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  • Research Article
  • 10.1007/s00210-026-05193-0
A year in pharmacology: new drugs approved by the US food and drug administration in 2025.
  • Mar 11, 2026
  • Naunyn-Schmiedeberg's archives of pharmacology
  • Gizem Kayki-Mutlu + 3 more

The US Food and Drug Administration approved 45 new drugs and 4 new cellular and gene therapy products in 2025, that is, a total of 49 new medical therapies. Oncology, hematology/immunotherapy, and cardiovascular/respiratory drugs remain most frequent. Among oncology drugs, there is a trend for targeting ever smaller subtypes of malignancies and/or rarer malignancies. Trends over the past 6years include steady levels of first-in-indication (about 10%), first-in-class (about 38%), and next-in-class (about 51%) approvals. Along with a large share of approvals in orphan indications (> 50%), fast track approval pathways are now regularly representing more than half of all new approvals. While small molecules remain the bedrock of novel medical treatments (about 60%), there is a growing segment of mRNA, gene, and cell-based pharmacological approaches. These data testify to the innovative strength of academia, biotechnology, and established pharmaceutical companies in providing innovative treatments, often related to previously unmet medical needs.

  • Research Article
  • 10.64744/tjiss.2025.28
<b>The Impact of One-Year UK Master’s Programme on the Identity of Chinese International Students: A Case Study Based on Xiaohongshu</b><b></b>
  • Mar 11, 2026
  • THE JOURNAL OF INTERACTIVE SOCIAL SCIENCES
  • Qi Huang

UK one-year master's programs offer a fast track to graduate degrees for Chinese international students. However, their market-driven, competitive nature and impact on identity formation are often overlooked. This study, using Norton's (2013) Investment and Identity theory and network ethnography on Xiaohongshu, explores identity negotiation among this student group. Results reveal identity formation as a contextualized, complex process involving pragmatic trade-offs amidst pressures from intensive coursework, compressed timeframes, high financial investments, and career anxieties. The absence of supportive structures may hinder deep integration, exacerbate vulnerability, and impact future employment. This study aims to enhance learners' navigation of high-pressure global environments and provide a proper perspective on contemporary international students in global education.

  • Research Article
  • 10.1136/rapm-2025-107507
Evaluation of a mental health screening tool to determine the need for psychological interview for patients offered neuromodulation implant therapies for pain.
  • Mar 4, 2026
  • Regional anesthesia and pain medicine
  • Maggie Z X Xiao + 10 more

Psychological comorbidities can negatively impact outcomes of spinal cord stimulation (SCS) for chronic pain. While psychological assessment is commonly required before SCS implantation, evidence supporting its impact on outcomes is limited, and such assessments may be unnecessary for many patients and contribute to delays in care. Our center implemented a screening tool incorporating validated questionnaires and a mental health checklist to triage the need for formal psychological evaluation. This prospective, observational cohort study compared outcomes of SCS trials and implants between patients who bypassed (fast track: FT) versus those who underwent a formal assessment by a psychologist (AP). Data were collected from patients undergoing SCS trials between July 2017 and December 2021. The screening tool used thresholds on validated questionnaires assessing anxiety, depression, catastrophizing, and opioid misuse risk, along with a checklist capturing significant anxiety or depression, self-harm, substance abuse, or mental-health-related hospitalization. Patients screening positive underwent an AP; others proceeded directly to trial (FT). 1 year post implantation outcomes were collected, with successful implantation defined as ≥30% pain reduction from baseline. Of 171 patients (114 AP, 57 FT), trial-to-implant rates were similar (72% AP vs 70% FT, p=0.811). The proportion of responders at 1 year post implant was also comparable (53% AP vs 60% FT, p=0.927). Multivariate logistic regression identified that higher baseline pain intensity (adjusted OR (aOR) 0.70, 95% CI 0.53 to 0.92, p=0.011) and use of tricyclic antidepressants (aOR 0.15, 95% CI 0.04 to 0.56, p=0.005) were associated with implant failure, whereas pain duration >10 years was associated with implant success (aOR 3.09, 95% CI 1.06 to 9.02, p=0.039). This screening tool effectively identifies patients who can bypass routine psychological assessment without compromising 1 year SCS outcomes. Implementation can streamline patient flow, reduce wait times, and reserve psychological resources for those who need formal evaluation.

  • Research Article
  • 10.1016/j.jopan.2025.12.010
The Role of Standardizing the White's Fast Track Handoff From Operating Room to Postanesthesia Care Unit: A Quality Improvement Project.
  • Mar 1, 2026
  • Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses
  • Naomi Lyle + 5 more

The Role of Standardizing the White's Fast Track Handoff From Operating Room to Postanesthesia Care Unit: A Quality Improvement Project.

