Biomedicine Daily · Wednesday, 28 October 2026
CBA FRONTIER INSIGHTS
Immunotherapy combo extends survival for patients with aggressive small cell lung cancer, based on trial results
Dana-Farber Cancer Institute reported phase 3 DeLLphi-305 results: tarlatamab plus durvalumab as first-line maintenance extended median overall survival by more than 8 months to 21.1 months in extensive-stage small cell lung cancer, compared with durvalumab alone.
medicalxpress.comSource Clinical readouts and safety
HORIZON-Breast06 Phase III Head-to-Head: SHR-A1811 Extends Median PFS From 6.8 to 16.4 Months in HER2-Low Advanced Breast Cancer
The phase III head-to-head HORIZON-Breast06 study showed that rezatruzumab (SHR-A1811) extended median PFS in the overall HER2-low advanced breast cancer population from 6.8 months in the control group to 16.4 months (HR=0.27, P<0.001).
Divarasib as Compared with Sotorasib or Adagrasib in KRAS G12C-Mutated NSCLC.
In the phase 3 Krascendo 1 trial, divarasib significantly prolonged progression-free survival and overall survival compared with sotorasib or adagrasib in patients with KRAS G12C-mutated advanced or metastatic NSCLC.
Sacituzumab Tirumotecan plus Pembrolizumab in PD-L1-Negative Advanced NSCLC.
The phase 3 randomized OptiTROP-Lung06 trial showed that sacituzumab tirumotecan plus pembrolizumab extended median progression-free survival from 5.7 months with the control regimen to 15.0 months in PD-L1-negative advanced nonsquamous NSCLC.
Osimertinib-Savolitinib in Advanced NSCLC after Progression during EGFR-TKI Therapy.
The phase 3 SAFFRON trial showed that osimertinib plus savolitinib significantly prolonged both progression-free survival and overall survival compared with platinum plus pemetrexed in patients with EGFR-mutated advanced NSCLC whose disease had progressed during osimertinib therapy.
medicalxpress.comNext-generation drug reduces endometrial cancer progression and death in trial
In the phase 3 TroFuse-005/ENGOT-en23/GOG-3095 trial, sacituzumab tirumotecan reduced the risk of progression and death in advanced or recurrent endometrial cancer compared with standard chemotherapy.
medicalxpress.comNew targeted therapy improved survival for patients with KRAS-mutated lung cancer
Divarasib prolonged survival in previously treated KRAS G12C-mutant NSCLC in the Phase III Krascendo 1 trial, with median OS of 17.7 months versus 12 months for the control. The MD Anderson Cancer Center team enrolled 338 patients; versus sotorasib or adagrasib, divarasib reduced the risk of disease progression by 42% and death by 44%, with median PFS of 9.8 versus 5.7 months and ORR of 58.4% versus 32.3%.
NEOTORCH Final Analysis: Toripalimab Perioperative Regimen Improves EFS, MPR and OS in Resectable Stage II-III NSCLC
The final analysis of the phase 3 NEOTORCH trial shows that perioperative toripalimab plus chemotherapy, compared with placebo plus chemotherapy, improved event-free survival, major pathological response, and overall survival in patients with resectable stage II-III non-small cell lung cancer.
Baili-Biofuels' izalontamab Shows 11.1-Month Median PFS in Phase 3 PANKU-Lung01 Second-Line EGFR-Mutant Lung Cancer
In the phase 3 PANKU-Lung01 trial, izalontamab as second-line therapy for EGFR-mutant lung cancer achieved a median PFS of 11.1 months with HR=0.40, a 60% reduction in risk of disease progression or death versus platinum-based chemotherapy. Published in The Lancet, the study reported an ORR of 60.2% versus 34.5% in the control arm, a 1.9% discontinuation rate due to TRAEs, and an ILD incidence of 0.9%. CDE has accepted the marketing application for this indication.
Hengrui HER3-ADC Extends PFS After EGFR-TKI Failure in EGFR-Mutant Advanced NSCLC in HERON-Lung01
In the interim analysis of the phase 3 HERON-Lung01 trial, Hengrui's HER3-ADC significantly prolonged progression-free survival versus platinum-based chemotherapy in patients with EGFR-mutant advanced NSCLC after progression on EGFR-TKI therapy, meeting the primary endpoint.
