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#免疫治疗

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Sep 25Fri
  1. medrxiv.org56

    Tumour extrinsic neutrophil regulation in mesothelioma correlates with responsiveness to AXL and PD1 inhibition in MIST3, a phase IIA clinical trial

    AXL and PD1 inhibition with bemcentinib plus pembrolizumab met its primary endpoint in the phase IIA MIST3 trial in ICB naïve-relapsed mesothelioma, with a 12-week disease control rate of 46.2% (90% CI 29.2-63.8%); grade 3 or greater adverse events occurred in 53.9% of patients. Multiomic analyses linked response to NF2 loss, immune response signalling, epithelial mesenchymal transition, and neutrophil-related transcriptional programmes including SPI1, ETS2 and FLI1 activation. Gut microbiota composition differed between responders and non-responders and correlated with neutrophil-associated transcription programmes, IRF3 and TLR2.

    Why it matters: Phase IIA evidence that neutrophil and gut microbiota features track response to AXL-PD1 inhibition in mesothelioma.

Sep 24Thu
  1. Nature Medicine56

    Evorpacept plus trastuzumab, ramucirumab and paclitaxel in HER2-positive gastric cancer: a randomized phase 2 trial

    Adding the CD47 inhibitor evorpacept to trastuzumab, ramucirumab and paclitaxel (TRP) produced a higher objective response rate than TRP alone in patients with HER2-positive advanced gastric cancer that had progressed on anti-HER2 treatment. The finding comes from the phase 2 part of the randomized ASPEN-06 trial. Response was associated with CD47 and HER2 expression.

    Why it matters: It tests CD47 blockade as a way to overcome resistance to anti-HER2 therapy in gastric cancer.

Sep 22Tue
  1. Nature Medicine52

    Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial

    A phase 1b/2 trial tested trastuzumab combined with nivolumab, gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer. The regimen showed encouraging clinical response rates, and HER2 expression was associated with clinical benefit. The results support HER2 status as a marker guiding trastuzumab-based treatment in this population.

    Why it matters: First data on adding trastuzumab and nivolumab to standard gemcitabine-cisplatin in HER2-positive biliary tract cancer.

Sep 15Tue
  1. Sci Adv55

    Synthetic long peptide and DNA personalized cancer vaccines induce robust neoantigen-specific T cell responses in pancreatic cancer.

    Personalized cancer vaccines, delivered as synthetic long peptide or DNA formulations after resection and adjuvant chemotherapy, were safe and immunogenic in pancreatic ductal adenocarcinoma: two phase 1 trials showed no grade ≥3 adverse events and induced polyclonal neoantigen-specific T cell responses confirmed by IFN-γ ELISpot, intracellular cytokine staining, and T cell receptor clonotype reconstruction. Compared with a propensity-matched cohort, vaccine recipients showed a trend toward longer median overall survival (4.4 versus 3.5 years, log-rank P = 0.23). The results establish feasibility of neoantigen vaccination in a tumor considered unresponsive to standard immunotherapy.

    Why it matters: It shows personalized neoantigen vaccines are safe and immunogenic in PDAC, a cancer unresponsive to standard immunotherapy.

  2. nature.com62

    Broadly neutralizing antibodies in adult males living with HIV undergoing analytical treatment interruption: secondary and exploratory outcomes of the phase II randomized controlled RIO trial

    In the phase 2 RIO trial, adult males living with HIV undergoing analytical treatment interruption showed delayed viral rebound after receiving broadly neutralizing antibodies 3BNC117-LS and 10-1074-LS, with resistance to these antibodies also observed. Initial reservoir sensitivity to autologous antibodies was associated with a longer time to rebound. The findings come from secondary and exploratory outcomes of this randomized controlled trial.

    Why it matters: Antibody-based delay of viral rebound and a predictor of longer rebound time inform HIV treatment-interruption strategies.

Sep 11Fri
  1. nature.com51

    Teclistamab versus lenalidomide-dexamethasone in high-risk smoldering multiple myeloma: a randomized phase 2 trial

    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.

    Why it matters: First randomized comparison of teclistamab against lenalidomide-dexamethasone in high-risk smoldering myeloma.

Sep 10Thu
  1. Nat Med56

    Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial.

