Biomedicine Daily · Monday, 14 September 2026
CBA FRONTIER INSIGHTS
Ivonescimab Beats Pembrolizumab on Overall Survival in Front-line PD-L1-positive NSCLC
Akeso's ivonescimab outperformed pembrolizumab on overall survival as first-line treatment for PD-L1-positive locally advanced or metastatic NSCLC in the registrational HARMONi-2 (AK112-303) trial, with the result reaching statistical significance. The randomised, double-blind, multicentre study was presented as a late-breaking oral at WCLC and featured in the official press programme, positioning ivonescimab as a direct competitor to pembrolizumab in this setting. The day's other headline from WCLC: the B7-H3 ADC Tam-Peli (YL201) cut the risk of death by 54% and the risk of progression or death by 71% versus topotecan in relapsed small cell lung cancer in the phase III TAISHAN-302 trial, a first for the target in second-line disease.
Clinical readouts and safety
B7-H3 ADC Tam-Peli Cuts Death Risk 54% in Relapsed Small Cell Lung Cancer Phase III Trial
The B7-H3-targeted ADC Tam-Peli (YL201) improved overall survival, progression-free survival and objective response rate in patients with relapsed small cell lung cancer versus topotecan hydrochloride, according to phase III TAISHAN-302 data presented at WCLC. The drug reduced the risk of death by 54% and the risk of disease progression or death by 71%. The results position the first B7-H3 ADC to break through in second-line treatment of this disease.
Ivonescimab Beats Pembrolizumab on Overall Survival in Front-line PD-L1-positive NSCLC in HARMONi-2
Ivonescimab beat pembrolizumab as first-line treatment for PD-L1-positive locally advanced or metastatic NSCLC on overall survival in the registrational HARMONi-2 (AK112-303) trial, with the result reaching statistical significance. The randomised, double-blind, multicentre study was presented as a late-breaking oral at WCLC and included in the official press programme. The finding positions ivonescimab, from Akeso, as a competitor to pembrolizumab in this setting.
First-in-human GPC3 armored CAR-T shows 91.7% disease control in advanced liver cancer, published in Nature
A first-in-human trial of GPC3 armored CAR-T (C-CAR031, AZD7003), reported in Nature by a team at the First Affiliated Hospital of Zhejiang University School of Medicine, achieved a disease control rate of 91.7% in patients with advanced hepatocellular carcinoma who had failed multiple lines of therapy. The cells are engineered to resist the TGF-β-rich immunosuppressive microenvironment that exhausts infiltrating CAR-T cells in liver cancer. It provides clinical evidence for cell therapy in a solid tumor where CAR-T has not previously translated.
Regulatory and policy
Novo Nordisk's semaglutide wins China's first approval for MASH
Novo Nordisk won Chinese approval on September 10, 2026 for semaglutide injection (Wegovy) in metabolic dysfunction-associated steatohepatitis (MASH), covering non-cirrhotic adults with moderate to severe fibrosis (stage F2-F3). It is the first drug approved for MASH in China and the only GLP-1 drug with this indication. MASLD affects about 38% of adults worldwide.
Industry and deals
Research papers
Widespread atypical UV-induced mutations form in single-stranded DNA.
UV light induces an extended array of noncanonical mutations in single-stranded DNA, including AT>AM, GT>GV, AC>AA, AT>TT, and TA>TT substitutions that resist photo-reversion and likely originate from atypical photoproducts. The work coupled temperature-induced telomeric end resection in yeast with serial UV irradiation and whole-genome sequencing. These ssDNA-specific lesions offer an additional damage-mediated route to oncogenic melanoma mutations such as BRAF V600E, which involves a GT>GA substitution.
Opinion and commentary
[Articles] Most-favoured-nation pricing for prescription drugs in US Medicare: a cohort study
A Lancet modelling study projected that applying most-favoured-nation pricing to brand-name prescription drugs in US Medicare would decrease net Medicare spending. The projected reductions would substantially exceed the sales generated in the reference countries used for price comparison. The authors note that if manufacturers change their behaviour once the model is implemented, possible savings could shrink.