Role of Aspirin in Prostate Cancer Highlights the Week in Cancer News
Top news of the week in oncology.
2015 Banner Year for FDA Approvals
There were 15 new molecular entities approved for cancer indications by the FDA in 2015, representing a substantial improvement over the 9 approved in 2014. Counting new indications for already approved molecules, there were 32 cancer-related approvals in 2015 versus 19 in 2014.
This represents a huge improvement over previous years. Chief among the new molecular entities approved were panobinostat, palbociclib, elotuzumab, and daratumumab. The immune checkpoint inhibitors were responsible for boosting the overall numbers, with several approvals granted to ipilimumab, nivolumab, and pembrolizumab throughout the year, a trend that is most likely to continue into 2016. Across the board, there were 45 new molecular entities approved in 2015, which is a record for the FDA. There were 41 in 2014.
See a list of the 2015 approvals here: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm
Here are a few decisions expected this month:
- Maintenance ofatumumab in CLL - January 21, 2016
- Carfilzomib Relapsed Myeloma - January 22, 2016
- Frontline nivolumab BRAF-mutant melanoma - January 23, 2016
GU Cancer Symposium
The GU Cancer Symposium officially kicked off last week. At the meeting, we can expect to hear updates from the celecoxib arm of the STAMPEDE trial, new data on atezolizumab in bladder cancer, findings for a triplet of gemcitabine, cisplatin, and ipilimumab in urothelial cancer, entinostat in renal cell carcinoma, and updated findings for nivolumab in RCC. Additionally, prior to the meeting, ASCO spotlighted 3 studies:
Cabozantinib Effective Across RCC Subgroups
According to a subgroup analysis of the phase III METEOR trial, cabozantinib significantly improved progression-free survival versus everolimus in patients with renal cell carcinoma regardless of the degree of metastases, type or number of prior treatments, or patient risk status. In patients with ≥3 metastases sites, the median PFS was 7.3 months versus 3.7 months for cabozantinib versus everolimus, respectively (HR, 0.38; 0.29-0.50).
Cabozantinib reduced the risk of disease progression by 74% in patients with visceral and bone metastases (5.6 vs 1.9 months; HR, 0.26; 95% CI, 0.16-0.43). Further, the HR for PFS favored cabozantinib across metastases sites, including lung (HR, 0.47), liver (HR, 0.53), and bone (HR, 0.50). In those labeled as “poor” prognostic risk by the MSKCC scale, the benefit was 5.4 versus 3.5 months with cabozantinib versus everolimus, respectively (HR, 0.70; 95% CI, 0.42-1.16). Data from the METEOR trial were recently submitted to the FDA. A deadline should be assigned to the application with the next two months.
Observational Study Shows Potential Role for Aspirin in Prostate Cancer
Men who took regular aspirin had a 24% lower risk of developing a lethal form of prostate cancer, according to an observational study. Moreover, among men already diagnosed, those who took aspirin lowered their risk of dying from prostate cancer by 39% (HR, 0.61; 95%CI, 0.47-0.78).
After adjusting for differences in age, race, body mass index, and smoking status, men without prostate cancer who took aspirin regularly had a 24% lower risk of developing the disease (HR, 0.76; 95% CI, 0.62-0.93). However, regular aspirin use before diagnosis did not confer a measurable benefit for the prevention of overall, high-grade, or locally advanced prostate cancer.
CTC Test Predicts Androgen Therapy Sensitivity
A circulating tumor cell blood test could help detect which patients with prostate cancer are most likely to be resistant to hormonal therapy, according to a study that assessed 221 blood samples from patients with metastatic castration-resistant prostate cancer. Overall, those with higher heterogeneity scores, by single-cell morphology and protein and genomic characterization, did not respond well to hormonal therapies compared with patients who had a low heterogeneity score.
Those with a high score had a shorter median progression-free survival (5 months versus 17 months) and overall survival (9 months versus not reached) compared with the patients with low scores. In contrast, heterogeneity scores were not associated with taxane resistance, suggesting those with higher scores could be candidates for chemotherapy versus androgen therapy.