    Adding atezolizumab to neoadjuvant taxane-carboplatin-anthracycline chemotherapy did not significantly improve event-free survival in stage II-III triple-negative breast cancer, with an HR of 0.80 (95% CI, 0.62-1.03; P = 0.083) and a 4-year EFS difference of 3.3%. Prespecified subgroup analysis suggested benefit in patients with clinical lymph node involvement (P interaction = 0.039), and an exploratory mRNA subset analysis pointed to basal-like immune-activated tumors as potential responders. Immune-related adverse events occurred in 27.6% with atezolizumab versus 11.4% with placebo.

    Why it matters: Negative phase 3 result for checkpoint inhibition in early TNBC, with subgroup data pointing to who might still benefit.

Sep 5Sat
  1. Lancet72

    Liver resection after atezolizumab and bevacizumab versus maintenance therapy for locally advanced hepatocellular carcinoma (TALENTOP): a multicentre, open-label, randomised, phase 3 trial.

    Liver resection after response to atezolizumab plus bevacizumab prolonged time to treatment failure in advanced hepatocellular carcinoma with macrovascular invasion and no extrahepatic metastasis. In the phase 3 TALENTOP trial, 201 responders were randomised to surgery plus 12 months of the combination or maintenance therapy; median time to treatment failure was 20·4 versus 11·8 months (hazard ratio 0·60, p=0·015). Grade 3 or 4 treatment-related adverse events were more frequent with surgery (39% vs 21%).

    Why it matters: Randomised phase 3 evidence that resection adds benefit after systemic therapy in advanced hepatocellular carcinoma.

Sep 1Tue
  1. nature.com68

    Atezolizumab in early triple-negative breast cancer: the randomized phase 3 NSABP B-59/GeparDouze trial

    Adding atezolizumab to neoadjuvant chemotherapy did not improve event-free survival in the phase 3 NSABP B-59/GeparDouze trial of patients with early-stage triple-negative breast cancer, missing its primary endpoint. Translational analyses identified tumor microenvironment-dependent determinants of response, indicating basal-like immune-activated tumors may respond to atezolizumab plus chemotherapy.

    Why it matters: Negative phase 3 result for atezolizumab in early triple-negative breast cancer, with biomarker data indicating which tumors may still benefit.

Aug 25Tue
  1. JAMA75

    Adjuvant Nivolumab vs Observation in Resected Non-Small Cell Lung Cancer: A Randomized Clinical Trial.

    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.

    Why it matters: A negative phase 3 trial clarifies that adjuvant nivolumab adds no benefit after upfront surgery in resected NSCLC.

Aug 20Thu
  1. nature.com47

    Intercepting pancreatic cancer with a vaccine

    An off-the-shelf vaccine targeting mutant KRAS safely and durably activated T cell responses in healthy people at high risk of developing pancreatic cancer, according to a phase 1 study published in Nature Medicine. The result indicates that a ready-made vaccine can engage the immune system against a key driver mutation before cancer arises. It points toward preventive interception of pancreatic cancer in high-risk individuals.

Aug 18Tue
  1. Nat Med60

    First-line PD-1/VEGF bispecific antibody plus chemotherapy in triple-negative breast cancer: a phase 2 trial.

    Ivonescimab plus paclitaxel or nab-paclitaxel as first-line therapy produced an objective response rate of 80.0% (95% CI 63.1-91.6) in 35 evaluable patients with locally advanced unresectable or metastatic triple-negative breast cancer, including 2 complete and 26 partial responses. In the 36-patient single-arm phase 2 trial, all patients had treatment-related adverse events, 58.3% were grade 3 or higher, and no treatment-related deaths occurred. The PD-1/VEGF bispecific plus chemotherapy pairing offers a first-line option for this population that merits further investigation.

    Why it matters: It tests a PD-1/VEGF bispecific antibody as first-line therapy in triple-negative breast cancer, where systemic options are limited.

Aug 17Mon
  1. Cancer Cell67

    Perioperative tislelizumab plus chemotherapy for locally advanced gastric cancer: A randomized, prospective phase 2 trial.

    Adding perioperative tislelizumab to chemotherapy raised the major pathological response rate in tsMHC-II-positive operable locally advanced gastric or gastroesophageal junction cancer (61.8% vs. 26.5%, p = 0.003), meeting the primary endpoint of the phase 2 Mountain-02 trial in 136 patients. No significant benefit appeared in tsMHC-II-negative patients, and tsMHC-II positivity also tracked with higher pCR (32.4% vs. 5.9%). The results position tumor-specific MHC class II expression as a candidate biomarker for selecting patients for perioperative immunotherapy.

    Why it matters: Identifies a predictive biomarker that separates responders from non-responders to perioperative immunotherapy in gastric cancer.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org