November 2015 News Roundup

The US Food and Drug Administration has approved the anti–PD-1 immunotherapy nivolumab (Opdivo) for the treatment of metastatic renal cell carcinoma (RCC) patients who have progressed on anti-angiogenic therapy. Nivolumab was approved based on results of CheckMate025, a phase III, open-label, randomized trial that included 821 RCC patients. Patients were randomized to either nivolumab or everolimus. Patients treated with nivolumab lived 5.4 months longer than those treated with everolimus (25 months vs 19.6 months), marking the first RCC trial in nearly a decade to show an overall survival improvement. Image © Alila Medical Media / Shutterstock.com

Older men are more likely to be diagnosed with multiple primary melanomas and have worse disease–specific survival than men with a single primary melanoma, according to a new study presented at the Society for Melanoma Research 2015 International Congress. The study identified 27,235 patients diagnosed with an invasive, primary cutaneous malignant melanoma in Sweden between 1990 and 2007, including 700 patients who developed two or more cutaneous malignant melanomas. The researchers found that men comprised a significantly higher proportion of patients with multiple primary melanomas compared to patients with a single primary melanoma (60% vs 49%). The multiple primary patients were significantly older at diagnosis as well (64 vs 62 years). The risk of cutaneous malignant melanoma–specific death increased by 57% with the diagnoses of a second melanoma. Image © Nathalie Speliers Ufermann / Shutterstock.com

Two new drugs were approved by the US Food and Drug Administration for non–small-cell lung cancer (NSCLC) this month-osimertinib (Tagrisso) and necitumumab (Portrazza). Osimertinib was granted approval for NSCLC patients with the T790M EGFR mutation who have progressed on or after use of another tyrosine kinase inhibitor (TKI). The approval was based on results from a pair of phase II trials that collectively included 411 patients and found that osimertinib produced an overall objective response rate of 59% in these patients. Necitumumab was approved for previously untreated patients with metastatic squamous NSCLC in combination with gemcitabine and cisplatin. The trial that led to the approval found that adding necitumumab to gemcitabine and cisplatin improved overall survival compared with the chemotherapy regimen alone (11.5 vs 9.9 months). Image © muratart / Shutterstock.com

A meta-analysis found that a number of dietary factors play a role in the risk of developing gastric cancer, with protective effects seen with fruit and certain vegetables and increased risk seen with high-salt foods and certain forms of alcohol. Consumption of white vegetables had a protective effect, with a relative risk (RR) of 0.67 (95% confidence interval [CI], 0.47–0.95). Consumption of all vegetables, however, did not yield a significant effect. Consumption of total fruit did yield such an effect, with an RR of 0.93 (95% CI, 0.89–0.98). Certain types of meat were also associated with an increased risk, though total meat was not. Ham, bacon, and sausage collectively had an RR of 1.21 (95% CI, 1.01–1.46). The most substantial effect was seen with high-salt foods, with an RR of 1.55 (95% CI, 1.17–2.05). Overall alcohol consumption also raised the risk for gastric cancer, with an RR of 1.15 (95% CI, 1.01–1.31). Beer and liquor consumption in particular raised the risk, while wine did not. Image © monticello / Shutterstock.com

Two new drugs were approved by the US Food and Drug Administration for multiple myeloma-daratumumab (Darzalex) and ixazomib (Ninlaro). Daratumumab, the first monoclonal antibody approved for treating multiple myeloma, was approved for the treatment of patients who have received at least three prior treatments. The trial that led to the approval was the phase II MMY2002 (SIRIUS) study, which showed treatment with single-agent daratumumab resulted in an overall response rate of 29.2% in patients who had received five prior lines of therapy. Ixazomib was approved in combination with lenalidomide and dexamethasone for patients who have been treated with at least one prior therapy based on results of the TOURMALINE-MM1 trial. The trial included 722 patients with myeloma who were randomly assigned to lenalidomide and dexamethasone with or without ixazomib. Patients assigned ixazomib had significantly improved progression-free survival (median 20.6 months vs 14.7 months). Image © KGH

Researchers in the United Kingdom have developed a sensitive blood-based assay that can detect mutations in the estrogen receptor gene ESR1, a known mechanism of resistance to aromatase inhibitors (AIs), in the circulating tumor DNA of patients with hormone receptor–positive breast cancer. ESR1 mutations were previously uncovered in analyses of metastatic tumors exposed to AI therapy. In the present study, only 5.8% of women exposed to an AI for early disease had detectable ESR1 mutations compared with 36.4% of women who first received an AI for the treatment of metastatic disease (P = .0002). Patients with these mutations had substantially shorter progression-free survival when treated on subsequent AI-based therapy (hazard ratio, 3.1). Image © science photo / Shutterstock.com

The US Food and Drug Administration approved a new drug in cobimetinib (Cotellic) and a new indication for nivolumab (Opdivo) for the treatment of patients with melanoma. The MEK inhibitor cobimetinib was approved in combination with vemurafenib for the treatment of advanced metastatic or unresectable BRAF-mutated melanoma. The trial that led to the approval included 495 patients with treatment-naive BRAF V600–mutated metastatic melanoma. With a median follow-up of 18.5 months, patients assigned to combination treatment with cobimetinib and vemurafenib had a median overall survival of 23.3 months compared with 17.4 months with vemurafenib alone. Nivolumab was approved as a single-agent frontline treatment for patients with BRAF wild-type advanced melanoma based on results of the CheckMate-066 trial. The trial found that in previously untreated patients, nivolumab improved overall survival compared with dacarbazine (median overall survival not reached vs 10.8 months for patients assigned dacarbazine). Photo by Larry Meyer

Adding rindopepimut to bevacizumab therapy was associated with improved long-term survival in patients with recurrent EGFRvIII-positive glioblastoma, according to data from the randomized, double-blind phase II ReACT (CDX-110) study. The findings were reported at the 20th Annual Scientific Meeting of the Society for Neuro-Oncology. The study enrolled 70 bevacizumab-naive patients with first- or second-relapse EGFRvIII-positive glioblastoma. Patients were randomized 1:1 to receive either bevacizumab and a control or bevacizumab plus rindopepimut. Investigator-assessed progression-free survival at 6 months, the study’s primary endpoint, was 28% vs 14% for the rindopepimut and control groups, respectively, though a separate expert review found this difference did not quite reach statistical significance. In a secondary analysis, median overall survival was 11.3 months with rindopepimut vs 9.3 months for the control group. Image © Semnic / Shutterstock.com

Researchers have developed a blood test that can identify mutations in the androgen receptor (AR) gene that drive resistance to treatment with abiraterone acetate. If validated, the test could identify patients with castration-resistant prostate cancer (CRPC) who will not respond to the treatment. The researchers used next-generation sequencing to analyze tumor DNA in the blood samples of 97 patients with CRPC who were treated with abiraterone, 80 were evaluable. Patients with a detectable increase in AR copy number or presence of AR (T878A or L702H) point mutations prior to abiraterone treatment had significantly worse progression-free (hazard ratio [HR], 3.73) and overall survival (HR, 7.33) compared with patients with normal AR gene variants in their tumor DNA. Image © Shawn Hempel / Shutterstock.com