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

XTalks

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.

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

The Pharma Data

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 52
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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

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

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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

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 52
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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

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.

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

The Pharma Data

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 52
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Combination of copanlisib and rituximab significantly increases progression-free survival in patients with relapsed indolent non-Hodgkin’s Lymphoma

The Pharma Data

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.,

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