Antibody, Clinical Development and HR - Clinical Research Informer

Truqap (capivasertib), First-In-Class AKT Inhibitor, Approved for Advanced Breast Cancer, Set to Take on Novartis’ Piqray

XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. It was also given FDA priority review.

HR

HR FDA Approval Gene Trials

Enhertu significantly improved both progression-free and overall survival in DESTINY-Breast04 trial in patients with HER2-low metastatic breast cancer

The Pharma Data

FEBRUARY 21, 2022

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. 1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. All patients in the trial received a HER2 test, and the results were centrally confirmed.

HR

HR Trials Hormones Antibody

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

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). The results passed the futility analysis (p<0.3

Antibody

Antibody Trials Production Clinical Trials

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Bridging Innovation & Patient Care: The Growing Role of AI

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Merck’s KEYTRUDA® (pembrolizumab) Given After Surgery Reduced the Risk of Disease Recurrence or Death by 32% Versus Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC)

The Pharma Data

JUNE 25, 2021

41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; Merck has the industry’s largest immuno-oncology clinical research program. After a median follow-up of 24.1 months (14.9-41.5),

HR

HR Trials Clinical Research Research

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

Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

The Pharma Data

JULY 15, 2021

After a median follow-up of 39 months, the KEYTRUDA regimen reduced the risk of EFS events by 37% (HR=0.63 [95% CI, 0.48-0.82]; 0.82]; p=0.00031) versus the chemotherapy-placebo regimen – a statistically significant and clinically meaningful EFS result. Merck has the industry’s largest immuno-oncology clinical research program.

HR

HR Trials Clinical Development Clinical Research

Combination of copanlisib and rituximab significantly increases progression-free survival in patients with relapsed indolent non-Hodgkin’s Lymphoma

The Pharma Data

APRIL 11, 2021

Patients treated with this combination had a decrease in risk of disease progression or death by 48% (HR=0.52, p=0.000002) compared to patients treated with placebo and rituximab, with a median PFS of 21.5 Patients must have relapsed after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g.,

HR

HR Trials Containment Development

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

The Pharma Data

NOVEMBER 18, 2021

The blessing is grounded on data from the vital Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant enhancement in complaint-free survival (DFS), reducing the threat of complaint rush or death by 32 (HR = 0.68 (95 CI,0.53-0.87); 0.87); p = 0.0010) compared to placebo. 0.87); p = 0.0010).

FDA Approval

FDA Approval HR Trials Drugs

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

The Pharma Data

APRIL 26, 2022

AstraZeneca’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 0.93; p=0.0035).4

Immune Response

Immune Response Trials Protein Antibody

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

The Pharma Data

SEPTEMBER 9, 2020

Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. In a separate pooled analysis, ENSPRYNG reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; ENSPRYNG was recently approved by the U.S.

Antibody

Antibody Medicine In-Vitro HR

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

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

BioSpace Movers & Shakers. Dec. 4

The Pharma Data

DECEMBER 3, 2020

Previously, Wiedmann served as Head of Human Resources, overseeing a global team and developing HR management strategies for international companies, including Siemens and the US-based biotech company, Vertex Pharmaceuticals. BioAge – Paul Rubin was named CMO of BioAge and will lead the company’s clinical development efforts.

Development

Development Business Development Manufacturing Clinical Development

Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ?50% PD-L1 expression

The Pharma Data

JUNE 26, 2021

In the overall study population, Libtayo significantly reduced the risk of death by 32% and extended median overall survival (OS) by 8 months compared to chemotherapy, even with 74% of patients crossing over to Libtayo following disease progression on chemotherapy (hazard ratio HR: 0.68; 95% confidence interval CI: 0.53-0.87; 0.87; p=0.0022).

Trials

Trials Genetics Antibody HR

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) is a HER2 directed antibody drug conjugate (ADC).

Medicine

Medicine Trials Antibody HR

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 Genomics

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. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). The list price of Stelara was stated to be $25,497.12

Sales

Sales Manufacturing FDA Approval Life Science

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

Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1).

Trials

Trials Medicine Development Clinical Trials

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

XTalks

DECEMBER 4, 2020

Developed in 1999 2. Considered to be more accurate than 24 hr urine creatinine clearance or Cockcroft-Gault formula. In contrast, the cause of most cases of primary membranous nephropathy is an autoimmune condition associated with the anti-PLA2R antibody. Data from 1,628 patients, primarily with CKD.

Trials

Trials Clinical Trials Clinical Trials Antibody

Clinical Research Informer

Truqap (capivasertib), First-In-Class AKT Inhibitor, Approved for Advanced Breast Cancer, Set to Take on Novartis’ Piqray

Enhertu significantly improved both progression-free and overall survival in DESTINY-Breast04 trial in patients with HER2-low metastatic breast cancer

Webinars

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

Webinars

Merck’s KEYTRUDA® (pembrolizumab) Given After Surgery Reduced the Risk of Disease Recurrence or Death by 32% Versus Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC)

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

Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

Combination of copanlisib and rituximab significantly increases progression-free survival in patients with relapsed indolent non-Hodgkin’s Lymphoma

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

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

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

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

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

BioSpace Movers & Shakers. Dec. 4

Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ?50% PD-L1 expression

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

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

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

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

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

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