  • Research Article
  • 10.1016/j.semerg.2026.102691
Utilization and diagnostic yield of the Fast-Track Referral Pathway for suspected melanoma: a six-year analysis
  • Mar 1, 2026
  • Semergen
  • V Alonso-Chornet + 1 more

Utilization and diagnostic yield of the Fast-Track Referral Pathway for suspected melanoma: a six-year analysis

  • Research Article
  • 10.1016/j.apm.2025.116429
A fast robust output tracking approach based on the GRU-ARX model with application to quadrotor
  • Mar 1, 2026
  • Applied Mathematical Modelling
  • Binbin Tian + 1 more

A fast robust output tracking approach based on the GRU-ARX model with application to quadrotor

  • Research Article
  • 10.1016/j.jclinane.2026.112137
From fast track to enhanced recovery after Cardiac surgery: 15years of experience with the Leipzig concept in a specialized post-anesthesia care unit.
  • Mar 1, 2026
  • Journal of clinical anesthesia
  • Waseem Zakhary + 6 more

Enhanced Recovery After Cardiac Surgery (ERACS) has become the standard of care for selected patients. This study evaluated the evolution of the Leipzig concept in a specialized postanaesthesia care unit (PACU) over 15years, with a focus on temporal trends and clinical outcomes. A retrospective cohort study was conducted on patients admitted to PACU after cardiac surgery at the Heart Center Leipzig between November 2005 and December 2020. Postoperative outcomes, including postprocedural complications, hospital length of stay, delirium, and mortality, were recorded. The outcomes were analyzed via multivariable models, and the adjusted results are reported. Among 56,371 cardiac surgery patients, 42% (n=23,724) were admitted to the PACU and managed according to the ERACS protocol. After excluding incomplete datasets, 20,773 patients were analyzed. Utilization increased from 19% in 2006 to 60% in 2020. Despite a rising proportion of moderate- and high-complexity surgeries, in-hospital mortality has remained stable. Improved adherence to the ERACS components, including the integration of a delirium prevention bundle, was associated with significant reductions in postoperative delirium (p=0.02) and in-hospital mortality (p=0.007). Patients treated with sufentanil exhibited significantly lower in-hospital mortality than did those receiving remifentanil (p=0.005). Subgroup analyses revealed higher in-hospital mortality in patients with EuroSCORE II ≥6%, complex procedures, and age≥75years (p<0.001, p=0.04, and p<0.001, respectively). This study presents the largest collection of consecutive ERACS patients ever collected and demonstrates the safety and efficacy of ERACS management with a specialized PACU, highlighting the benefits of continuous protocol optimization.

  • Research Article
  • 10.3389/fnhum.2026.1750499
Authority reliance vs. deliberative assessment in processing online rumors: evidence from fNIRS
  • Feb 24, 2026
  • Frontiers in Human Neuroscience
  • Shuhua Cheng + 2 more

PurposeThis study aimed to clarify how the authority of a fact-checker shapes neurocognitive processing of online rumors. Specifically, this study examined differences in neural responses to corrections provided by authoritative and non-authoritative sources.ApproachFunctional near-infrared spectroscopy (fNIRS) was used to measure neural activity in the prefrontal cortex while participants evaluated information that had been fact-checked by either authoritative or non-authoritative third-party sources. Behavioral metrics, such as judgment accuracy, were collected alongside neural data to correlate brain activity with decision-making outcomes.Results/findingsAuthoritative fact-checkers produced stronger activation in the left prefrontal cortex (LPFC) and improved overall judgment accuracy, suggesting a cognitive “fast track” that facilitates information acceptance. This enhanced accuracy was accompanied by increased LPFC engagement, indicating deeper analytical engagement. For true information, non-authoritative fact-checking led to reduced right prefrontal cortex (RPFC) activation and only marginal behavioral improvements, suggesting participants relied on heuristic shortcuts or “cognitive offloading” rather than rigorous deliberation. During false information processing, RPFC activation decreased across specific channels (e.g., Ch19), with non-authoritative sources yielding higher false-information judgment accuracy (59%) compared to authoritative sources (55%). This paradoxical effect suggests that lower source credibility can, in certain contexts, elicit more vigilant evaluation of false claims. The neural and behavioral responses to authoritative versus non-authoritative sources varied based on information veracity, consistent with cognitive dissonance theory, which posits adaptive shifts in processing strategies in response to credibility cues.ValueBy linking source credibility to distinct neural signatures and accuracy outcomes, this work provides a neurocognitive account of how fact-checker authority influences belief updating. The findings highlight that credibility cues can promote heuristic acceptance or more careful analysis, depending on the situation. Furthermore, this evidence can inform more effective rumor-intervention strategies that are sensitive to both source attributes and information type.

