Renal Cell Carcinoma

Adjuvant therapy with TKIs for patients with high-risk renal cell carcinoma who have undergone a nephrectomy may be supported by level IIa evidence from the National Comprehensive Cancer Network guidelines, yet this approach is still controversial, with many physicians believing that there are not yet enough data in support of its use. 

While currently-approved treatments for HCC are typically associated with responses rates of 10% or less, findings presented at the 11th Annual Conference of the ILCA, BLU-554, a potent and highly selective inhibitor of fibroblast growth factor receptor 4 (FGFR4), induced an overall response rate of 16% (95% CI, 6-31) in patients with FGF 19 IHC-positive HCC.

In updated phase III results, lenvatinib continued to be noninferior in overall survival compared with sorafenib for patients with unresectable hepatocellular carcinoma, and achieved significant improvements in progression-free survival, time to progression, and objective response rate compared with sorafenib.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6-6 on the potential approval of sunitinib (Sutent) for use as an adjuvant therapy in patients with renal cell carcinoma (RCC) who have received nephrectomy and are at high risk of recurrence. The FDA will take this vote into consideration when determining its final approval decision, which is scheduled to be made by January 2018.

Today, ABP-215, a biosimilar for bevacizumab developed by Amgen and Allergan, received FDA approval for the treatment of several different cancer types, making it the first biosimilar approved for the treatment of cancer.

The combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) demonstrated greater progression-free survival in patients with untreated metatatic renal cell carcinoma compared with standard sunitinib (Sutent), according to findings presented at the 2017 ESMO Congress held in Madrid, Spain. 

Exelixis has submitted a supplemental New Drug Application to the FDA for the multikinase inhibitor cabozantinib as treatment for previously untreated patients with advanced renal cell carcinoma.

Supplemental Biologics License Applications (sBLAs) were sent to and accepted by the FDA for a new dosing schedule for nivolumab (Opdivo) across all of the agent's indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor. 

Michael B. Atkins, MD, recently shared treatment considerations he would make when treating patients with metastatic renal cell carcinoma (RCC), based on 2 case scenarios.

Brian Rini, MD, professor of medicine, Cleveland Clinic, discusses the basis for the ongoing phase III KEYNOTE-426 trial, which is exploring pembrolizumab (Keytruda) plus axitinib (Inlyta) versus sunitinib (Sutent) alone in treatment-naive advanced metastatic renal cell carcinoma.

The combination of the PD-L1 inhibitor avelumab with the VEGF inhibitor axitinib as a frontline regimen for advanced renal cell carcinoma induced a response rate of 58.2% in patients with advanced renal cell carcinoma.

Sunitinib (Sutent) has been granted a priority review designation by the FDA for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.

Much research has been done to define the role of neoadjuvant and adjuvant therapies in metastatic renal cell carcinoma patients who have diseease recurrence after surgical resection, but the standard of care has not significantly changed.

Bradley C. Leibovich, MD, discusses the benefits of surgery and the need for more effective drug treatments for patients with metastatic renal cell carcinoma.

Daniel James George, MD, professor of Medicine, professor in Surgery, Duke University School of Medicine, discusses how cabozantinib (Cabometyx) is currently being used in practice for patients with renal cell carcinoma (RCC).

Amit Singal, MD, discusses the recent successes in the HCC treatment landscape and the challenges that still remain.

According to an assessment of a large global dataset reported at the 2017 International Liver Congress, log₁₀ alpha fetoprotein level in the blood directly corresponded to the years of posttreatment survival in patients with hepatocellular carcinoma.

Patients with advanced hepatocellular carcinoma who were previously treated with sorafenib had long-term responses to nivolumab of more than 1 year.

In patients with hepatocellular carcinoma, liver-targeting treatment with selective internal radiation therapy more effectively controlled liver tumor progression and was better tolerated, but the therapy did not improve rates of overall or progression-free survival over sorafenib.

Mipsagargin, a first-in-class prodrug, showed promising antitumor activity and enabled patients with advanced sorafenib-refractory hepatocellular carcinoma to achieve disease stabilization.

Jordi Bruix, MD, discusses findings of a comparison of modified (m)RECIST and RECIST 1.1 assessments in the RESORCE trial.

In updated results presented at the 2017 International Liver Congress, Spanish researchers raised a red flag regarding observations of unexpected higher rates of hepatocellular carcinoma recurrence following treatment with direct-acting antivirals for hepatitis C virus infection.

Researchers have identified higher levels of hepatocytes positive for pERK immunostaining and greater microvascular invasion as independent prognostic factors of recurrence in patients treated with sorafenib Nexavar for hepatocellular carcinoma.

Results from a study of microRNA-34a and natural killer cells presented at the 2017 International Liver Congress suggest that microRNA-34a, one of the most documented tumor suppressor microRNAs, could have a role in regulating cytotoxicity and development of the effector NK cells and their target cells.

Hans J. Hammers, MD, PhD, discusses findings from a phase I study of alpha-1, 3 galactosyltransferase-expressing allogeneic RCC immunotherapy.