Articles related to Hematology/Oncology

In this Original Investigation from JAMA Oncology, the authors seek to discover the characteristics that define modern randomized clinical trials (RCTs) in oncology and whether they differ from characteristics of RCTs from the preceding decades, as concerns have emerged regarding the use of putative surrogate end points, such as progression-free survival (PFS) and marginal effect sizes.

The data, concluded in a report posted to the preprint server medRxiv, support prioritization of cancer patients for an early (21-day) second dose of the BNT162b2 vaccine, as barely one-quarter of patients with cancer obtained protection (28% immune efficacy rate, including 13% in patients with blood cancers) against COVID-19 after one dose of the Pfizer/BioNTech vaccine.

The approval of the drug (Fotivda, Aveo Pharmaceuticals) was based on the results of the open-label, multi-center TIVO-3 trial, which looked at progression-free survival (PFS) as the main efficacy endpoint, assessed by a blinded independent radiology review committee. Secondary end points included overall survival (OS) and objective response rate (ORR).

More good news for zanubrutinib, which received accelerated approval in November 2019 in the US for the treatment of mantle cell lymphoma (MCL) in adult patients who have undergone at least one prior therapy. The supplemental new drug application (sNDA) was submitted by the drug’s manufacturer, BeiGene, based on data from the global phase III ASPEN trial.

In this “Clinical Trials & Observations” report/visual abstract from the pages of Blood Advances (ASH), the authors focus on two key points: 1) In patients with R/R AML, venetoclax combination therapy resulted in responses in 31% of patients and a median OS of 6.1 months, and 2) NPM1 mutations predicted higher response rates; adverse cytogenetics and mutations in TP53, KRAS/NRAS, and SF3B1 predicted worse OS.

In this Original Investigation from JAMA, the authors discuss the results of a randomized clinical trial that included 208 patients with high- and intermediate-risk first relapse of B-cell acute lymphoblastic leukemia (ALL). Did postreinduction treatment with blinatumomab compared with chemotherapy, followed by hematopoietic stem cell transplant, result in a statistically significant difference in disease-free survival?