GlaxoSmithKline

The ZEST trial, aiming to evaluate niraparib for breast cancer recurrence prevention in ctDNA-positive patients, failed to accrue enough eligible patients. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Only 40 patients were enrolled, with insufficient data to assess niraparib efficacy.

Grace Liu from Sino Biological discusses Antibody-Drug Conjugates (ADCs), a cancer therapy combining precision targeting with potent cytotoxic drugs. ADCs consist of a monoclonal antibody, cytotoxic payload, and linker, balancing efficacy and safety. Sino Biological offers comprehensive ADC development solutions, aiding in the complex process from discovery to clinical studies.

GSK's Jemperli (dostarlimab) received FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer, based on 100% clinical complete response in 42 patients. This follows Fast Track designation in 2023. The designation aims to expedite development of drugs showing substantial improvement over current therapies, which can have significant negative quality-of-life effects.

FDA grants Breakthrough Therapy Designation to GSK's dostarlimab for locally advanced dMMR/MSI-H rectal cancer, based on 100% clinical complete response in 42 patients. Current standard of care involves surgery and chemoradiotherapy with significant quality-of-life impacts.

CHMP recommended expanding approval of Jemperli (dostarlimab) with chemotherapy for first-line treatment of advanced or recurrent endometrial cancer, including MMRp/MSS tumours. Based on RUBY trial data, approval decision expected Q1 2025.

The enzyme inhibitor market is projected to grow from US$2.8 Bn in 2023 to US$5.9 Bn by 2034, driven by applications in disease management, particularly cardiovascular diseases, oncology, and autoimmune disorders. Key drivers include advancements in monoclonal antibodies, RNA-based inhibitors, and oncology therapies. Major players like Merck & Co., Novartis AG, and Pfizer Inc. are investing in R&D and strategic partnerships to meet healthcare demands.

The global Epidermal Growth Factors (EGFs) market was valued at US$ 1.1 Bn in 2023 and is expected to grow at a CAGR of 11.3% to reach US$ 3.7 Bn by 2034, driven by applications in wound healing, cancer therapies, skincare, and regenerative medicine. Key drivers include rising demand for anti-aging products, advancements in biopharmaceutical research, increasing prevalence of chronic diseases, and strategic investments by companies like Thermo Fisher Scientific and Johnson & Johnson.

GSK reported positive regulatory updates for two cancer drugs: jemperli (dostarlimab) received expanded approval opinion for endometrial cancer and Breakthrough Therapy Designation for rectal cancer; GSK’227 got Priority Medicines Designation for small-cell lung cancer.

GSK's Jemperli, in combo with chemo, recommended by EMA's CHMP for advanced/recurrent endometrial cancer. Decision expected Q1 2025. Based on RUBY phase III trial results meeting PFS and OS goals. FDA expanded approval in August.