Hansoh's HS-20093 Meets Primary Endpoint in Phase 3 ARTEMIS-011 in Relapsed or Refractory Osteosarcoma, Cutting Risk of Progression or Death by 67%
HS-20093, independently developed by Hansoh Pharmaceutical, met its primary endpoint in the Phase 3 ARTEMIS-011 study in osteosarcoma, reducing the risk of disease progression or death by 67% versus gemcitabine plus docetaxel. The study enrolled 122 patients whose disease had progressed or relapsed after at least two prior lines of systemic therapy, with a median follow-up of 7.1 months. By BICR assessment, median PFS was 5.5 months with HS-20093 versus 1.4 months with chemotherapy, HR 0.33 (95% CI 0.20–0.55, P<0.0001).
Izalontamab brengitecan versus platinum-based chemotherapy in EGFR-mutated advanced non-squamous non-small-cell lung cancer after progression on third-generation EGFR tyrosine kinase inhibitors (PANKU-Lung01): a multicentre, randomised, open-label, phase 3 trial in China.
Izalontamab brengitecan significantly prolonged progression-free survival versus platinum-based chemotherapy in the phase 3 PANKU-Lung01 trial in EGFR-mutated advanced non-squamous NSCLC. The study randomized 432 patients who had progressed after third-generation EGFR TKI treatment at 73 centers in China. Median PFS by blinded independent central review was 11.1 months versus 5.7 months, HR 0.40 (95% CI 0.31-0.51, one-sided p<0.0001).
Regulatory and policy
NMPA Approves Bayer's Asundexian to Reduce Stroke Risk in Adults with Non-Cardioembolic Ischemic Stroke or High-Risk TIA
Bayer's asundexian tablets were approved by China's NMPA on October 26, 2026, to reduce stroke risk in adults with non-cardioembolic ischemic stroke or high-risk TIA. The drug is taken orally once daily, and its indication excludes patients with cardioembolic stroke.
FDA Approves Pfizer's Talazoparib Plus Enzalutamide for HRR-Mutated mHSPC, a First for PARP Inhibitors
On October 27 local time, the FDA approved Pfizer's talazoparib in combination with enzalutamide for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).
FDA Approves Novo Nordisk Awiqli for Type 2 Diabetes in Children and Adolescents Aged 10 and Older
The FDA has approved Novo Nordisk's Awiqli injection for children and adolescents aged 10 and older with type 2 diabetes. The approval extends the pediatric indication, making Awiqli the first once-weekly basal insulin approved worldwide for this population. It relies on adequate controlled studies in adults with type 2 diabetes and a single-dose pharmacokinetic study of 18 patients aged 10 to under 18, which showed drug concentrations similar to adults after the first few doses, with similar expected glucose-lowering effects.
Bepirovirsen Approved in the US with 19% Functional Cure Rate
The US has approved bepirovirsen, an antisense oligonucleotide (ASO) developed by Ionis and licensed by GSK, for chronic hepatitis B, with a functional cure rate of 19%. In the global Phase III trial, the placebo group cure rate was 0% and the China subgroup was 24%; patients with HBsAg below 200 had a 61% cure rate at 72 weeks. The drug binds to viral mRNA and promotes its degradation, blocking viral protein expression and replication.
medicalxpress.comReproductive health and cystic fibrosis: New guidance offers options and hope
The Cystic Fibrosis Foundation convened a multidisciplinary panel of experts to issue the first clinical guidance on reproductive health spanning the full lifespan. The position paper was published in August 2026 in The Lancet Respiratory Medicine.
Societies Release Vaccine Recommendations for Respiratory Virus Season
With federal guidance for the 2026 to 2027 respiratory virus season not yet updated, US medical societies have issued vaccine recommendations for influenza, COVID-19, and respiratory syncytial virus (RSV). The recommendations draw on evidence reviews from the Vaccine Integrity Project at the University of Minnesota's CIDRAP; the reviews for all three viruses were published in JAMA.
Best Chinese Medicines LLC - 738556 - 10/23/2026
The FDA sent a warning letter to Best Chinese Medicines LLC on October 23, 2026, stating that five products promoted on its website are unapproved new drugs. The FDA determined that these products lack effective marketing applications under section 505 and that introducing them into interstate commerce violates sections 301(d) and 505(a). The company must promptly correct the violations and prevent their recurrence or may face regulatory or legal action, including seizure and injunction.
