GlaxoSmithKline

Digital transformation in pharma is crucial, with 75% of organizations implementing Pharma 4.0. Key drivers include patient demands, regulatory changes, and competition. Top technologies include AI, IoT, blockchain, and digital twins. Strategic insights focus on R&D, supply chain, marketing, and patient engagement.

GSK announced EMA granted PRIME Designation to GSK5764227, its B7-H3-targeted ADC for relapsed ES-SCLC. This follows FDA's Breakthrough Therapy Designation in August 2024.

FDA granted Breakthrough Therapy Designation to GSK's Jemperli for locally advanced dMMR/MSI-H rectal cancer, based on a Phase II study showing 100% clinical complete response. Jemperli, a PD-1 blocking antibody, demonstrated potential as a monotherapy and in combination with other therapies, with sustained cCR in 24 patients. The trial continues with GSK's AZUR-1 study.

GSK announced that ViiV Healthcare, with Pfizer and Shionogi as shareholders, received a positive CHMP opinion for Vocabria in combination with J&J's Rekambys for treating HIV-1 in adolescents.

FDA grants breakthrough therapy designation to dostarlimab for locally advanced dMMR/MSI-H rectal cancer, marking its second regulatory designation in this population. Dostarlimab, a PD-1-blocking antibody, shows potential alone and in combination with standard care, with a 100% clinical complete response rate in a phase 2 study.

Dostarlimab achieved a 100% clinical complete response rate in patients with dMMR/MSI-H advanced rectal cancer, according to a phase 2 study. The FDA granted dostarlimab breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer treatment. No grade 3 or higher adverse events were reported, and the safety profile was consistent with previous data.

The CHMP recommended expanding dostarlimab (Jemperli) approval with carboplatin and paclitaxel for first-line treatment of all adult patients with primary advanced or recurrent endometrial cancer. The EC is expected to decide on the expanded authorization in Q1 2025, supported by phase 3 RUBY trial data showing improved overall survival with dostarlimab plus chemotherapy.

GSK received FDA Breakthrough Therapy Designation for Jemperli (dostarlimab) to treat locally advanced dMMR/MSI-H rectal cancer, based on a phase II study showing a 100% clinical complete response rate in 42 patients. GSK's financial health score is 'GREAT', suggesting strong R&D investment potential. Dostarlimab aims to avoid standard treatment's long-term adverse effects, with ongoing studies to confirm findings and establish a new standard of care.

Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone significantly improved overall survival, progression-free survival, minimal residual disease negativity rate, and duration of response compared to Darzalex plus the same in relapsed or refractory multiple myeloma patients, according to the DREAMM-7 trial results.

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.