The ErbB family of receptor tyrosine kinases are key targets for antitumor therapy. Although neratinib, a pan-ErbB kinase inhibitor, is approved in ErbB2-positive breast cancer, drug resistance is common. Preclinical data suggest that combining neratinib with the mTOR inhibitor everolimus may overcome such resistance.

Neuregulin 1 (NRG1) fusions are recurrent oncogenic drivers found in multiple solid tumors. NRG1 binds to human epidermal growth factor receptor 3 (HER3), leading to heterodimerization with HER2 and activation of downstream growth and proliferation pathways. The efficacy and safety of zenocutuzumab, a bispecific antibody against HER2 and HER3, in patients with NRG1 fusion-positive solid tumors are unclear.

IMscin001 is a two-part dose-finding (Phase Ib) and -confirmation (Phase III) study to evaluate atezolizumab pharmacokinetics of subcutaneous (SC) compared with intravenous (IV) administration in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The objectives of the current analyses were to characterize the population pharmacokinetics (popPK) of atezolizumab and to determine the relationship between atezolizumab exposure and safety and efficacy endpoints in IMscin001. A previously validated IV popPK model was extended to add SC absorption parameters using SC and IV data from Phase Ib and Phase III of IMscin001 (N = 435), and covariate effects were investigated on the SC absorption parameters. The exposure-response (ER) investigation was performed using SC data following 1875 mg every three weeks (q3w) administration in the Phase III portion of IMscin001 (N = 246). The clinical endpoints were objective response rate, progression-free survival, or overall survival for efficacy, serious adverse events, special interest adverse events, Grades 3-5 adverse events, infusion-related reaction, or injection site reactions for safety. Atezolizumab SC absorption was characterized by a first-order absorption with a bioavailability of 71.8% and an absorption rate constant of 0.304 day-1. The extended popPK model was adequate to predict atezolizumab PK after IV and SC administrations and to predict individual exposure metrics. For all efficacy and safety endpoints, atezolizumab exposure was not statistically significant (p-value > 0.05) in the ER models. The non-inferior popPK exposure and flat ER results supported atezolizumab SC dose at 1875 mg q3w.

Hypersensitivity reactions (HSRs), an unpredictable and sometimes harmful reaction, may hamper the effectiveness of chemotherapy and lead to the need for drug switching. The recall of ranitidine from the drug market due to the N-nitrosodimethylamine production necessitates the identification of a proper alternative for the prevention of HSRs. Our study aimed to evaluate the efficacy of oral famotidine in the prevention of HSRs in patients who received chemotherapy agents, particularly platinum-based and taxanes.

Our study was designed to determine the safety, efficacy, and immunological effects of perioperative pembrolizumab in early-stage NSCLC.

This open-label, multicenter study (NCT03010982) evaluated the absolute bioavailability, characterized the disposition and metabolism, and investigated the metabolic profile of tazemetostat, a US Food and Drug Administration-approved inhibitor of enhancer of zeste homolog 2, following intravenous and oral [14C]-labeled and unlabeled tazemetostat in patients with B-cell lymphomas or advanced solid tumors. Patients received oral tazemetostat 800 mg twice daily for 14 days. On Day 15, patients received tazemetostat 800-mg tablets in a fasted state followed by an intravenous microdose of 12 µg [14C]-tazemetostat. On Day 16, patients received a [14C]-tazemetostat 800-mg solution with a meal, then continued tazemetostat 800 mg twice daily. Blood, plasma, urine, and fecal samples were collected for pharmacokinetic analyses, and recovery and excretion of the radioactivity of [14C]-labeled/unlabeled tazemetostat and its metabolites. The median absolute bioavailability was 31.8% (range, 20.2%-49.8%). Notable plasma components were EPZ-6930, unchanged tazemetostat, EPZ006931, and EPZ034163, accounting for 31.8%, 22.4%, 11.0%, and 3.5% of total drug-related exposure, respectively. Recovery of radiolabeled material ranged from 93.2% to 94.7%, with most excreted doses recovered within 48 hours in urine and by 96 hours in feces. Fecal elimination represented the principal route of elimination with a mean of 78.9% of the administered radioactive dose and renal excretion accounted for 15.4%.

To explore the experiences patients with cancer using immersive virtual reality (iVR) during antineoplastic infusion therapy.

Mogamulizumab demonstrated improved outcomes vs. vorinostat across a range of disease and patient characteristics in patients with mycosis fungoides or Sézary syndrome in the MAVORIC trial.

Radiotherapy is essential for locoregional control in resectable soft-tissue sarcoma and remains a key strategy for unresectable soft-tissue sarcoma. Poly-ADP-ribose polymerase inhibitors, such as olaparib, may enhance radiosensitivity by targeting DNA damage repair pathways.

Treatment options for recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) are limited, especially for patients who progress after immune checkpoint inhibitor (ICI) therapy. This phase Ib study investigates the efficacy and safety of SCT200, an epidermal growth factor receptor (EGFR) antibody, combined with paclitaxel or docetaxel in R/M HNSCC patients who have failed both platinum-based chemotherapy and programmed cell death protein 1 (PD-1) inhibitors. This was a multicenter, open-label study enrolling patients with resistance or intolerance to platinum-based chemotherapy and PD-1 inhibitors. Patients received intravenous SCT200 (6 mg/kg weekly for 12 weeks, followed by 8 mg/kg every two weeks). Paclitaxel (80 mg/m2 weekly) or docetaxel (75 mg/m2 every three weeks) was administered according to the patient's prior paclitaxel treatment history. The primary endpoint was objective response rate (ORR). Thirty patients were included in the efficacy and safety analyses. The ORR was 26.7 % (95 % confidence interval [CI]: 12.3-45.9). The median progression-free survival (PFS) was 4.1 months (95 % CI: 2.7-5.7), and the median overall survival (OS) was 8.7 months (95 % CI: 5.0-11.9). For patients receiving SCT200 with docetaxel, median PFS was 5.7 months, and OS was 9.5 months. Common adverse events (AEs) included hypomagnesemia, acneiform dermatitis, and rash. No unexpected safety signals were observed. SCT200 in combination with paclitaxel or docetaxel shows promising efficacy in patients with R/M HNSCC following platinum-based chemotherapy and PD-1 inhibitors, warranting further investigation. ClinicalTrials.gov identifier: NCT05552807.

