rhIL-7-hyFc (Efineptakin alfa) is a novel, long-acting recombinant human interleukin-7 developed to enhance immune responses by correcting T-cell deficiencies through increased lymphocyte counts. This study aimed to develop a population pharmacokinetic-pharmacodynamic (PK-PD) model to support selection of the recommended Phase 2 dose (RP2D) through optimization of dosing regimens.

Surgical resection is the preferred curative approach for patients with early-stage hepatocellular carcinoma, but recurrence remains a major challenge. Consequently, neoadjuvant and adjuvant therapies have been proposed to reduce tumour burden and mitigate the risk of recurrence. The CARES-009 trial aimed to evaluate perioperative camrelizumab plus rivoceranib in patients with resectable hepatocellular carcinoma at intermediate or high risk of recurrence.

Patients with previously untreated, locally advanced, unresectable or metastatic triple-negative breast cancer who are not candidates for inhibitors of programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) have limited treatment options.

Pheochromocytoma and paraganglioma are neoplasms originating in the adrenal medulla and extraadrenal paraganglia, respectively. Most cases of metastatic pheochromocytoma and paraganglioma are driven by dysregulation of the hypoxia-inducible factor 2α (HIF-2α) pathway. Belzutifan is a HIF-2α inhibitor that may provide antitumor activity in patients with advanced pheochromocytoma or paraganglioma.

Patients with muscle-invasive bladder cancer have varied outcomes after cystectomy. Circulating tumor DNA (ctDNA)-based detection of molecular residual disease may identify patients at high risk for recurrence after cystectomy who can benefit from adjuvant immunotherapy, thus sparing patients at lower risk from unnecessary treatment burden.

In the phase 3 EMBARK trial, enzalutamide plus leuprolide and enzalutamide monotherapy were associated with longer metastasis-free survival than leuprolide alone among patients with biochemically recurrent prostate cancer. The final analysis of overall survival has not been reported.

In the CheckMate 238 trial, patients with resected stage IIIB-C or stage IV melanoma who were treated with nivolumab had longer recurrence-free survival than those who received ipilimumab. Data were needed on longer-term survival.

Malignant perivascular epithelioid cell tumors (PEComas) are ultra-rare, aggressive mesenchymal neoplasms associated with poor outcomes. Standard-of-care systemic therapy includes mammalian target of rapamycin (mTOR) inhibition and chemotherapy. Immune checkpoint inhibition has not been previously studied in patients with advanced PEComas in a prospective clinical trial.

Receipt of anthracycline-based chemotherapy and statin therapy have been found to be associated with deterioration of cognitive function in patients with cancer.

This study aimed to evaluate the effects of a 12-week programme, including moderate strength training with and without whole-body vibration (WBV), on chemotherapy-induced peripheral neuropathy (CIPN) associated symptoms in breast cancer patients undergoing paclitaxel-containing therapy. The goal was to assess the effects on sensory, motor, and autonomic symptoms and on balance, depth sensitivity, and the vibration sensation.

We report the long-term efficacy and safety from the multicenter, randomized, double-blind, placebo-controlled, phase III ATHENA-MONO/GOG-3020/ENGOT-ov45 (NCT03522246) study of first-line rucaparib maintenance for advanced ovarian cancer.

First-line treatments for metastatic clear-cell renal-cell carcinoma (ccRCC) combine programmed cell death protein 1 (PD-1) immune checkpoint inhibition (ICI) with cytotoxic T-lymphocyte associated protein 4 ICI or angiogenesis targeted therapies (TT). Upon progression, common options include cabozantinib or lenvatinib + everolimus, although these regimens have never been directly compared. We hypothesized that lenvatinib + everolimus will improve progression-free survival (PFS) compared with cabozantinib after progression on PD-1 ICI.

Purpose This study aimed to clinically evaluate the high-energy light-emitting device (Germinator) in preventing pain and oral mucositis in patients undergoing chemotherapy. Methods Sixty patients were selected, being randomly divided into two groups(n = 30), according to preventive protocol: G1(Lasertherapy)-conventional low-intensity red laser protocol; G2(Germinator)-protocol with high-energy light-emitting device. Before and after these protocols, the pain and oral mucositis degrees were recorded by visual analog scale(VAS) for pain and World Health Organization(WHO) classification for oral mucositis. The VAS was used to assess pain symptoms, where 0 represented the absence of pain and 10 the highest pain score. The oral mucositis scoring was performed according to the WHO classification: grade 0(none), grade I(oral soreness, erythema), grade II(oral erythema, ulcers, solid and liquid diet tolerated), grade III(oral ulcers, liquid diet only), and grade IV(oral alimentation impossible). Statistical analysis was performed by Mann-Whitney U test(α = 5%), in order to provide the intergroup comparison. Results The median (interquartile range-IQR) of pain score was 0.0(0.0-2.0) for G1 group(Lasertherapy), whereas it was 0.0(0.0-2.0) for G2 group(Germinator), revealing no statistically significant differences (p > 0.05). The median(minimum and maximum value) of the oral mucositis score was 0.0(0.0-1.0) for G1 group(Lasertherapy), whereas it was 0.0(0.0-1.0) for G2 group(Germinator), also revealing no statistically significant differences (p > 0.05). Both treatments proved equally effective in preventing and controlling these symptoms in patients undergoing chemotherapy, recognizing that no statistically significant difference was found between the two preventive modalities. Conclusions The high-energy light-emitting device(Germinator) appears promising in preventing pain and oral mucositis in patients undergoing chemotherapy.

