FDA Decisions Highlight Top Cancer News
Top news of the week in cancer drug development and research.
FDA Grants Priority Review to Lenvatinib Combo in RCC
The FDA granted a priority review designation to the combination of lenvatinib and everolimus as a treatment for patients with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted therapy. In this trial, the combination of lenvatinib and everolimus reduced the risk of progression or death by 60% compared with the mTOR inhibitor everolimus alone.
Median progression-free survival with the combination was 14.6 versus 5.5 months with everolimus (HR, 0.40; P <.001). Median OS was 25.5 months in the combination arm, 19.1 months in the lenvatinib monotherapy arm, and 15.4 months in the everolimus arm.
There was a 49% improvement seen in survival for the combination versus everolimus (HR, 0.51; P = .024). The ORR was 43% in the combination arm, 27% with lenvatinib, and 6% with everolimus. The median duration of response was 13.1 months in the combination arm compared with 7.5 months and 8.5 months in the lenvatinib and everolimus monotherapy arms, respectively.
Under the priority review program, the FDA plans to make a decision on the new drug application for the combination of lenvatinib and everolimus within 6 months compared with the standard 10-month review.
FDA Delays Decision on Granisetron in CINV
The FDA has delayed a decision until late February on a new drug application for the 5-HT3 antagonist granisetron for acute and delayed nausea and vomiting associated with moderately or highly emetogenic chemotherapy. Heron Therapeutics, the developer of the drug, submitted the application in July 2015 and received a priority review designation from the FDA, with a Prescription Drug User Fee Act goal date of January 17, 2016.
The application was based on findings from the phase III MAGIC study, which explored granisetron with fosaprepitant and dexamethasone versus ondansetron, aprepitant, and dexamethasone for the prevention of delayed nausea and vomiting in patients receiving highly emetogenic chemotherapy. Overall, 64.7% of patients had a complete response in the granisetron arm compared with 56.6% with ondansetron (P = .014).
This represented an 8% improvement in complete response, which the trial defined as no emesis or rescue medication. Adverse events were the same between arms. The phase III MAGIC trial was conducted following two prior failed attempts at gaining FDA approval for granisetron. With results from the phase III trial, Heron remains optimistic that granisetron will gain FDA approval.
NYU Study Reveals Potential Treatments for Breast Cancer
A large analysis of breast cancer cell function suggested that several new uses for existing therapies, as well as new targets for drug discovery and new treatment combinations, according to findings published in Cell by researchers at the NYU Langone Medical Center. In the study, short hairpin RNA screens were conducted on 77 breast cancer cell lines along with a newly designed statistical technique called the si/shRNA Mixed-Effect Model, which was used to identify candidate genes most vital to cancer growth.
For triple-negative breast cancer, new and potentially druggable targets were identified in signaling proteins (EFNB3 and EPHA4), proteins that regulate cell growth pathways (MAP2K4 and MAPK13), and a protein known to drive inflammation (interleukin 32). Additionally, across various types of breast cancer, potential was seen for combinations of RAF/MEK and CDK4 inhibitors, EGFR inhibitors and BET inhibitors with epirubicin and vinorelbine, and PLK1 inhibitors with AKT inhibitors.
Further experiments validated BRD4 as a gene essential to the survival of most luminal/HER2-positive cancer cells, as well as a subset of triple negative breast cancer cells. These findings suggest that BET inhibitors might be effective in types of breast cancer.
Cancer Survivorship Symposium
The inaugural Cancer Survivorship Symposium took place at the San Francisco Marriott Marquis this past weekend. The conference focused on a variety of issues facing cancer survivors, including the late effects of treatment. One study found that nearly half of all women treated for cancer (45%) reported symptoms of chemotherapy-induced peripheral neuropathy.
Overall, 31% of the women with CIPN experienced a fall in the previous year versus 19% of those without CIPN. In most cases, this CIPN is under-reported and under-recognized in practice, according to ASCO experts.
Another study demonstrated that despite national evidence- and consensus-based guidelines on post-treatment care, less than half of adolescents and young adults with Hodgkin lymphoma receive all of the recommended services within the first year after treatment. In addition, only 30% of survivors at high risk for cardiac damage adhered to long-term recommendations including an echocardiogram, electrocardiogram, or multigated acquisition scan.
Full coverage can be accessed at http://nursing.onclive.com/conference-coverage/css-2016