NEWS

Alone and with clinical and molecular characteristics, “junk” DNA may serve as prognostic marker.
July 24

Strategic plans to accelerate research on two recalcitrant cancers released by NCI.
July 24

Study identifies patient subgroup that might benefit from treatment.
July 24

Organization’s 5-year investment strategy boosts spending in key areas of research.
July 24

HDAC inhibitor showed an overall response rate of 25.8% in a phase II trial.
July 17

Study shows GTF2I mutation differentiates non-aggressive from aggressive thymic epithelial tumors.
July 17

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RESEARCH WATCH

TARBP2 binding to sRSEs within metastasis suppressor transcripts promotes their decay.
July 24

AML cells generate a leukemia-supportive niche via induction of sympathetic neuropathy.
July 24

CFI-400945 is a potent, selective, orally bioavailable PLK4 inhibitor with antitumor activity in vivo.
July 24

Mutant IDH prevents hepatocyte differentiation and promotes tumorigenesis via HNF-4α inhibition.
July 17

Oncogene-induced metabolic reprogramming alters global histone acetylation during tumorigenesis.
July 17

Mutations in ERBB family receptors or downstream effectors are found in 37% of gallbladder carcinomas.
July 17

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NOTED THIS WEEK

July 24, 2014

The FDA granted traditional approval to idelalisib (Zydelig; Gilead) for use with rituximab (Rituxan; Genentech) for the treatment of relapsed chronic lympho- cytic leukemia. The agency also granted accelerated approval to the drug for the treatment of relapsed follicular B-cell non- Hodgkin lymphoma and relapsed small lymphocytic lymphoma, another type of non- Hodgkin lymphoma.

A week after five U.S. senators wrote to the Office and Management and Budget (OMB) seeking the release of draft guidance on laboratory-developed tests (LDT) from the FDA, 20 lab directors penned a letter to the OMB “in opposition to FDA reg- ulation of LDTs.” They argued that LDTs are vital to the practice of medicine and “often created in response to unmet clinical needs”; that LDTs are not medical devices and thus are not subject to FDA regulation; that LDTs are already highly regulated; and that FDA regulation would “stifle innovation” and “be contrary to the public health.” In their letter, the senators wrote that the draft guidance “has languished” at the OMB for years.

Los Angeles, CA–based Puma Biotechnology announced that women with early-stage HER2+ breast cancer who took neratinib (PB272) for adjuvant treatment of their disease as part of a phase III clinical trial experienced 33% improvement in disease-free survival compared with those who took a placebo. The trial included 2,821 patients in 41 countries who had had surgery and adjuvant treatment with trastuzumab who then received extended adjuvant treatment with neratinib or a placebo for 1 year. Based on the study’s findings, which will be reported in detail at an upcoming scientific meeting, Puma plans to file for FDA approval of neratinib in the first half of 2015.

The FDA granted its Breakthrough Therapy designation to Aduro BioTech’s pancreatic cancer combination treatment consisting of the immuno- therapies CRS-207 and GVAX Pancreas. The Berkeley, CA, company noted that the designation was based a phase II trial in which the median overall survival of patients who received the combination treatment was 6.1 months compared with 3.9 months for those who received GVAX Pancreas alone.

GlaxoSmithKline halted a phase III
trial of its MEK inhibitor trametinib (Mekinist) in combination with its BRAF inhibitor dabrafenib (Tafinlar) based on an interim analysis showing an overall survival benefit.
The trial was comparing the combination to vemurafenib (Zelboraf; Genentech) in patients with BRAF V600E or V600K mutation–positive unresectable or metastatic cutaneous melanoma. Patients taking vemurafenib will be allowed to the switch to the trametinib–dabrafenib combination.

The FDA granted Priority Review to Genentech’s bevacizumab (Avastin) plus chemotherapy for certain cervical and ovarian cancers based on data from two separate phase III trials. In one trial, women with persistent, recurrent, or metastatic cervical cancer who received bevacizumab plus chemotherapy experienced a 29% reduction in the risk of death compared with those who received chemotherapy alone. In the other, women with platinum-resistant, recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer who took bevacizumab plus chemotherapy reduced their risk of the disease worsening by 52% compared with those taking chemotherapy alone.

Eli Lilly and Company and Immunocore Limited announced that they will collaborate to discover and develop novel T cell–based cancer therapies using Immunocore’s ImmTAC technology.
The deal will earn UK-based Immunocore
$25 million for each candidate therapy developed, the companies said.

NIH is piloting longer grant awards “to provide more stable support for inves-
tigators at all career stages,”
wrote Sally Rockey, PhD, deputy director for extramural research at NIH, and NIH Director Francis Collins, MD, PhD, on Rockey’s “Rock Talk” blog. To that end, NCI is launching the Outstanding Investigator Award, “which will provide long-term support to investigators who have extraordinary records of cancer research productivity and who propose to conduct exceptional research.” Applicants
can request up to $600,000 a year for up to
7 years.

RESEARCH WATCH