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Background: Patients with advanced melanoma have a poor outcome. We hypothesize that combination immunotherapy can synergistically activate host immunity to generate an effective treatment for patients with high-risk, resected stage 3, recurrent, refractory, or stage 4 melanoma. Methods: We conducted a phase 2 clinical trial of HyperAcute Melanoma (HAM) vaccine (NLG-12036, NewLink Genetics) combined with pegylated interferon (Sylatron, Merck). Trial design consisted of a 12-week regimen with the initial 4 weekly treatments consisting of HAM alone (intradermally) followed by 8 additional treatments of HAM plus Sylatron (subcutaneously, 6 μg/kg). Trial endpoint outcomes include clinical response, overall safety, and correlative findings for observed antitumor effect. [ABSTRACT FROM AUTHOR]

Important advances have been made in the treatment of chronic myelogenous leukemia (CML). In the past two decades, treatment of this disease has changed and now includes the use of hydroxyurea, interferon, tyrosine kinase inhibitors, and high-dose chemotherapy followed by hematopoietic stem cell transplantation. Because several relatively effective forms of therapy now exist, the care and management of patients with CML has become more complex. Through continued research and drug development, additional therapies are expected to emerge offering new hope and expanded treatment options for patients with CML. [ABSTRACT FROM AUTHOR]

Deals with the factors that motivated several nurses to write for publication. Importance of the internal motivation to share his or her knowledge with others; Misconceptions that prevent a number of nurses to write for publication.

An abstract of the article "A Phase I Study of Antitumor Vaccination Using Genetically Modified Tumor Cells Expressing α(1,3)Galactosyltransferase in Patients with Refractory or Recurrent Non-Small Cell Lung Cancer (NSCLC): Preliminary Results," by John C. Morris and colleagues is presented.

Background: The indoleamine 2,3-dioxygenase (IDO) pathway is a key counter-regulatory mechanism that, in cancer, is exploited by tumors to evade antitumor immunity. Indoximod is a small-molecule IDO pathway inhibitor that reverses the immunosuppressive effects of low tryptophan (Trp) and high kynurenine (Kyn) that result from IDO activity. In this study, indoximod was used in combination with a checkpoint inhibitor (CPI) pembrolizumab for the treatment for advanced melanoma., Methods: Patients with advanced melanoma were enrolled in a single-arm phase II clinical trial evaluating the addition of indoximod to standard of care CPI approved for melanoma. Investigators administered their choice of CPI including pembrolizumab (P), nivolumab (N), or ipilimumab (I). Indoximod was administered continuously (1200 mg orally two times per day), with concurrent CPI dosed per US Food and Drug Administration (FDA)-approved label., Results: Between July 2014 and July 2017, 131 patients were enrolled. (P) was used more frequently (n=114, 87%) per investigator's choice. The efficacy evaluable population consisted of 89 patients from the phase II cohort with non-ocular melanoma who received indoximod combined with (P).The objective response rate (ORR) for the evaluable population was 51% with confirmed complete response of 20% and disease control rate of 70%. Median progression-free survival was 12.4 months (95% CI 6.4 to 24.9). The ORR for Programmed Death-Ligand 1 (PD-L1)-positive patients was 70% compared with 46% for PD-L1-negative patients. The combination was well tolerated, and side effects were similar to what was expected from single agent (P)., Conclusion: In this study, the combination of indoximod and (P) was well tolerated and showed antitumor efficacy that is worth further evaluation in selected patients with advanced melanoma., Competing Interests: Competing interests: YZ reports personal fees for Advisory Board: Amgen, Roche Diagnostics, Novartis, Janssen, Eisai, Exelixis, Castle Bioscience, Array, Bayer, Pfizer, Clovis, and EMD serono. Grant/research support from Institutional clinical trial support from NewLink Genetics, Pfizer, Exelixis, and Eisai. DSMC honorarium: Janssen Research and Development. Consultant honorarium: Pfizer, Novartis. RRM reports personal fees from Newlink Genetics, outside the submitted work. MFS and RK report personal fees from Illumina Inc, BMS, and Qiagen. DM reports grants from NewLink Genetics, during the conduct of the study; grants and personal fees from NewLink Genetics, outside the submitted work. In addition, DM has a patent US patent 8,232,313 licensed to NewLink Genetics, and a patent US patent 6,451,840 licensed to NewLink Genetics. MM reports personal fees from Blueprints Medicine, Immunocore, Amgen, Treiza, Array Biopharma, Biontech, and Novartis. LLT, CMS, EPK, CJL, NNV, JY, ELB, and GRR were employed by NewLink Genetics at the time of conducting the study. All remaining authors have declared no conflicts of interest., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The immunogenicity of a cellular immunotherapy using genetically modified vaccines to express α(1,3)galactosyl epitopes (αGal) was evaluated in advanced prostate cancer (PC) patients. In this dose escalation phase I study, we report safety, feasibility, and immunologic data of an immunotherapy composed of 2 human PC cell lines engineered to express αGal epitopes (HyperAcute-Prostate, HAP, NewLink Genetics). Eight patients received up to 12 biweekly vaccinations with HAP. Enrolled patients (aged range, 53-85 y) had American Joint Committee on Cancer stage IV, any T, any N, M1, Eastern Cooperative Oncology Group PS≤2, at least 1 prior hormonal treatment and <3 prior chemotherapies, adequate bone marrow and organ function, and albumin ≥3.0 g/dL. Serum IgG antibodies to synthetic peptides overexpressed in PC were determined by enzyme-linked immunosorbent assay. Results indicate that HAP immunotherapy induced humoral immune responses to autoantigens in 2 of 8 patients. These patients developed IgG antibody to multiple epitopes overexpressed in PC after immunization. These responding patients received higher doses of the immunotherapy suggesting a dose response. Two immunogenic proteins (prostate-specific membrane antigen, hepsin) belong to the extracellular molecules family participating in malignant cell invasion. Median overall survival for patients was 25.1 months with 1 patient surviving over 70 months with stable PSA and bone metastasis before expiring of other causes. Three of 8 patients showed PSA stabilization (>100 d). In conclusion, HAP immunotherapy induces IgG responses to epitopes from autoantigens overexpressed in PC suggesting dose-dependent effect. HAP represents a viable immunotherapy approach to induce immune responses against tumor cells and may provide clinical benefit with minimal toxicity.