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.
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.
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.
A multimodal explainable AI model predicted immunotherapy outcomes in non-small cell lung cancer better than established biomarkers, in a large international real-world study. The tool also improved physician decision-making. It offers an explainable alternative to current biomarkers for guiding immunotherapy choices.
GSK is preparing to submit a first-line FDA application for Jideytro, its first lung cancer drug. The filing is supported by data showing an unprecedented complete response rate. Jideytro is positioned as GSK's first lung cancer asset.
DeepSomatic, a deep-learning method, detects somatic small nucleotide variations and insertions and deletions from both short-read and long-read data, with modes for whole-genome and whole-exome sequencing and support for tumor-normal, tumor-only and FFPE samples. To enable training and benchmarking, the authors generated the openly available CASTLE dataset of six matched tumor-normal cell line pairs sequenced with Illumina, PacBio HiFi and Oxford Nanopore Technologies. Across cell line and patient-derived samples and across sequencing technologies, DeepSomatic consistently outperforms existing callers.
On August 11, 2026, China's NMPA approved trastuzumab deruxtecan (T-DXd) combined with pertuzumab for first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. The approval rests on the global DESTINY-Breast09 trial, which showed efficacy exceeding standard treatment with a safety profile validated in clinical testing. Professor Liao Ning offers a comprehensive assessment of the regimen, citing durable survival and manageable safety.
AstraZeneca's oral drug camizestrant, sold as Etcamah, failed to beat standard treatment in the pivotal SERENA-4 trial as first-line therapy for ER-positive, HER2-negative advanced breast cancer. The combination did not extend the time patients went before their cancer progressed. The miss limits expansion beyond the accelerated U.S. approval for tumors with a drug-resistance mutation, though testing continues in early-stage disease.
Glutathione reductase (GSR) controls tumor cell susceptibility to both ferroptosis and cuproptosis, and shapes the immunogenicity of these two forms of regulated cell death. Genome-wide CRISPR screening, combined with genetic, pharmacological and in vivo experiments, showed that loss of GSR disrupts glutathione-dependent redox homeostasis and markedly increases sensitivity to ferroptosis and cuproptosis across multiple tumor models.
A machine-learning classifier detected early-stage ovarian cancer from untargeted metabolomic profiles with cross-validated sensitivity and specificity of 99.0% and 99.8% in serum (59 cancer, 32 controls) and 97.7% and 99.7% in plasma (63 cancer, 20 controls). Both cohorts shared 239 concordantly altered features across lipid, amino-acid, steroid, central-carbon, and redox metabolism, supporting a distributed metabolic 'Systemotype' detectable in blood.
Patient-specific proliferation and diffusion rates of a reaction-diffusion model can be inferred from a single routine H&E biopsy by fitting cell-nucleus point patterns, validated across eleven multicenter cohorts. The derived dispersion length and front velocity stratified progression-free and overall survival independent of routine covariates. A virtual glioblastoma trial allocating hypofractionation to faster-growing tumors and dose intensification to slower-growing ones added 96.7 days of restricted mean progression-free survival over standard of care (permutation p < 0.001).
Why it matters: It turns a single routine H&E biopsy into patient-specific tumor growth parameters usable for survival prediction and virtual treatment trials.
Solstice Oncology has launched with a $225 million series A led by RA Capital Management, with Canaan Partners and Forbion also investing, to develop its Fc-enhanced, shorter-acting CTLA-4 antibody porustobart (HBM4003), for which it holds ex-China rights. The NewCo will test the antibody in the neoadjuvant setting to see whether giving it before surgery improves responses without toxicity delaying tumor removal. CEO Caroline Loew said the round closed at the time of the licensing deal.
Merck and Gilead's Trodelvy failed a global phase 3 trial in first-line non-small cell lung cancer, but the China subgroup data outperformed the overall global results. FiercePharma reported that this gap could reignite debate over whether Chinese trial data can be extrapolated to Western populations.
Why it matters: A failed global phase 3 with better China subgroup results offers a direct comparison for whether Chinese trial data extrapolate to Western populations.
Cullinan Therapeutics and Taiho Oncology reported phase 3 data showing their therapy improved survival by more than Johnson & Johnson's Rybrevant in patients with advanced non-small cell lung cancer in the front-line setting. The comparison comes from a head-to-head context in the front-line advanced disease population.
In the I3LUNG study of 2,396 patients with non-small cell lung cancer, machine learning and deep learning models using clinical and blood data predicted immunotherapy outcomes with AUC up to 0.77 in the test set and surpassed PD-L1, ECOG performance status, NLR, LDH and LIPI scores. External validation gave AUC of 0.55 to 0.72. An explainable AI tool improved predictions by lung expert and nonexpert physicians, while multimodal fusion added no consistent benefit over clinical and blood data alone. Prospective validation in more than 2,000 patients is underway.
GSK's risvutatug rezetecan, an antibody-drug conjugate developed with Hansoh, achieved a median overall survival of 18.5 months in a phase 3 trial. The result positions the drug as a threat to Amgen and Merck & Co. in the lung cancer field.
Teclistamab produced higher rates of complete clinical responses than lenalidomide-dexamethasone in patients with high-risk smoldering multiple myeloma in the randomized phase 2 ImmunoPRISM trial. Longer follow-up is needed to determine whether it durably prevents progression to multiple myeloma.
The FDA has approved AstraZeneca's camizestrant (Etcamah), a selective oestrogen receptor degrader, as part of a combination therapy for a subset of breast cancer patients. The drug targets patients whose tumours have acquired resistance mutations to aromatase inhibitors. It expands the SERD class of therapies.
An integrated model combining STAR-CAP cancer-specific risk, OCCAM other-cause mortality risk, and MARCAP efficacy estimates shows wide variation in absolute benefit from androgen deprivation therapy within NCCN risk groups. Applied to 5468 PLCO prostate cancer patients, adding short-term ADT to radiotherapy in unfavorable intermediate-risk disease gave a median 10-year distant metastasis ARR of 4% (range <1% to almost 15%), while prolonging ADT in high-risk disease gave a median ARR of 9% (0.4%-17.2%). The model provides individualized estimates to support treatment discussions rather than uniform group-level recommendations.