  • Research Article
  • 10.1136/heartjnl-2025-327383
Impact of name-based implicit bias on time to diagnosis and outcomes in ST-elevation myocardial infarction.
  • Feb 23, 2026
  • Heart (British Cardiac Society)
  • Dorian Garin + 8 more

Patients with marginalised characteristics experience delayed ST-elevation myocardial infarction (STEMI) diagnosis despite fast-track protocols. We aimed to determine whether patients with phonetically uncommon surnames in our community experience delays from first medical contact (FMC) to STEMI diagnosis compared with patients with common surnames within an established fast-track network. The Fast-Track Protocol for ST-Elevation Myocardial Infarction prospective registry enrolled consecutive STEMI patients from June 2008 to November 2024. Patient surnames were classified as phonetically common or uncommon using standardised phonetic matching against Canton Fribourg population data. Generalised linear models examined FMC-to-diagnosis time, FMC-to-balloon time and infarct size markers. Cox regression assessed major adverse cardiac and cerebrovascular events (MACE) at 30 days, 1 year and 5 years. Among 1208 patients, 284 (23.5%) had phonetically uncommon surnames. Patients with uncommon names experienced prolonged FMC-to-diagnosis time (59.4±87.6 vs 40.6±37.6 min; mean difference +16.8 min; p=0.009) and FMC-to-balloon time (116.8±90.5 vs 97.5±45.7 min; mean difference +17.5 min; p=0.016). Patients with uncommon names were significantly more likely to exceed the 90 min FMC-to-balloon threshold (39.2% vs 48.4%; p=0.010) and the 120 min threshold (16.4% vs 23.5%; p=0.018). Diagnosis-to-balloon time remained unaffected (p>0.80). Peak creatine kinase muscle-brain showed non-significant elevation (mean difference +52.0 U/L; p=0.077). No differences were observed in MACE at 30 days and 5 years between patients with common and uncommon names. Patients with phonetically uncommon surnames experienced significant STEMI diagnostic delays within an efficient fast-track network. Protocol-driven care following diagnosis operated equitably, leading to no difference in long-term MACE.

  • Research Article
  • 10.24884/0042-4625-2026-185-1-49-58
Abdominoplasty in patients with endometrial cancer and morbid obesity
  • Feb 20, 2026
  • Grekov's Bulletin of Surgery
  • A B Villert + 7 more

Endometrial cancer (EC) is the most common gynecological cancer, and obesity is recognized as one of the key factors in its development. A significant increase in the EC risk has been confirmed in women with BMI&gt;40 kg/m2. The main points concerning the EC risks in obesity, methods of risk modification and approaches to cancer treatment in obese patients are presented. Despite the fact that the use of minimally invasive methods, sentinel lymph node mapping, ERAS and Fast Track programs can minimize complications and improve outcomes, surgical intervention in patients with morbid obesity is associated with technical difficulties, including limited access to the pelvic organs, a high risk of intraoperative and postoperative complications, as well as prolongation of anesthesia time. Abdominoplasty and panniculectomy may be useful for improving surgical access and reducing risks in this category of patients. The clinical observations of female patients underwent abdominoplasty in combination with uterine extirpation and lymphadenectomy are presented. The use of abdominoplasty in pronounced panniculus helps to improve the quality of the surgical stage, does not contradict the use of video endoscopic access.

  • Research Article
  • 10.1177/26345161261419687
Safety and Efficacy of an Accelerated Recovery Protocol for Patients Undergoing Elective Esophagectomy: What Are We Waiting For?
  • Feb 17, 2026
  • Foregut: The Journal of the American Foregut Society
  • Adam R Dyas + 3 more