Chemotherapy-induced gastrointestinal reactions are common in non-small cell lung cancer (NSCLC) patients undergoing carboplatin-based chemotherapy. Jianpi Yiwei granules (JPYW), a traditional Chinese medicine (TCM) formula, can alleviate these symptoms.

Patients receiving moderately emetogenic chemotherapy (MEC) are commonly prescribed a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist (RA) and dexamethasone (DEX) as standard-of-care (SOC) antiemetic prophylaxis. However, in patients with an elevated risk of chemotherapy-induced nausea and vomiting (CINV) due to individual risk factors, prophylaxis with an neurokinin-1 (NK1) RA-containing regimen may optimise their antiemetic prevention. To address this unmet need for a more personalised antiemetic strategy, the MyRisk trial incorporated a predictive risk factor algorithm to select patients at increased risk of CINV who may benefit from enhanced antiemetic prophylaxis.

Despite recent chronic lymphocytic leukemia (CLL) treatment advances, resistance and intolerance are challenges. Lisaftoclax is a selective, small-molecule oral BCL-2 inhibitor.

HER2 gene mutations occur in 2 to 4% of patients with non-small-cell lung cancer (NSCLC). Sevabertinib is an oral, reversible tyrosine kinase inhibitor that has shown anti-HER2 activity in preclinical models.

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect among breast cancer patients, leading to impaired functional capacity and diminished quality of life. Although non-pharmacological methods such as local heat and cold applications are gaining attention, their comparative efficacy has not been sufficiently explored. This study aimed to examine the effectiveness of local heat and cold applications on CIPN symptoms in breast cancer patients undergoing chemotherapy.

Chronic human immunodeficiency virus type 1 (HIV-1) disease results in immune exhaustion and dampened T cell responses, and programmed cell death 1 (PD-1) inhibitors offer a potential approach to enable viral control without antiretroviral therapy (ART) through reversal of these effects. Budigalimab is an investigational humanized anti-PD-1 monoclonal antibody. Multiple intravenous (IV) low doses of budigalimab (Stage 1: 2 mg n = 10, 10 mg n = 10, placebo n = 5, two doses every 4 weeks; Stage 2: 10 mg n = 11, placebo n = 5, four doses every 2 weeks (Q2W)) were assessed in people living with HIV (PLWH; n = 41) in a randomized, double-blind, multicenter, placebo-controlled phase 1 study with an analytical treatment interruption (ATI) to identify an efficacious regimen with a favorable safety profile in PLWH. The primary endpoints were safety, tolerability and pharmacokinetics. Demographics and baseline characteristics were balanced across treatment groups, except for sex, which was mostly male. All participants identified as cisgender. Budigalimab was well tolerated for up to 44 weeks, with 29 of 41 participants experiencing an adverse event (AE), including 2 participants who each experienced one grade 1 reversible immune-related AE (thyroiditis, hyperthyroidism). Three grade 3 AEs were reported by two participants and one serious AE by one participant; none were deemed related to treatment. IV budigalimab 10 mg Q2W resulted in a slight accumulation of drug in serum, with concentrations remaining above the estimated concentration required for near-complete (>95%) PD-1 receptor saturation on CD8+ T cells for ~10 weeks in peripheral blood. In an exploratory efficacy analysis of a 12-week ATI initiated with the first of four 10 mg Q2W doses, 6 of 11 participants experienced a delayed rebound with a relatively low viral peak and/or off-ART viral control (<200 copies ml-1) for ≥6 weeks during ATI, with 2 sustaining ART-free viral control to study end (204-252 days). The study achieved prespecified endpoints, supporting further evaluation of budigalimab in PLWH in a phase 2 study. ClinicalTrials.gov identifier: NCT04223804 .

Despite recent advances in the treatment of fibroblast growth factor receptor 3 (FGFR3)-altered metastatic urothelial carcinoma, there is no approved precision therapy that selectively targets FGFR3 while sparing other FGFR isoforms. Dabogratinib (TYRA-300)-a rationally designed selective FGFR3 inhibitor-was evaluated in vitro and in vivo. We also report three patient cases from the ongoing first-in-human, phase I/II SURF301 study (NCT05544552). Dabogratinib elicited a dose-dependent reduction in downstream signaling across three bladder cancer cell lines harboring an FGFR3 fusion, mutation, or gatekeeper resistance mutation. In a xenograft model driven by an FGFR3S249C-activating mutation, dabogratinib treatment resulted in dose-dependent tumor growth inhibition with tumor regression observed at the highest doses. These preclinical findings are supported by the three case reports from the SURF301 study, which demonstrate early clinical activity in patients with advanced metastatic urothelial carcinoma with an FGFR3 fusion or activating mutation.