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Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

The Pharma Data

The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. 1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease.

HR 52
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Phase II/III trial to assess LAG-3 immunotherapy in breast cancer 

Drug Discovery World

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.

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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

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. HR (95% CI): 0.68.

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Keytruda approved as first-line advanced cervical cancer therapy

pharmaphorum

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 45
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Three trends in the antibody-drug conjugate (ADC) market 

Drug Discovery World

6 Also in May 2023, Shanghai-native LaNova Medicines entered into an exclusive license agreement with AstraZeneca for LM-305, a pre-clinical stage ADC targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D).

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Thirteen potential blockbuster drugs to watch in 2024

Drug Discovery World

Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year’s Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes.” The 2024 Drugs to Watch, are: 1.

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New phase III clinical trial data support the advantage of Roche’s Tecentriq in early-stage carcinoma

The Pharma Data

Data from the IMpower010 trial were published simultaneously within the Lancet. Data from the IMpower010 trial were published simultaneously within the Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the danger of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88)