Objective: There is little evidence that delaying oral intake and hospital discharge leads to fewer complications after esophagectomy. The purpose of this study was to determine the safety and efficacy of a fast-track protocol for patients at low risk of perioperative complications undergoing oncologic esophagectomy. Methods: This is a retrospective review of patients undergoing oncologic esophagectomy at one hospital between February 2019 and December 2024. Patients were fast-tracked if: (1) a gastric conduit was used, (2) resection was part of first course oncologic therapy (tri-modality or as sole modality), and (3) patients were able to maintain weight preoperatively with oral nutrition alone. The patient demographics, comorbidities, and postoperative outcomes are reported and compared to published data. Results: Forty of 43 esophagectomies were included. Most patients were male (90.0%), white (82.5%), and received neoadjuvant chemoradiation (82.5%). Oral intake was initiated on post-operative day (POD) 1 (70%) or 2 (30%). Fourteen patients (35.0%) had at least one 30-day complication, but there were no aspiration events, issues with conduit distention or mortalities. One patient (2.5%) had gastric conduit necrosis requiring resection and surgical revision. There were no anastomotic leaks. Only two patients (5.0%) were readmitted before first outpatient follow-up, and thus, readmission was possibly avoidable with a longer inpatient stay. Length of hospital stay (LOS) averaged 5 days. Conclusions: Early feeding after esophagectomy did not increase complication rates for low-risk patients. Fast-tracking perioperative care for low-risk patients did not result in conduit or anastomotic complications and significantly reduced postoperative LOS.

  • Research Article
  • 10.1158/1557-3265.sabcs25-ps1-08-23
Abstract PS1-08-23: Emiltatug Ledadotin (Emi-Le): A B7-H4-Directed Dolasynthen Antibody-Drug Conjugate (ADC) Being Investigated in Phase 1 Dose Expansion in Patients with Triple Negative Breast Cancer who Received at Least One Prior Topoisomarase-1 Inhibitor ADC
  • Feb 17, 2026
  • Clinical Cancer Research
  • N Abuhadra + 23 more

Abstract Background: Breast cancer is the leading cause of cancer death for women worldwide, with triple-negative breast cancer (TNBC) considered one of the most aggressive sub-types and accounting for ∼15-20% of all cases. Unfortunately, there remains an unmet medical need for effective and well-tolerated treatments for advanced/metastatic TNBC, particularly for patients who have received a prior standard-of-care topoisomerase-1 inhibitor (topo-1) ADC. In heavily pretreated patients, standard-of-care single-agent chemotherapy has limited efficacy, with response rates of ∼5%, median PFS ∼7 weeks, median OS ∼6.7 months. Emiltatug ledadotin (Emi-Le; XMT-1660) is a B7-H4-directed Dolasynthen ADC designed with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin F-HPA microtubule inhibitor payload with controlled bystander effect. The FDA has granted Emi-Le two Fast Track designations for the treatment of adult patients with certain breast cancers, including patients with advanced or metastatic TNBC and patients with advanced or metastatic HER-2 low / HER-2 negative breast cancer who have previously been treated with topo-1 ADCs. As of March 8, 2025 data cutoff, treatment was generally well tolerated in the dose escalation portion of the ongoing Phase 1 trial. In patients with TNBC dosed with 38.1-67.4 mg/m2 per cycle, the most common TRAEs were transient AST increase (43%, G3 18%), fatigue (32%, G3 0%), typically asymptomatic proteinuria (30%, G3 7%), and nausea (27%, G3 2%). In patients with B7-H4 high TNBC dosed with 38.1-67.4 mg/m2 per cycle dose range, all of whom were heavily pretreated and had received at least one prior topo-1 ADC, interim clinical data demonstrated: 23% (3/13) confirmed response rate overall; 29% (2/7) in patients with ≤4 prior lines in locally advanced/metastatic setting; a preliminary median PFS of 16 weeks (6.1, NR) and a median OS not yet reached in patients with ≤4 prior lines in the locally advanced/metastatic setting. Method: Based on these encouraging clinical activity and tolerability data, the expansion portion (EXP) of the Phase 1 trial has been initiated and is actively enrolling patients with TNBC who have received 1-4 prior lines of systemic therapy in the advanced/metastatic setting, including at least one topo-1 ADC. EXP has a Simon 2-stage design and will evaluate two dosing regimens: 67.4 mg/m2 Q4W or 80 mg/m2 Q4W with a 44.5 mg/m2 loading dose on days 1 and 8 of the first 4-week cycle. Patients are being evaluated for B7-H4 expression by IHC and are stratified into B7-H4 TPS “high” and B7-H4 TPS “low” cohorts. NCT05377996 Citation Format: N. Abuhadra, A. Giordano, K. M. Kalinsky, H. Han, N. P. McAndrew, A. I. Spira, K. C. Kelley, J. A. O'Shaughnessy, D. Starks, N. Chan, R. Parajuli, G. M. Wulf, A. Chaudhry, J. S. Wang, F. Meric-Bernstam, A. Tiersten, A. M. Weise, D. L. Richardson, P. A. Robinson, L. A. Huppert, C. Rogalski, N. Zizlsperger, A. Reske, E. P. Hamilton. Emiltatug Ledadotin (Emi-Le): A B7-H4-Directed Dolasynthen Antibody-Drug Conjugate (ADC) Being Investigated in Phase 1 Dose Expansion in Patients with Triple Negative Breast Cancer who Received at Least One Prior Topoisomarase-1 Inhibitor ADC [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS1-08-23.

