NEWS

Findings represent a new standard of care following treatment with platinum-based chemotherapy.

May 23

BRAF inhibitor is superior to chemotherapy—and more effective combined with a MEK inhibitor.

May 20

Revisions include new criteria for initiating treatment and preferred therapy regimens.

May 20

Chemokine inhibitor seems safe and improves response to FOLFIRINOX in phase I trial.

May 11

Program aims to define common mutations in pediatric cancers, make precision medicine more accessible to children.

May 11

Study finds that resistance occurs through rewiring of signaling networks.

May 10

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RESEARCH WATCH

H3K36M-mutant histones prevent mesenchymal progenitor cell differentiation and induce sarcoma.

May 20

Analysis of TCGA copy number and clinical data identified candidate drivers within prognostic SCNAs.

May 20

A distinct mutational signature is linked to NER pathway mutations and smoking in urothelial tumors.

May 13

T cell–derived IFNγ signaling shapes cancer chemosensitivity.

May 13

Mutant SMAD4 PDAC increases tumor cell tension to modulate fibrosis and increase malignancy.

May 5

A mutation in the CYCLTR2 G-protein–coupled receptor promotes tumorigenesis in uveal melanomas.

May 5

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NOTED THIS WEEK

May 20, 2016

The FDA granted accelerated approval to atezolizumab (Tecentriq; Genentech), a PD-L1–blocking antibody, for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or following platinum-based chemotherapy. The approval was based on a multicenter, single-arm trial in 310 such patients whose tumors were analyzed for PD-L1 expression using the Ventana PD-L1 (SP142) Assay, which was also given the green light by the FDA. The overall response rate was 14.8%; however, 26% of patients considered PD-L1 positive (greater than 5% of tumor cells expressing the marker) responded compared with 9.5% of those with tumors considered PD-L1 negative.

The FDA also gave a thumbs-up to two already-approved drugs for new indications. The agency OK’d lenvatinib (Lenvima; Eisai), a multiple receptor tyrosine kinase inhibitor, in combination with everolimus (Afinitor; Novartis) for the treatment of patients with advanced renal cell carcinoma. In addition, it granted accelerated approval to nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of classic Hodgkin lymphoma that has progressed following autologous hematopoietic stem cell transplantation and post-transplantation use of brentuximab vedotin (Adcetris; Seattle Genetics), making it the first PD-1 inhibitor approved for a blood cancer.

Merck KGaA announced promising interim data from a phase I single-arm trial of the PD-L1 inhibitor avelumab for the treatment of Merkel cell carcinoma. The trial included 61 patients previously treated with standard chemotherapy, six of whom experienced a complete response and 12 of whom had significant tumor shrinkage. Currently, there are no approved second-line therapies for the disease.

Aduro Biotech announced that a clinical trial testing its immunotherapy combination of GVAX Pancreas and CRS-207 failed to increase overall survival in patients who had received at least two prior treatments for pancreatic cancer. In fact, data from the Phase IIb trial showed that patients who received either CRS-207 alone or chemotherapy lived longer (5.4 months and 4.6 months, respectively) than those who received the combination therapy (3.8 months). The company said that “full study findings will be presented at a future scientific congress.”

Roche filed a lawsuit against the Drug Controller General of India, arguing that the process to approve biosimilars of bevacizumab (Avastin) is flawed and could compromise patient safety. Roche has also sued the Hyderabad, India–based company Hetero Drugs, which aims to market a copy of bevacizumab. Opponents contend that Roche is simply trying to protect its bottom line by blocking competition.

In other Roche news, the company failed to gain the endorsement of the UK’s National Institute for Health and Care Excellence (NICE) for its breast cancer drug pertuzumab (Perjeta). NICE, which advises the British National Health Service (NHS) on which drugs demonstrate high value for the price, said that more evidence of an overall survival benefit would be necessary to earn its support.

Leaders of 15 major UK charities wrote to Prime Minister David Cameron encouraging him to review changes at the NHS that could result in 20,000 patients losing access to potentially lifesaving cancer drugs, according to a report by The Telegraph. In 2010, the Cancer Drugs Fund was established to pay for treatments rejected by NICE. However, after costs exceeded the fund’s budget, soon-to-be-released plans will call for funding only those drugs that earn the support of NICE.

Legislation that took effect in the UK today calls for all tobacco products to be sold in plain, standardized packaging within the next 12 months, meaning that packaging for all cigarettes and hand-rolled tobacco will look the same. Brand names will appear in a standard type face, color, and font; company logos cannot be shown. Graphic images that underscore health warnings will need to cover 65% of the packaging.

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RESEARCH WATCH