Renal Cell Carcinoma

According to results of a subgroup analysis of the phase III METEOR trial, cabozantinib (Cabometyx) demonstrated a 4.7 month improvement in progression-free survival compared with everolimus (Afinitor) in pretreated patients with advanced renal cell carcinoma with bone metastases at baseline.

In phase II data reported at the 2018 Gastrointestinal Cancers Symposium, treatment with the PD-1 inhibitor pembrolizumab (Keytruda) elicited promising progression-free survival and overall survival results in patients with advanced hepatocellular carcinoma who received previous treatment with sorafenib.

According to findings from the phase III CELESTIAL trial released ahead of the 2018 Gastrointestinal Cancers Symposium, cabozantinib (Cabometyx) improved median overall survival by 2.2 months compared with placebo for patients with previously treated advanced hepatocellular carcinoma.

Madappa Kundranda, MD, PhD, recently discussed the cases of 2 patients with hepatocellular carcinoma (HCC), and the treatment considerations and decisions he would make when treating these patients. Dr. Kundranda, Director of Gastrointestinal Oncology at Banner MD Anderson Cancer Center, Phoenix discussed these cases during a <em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

Based on results of the Ib/II Study 111, the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib has been granted a breakthrough therapy designation by the FDA for the treatment of patients with advanced and/or metastatic renal cell carcinoma.

The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.

The PD-L1 inhibitor avelumab (Bavencio) has been granted a breakthrough therapy designation by the FDA&nbsp;for use in combination with the VEGF inhibitor axitinib (Inlyta) in treatment-na&iuml;ve patients with advanced renal cell carcinoma.

Based on results of the CABOSUN trial, cabozantinib&nbsp;(Cabometyx) has been approved by the FDA for previously untreated patients with advanced renal cell carcinoma.

An extension in overall survival (OS) with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) has completely changed the standard of care for patients with metastatic renal cell carcinoma (mRCC), Thomas Powles, MD, MBBS, MRCP, told audience members during the 9th European Multidisciplinary Meeting on Urological Cancers.<br /> &nbsp;

Based on findings of the phase III CheckMate-214 trial, a&nbsp;supplemental biologics license application for the combination of nivolumab and&nbsp;ipilimumab has been granted a priority review by the FDA&nbsp;as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.

Chimeric antigen receptor T-cell therapy with bb2121 demonstrated an objective response rate of 94% in patients with&nbsp;relapsed/refractory multiple myeloma, according to findings from a dose-escalation study. The senior study author, James N. Kochenderfer, MD, presented updated findings from the study during the 2017 ASH Annual Meeting, and commented that 89% of patients had a very good partial response or better, and 56% of patients had a complete remission.&nbsp;<br /> &nbsp;

Sunitinib (Sutent) has been granted FDA approval for the adjuvant treatment of patients with renal cell carcinoma (RCC) who&nbsp;have received nephrectomy and are high risk for recurrence.

The researchers review intra-arterial therapies and the latest literature supporting their use, categorized by different tumor types.

A look back at all the FDA news that occurred in the month of September.

Toni K. Choueiri, MD, clinical director, Lank Center for Genitourinary Oncology, director, Kidney Cancer Center, senior physician, Dana-Farber Cancer Institute, discusses a phase 1b trial of first-line avelumab (Bavencio) plus axitinib (Inlyta) in patients with advanced renal cell carcinoma (RCC).

Patients with metastatic papillary renal cell carcinoma have limited therapeutic options, but results of a phase II safety and efficacy study suggest that a small-molecule inhibitor, savolitinib, could help patients with MET-driven disease.

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.&nbsp;

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&nbsp;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&rsquo;s Oncologic Drugs Advisory Committee (ODAC) voted 6-6&nbsp;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.&nbsp;

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&#39;s indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.&nbsp;

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.