  • Research Article
  • 10.1158/1557-3265.sabcs25-ps4-06-28
Abstract PS4-06-28: Initial clinical and pharmacology results from START-002: A phase 1b/2 clinical investigation of invikafusp alfa (STAR0602), a first-in-class dual T cell agonist, in combination with sacituzumab govitecan in patients with mTNBC or HR+/HER2- mBC
  • Feb 17, 2026
  • Clinical Cancer Research
  • S J Isakoff + 16 more

Abstract Background: Invikafusp alfa (“invika”) is a novel, first-in-class dual T cell agonist that selectively targets subsets of T cells expressing the germline-encoded variable Vβ6 and Vβ10 variant TCRs that are enriched in TILs. Clinically, invika monotherapy generates a potent and selective expansion of mainly CD8+ Vβ6/ Vβ10 T cells. 0.08mg/kg was selected as RP2D and has demonstrated clinically meaningful single-agent anti-tumor activity in anti-PD(L)-1 resistant tumors, including objective responses in patients with TMB-H TNBC, CRC, NSCLC, and other tumor types resistant to anti-PD(L)-1. Based on these initial results, US FDA granted Fast Track Designation for invika in TMB-H CRC. Sacituzumab govitecan (SG), an antibody drug conjugate (ADC), is FDA approved for patients with metastatic TNBC and HR+/HER2- mBC. Preclinical studies indicate ADCs enhance tumor immunogenicity by promoting immunogenic cell death, increased antigen presentation, and tumor immune infiltration. Combination of ADCs with immunotherapy has the synergistic potential to enhance tumor eradication, help overcome resistance mechanisms, and improve overall treatment outcomes in breast cancer patients. Methods: START-002 is a Ph 1b/2 study to evaluate invika in combination with SG in patients with mTNBC or HR+/HER2- MBC. In Ph1b, patients were enrolled to 2 safety run-in cohorts at 0.04 mg/kg or 0.08mg/kg of invika with standard dose of SG (10mg/kg). Ph2 includes expansion cohorts for patients with mTNBC or HR+/HER2- mBC. Primary objective is to characterize the safety of invika + SG and to evaluate preliminary anti-tumor activity of the combination. Results: As of 15 Sep 2025, 11 patients with mTNBC or HR+/HER2- mBC were enrolled in 2 safety run-in cohorts. No DLTs were observed. Most common AEs (occurring in ≥2 patients) included neutrophil count decreased, diarrhea, alopecia, and stomatitis considered related to SG; cytokine release syndrome related to invika; fatigue and platelet count decreased considered related to either or both drugs. No ICANS or irAEs were reported. Treatment-related AEs were predominantly low grade 1 or 2, with exception of neutrophil count decreases, which were mainly grade 3. In the 0.04 mg/kg safety run-in cohort, 5 patients had at least 1 tumor assessment. Four experienced disease control (1 confirmed partial response (cPR) +3 SD) and 1 disease progression. The cPR was observed in a patient with HR+/HER2- mBC with liver and bone metastases, who progressed after 4 lines of endocrine and chemo-based regimens. The 3 patients with SD all experienced some degree of tumor reduction at the first scan but did not meet criteria for PR. Enrollment to the 0.08 mg/kg safety cohort has been completed with the first 3 patients reporting SD after completing at least one tumor assessment. Nanostring gene expression analyses in Ph1b demonstrated unequivocal expansion of Vβ6/10 T cells after the 1st dose of invika in mBC patients treated with this combination, similar to the selective expansion of Vβ6/10 T cells observed with invika monotherapy. Conclusions: Invika in combination with SG is feasible and safe at the doses tested. Combination safety profile is consistent with the known safety profile of each individual agent. Consistent with its mechanism of action, invika demonstrated unequivocal expansion of Vβ6/10 T cells when given with SG in mBC patients. Initial clinical anti-tumor activity including a cPR has been observed in patients with previously treated mBC. A RP2D has been selected and enrollment to Ph2 expansion cohorts is ongoing to further investigate the clinical activity of this promising novel combination therapy. Citation Format: S. J. Isakoff, A. Martynova, P. L. Bedard, A. Bardia, M. E. Gatti-Mays, N. LeVasseur, A. Varkaris, A. Bayliffe, W. Randolph, K. Srinivasan, S. McCue, K. Liu, Z. Su, K. Chin, V. Kaklamani, K. McCann, E. Hamilton. Initial clinical and pharmacology results from START-002: A phase 1b/2 clinical investigation of invikafusp alfa (STAR0602), a first-in-class dual T cell agonist, in combination with sacituzumab govitecan in patients with mTNBC or HR+/HER2- mBC [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS4-06-28.

