AstraZeneca

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AstraZeneca's Phase III CAPItello-281 trial showed Truqap improved radiographic progression-free survival (rPFS) when combined with abiraterone and androgen deprivation therapy (ADT) for PTEN-deficient de novo metastatic hormone-sensitive prostate cancer. The combination also showed a promising trend towards improved overall survival (OS) compared to abiraterone, ADT, and placebo.

GCAR and AstraZeneca will evaluate AZD1390 in GBM AGILE trial for newly diagnosed glioblastoma, with recruitment starting Q2 2025. GBM AGILE, the first global adaptive platform trial for glioblastoma, aims to identify effective therapies through adaptive randomization. AZD1390, an ATM kinase inhibitor, showed preliminary efficacy and manageable safety profile in Phase I data.

Mirdametinib, a MEK1/2 inhibitor, showed significant improvements in health-related quality of life (HRQOL) in adult and pediatric patients with NF1-PN in the ReNeu trial, with sustained improvements in physical, emotional, social, and school/work functioning. The trial met its primary endpoint of overall response rate (ORR) and demonstrated a manageable safety profile.

BridgeBio Pharma's acoramidis (Attruby) wins FDA approval for treating ATTR cardiomyopathy, competing with Pfizer's tafamidis. Attruby, a near-complete TTR stabilizer, aims to reduce cardiovascular death and hospitalization. Despite initial trial setbacks, 30-month data supported approval, positioning Attruby as the first oral stabilizer with near-complete stabilization claims. BridgeBio estimates a $15-20 billion market, dominated by Pfizer, with Alnylam and AstraZeneca also entering the space. Attruby's pricing is competitive but above cost-effectiveness benchmarks, with ongoing European review and a Bayer licensing deal.

The FDA approved BridgeBio's Attruby for ATTR-CM, a rare heart condition, offering a new treatment option. Priced at $18,759.12 for a 28-day supply, it competes with Pfizer's Vyndaqel. Attruby showed improved survival in trials but not in reducing overall deaths. BridgeBio partners with Bayer and AstraZeneca for European and Japanese markets.

Capivasertib, abiraterone, and ADT combo significantly improved radiographic progression-free survival in PTEN-deficient mHSPC patients, per CAPItello-281 trial. OS data showed a favorable trend. Safety profile consistent with individual agents. Full data to be presented. FDA approved capivasertib with fulvestrant for breast cancer in 2023.

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Capivasertib (Truqap) + abiraterone acetate (Zytiga) + androgen deprivation therapy (ADT) significantly extended radiographic progression-free survival (rPFS) vs placebo + abiraterone + ADT in PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC) patients, according to phase 3 CAPItello-281 trial data. A trend toward improved overall survival (OS) was observed, with safety data consistent with known profiles. The trial remains ongoing to assess OS and other secondary end points, with final completion anticipated in March 2027.