On August 25, the FDA approved zanidatamab (Ziihera) combined with tislelizumab (Tevimbra) and chemotherapy for first-line treatment of HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma. The FDA also approved zanidatamab plus chemotherapy without a PD-1 inhibitor for the same indication in HER2 IHC 3+ patients. This is the first approved HER2 bispecific plus PD-1 antibody combination worldwide, developed by BeiGene.
China's NMPA has approved Novartis's radioligand therapy Pluvicto (lutetium vipivotide tetraxetan injection) on August 26, 2026, combined with an androgen receptor pathway inhibitor, for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The approval extends Pluvicto's use in China from metastatic castration-resistant prostate cancer into the earlier mHSPC setting.
On August 13, 2026, the FDA granted accelerated approval to Bristol Myers Squibb's Zenbexus (iberdomide) combined with subcutaneous daratumumab and dexamethasone for multiple myeloma patients who received at least one prior line of therapy including a proteasome inhibitor and an immunomodulator. Zenbexus is the first cereblon E3 ligase modulator (CELMoD) approved by the FDA. The decision is also the FDA's first approval in relapsed or refractory multiple myeloma based on minimal residual disease (MRD)-negative complete response rather than progression-free survival.
The FDA has approved BeiGene's supplemental application for Tevimbra (tislelizumab) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma (GEA). About 20% of GEA patients are HER2-positive, a subtype that has long been difficult to treat.
Akeso announced that its PD-1/VEGF bispecific antibody ivonescimab plus chemotherapy met the OS primary endpoint at an interim analysis assessed by the IDMC in the HARMONi-GI1 study in first-line advanced biliary tract cancer, and also met key secondary endpoints of PFS and ORR. The control arm was durvalumab plus chemotherapy, the guideline-recommended optimal first-line immunotherapy regimen. Akeso shares rose as much as 8.72% on the news.
BeiGene said the FDA has approved a supplemental application for its PD-1 antibody tislelizumab (BaiZeAn) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma. Results were published earlier this year in the New England Journal of Medicine. The material cites five-year survival below 30 percent for gastric cancer and about 19 percent for esophageal adenocarcinoma.
The US FDA approved two first-line treatment regimens combining Jazz Pharmaceuticals' HER2 bispecific antibody Ziihera (zanidatamab-hrii) with tislelizumab, a PD-1 antibody originally developed by BeiGene, on August 25. The approval adds tislelizumab to first-line combination treatment for HER2-positive gastroesophageal adenocarcinoma in the United States. The approval covers two distinct Ziihera-based regimens.
China's NMPA has approved Novartis' radioligand therapy Paiveituo (lutetium-177 teruxvipitide injection) combined with androgen receptor pathway inhibitors for adults with PSMA-positive metastatic hormone-sensitive prostate cancer. The decision on August 25, 2026, follows two mCRPC approvals in China on November 5, 2025, and US FDA approval for the same mHSPC combination on July 31, 2026.
Akeso's ivonescimab met the primary endpoint in a late-stage head-to-head trial in biliary tract cancer. On the news, Akeso shares rose as much as over 8% in morning trading, lifting its market value above HK$86.7 billion. Biliary tract cancer is a recognized refractory gastrointestinal tumor with limited first-line options; ivonescimab previously achieved a breakthrough in lung cancer, and this trial extends its scope. The report gives no trial name, hazard ratio, or confidence interval.
Why it matters: Ivonescimab met the primary endpoint in a head-to-head design where first-line biliary tract cancer options are limited, letting readers compare with existing data.
China has approved BeiGene's regimen combining a HER2 bispecific antibody with a PD-1 inhibitor for first-line treatment of HER2-positive gastroesophageal adenocarcinoma, regardless of patients' PD-L1 expression status. The article calls it the first and only immuno-oncology combination in that first-line setting to achieve a median overall survival of more than two years. A marketing application for the indication had already been filed in China.
The FDA has approved Revolution Medicines' Ras inhibitor daraxonrasib for metastatic pancreatic cancer. The decision follows data presented at the American Society of Clinical Oncology meeting in May. Daraxonrasib targets Ras in a disease setting with limited options.
FDA has approved Revolution Medicines' Ras inhibitor daraxonrasib for metastatic pancreatic cancer. The approval is based on clinical data that drew a standing ovation at the American Society of Clinical Oncology (ASCO) annual meeting in May.