  • Research Article
  • 10.1158/1557-3265.sabcs25-ps5-09-16
PS5-09-16: A phase 1b/2 clinical investigation of invikafusp alfa (STAR0602), a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan in patients with metastatic TNBC or HR+/HER2- MBC (START-002 trial)
  • Feb 17, 2026
  • Clinical Cancer Research
  • S Isakoff + 16 more

Abstract Background: Invikafusp alfa (STAR0602) is a novel, first-in-class dual T cell agonist that selectively targets subsets of T cells expressing the germline-encoded variable Vβ6 and Vβ10 variant TCRs that are enriched in tumor-infiltrating lymphocytes. The completed Ph1 dose escalation of monotherapy invikafusp alfa identified a recommended Ph 2 dose (0.08mg/kg IV Q2W) and demonstrated clinically meaningful single-agent anti-tumor activity in anti-PD(L)-1 resistant tumors, including objective responses in patients with tumor mutation burden-high (TMB-H) colorectal cancer (CRC), non small cell lung cancer, and gastroesophageal junction cancer. Invikafusp alfa promoted potent and selective expansion of mainly CD8+ Vβ6/ Vβ10 T-cells. Based on these initial clinical results, US FDA granted Fast Track Designation for invikafusp alfa in TMB-H CRC. Sacituzumab govitecan (SG), an antibody-drug conjugate (ADC), is FDA approved for patients with pre-treated unresectable locally advanced (LA) or metastatic triple-negative breast cancer (mTNBC) and HR-positive/HER2-negative breast cancer (HR+/HER2- mBC). Preclinical studies indicate that treatment with ADCs enhances tumor immunogenicity by promoting immunogenic cell death, increased antigen presentation and tumor immune infiltration. These effects are likely mediated by cytotoxic tumor cell death and subsequent release of tumor-associated antigens. Recent clinical results from the ASCENT-04 trial demonstrated improved progression-free survival in previously untreated PD-L1+ mTNBC patients who received the combination of SG and pembrolizumab, thus confirming the clinical potential of combining an ADC with an IO agent in metastatic breast cancer. START-002 explores the hypothesis that combining SG’s immunomodulatory potential with invikafusp alfa’s selective activation and expansion of tumor-reactive Vβ6/Vβ10 T-cells, will enhance anti-tumor responses and result in improved clinical outcomes in breast cancer patients. Methods: Study design: START-002 is a phase 1b/2 open label, multi-center study to determine the safety, feasibility, and anti-tumor activity of invikafusp alfa in combination with SG in patients with mTNBC or HR+/HER2- mBC. Patients will receive SG on Days 1 and 8 of a 21-day cycle and STAR0602 only on Day 8. Ph1 enrollment will start with an initial 5 patient Safety Run-in cohort at the 0.04 mg/kg dose level of STAR0602 + SG and may proceed to include 1 of 2 dose groups of STAR0602 (0.08 mg/kg or 0.02 mg/kg) + SG in order to determine the recommended dose of STAR0602 that will be used in the Ph2 cohort expansion phase. Using a Simon’s 2-stage design, Ph2 will enroll 20 participants into 2 separate expansion cohorts of patients who have either mTNBC or HR+/HER2- mBC. Major eligibility criteria: TNBC cohort: LA or mTNBC, ≥2 prior systemic therapies, at least 1 for metastatic disease. HR+/HER2- mBC cohort: LA or metastatic HR+/HER2- BC, prior endocrine based therapy and ≥1 additional systemic therapy in the metastatic setting. Prior topoisomerase 1 inhibitor therapy is excluded. Primary objective and endpoint: The primary objective of this Ph1b/2 study is to characterize the safety and tolerability of invikafusp alfa when given together with sacituzumab govitecan, and to evaluate preliminary anti-tumor activity of the combination treatment. The primary endpoints are safety and overall response rate per RECIST and iRECIST. Enrollment to the Ph1 safety run-in cohorts is ongoing. Clinical Trial Information: NCT06827613 Citation Format: S. Isakoff, P. Bedard, A. Martynova, A. Bardia, M. Gatti-Mays, N. LeVasseur, A. Varkaris, W. Randolph, K. Srinivasan, S. McCue, A. Bayliffe, K. Liu, Z. Su, K. Chin, V. Kaklamani, K. McCann, E. Hamilton. A phase 1b/2 clinical investigation of invikafusp alfa (STAR0602), a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan in patients with metastatic TNBC or HR+/HER2- MBC (START-002 trial) [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-09-16.

