AstraZeneca

LYNPARZA® (olaparib) showed sustained survival benefits in gBRCAm HER2-negative high-risk early breast cancer patients, reducing death risk by 28% at 6 years. It improved IDFS, DDFS, and OS, with 87.5% survival rate vs. 83.2% in placebo. This PARP inhibitor is the first to improve survival in early breast cancer.

LYNPARZA's safety profile in the OlympiA trial aligns with prior trials; no new safety signals or increased risk of myelodysplastic syndrome or acute myeloid leukemia were observed. LYNPARZA is approved for various gBRCAm, HER2-negative breast and ovarian cancers in multiple countries. Key warnings include potential for myelodysplastic syndrome/acute myeloid leukemia, pneumonitis, and venous thromboembolism. Common adverse reactions include nausea, fatigue, and anemia. LYNPARZA is a PARP inhibitor indicated for maintenance and treatment of various cancers.

Lynparza's safety and tolerability in the OlympiA trial align with prior trials, showing no new safety signals or increased risk of myelodysplastic syndrome or acute myeloid leukaemia. Lynparza is approved for gBRCAm, HER2-negative high-risk early and metastatic breast cancer in the US, EU, Japan, and other countries. The trial is coordinated by the Breast International Group (BIG) in partnership with NRG Oncology, the US National Cancer Institute, Frontier Science & Technology Research Foundation, AstraZeneca, and MSD. Lynparza, a PARP inhibitor, targets DNA damage response in cells with BRCA mutations, leading to cancer cell death.

Olaparib treatment improves long-term survival in women with high-risk, early-stage breast cancer and BRCA1/2 mutations, reducing cancer recurrence risk by 35% and death risk by 28%, according to the OlympiA trial. After six years, 87.5% of olaparib-treated patients were alive compared to 83.2% with placebo. The trial led to NICE recommending olaparib for early-stage, high-risk breast cancer patients with BRCA1/2 mutations in England and Wales.

LYNPARZA (olaparib) showed sustained improvements in overall survival, invasive disease-free survival, and distant disease-free survival for germline BRCA-mutated HER2-negative high-risk early breast cancer patients, with 87.5% alive at six years compared to 83.2% in the placebo group. These results were presented at the 2024 San Antonio Breast Cancer Symposium and published in The New England Journal of Medicine.

Candel Therapeutics' stock surged 172% after CAN-2409, a viral immunotherapy for localized prostate cancer, met its primary endpoint in a Phase III trial. Patients showed a 14.5% improvement in disease-free survival over 54 months. The trial, conducted under an FDA Special Protocol Assessment, demonstrated a consistent safety profile. The company plans to use these results to seek regulatory approval.

ASH meeting featured studies on BTK inhibitors in CLL, including Jaypirca's Phase 3 trial showing improved progression-free survival and fewer side effects. AstraZeneca's Calquence combined with Venclexta reduced progression risk by 35%. Pfizer's Oxbryta withdrawal due to safety concerns raised questions on sickle cell drug approvals. Bristol Myers Squibb presented positive survival data for its GPRC5D-targeted CAR-T therapy, arlo-cel, in multiple myeloma.

Daiichi Sankyo initiated the Phase III QuANTUM-Wild trial of oral Vanflyta (quizartinib) for newly diagnosed FLT3-ITD negative AML. The placebo-controlled, double-blind trial aims to assess Vanflyta with standard intensive induction and consolidation therapy, HSCT, and post-maintenance monotherapy in subjects aged 18-70. The global trial plans to enroll nearly 700 subjects across continents, with overall survival as the primary endpoint.

The report covers idiopathic inflammatory myositis epidemiology, market trends, and emerging drugs in the US, EU4, UK, and Japan. Key highlights include 191,589 diagnosed cases in 2023, expected to rise by 2034, with the US having the highest cases (91,734). Marketed drugs like OCTAGAM 10% and VENOGLOBULIN-IH 5% IV, and emerging therapies such as Dazukibart and Efgartigimod are discussed. The market size was $447M in 2023, projected to grow due to emerging therapies.

The 'Idiopathic Inflammatory Myositis - Market Insights, Epidemiology, and Forecast to 2034' report by ResearchAndMarkets.com provides an in-depth analysis of the market, epidemiology, and emerging therapies for idiopathic inflammatory myositis. Key highlights include the projected growth of the market driven by innovative therapies like dazukibart and efgartigimod, the rising prevalence of cases, and the market size of approximately USD 447 million in 2023, expected to grow at a CAGR of 21.1% by 2034. The report also covers current treatment practices, unmet medical needs, and market share by therapies in the 7MM (US, EU4, UK, Japan).