Why it matters: The FDA approval, based on data that drew a standing ovation at ASCO in May, gives regulatory backing to a Ras inhibitor in pancreatic cancer.
Proteogenomic profiling of tumors and paired normal adjacent tissues from 107 patients with pulmonary large-cell neuroendocrine carcinoma (81 pure, 26 combined) identified three subtypes with distinct prognosis, microenvironment dysregulation, genetic alterations and therapeutic targets. APOBEC mutational signatures correlated with tumor initiation and immune suppression, and KEAP1 mutations with metabolic reprogramming in combined LCNEC. IL-33 emerged as a therapeutic biomarker linked to T cell infiltration, and a PEGylated recombinant IL-33 showed prolonged circulation in cynomolgus monkeys and superior immune agonist activity in mouse models.
The FDA approved Revolution Medicines' Rasonque (daraxonrasib), a once-daily RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have had at least one prior systemic therapy or are not candidates for multiagent systemic therapy. In a 500-patient randomized trial, Rasonque improved median overall survival to 13.2 months versus 6.7 months on standard chemotherapy. The approval came 6.5 months ahead of the user fee deadline, under Breakthrough Therapy, Orphan Drug and Priority Review designations and the National Priority Voucher pilot program.
Why it matters: First-in-class RAS inhibitor approval gives a survival benefit in metastatic pancreatic adenocarcinoma, a high-mortality cancer with few options.
DDIAS is a single-stranded DNA-binding protein that acts downstream of the CIP2A-TOPBP1 complex to repair ssDNA carried from interphase into mitosis, promoting accurate chromosome segregation and survival. HR-deficient tumors upregulate DDIAS to tolerate genomic instability, and DDIAS inactivation is synthetically lethal with BRCA1 and BRCA2 deficiency. PARP inhibition exacerbates mitotic ssDNA in HR-deficient cells, and DDIAS suppresses these lesions through mitotic DNA synthesis. Its loss is synthetically lethal with BRCA1 or BRCA2 deficiency, pointing to a vulnerability in homologous recombination-deficient tumors.
A Nature study reports a modular ADC platform based on click chemistry. In preclinical models co-expressing HER2 and EGFR, it showed stronger antitumor activity than standard ADC monotherapy or antibody combinations. The platform works against tumors with low, ultralow, negative, or heterogeneous HER2 expression, and overcomes limitations of conventional HER2-ADC resistance models.
Why it matters: Click chemistry ADC platform bypasses dependence on high single-target expression in preclinical models, offering a modular approach for HER2-low and heterogeneous tumors.
In August 2026, AstraZeneca announced it would discontinue eVOLVE-Lung02, a global Phase III study of the PD-1/CTLA-4 bispecific antibody Volrustomig plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer. In the primary analysis of the PD-L1 negative population, the regimen was unlikely to meet the dual primary endpoints of PFS and OS, and no new safety signals were found. The regimen was Volrustomig plus chemotherapy versus pembrolizumab plus chemotherapy head to head.
Why it matters: Reports negative results for Volrustomig plus chemotherapy versus pembrolizumab plus chemotherapy, a reference for same-target bispecifics in first-line NSCLC.
Human gliomas synthesize proline extensively in vivo, and hypoxia enhances their proliferative sensitivity to environmental proline. NNT-mediated NADH-to-NADPH transhydrogenation from a mitochondrial pool drives proline accumulation, maintains antioxidant systems, and supports reductive metabolism in hypoxic glioma cells in vitro and tumor progression in vivo. The work identifies NNT as a specific metabolic dependency and proline accumulation as a marker of mitochondrial NAD(P)(H) homeostasis.
McKesson, ranked eighth on the Fortune 500 list, has agreed to acquire privately held Precision Medicine Group for $2.25 billion. The deal will fold the company into McKesson's oncology branch as part of an effort to grow its high-margin cancer and biopharma services businesses. The acquisition has not yet closed.
Adjuvant nivolumab after upfront surgery did not improve disease-free survival in resected non-small cell lung cancer. Median disease-free survival was 71.3 months with nivolumab vs 68.8 months with observation (hazard ratio, 0.97; 1-sided P = .39), and the trial was stopped for futility. This contrasts with the established benefit of preoperative and perioperative nivolumab in this setting.