  • Research Article
  • 10.69554/uuvz6884
Reinventing resilience: Enterprise resilience in the age of digital disruption.
  • Feb 15, 2026
  • Journal of business continuity & emergency planning
  • Tariq Munir

This paper explores how digital disruption necessitates a new understanding of business resilience. The rules of business resilience are being rewritten, rendering traditional disaster recovery inadequate and accelerating corporate obsolescence. Standing on the sidelines is no longer an option; rather, it is a fast track to irrelevance. This paper addresses the critical challenge of navigating an era of unprecedented digital disruption by presenting a holistic, transformational framework for building reimagined resilience. It involves three core phases: align, react and reinvent. The align phase emphasises establishing a clear 'north star' and 'why', driven by C-suite accountability and fostering an engaging, psychologically safe environment for co-creation. Next, the react phase focuses on building a robust digital and data foundation. This includes a business-driven data strategy, building a comprehensive cybersecurity posture beyond mere technical measures, and an agile, platform-based infrastructure. Most importantly, the author presents an argument for cultivating a digital-ready workforce skilled in experimentation and collaboration. Finally, reinvent necessitates the continuous re-architecture of operating models, leveraging digital factories and treating data as a strategic asset through data productisation. Crucially, it involves fostering an adaptive culture that embraces continuous innovation and learns from failure, recognising that building digital resilience is not a one-off exercise, nor is it a hype-induced necessity. Readers will gain actionable insights into navigating this ongoing transformation, understanding that building digital resilience is the fundamental license to operate in our rapidly evolving world. This article is also included in The Business & Management Collection which can be accessed at https://hstalks.com/ business/.

  • Research Article
  • 10.1080/15361055.2026.2612672
Research on Current Sharing Control Strategy of CRAFT Rectifier Power Supply
  • Feb 12, 2026
  • Fusion Science and Technology
  • Haihong Huang + 2 more

Fast and stable control of the Comprehensive Research Facility for Fusion Technology (CRAFT) high-power rectifier power supply output current is an important guarantee for reliable plasma operation, and achieving current sharing control in each parallel branch is key to ensuring stable operation of the high-power rectifier power supply. The total output current feedback compensation control method is proposed to achieve fast and stable reference current tracking and branch current balance control in the high-power rectifier power supply. Based on independent current control in each rectifier bridge branch, the error of total current tracking reference current is used as the compensation factor to adjust each branch current in real time, ensuring branch current balance. The branch current balance tracking reference current further ensures the total output current tracking error being smaller. Independent tracking control of the branch current and compensation control of the total output current work together in the dynamic regulation process, and the control structure is simple and reliable. Simulation and practical engineering experiments of the CRAFT high-power rectifier power supply verify that the total output current can quickly and stably track the reference current output to 50 kA, effectively suppressing the circulating current for parallel branches and achieving a good current sharing effect for branches.

  • Research Article
  • 10.1111/jcpp.70133
The randomized controlled trial Fast Track multilevel intervention for children with early-emerging conduct problems breaks intergenerational transmission of violence across three generations.
  • Feb 11, 2026
  • Journal of child psychology and psychiatry, and allied disciplines
  • Laura Gorla + 2 more

Domestic violence mechanisms are frequently transmitted across generations, representing a global issue demanding particular attention. This study investigates the intergenerational transmission of intimate partner violence (IPV) and parent-to-child violence (PCV) and whether participating in a multilevel preventive intervention (Fast Track) breaks this transmission. In high-risk elementary schools located in the United States, children considered at high risk for aggressive behavior based on teachers' and parents' screen scores were assigned to either a 10-year intervention or a control group based on their school. The Fast Track trial was registered at clinicaltrials.gov (NCT01653535) and was focused on parenting practices and children's intrapersonal, interpersonal, and academic skills. From the original 891 children, 374 participants with children aged less than 18 years (n = 191 intervention group, n = 183 control group) reported at age 34 their experience with domestic violence and their children's psychological adjustment. The intergenerational mediating pathway from high IPV in the first generation to high PCV in the second generation to greater total mental health difficulties in the third generation was statistically significant in the control group but not in the intervention group. IPV was intergenerationally transmitted by influencing PCV, with a negative effect on the third generation's mental health. Nevertheless, participation in the Fast Track intervention disrupted this cycle. These findings suggest the importance of policies to support preventive childhood interventions.