Industry and deals
Ferring to acquire next-gen IVF startup Gameto for up to $1.4B
Ferring has agreed to acquire reproductive medicine startup Gameto for up to $1.4 billion, without disclosing the upfront payment; deal payments are tied to development, regulatory and sales milestones. Once completed, Ferring will gain Fertilo, a technology that uses stem cell-derived ovarian support cells to mature eggs in vitro. It is approved in Australia and parts of Latin America, with a Phase 3 trial underway in the U.S. Gameto is also developing Deovo, an in vitro model of the female reproductive system, and Ameno, a cell therapy designed to delay menopause.
Novartis faces $1.9B hit from Avidity fail but maintains confidence in $12B buy
Del-desiran failed to significantly improve hand function in the Phase 3 HARBOR trial, missing its primary endpoint, and Novartis took a $1.9 billion impairment charge on its $12 billion acquisition of Avidity. HARBOR randomly enrolled 159 patients with myotonic dystrophy type 1; del-desiran showed clinical activity in secondary and exploratory endpoints, and Novartis plans an additional pivotal study.
Alphabet’s GV is one of biotech’s most influential corporate investors
Alphabet's GV has participated in 20 biotech deals since the beginning of 2025, with a cumulative investment of $5.23 billion, making it the largest corporate venture spender according to PitchBook data.
Court rejects Novo bid to block Lilly obesity drug ads
U.S. federal judge Zahid Quraishi denied Novo Nordisk's request for a preliminary injunction to block Eli Lilly's advertising comparing Wegovy and Zepbound. The court found that Wegovy prescription volume did not decline while the ads aired, that the ads disclosed the higher-dose Wegovy, and that Novo Nordisk failed to prove the campaign caused material harm to its sales. The ruling addresses only whether to issue an injunction at this stage; Novo Nordisk said the substantive dispute over whether the ads are false and misleading remains unresolved.
STAT+: Pennsylvania Dutch country, tired of waiting for biopharma, builds drug company of its own
A Mennonite community in Pennsylvania, tired of waiting for biopharma, built its own drug company to develop a one-time gene therapy for bovine maple syrup urine disease (MSUD). Researchers treated a cow named Petunia with a virus carrying new genes; she is now 5 years old and weighs 1,500 pounds. No patient has yet received the therapy, not even in a clinical trial.
Fired biologist wins $6 million in defamation lawsuit
Research papers
Nature Cell Biology study shows GITR signalling reactivates COTL1high NK cells and may overcome ICB resistance in tsMHC-I-impaired tumours
A Nature Cell Biology study shows that PD-1/PD-L1 blockade releases SHP-1-mediated inhibition of GITR-STAT5 signalling, reactivating COTL1high NK cells. Their IFN-γ in turn upregulates tumour tsMHC-I and strengthens CD8+ T cell responses.
medicalxpress.comMetabolic vulnerability identified in small cell lung cancer
A University of Cologne team found that the small cell lung cancer cell states studied all depend on cysteine, but when deprived of the amino acid, cells die by ferroptosis or apoptosis depending on their state. Combining transcriptomics, metabolite analysis and metabolic tracing, the work was done in cell culture, animal models and patient-derived tumor models. Low ASCL1 states are prone to ferroptosis, while high ASCL1 activates GCH1 to promote antioxidant production and resist ferroptosis.
medicalxpress.comMultiomic atlas of the developing thalamus reveals how neuronal identities emerge
A team at the Institute for Neurosciences, a joint center of CSIC and Miguel Hernández University of Elche (UMH), has built a multiomic atlas of the developing mouse thalamus, showing that sensory neurons and neurons with motor and associative functions follow distinct differentiation trajectories from early embryonic stages. Integrating single-cell gene expression with chromatin accessibility analysis, and using genetic labeling to trace progenitor fate, the team confirmed that sensory lineages pass through a state resembling higher-order nucleus neurons before specializing.
An autonomous macrophage-nociceptor mechanosensory relay drives chronic visceral pain.
A study in Science Immunology shows that ulcerative colitis-associated visceral pain does not depend solely on inflammatory cascades. Tissue-resident CX3CR1+ macrophages directly sense mechanical stimuli through Piezo1 channels, triggering calcium influx and NF-κB nuclear translocation that induces NGF synthesis. NGF then remodels and sensitizes TRPV1+ nociceptive nerve endings.
The 9-1-1 complex protects ssDNA gaps in BRCA2-deficient cancer.
