Nichole Tucker

Articles by Nichole Tucker

The FDA has granted Fast Track designation to balstilimab, an investigational anti-PD-1 agent for the treatment of patients with cervical cancer, based on comprehensive data that suggest balstilimab can fill an unmet medical need in the space, Agenus, Inc announced in a press release. In light of the new designation, the company now plans to submit 2 Biologic License Applications in 2020, for this indication and the other for the combination of balstilimab and zalifrelimab in metastatic cervical cancer.

Durable remissions were elicited with KTE-X19 in a majority of patients with relapsed or refractory mantle cell lymphoma, according to the updated results from the ZUMA-2 trial published in the New England Journal of Medicine. The treatment did, however, cause serious adverse events that were consistent with known toxicities of chimeric antigen receptor T-cell therapy.

The immunotherapeutic vaccine OSE-2101 demonstrated a favorable 12-month survival rate as second- or third-line treatment of patients with HLA-A2-positive advanced non–small cell lung cancer, meeting the primary end point of overall survival in the phase III Atalante 1 study, according to a press release from the drug developer, OSE Immunotherapeutics, Inc.

Subcutaneous daratumumab, a monoclonal antibody was determined to be non-inferior to FDA approved intravenous daratumumab in terms of efficacy and pharmacokinetics as treatment of patients with relapsed or refractory multiple myeloma, according to results from the phase III COLUMBA trial. The study also showed an improved safety profile with SC versus IV daratumumab.

The spread of COVID-19 has slowed down processes in many areas of health care, and there is widespread curiosity on how the pandemic will impact regulatory action in the United States. In the oncology community, providers and their patients await vital drugs that have been shown to approve upon survival and in some case are considered curative for different cancers.

Venetoclax in combination with azacytidine demonstrated a statistically significant improvement in overall survival and achieved a satisfactory composite complete remission rate in previously untreated patients with acute myeloid leukemia, meeting the co-primary end points of the phase III VIALE-A study. Genentech, the developer of venetoclax, announced the positive news in a press release, also noting that safety profiles of both drugs were consistent with prior reports.

GEN-1 immunotherapy demonstrated dose-dependent efficacy results in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer when treated in combination with the standard of care, according to results from the OVATION 2 study. Based on positive data in the phase I portion, the study is moving on to phase II with enrollment expected to begin in the second half of the year.

Nelipepimut-S in combination with granulocyte-macrophage colony-stimulating factor demonstrated doubling of the difference in the increase in antigen-specific CD8 cytotoxic T-lymphocytes in patients with ductal carcinoma in situ of the breast who were HLA-A2-positive or A3-positive, express HER2 at immunohistochemistry1+, 2+, or 3+ levels, and are pre- or post-menopausal, according to preliminary results from the phase II VADIS study.

The addition of tremelimumab to frontline durvalumab and the standard of care, platinum-based chemotherapy, did not demonstrate a statistically significant improvement in overall survival in patients with extensive-stage small cell lung cancer, missing the co-primary end point of the phase III CASPIAN trial, according to high-level results from the final analysis of the trial.

Vemurafenib monotherapy is an effective treatment for patients with BRAF V600-mutated non–small cell lung cancer, according to results from the phase II AcSe vemurafenib trial II study published in the Annals of Oncology.