Melanomas harbor decidual-like NK cells with a CD56 Bright CD16 - CD49a + CD9 + phenotype, a population rare or absent in peripheral blood from patients with melanoma and healthy donors. The cells appear in tumors across sex, melanoma subtype, and disease site, and tumor CD9 expression correlated with intratumoral dl-NK frequency (Pearson rho = 0.40, p = 0.056). Co-culture showed direct contact with CD9-expressing melanoma cells induces CD9 acquisition by NK cells, suggesting an immunologic parallel between melanoma and the maternal-fetal interface.
In a French nationwide cohort of 95,015 adults initiating immune checkpoint inhibitor therapy, mRNA COVID-19 vaccination within 100 days before or after ICI start was associated with modestly lower early all-cause mortality (pre-ICI HR 0.90 at 1-3 months; post-ICI HR 0.84 at 3 months), with no significant association after 12 months. Similar patterns for non-mRNA COVID-19 and other adult vaccines point to healthy-vaccinee effects rather than a specific mRNA vaccine benefit.
Why it matters: Population-scale evidence that the observed survival signal after COVID-19 vaccination near ICI start is likely a healthy-vaccinee effect.
The 2026 edition of the CSCO biliary tract cancer guidelines, released on September 18, 2026 at the 26th CSCO annual meeting, adds envafolimab combined with gemcitabine plus oxaliplatin (GEMOX) as a grade I recommendation (category IA evidence) for first-line treatment of unresectable locally advanced or metastatic biliary tract malignancies in patients who can tolerate intensive chemotherapy. It is the first first-line immune combination regimen for biliary cancer based on a trial enrolling only Chinese patients, with evidence from 462 patients at 36 centers across China.
Ivonescimab, a PD-1/VEGF bispecific antibody, delivered a median progression-free survival of 16.9 months in patients with locally advanced or metastatic non-squamous NSCLC whose disease progressed on third-generation EGFR-TKI treatment, compared with 4-5 months for traditional chemotherapy in this setting. China's NMPA has approved it for this population, giving third-generation EGFR-TKI-resistant disease a new treatment standard.
The first prescription for Jie'entai, written by Professor Zhou Jun, has been dispensed in China, moving the drug into clinical use. It is described as the first targeted therapy approved worldwide for biliary tract cancer that has progressed after FGFR inhibitor treatment, giving Chinese patients with drug-resistant advanced disease a treatment option where none existed. The shift is from no available drug to an accessible therapy.
A methylation-based ctDNA assay (Guardant360) detected recurrence in non-virally associated head and neck squamous cell carcinoma with 76.9% sensitivity and 94.6% specificity (AUC 0.858) in a 50-patient post-treatment cohort. Positive ctDNA preceded clinical detection in 6 of 10 recurrences by a median of 131 days and tracked with worse survival: 1-year progression-free survival was 25.0% versus 96.4%. The findings support adding methylation-based ctDNA to surveillance for this population, pending prospective validation.
An AI model integrating H&E pathology image features with clinical variables (Ataraxis Breast CTX) identified which intermediate-RS node-negative HR+/HER2- breast cancer patients benefit from adjuvant chemotherapy in a prespecified analysis of 6735 TAILORx patients. CTX-benefit showed a significant treatment-by-biomarker interaction (p = 0.016), with high-benefit patients gaining 5.6% in 5-year disease-free interval from chemotherapy while low-benefit patients showed none; stratifying by RS alone at a matching threshold was not significant (p = 0.20). CTX-prognostic also predicted DFI independent of RS (C-index 0.736 with endocrine therapy alone).
Ivonescimab, Akesu Bio's PD-1/VEGF bispecific antibody, beat pembrolizumab as first-line monotherapy in PD-L1-positive non-small cell lung cancer in the HARMONi-2 trial. Median overall survival was 30.8 months versus 22.6 months with pembrolizumab, HR=0.73, P=0.009, presented by Professor Zhou Caicun at the WCLC presidential symposium. It is the first drug to beat pembrolizumab in a randomized controlled trial on two endpoints.
EMA's CHMP issued positive opinions for eight new medicines at its September meeting, including two small molecules for ovarian cancer, a potential first daily oral therapy for some adults with hidradenitis suppurativa, and a GLP-2R agonist for short bowel syndrome that FDA previously rebuffed, plus two biosimilars and two generics. Among them is Lifyorli relacorilant, Corcept Therapeutics' selective glucocorticoid receptor antagonist, recommended with nab-paclitaxel for adults with platinum-resistant, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who have had one to three prior systemic regimens. EU approval decisions from the European Commission follow.