Using genome-wide CRISPR screens in isogenic cancer cells differing only in BRCA2 status, researchers found that the 9-1-1 complex supports BRCA2-deficient cell survival through an ATR-independent mechanism. Loss of 9-1-1 leads to accumulation of PRIMPOL-dependent gaps that fail post-replicative repair, causing pathological gap expansion and increased DNA damage, a phenotype rescued by EXO1 depletion. The study also shows 9-1-1 participates in POLζ-dependent gap filling.
How the TREX-2 complex associates with the nuclear pore.
A research team resolved an extended structure of the human nuclear pore complex (NPC), showing that GANP, Centrin-2, and ENY2 are built into the nuclear ring, forming a TREX-2 integration module positioned opposite the cytoplasmic NUP214 mRNA export platform.
Amyloid-mediated RNA uptake by sperm for embryonic delivery.
A study finds that functional amyloid fibrils in seminal plasma bind and transport RNA into mammalian sperm, and the RNA reaches the zygote after fertilization. Highly cationic peptides phase-separate with RNA to form amyloid fibrils; cryo-ET, volume EM, and fluorescence live-cell imaging show the fibrils are internalized by sperm, while biophysical and IVF experiments show molecular chaperones can control RNA dissociation from the fibrils. The work proposes amyloid fibrils as possible RNA delivery tools during fertilization; the paper's DOI is 10.1016/j.molcel.2026.10.004.
medicalxpress.comFructose slows liver tumors in mice when key sugar-processing gene is missing, may lead to new treatments
A City University of Hong Kong team found that in liver-specific ALDOB knockout mice, fructose supplementation reduces tumor formation and slows tumor growth by accumulating F1P and inhibiting MPI. F1P binds directly to Arg295 of MPI, disrupting protein N-glycosylation and inducing endoplasmic reticulum stress and apoptosis of cancer cells; mannose supplementation reverses this effect.
Lymphoma response to chimeric antigen receptor T cell therapy is driven by endogenous tumor-reactive CD8⁺ T cells
Durable efficacy of CD19 CAR-T therapy in large B-cell lymphoma depends on CAR-T cells cooperating with endogenous CD8+ T cells (eCD8) to eliminate malignant cells. The bioRxiv preprint integrates whole-genome and transcriptome data from 54 relapsed or refractory patients with functional assays and mathematical modeling; tumors with biallelic loss of MHC-I or CD58 showed higher genomic complexity and neoantigen burden and were resistant to CAR-T therapy.
Colorectal cancers with distinct metastatic potential trigger divergent early T cell responses
Colorectal cancers with different metastatic potential trigger distinct early T cell responses. Nonmetastatic tumors early on recruit CD8αβ+ and CD4+ T cells and shape cytotoxic and Th1-like programs, whereas pro-metastatic tumors induce a naive-like, hypoactivated state.
Macrophage lipid signaling drives glioblastoma invasion and represents a therapeutic vulnerability
Glioblastoma cells reprogram tumor-associated macrophages via CSF1R-PI3K, inducing LPC secretion and its conversion to LPAs that drive tumor invasion. Disrupting the TAM-glioblastoma crosstalk suppresses tumor infiltration, offering a therapeutic strategy to improve surgical resection outcomes.
Direct effects on gene transcription revealed by global and CRISPR-targeted oxidative DNA damage
Oxidative stress rapidly represses or activates many genes and upregulates numerous read-through RNAs, and the early repression of genes partially depends on OGG1-mediated repair processing of oxidized DNA. Total RNA-Seq and ChIP-seq of RNA polymerase II show that recruitment of RNA polymerase II to transcription start sites changes under oxidative stress.
medicalxpress.comLarge meta-analysis sheds new light on how SGLT2 inhibitors affect blood and iron parameters
A University Medical Center Groningen team pooled 85 randomized clinical trials with 70,543 participants and found that SGLT2 inhibitors consistently raised hemoglobin and hematocrit versus placebo or other glucose-lowering drugs. At a median follow-up of 24 weeks, hemoglobin increased by 0.60 g/dL on average and hematocrit by 2.36%; EPO rose, transferrin saturation and ferritin fell, and serum iron was largely unchanged, suggesting the body mobilizes iron stores to support red blood cell production.
Lineage-specific and gestational age-dependent DNA methylation programming orchestrates human placental development.
A research team built a single-base-resolution DNA methylation atlas of human placental trophoblasts across gestational ages. A lineage-specific methylation program is established immediately after implantation, followed by methylation accumulation with gestational age. This program acts as a developmental barrier coordinating placental maturation and immune homeostasis. Integrating histone modifications and functional perturbations showed that H3K27me3 and DNA methylation change temporally and silence proinflammatory loci, while repeat elements switch from H3K9me3 to DNA methylation to maintain genome stability.
