NEWS

Experiments in mice show that combining therapies shrinks tumors and improves survival.
October 16

Pertuzumab–trastuzumab-containing regimen should be standard for HER2-positive breast cancer, says study author.
October 16

Studies solidify evidence for BRAF and MEK inhibitors as standard of care for advanced or metastatic disease.
October 15

Agency aims to phase in a risk-based framework over 9 years.
October 14

Prototype molecule increases production of cord-blood stem cells.
October 9

A recently identified ALL subtype is driven by genetic changes that activate kinase signaling.
October 9

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RESEARCH WATCH

KLHL9 deletions stabilize C/EBPβ and C/EBPδ and are a causal driver of the mesenchymal GBM subtype.
October 16

Acquired resistance to everolimus in an exceptional responder was associated with an MTOR mutation.
October 16

Epigenetic changes induced by TET1-mediated 5hmC production are required for glioblastomagenesis.
October 16

PROX1 is required for cancer stem cell expansion and metastatic outgrowth in colorectal cancer.
October 9

Crizotinib treatment elicited objective responses in 72% of patients with ROS1-rearranged NSCLC.
October 9

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NOTED THIS WEEK

October 16, 2014

The Indiana University Melvin and Bren Simon Cancer Center in Indianapolis has once again been recognized as an NCI-designated cancer center. The designation will bring $7.8 million in federal grant money to the institution over the next 5 years, an increase of 20% from its previous award in 2008.

Millennium announced that the FDA approved Velcade (bortezomib) for use in previously untreated patients with mantle cell lymphoma (MCL), a subtype of non-Hodgkin lymphoma that is usually aggressive. According to the Cambridge, MA, company, Velcade is the first treatment to be approved for these patients in the United States. The drug was approved in 2006 for patients with relapsed or refractory MCL.

The FDA granted priority review to multiple cancer drugs: palbociclib (Pfizer), in combination with letrozole, as
a first-line treatment for postmenopausal women with ER-positive, HER2-negative advanced breast cancer; lenvatinib (Eisai),
a VEGF inhibitor, for the treatment of progressive radioactive iodine–refractory differentiated thyroid cancer; and blina-
tumomab (Amgen)
, an investigational bispecific T cell engager antibody construct,
for the treatment of adults with Philadelphia-negative, relapsed or refractory B-precursor acute lymphoblastic leukemia. Decisions on the drugs are anticipated in April (palbociclib and lenvatinib) and May (blinatumomab) 2015.

The NIH announced $32 million in grants to fund the development of software and tools to help researchers mine large amounts of biomedical data, while protecting patient privacy, to improve human health. The awards are part of the agency’s Big Data to Knowledge initiative, dubbed BD2K, which aims to invest nearly $656 million through 2020 in efforts to manage complex data sets.

Princeton, NJ–based Advaxis, a clinical stage biotechnology company devel-
oping cancer immunotherapies, announced preliminary data from a phase I/II study of its immunothera-
peutic ADXS-HPV in anal cancer
associated with human papillomavirus (HPV). All seven patients who have completed the treatment regimen experienced a “clinical complete response,” the company said. The trial is a nonrandomized, open-label, multicenter study of 25 patients with anal cancer designed to assess the safety and effectiveness of ADXS-HPV in combination with standard chemotherapy and radiation.

To help speed the development and approval of drugs for certain breast cancers, the FDA released a guidance document for industry called “Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval,” which defines pathological complete response (pCR), discusses endpoints for neoadjuvant trials, and identifies suitable patient populations. However, the agency acknow-
ledges that “important regulatory questions remain … regarding the use of pCR to support accelerated approval. A relationship between magnitude of improvement in pCR and improvement in long-term outcome has not been established at a trial level.”

In conjunction with Ohio State University’s (OSU) Comprehensive Cancer Center, named the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, OSU’s Wexner Medical Center in Columbus has opened an emergency department dedicated solely to patients with cancer. The department will be staffed by oncologists and emergency medicine physicians who will treat an estimated 6,500 patients per year who seek emergency care for conditions related to cancer treatment such as severe dehydration, fever, and neutropenia.

RESEARCH WATCH