATION TO DEVELOP AND COMMERCIALIZE PROTAC® PROTEIN DEGRADER ARV-471

The Pharma Data

JULY 22, 2021

NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. The companies will equally share worldwide development costs, commercialization expenses, and profits. (Nasdaq: ARVN) and Pfizer Inc.

Protein

Protein Development HR Hormones

Keytruda approved as first-line advanced cervical cancer therapy

pharmaphorum

OCTOBER 14, 2021

The protein, Programmed Death-Ligand 1 (PD-L1), is found on the surface of many cells throughout the body. The approved treatment regime demonstrated superior overall survival (OS; HR=0.64 [95% CI, 0.50-0.81]; 0.81]; p=0.0001) and progression-free survival (PFS; HR=0.62 [95% CI, 0.50-0.77];

HR

HR Containment Protein Clinical Development

Phase II/III trial to assess LAG-3 immunotherapy in breast cancer

Drug Discovery World

MARCH 24, 2023

Efti As a first-in-class soluble LAG-3 protein targeting MHC Class II ligands on antigen-presenting cells (APC), efti is positioned to improve clinical outcomes from standard-of-care chemotherapy. Its activation of APCs (e.g., The first patient is expected to be enrolled early in the second quarter of the 2023 calendar year.

Trials

Trials Immune Response HR Clinical Development

Three trends in the antibody-drug conjugate (ADC) market

Drug Discovery World

JUNE 1, 2023

BB-1701 is an ADC that is composed of Eisai’s in-house developed anticancer agent eribulin, and anti-HER2 antibody using a linker, and is expected to have anti-tumour effects on breast, lung and other solid tumors that express HER2.

Antibody

Antibody Marketing Drugs Licensing

Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

The Pharma Data

JANUARY 14, 2021

HR (95% CI): 0.68. HR (95% CI): 0.54 (0.33, 0.87). HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027. HR (95% CI): 0.44 (0.25, 0.77). HR (95% CI): 0.58; (0.35, 0.95); p=0.027.

Trials

Trials HR Containment Development

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

The Pharma Data

SEPTEMBER 16, 2020

New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Data will also be presented for two of our investigational hormone receptor (HR)-positive breast cancer treatments, both of which target the PI3K/AKT signalling pathway, a key driver of cancer cell growth and proliferation.

HR

HR Medicine Hormones Trials

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

HR

HR Medicine In-Vitro Development

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

The Pharma Data

JANUARY 15, 2021

In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; 4.3] (HR=0.47; 95% CI 0.31-0.71) About the Enhertu Clinical Development Program.

Medicine

Medicine Trials Antibody HR

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. Stelara’s patents are expiring in September 2023, while a handful of biosimilar drugs are in late-stage development or seeking FDA approval.

Sales

Sales Manufacturing FDA Approval Life Science

Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021

The Pharma Data

MARCH 17, 2021

percent compared to ET alone – a statistically significant improvement in invasive disease-free survival for HR+, HER2- high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). Accepted as ePoster – Adjuvant Systemic Therapy. Available on-demand on March 10, 2021. Selected for one of the three St.

HR

HR Trials In-Vitro Manufacturing

Chronic Kidney Disease: Diagnostics, Biomarkers and Strategies for More Representative Trials

XTalks

DECEMBER 4, 2020

Imaging techniques such as ultrasound and computerized tomography (CT) are used to visualize structural changes or abnormalities resulting from kidney damage or congenital causes, while urinalysis can be used to detect blood or protein in the urine — another indication of kidney damage. Developed in 1999 2. Expressed in mL/min/1.73m 2.

Trials

Trials Clinical Trials Clinical Trials Antibody

Merck’s KEYTRUDA® (pembrolizumab) Receives Two New Approvals in Japan

The Pharma Data

AUGUST 30, 2021

“We are pleased to offer two potential new treatment options with KEYTRUDA for patients in Japan based on compelling data from our clinical trial program,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. months (95% CI, 7.6-11.3)

Hormones

Hormones HR Trials Protein

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

one-sided), as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation (HR: 0.78; 80% CI: 0.51-1.2). Senior Vice President and Head of Global Clinical Development at Regeneron. The results passed the futility analysis (p<0.3 log 10 copies/mL for combined doses).

Antibody

Antibody Trials Production Clinical Trials

Tremelimumab accepted under Priority Review in the US for patients with unresectable liver cancer in combination with Imfinzi

The Pharma Data

APRIL 26, 2022

The BLA for tremelimumab and sBLA for Imfinzi are based on final results from the HIMALAYA Phase III trial presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium. 0.93; p=0.0035).4 4 Nearly one in three (31%) patients were still alive at three years versus one in five (20%) for sorafenib.4.

Immune Response

Immune Response Trials Protein Antibody

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

The Pharma Data

MARCH 23, 2021

For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; 0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; for the placebo arm, with a HR of 0.62 (95% CI, 0.49-0.78; for the placebo arm, with a HR of 0.86 (95% CI, 0.68-1.10).

HR

HR FDA Approval Containment Genome

Enhertu significantly improved progression-free survival in DESTINY-Breast03 head-to-head trial vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer

The Pharma Data

AUGUST 9, 2021

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. 1 More than two million patients with breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.

Trials

Trials Medicine Development Clinical Trials

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

The Pharma Data

NOVEMBER 24, 2020

Together, the ILLUMINATE studies comprise a comprehensive clinical development program intended to demonstrate the safety and efficacy of Oxlumo across the full spectrum of patients diagnosed with PH1. 0.514 mmol/24 hr/1.73 0.514 mmol/24 hr/1.73 0.771 mmol/24 hr/1.73 IMPORTANT SAFETY INFORMATION.

FDA Approval

FDA Approval Production RNA Medicine

Clinical Research Informer

ARVINAS AND PFIZER ANNOUNCE GLOBAL COLLABORATION TO DEVELOP AND COMMERCIALIZE PROTAC® PROTEIN DEGRADER ARV-471

Keytruda approved as first-line advanced cervical cancer therapy

Trending Sources

Phase II/III trial to assess LAG-3 immunotherapy in breast cancer

Three trends in the antibody-drug conjugate (ADC) market

Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

Roche to present a broad range of data across multiple cancer types at the ESMO Virtual Congress 2020

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021

Chronic Kidney Disease: Diagnostics, Biomarkers and Strategies for More Representative Trials

Merck’s KEYTRUDA® (pembrolizumab) Receives Two New Approvals in Japan

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Tremelimumab accepted under Priority Review in the US for patients with unresectable liver cancer in combination with Imfinzi

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

Enhertu significantly improved progression-free survival in DESTINY-Breast03 head-to-head trial vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1

Stay Connected