Matrix stiffness shapes immunometabolic states and response to PD-1 blockade in gastric cancer
High matrix stiffness in gastric cancer is associated with collagen deposition, immune exclusion, and poorer response to PD-1 blockade, and it weakens CD8+ T cell effector function through F-actin remodeling, YAP nuclear enrichment, and LDHA-dependent glycolysis.
Methods and resources
Google DeepMind publishes SynthIDBio in Nature, invisible function-preserving watermarks for AI-generated proteins
A Google DeepMind team published the SynthIDBio method family in Nature, embedding detectable, hard-to-remove and imperceptible invisible watermarks into AI-generated protein sequences and structures. The method integrates SynthID's tournament sampling strategy into ProteinMPNN; calibrated at a 0.1% false positive rate, sequence watermark detection (TPR) reached 100%, and watermarked binders showed no significant difference in binding affinity to SC2RBD, VEGF-A and PD-L1 versus non-watermarked controls.
High ambipolar mobility fluorinated MXene for ultrasensitive biosensing transistors.
An in-situ fluorinated MXene biosensing platform achieved a detection limit of 0.26 fg ml-1 for Mycobacterium tuberculosis antigen MPT64 in an MXene FET, and reached 97.6% diagnostic accuracy across 126 serum samples.
medicalxpress.comWireless neural chip tracks brain changes in real time after Alzheimer's drug administration
A KAIST team used an implantable wireless neural chip to track acetylcholine changes in real time in the prefrontal cortex of minipigs after donepezil administration, observing the signal rise and then gradually return to baseline. The chip converts chemical changes into electrical signals via enzyme-coated electrodes and Ag@Pt nanowires and transmits them wirelessly; it also carries a μLED optogenetic function, and stimulation increased acetylcholine signals in transgenic mice.
medicalxpress.comImplantable device uses ultrasound to improve drug delivery to the brain
An MIT team has developed LUCID, an implantable device with 24 miniature ultrasound transducers that promote drug diffusion in the brain. Tissue models and mouse experiments both showed an enlarged spread. The mouse study used an MRI contrast agent; the system combines local infusion with programmable ultrasound, aims to help drugs bypass the blood-brain barrier, and allows ultrasound dosage to be adjusted via a wireless controller.
SPARK: Bayesian structure learning of enhancer-based gene regulatory networks from single-cell multiomics data and prior knowledge
The authors present SPARK, a framework that combines single-cell multiomics data with mechanistic prior knowledge to reconstruct enhancer-based gene regulatory networks through Bayesian inference. SPARK represents eGRNs as directed acyclic graphs (DAGs), with a prior on network structure derived from heterogeneous evidence. Simulation studies show it benefits from prior knowledge and outperforms existing DAG-based and regression-based algorithms.
Collapsed Site Coalescent Facilitates Detection of Adaptive Divergences Between Segmental Duplicates
LeMay and Harpak propose the Collapsed Site Coalescent (CSC) model, which collapses each pair of paralogous sites into a pseudo-site with an independent genealogy, to support ARG inference for segmental duplications.
Opinion and commentary
Opinion: Cancer vaccines are finally here. How do we get them to patients?
A Phase 3 study presented at the ESMO Congress showed that intismeran autogene reduced the risk of recurrence or death by 42% compared with pembrolizumab (Keytruda) alone.
Chinese and Japanese Experts Discuss Evidence-Based Treatment and Whole-Course Management of Elderly Advanced NSCLC
Chinese and Japanese experts met online on October 15, 2026, to discuss assessment, stratified treatment, and whole-course management of elderly advanced NSCLC. Citing studies including NEJ057, they noted that elderly PD-L1-positive patients had similar PFS and OS with ICI plus chemotherapy versus ICI monotherapy, but the combination group had more grade 3 or higher immune-related adverse events. The Chinese side presented the 9 recommendations of the 2026 Expert Consensus on Treatment of Elderly Advanced Lung Cancer, plus practical experience of initiating CGA after a G-8 score of 14 or below and embedding it in MDT and follow-up.
Putting glucose metabolism under electronic control.
Science reports that an electronic device can control the redox mechanisms that regulate glucose concentrations in mice. The paper's DOI is https://doi.org/10.1126/science.aem0762.
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