The FDA has approved Eli Lilly's Inluriyo in combination with Verzenio, entering the oral SERD market competition. Jake Van Naarden, president of Lilly Oncology, told Fierce that the combination shows longer progression-free survival (PFS) than oral SERD monotherapy and that most patients are expected to choose the combination.
TRI-611, a brain-penetrant molecular glue degrader, bridges the ALK kinase domain and the CRL4 adaptor CRBN through a degron interface distinct from the kinase active site, yielding proteome-wide selectivity. It degrades all ALK fusion protein forms tested, including wild-type and TKI-resistant versions, driving regression of subcutaneous and intracranial tumour models of ALK-positive NSCLC, alone and synergistically with ALK TKIs. It is described as the first clinical-stage molecular glue degrader targeting an oncogenic gene fusion.
Ascentage Pharma's APG-2575 (lisatocla) has been proposed for breakthrough therapy designation in China, in combination with acalabrutinib for previously untreated adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Lisatocla is an orally administered selective Bcl-2 inhibitor developed by Ascentage, described as the second worldwide and first in China to show clear efficacy and reach pivotal registration-stage trials as a Bcl-2 inhibitor. The combination regimen showed an overall response rate of 97.7%.
At the World Conference on Lung Cancer in Seoul, the B7-H3 antibody-drug conjugate Tam-Peli prolonged survival in recurrent small cell lung cancer, with median overall survival of 13.3 months versus 9.4 months (HR 0.46, P<0.001), results published simultaneously in NEJM. The RAS(ON) inhibitor daraxonrasib also showed activity in RAS-mutant non-small cell lung cancer.
TACE combined with Hengrui's "dual ai" regimen has been added to the CSCO Primary Liver Cancer Guideline 2026 as a grade I recommendation with 1A-class evidence. The recommendation rests on the CARES-336 trial, described as China-originated phase III evidence with international presentation. The guideline update was dated 2026-09-18.
Eli Lilly's selpercatinib has been approved in China in tablet form, the first domestic approval of this formulation. Selpercatinib, the first highly selective RET kinase inhibitor approved worldwide and able to cross into the central nervous system, was first approved by the US FDA in May 2020 and entered China in September 2022 as a capsule for RET fusion-positive advanced or metastatic NSCLC, RET-mutant medullary thyroid cancer and RET fusion-positive radioactive-iodine-refractory thyroid cancer in adults and patients aged 12 and older.
Ivonescimab (AK112) significantly improved overall survival versus pembrolizumab monotherapy in the phase 3 HARMONi-2 trial, raising median OS to 30.75 months from 22.57 months and reducing the risk of death by 27% in first-line advanced wild-type NSCLC with TPS at least 1%. The OS result, presented at WCLC, follows the previously reported PFS benefit, with median PFS of 11.1 months versus 5.8 months (HR=0.51). AK112 is the first domestic Chinese innovative drug to beat pembrolizumab head-to-head in a phase 3 lung cancer trial.
Ivonescimab from Akeso became the first therapy to beat pembrolizumab head to head on overall survival in a randomized phase 3 trial, with median OS of 30.8 months versus 22.6 months and a 27% reduction in death risk in HARMONi-2. Benefit concentrated in PD-L1-high (HR=0.58) and squamous (HR=0.65) patients. The same WCLC also featured two Chinese B7-H3 ADCs, HS-20093 and YL201, each cutting death risk 54% versus topotecan in relapsed small cell lung cancer.
γδ T cells infiltrate small cell lung cancer and can kill tumor cells through multiple therapeutic approaches, including MHC-independent recognition via BTN2A1. High levels of γδ T cell infiltration predict improved outcomes with αPD-L1 therapy in SCLC, pointing to these cells as a target for immunotherapy.
Ng et al. characterize cytotoxic γδ T cells in small cell lung cancer and target them with a bispecific T cell engager (BiTE) that engages Vδ2+ cells. The approach is designed to overcome unsuccessful checkpoint blockade immunotherapy by bypassing low MHC-I expression and ineffective CD8+ T cells. The work points to an alternative effector cell for immunotherapy in this cancer.
A very rare genetic variant is associated with 25-fold higher odds of lung cancer in people who never smoked, researchers reported in Science. The variant is far more common in Southern Appalachia than elsewhere in the U.S. The finding, drawn from genetic data including 23andMe records, points to distinct risk factors that could shape screening and treatment for never-smokers.