  • Research Article
  • 10.1109/tcyb.2026.3658831
Adaptive Shared Cascade Navigation Control of Magnetic Microrobots in Unstructured Dynamic Environments.
  • Feb 10, 2026
  • IEEE transactions on cybernetics
  • Shihao Zhong + 7 more

Precise motion control of magnetic microrobots in complex and dynamic environments remains a critical challenge for enabling key applications such as targeted therapy and micromanipulation. Purely manual teleoperation is prone to operator fatigue and error, while fully autonomous systems often lack the robustness and adaptability to handle. Here, we propose a human-machine shared cascade control method for magnetically driven microrobots, which effectively integrates human cognitive intelligence with machine autonomy for collision-free navigation in dynamic environments. The outer-loop hybrid shared control unit smoothly modulates control authority in response to real-time collision risk, dynamically integrating the operator instructions and the autonomous navigation system output guided by the enhanced artificial potential field method to formulate the guidance law. For the inner-loop motion tracking, a data-driven adaptive orientation controller is designed, which integrates a nonlinear feedforward compensator leveraging a Gaussian process regression (GPR) model with a linear feedback controller whose parameters are optimized using the virtual reference feedback tuning (VRFT) method, ensuring fast and precise tracking of the desired motion. The effectiveness of the proposed method was validated through both simulation and physical experiments. In human-subject studies conducted on a physical magnetic actuation platform featuring both static and dynamic obstacle scenarios, quantitative results demonstrate that the shared control strategy significantly outperforms both purely manual and fully autonomous modes across all key metrics, including success rate, task completion time, stability, and safety ( $p \lt 0.001$ ). Furthermore, successful navigation within a complex gastric model demonstrates the potential of the shared control system for practical application in unstructured environments.

  • Research Article
  • 10.1109/tcyb.2025.3633231
Cooperative Tracking Control of VTOL Drones: A Fixed-Time Super-Twisting Approach.
  • Feb 10, 2026
  • IEEE transactions on cybernetics
  • Ning Zhou + 4 more

This study addresses the cooperative tracking control for multiple vertical take-off and landing (VTOL) drones operating in networked environments. The problem is particularly challenging due to the strongly nonlinear dynamics of drones, uncertain time-varying disturbances, limited communication bandwidth, and control chattering on the first-order sliding manifold. Existing approaches often address only part of these challenges or lack rigorous fixed-time convergence guarantees. To tackle these issues, this article proposes a novel adaptive neural network event-triggered fixed-time super-twisting (ANEFS) control strategy within a double closed-loop hierarchical framework. In the outer loop, a novel auxiliary variable-based distributed fixed-time estimator (ADFE) is designed, which, unlike conventional asymptotic estimators, guarantees fast and accurate estimation of the leader's trajectory. This is integrated into an event-triggered fixed-time super-twisting (EFST) control law that ensures precise position tracking while significantly reducing network usage. In the inner loop, an adaptive neural network fixed-time super-twisting (ANFST) torque controller robustly handles complex system nonlinearities and uncertainties, ensuring rapid attitude tracking. The effectiveness of the proposed method in providing fast, robust, and resource-efficient cooperative tracking is demonstrated through both numerical simulations and real-world flight experiments using lightweight Crazyflie quadcopters.

  • Research Article
  • 10.1108/ria-07-2025-0213
Event-triggered finite-time cooperative tracking control for unmanned surface vehicles
  • Feb 10, 2026
  • Robotic Intelligence and Automation
  • Zhuo Liu + 2 more

Purpose Despite recent progress in target tracking control of unmanned surface vehicles (USVs), achieving fast and effective tracking performance still faces challenges. To address this issue, this paper aims to design a distributed finite-time (FT) cooperative control method, which enables multiple USVs to track a target in FT with external disturbances. Design/methodology/approach By incorporating the position difference between the USV and the target as the system state in the USV model, an error system can be formed. Cooperative target tracking control can be achieved by driving these system states to zero. First, a Lyapunov function is constructed for each USV under the directed communication topology. Using the proposed controller, it is proven that all system states converge to zero in FT. Then, an event-triggered mechanism (ETM) with the control error term is incorporated, which reduces computing burden while maintaining the expected control performance. Finally, theoretical analysis and simulation results demonstrate that the proposed event-triggered FT cooperative tracking controller can effectively achieve the purpose of this paper. Findings In the presence of nonlinear time-varying external disturbances, USVs are able to track the target in FT. Furthermore, the ETM effectively prevents Zeno behavior, demonstrating that the presented method can be applied to actual physical systems. Originality/value The proposed method, which ensures FT stability while guaranteeing Zeno-free, can be applied not only to USVs, but also to the control problems of other multi-agent systems, such as multiple unmanned aerial vehicles and multiple unmanned ground vehicles.

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