HMPL-306 has equally high inhibitory activity against mutated isocitrate dehydrogenases 1 and 2 (mIDH1/2).

Recent preclinical and retrospective clinical evidence shows that androgen receptor (AR)-mediated signals have significant roles in development of non-muscle invasive bladder cancer (NMIBC). Here, we conducted a single-center, phase I study to assess the feasibility and efficacy of enzalutamide in patients having recurrent NMIBC with marker tumors. Patients with NMIBC who cannot achieve complete transurethral resection (TUR) or with recurrence within a year after the TUR, were enrolled. The patients were administered oral enzalutamide at 160 mg dose, once daily for four weeks. Clinical response at the end of the treatment was evaluated using cystoscopy.

Approximately 50% of patients with advanced Merkel cell carcinoma (MCC) have primary or acquired resistance to PD-(L)1 blockade, which may be overcome using combination immune checkpoint inhibition (ICI) with anti-cytotoxic T lymphocyte antigen-4 antibody. We present results from the recurrent/metastatic MCC cohort in CheckMate 358, a nonrandomized, multicohort, phase I/II study of nivolumab (NIVO) with or without ipilimumab (IPI) in virus-associated cancers (ClinicalTrials.gov identifier: NCT02488759).

Immune checkpoint inhibitors (ICIs) combined with anti-vascular endothelial growth factor (VEGF) have been the standard first-line treatment of hepatocellular carcinoma (HCC). However, the efficacy of this combination in post-line treatment is still unknown. This study aimed to evaluate the efficacy and safety of the combination of anti-PD-L1 envafolimab and novel humanized anti-VEGF suvemcitug as second-line treatment for patients with HCC.

Interest in noninvasive treatment of basal cell carcinoma (BCC) has been increasing. For superficial BCC, it has been demonstrated that imiquimod cream, 5%, has high long-term efficacy, but for nodular BCC (nBCC), long-term evidence is sparse.

Anlotinib, a tyrosine kinase inhibitor, has shown encouraging antitumor activity in platinum-resistant/refractory ovarian cancer. The efficacy of anlotinib as maintenance therapy in advanced ovarian cancer remains unclear. Therefore, we designed this study to evaluate the efficacy and safety of anlotinib maintenance therapy following first-line treatment with paclitaxel and platinum-based chemotherapy in advanced ovarian cancer. In this single-arm, phase II clinical trial, patients with newly diagnosed advanced ovarian cancer were received anlotinib monotherapy as maintenance therapy once after a response to platinum-based chemotherapy until tumor progression or intolerable toxicity. The primary endpoint was progression-free survival. From April 2020 to June 2021, 24 patients were enrolled in this study. The median follow-up was 40.17 months (interquartile range, 32.40-47.93 months). Of 21 patients with efficacy value, the median progression-free survival and median overall survival were 15.8 months (95% confidence interval, 6.8-24.8 months) and 43.8 months (95% confidence interval, 25.45-62.15 months). The quality-adjusted progression-free survival was 14.4 months and there were no observed treatment-related deaths or serious treatment-emergent adverse events, demonstrating the safety of anlotinib in maintenance therapy. Anlotinib shows significant potential as a first-line maintenance therapy for advanced ovarian cancer, extending survival and providing a reliable treatment option.

CheckMate 8HW prespecified dual primary endpoints, assessed in patients with centrally confirmed microsatellite instability-high or mismatch repair-deficient status: progression-free survival with nivolumab plus ipilimumab compared with chemotherapy as first-line therapy and progression-free survival with nivolumab plus ipilimumab compared with nivolumab alone, regardless of previous systemic treatment for metastatic disease. In our previous report, nivolumab plus ipilimumab showed superior progression-free survival versus chemotherapy in first-line microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer in the CheckMate 8HW trial. Here, we report results from the prespecified interim analysis for the other primary endpoint of progression-free survival for nivolumab plus ipilimumab versus nivolumab across all treatment lines.

To compare the effectiveness of auriculotherapy in managing nausea and vomiting caused by platinum-based chemotherapy METHODS: 96 patients with gastrointestinal cancer undergoing platinum chemotherapy were randomly divided into three groups, with 32 patients in each group. The control group received conventional treatment, including 5-hydroxytryptamine 3 receptor antagonist and routine nursing care; the remaining two groups received additional auricular point sticking or ear scraping. The outcomes measured included the incidence and frequency of acute and delayed nausea and vomiting, severity of nausea, appetite, and quality of life function index 24 h and 5 d post chemotherapy.

Hydration and urine alkalinization are the mainstays for the prevention of methotrexate-induced nephrotoxicity. Current oncology protocols recommend pediatric patients who are administered high-dose methotrexate (HDMTX) to be aggressively hydrated with an alkaline solution, which may lead to overhydration. This pilot study sought to determine whether reduced posthydration results in a shorter time to methotrexate elimination without increasing adverse effects.

Radiotherapy is thought to enhance anti-tumor immunity, particularly when delivered in a hypofractionated and multisite manner. Therefore, we investigated the effects of combining radiotherapy with nivolumab in patients with advanced melanoma.