Highlighting Key Developments in Clinical and Strategic Thinking From Web-Based Sources

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Newsworthy, Late-breaking Information from Web-based Sources, Professional Societies and Government Agencies

New KCJ Website Will Offer Exciting Resource With Impact, Analyses to Unpack Emerging Data
NEW YORK—Where do you go for reliable, insightful, and late-breaking news online? Beginning April 15, the Kidney Cancer Journal will unveil dramatic changes to its website, providing readers with a new dimension of content all ob­tainable digitally. From a regularly updated newsfeed to analyses following articles in the journal, readers will have a dynamic source of information that digs behind the head­lines to unpack the most impactful information, bringing you results with translational importance. For 17 years the journal has established a reputation as the most compre­hensive source on renal cell carcinoma trends. By enhanc­ing the website, the journal will keep you up to date on late-breaking news while analyzing its significance.

A Demographic Snapshot: Who Attends GU ASCO Meeting?
SAN FRANCISCO—The American Society of Clinical Oncol­ogy (ASCO) offers a quick summary on who attends its GU meeting. The demographics for 2019 are expected to be similar to last year’s results when 4500 attended the meet­ing. Here is the breakout of who attends:

  • Professionals—4150
  • Exhibitors—284
  • Spouse, Guest, Media—66
  • Domestic Attendees—50%
  • International Attendees—50%

TOP 5 COUNTRIES

  • United States—2057
  • France—210
  • Canada—204
  • United Kingdom—161
  • Germany—153
  • 65 Other Countries—1365

FDA Gives Priority Status to Avelumab-Axitinib Combination
SILVER SPRING, MD—The FDA has accepted for priority review a supplemental Biologics License Application for Merck’s Bavencio (avelumab) in combination with Inlyta (axitinib) for patients with advanced renal cell carcinoma (RCC). The submission is based on data from the pivotal Phase III JAVELIN Renal 101 trial, in which 30 clinical pro­grams and more than 9,000 patients evaluated across more than 15 different tumor types.In addition to RCC, these tumor types include breast, gastric/gastro-esophageal junc­tion, and head and neck cancers, Merkel cell carcinoma, non-small cell lung cancer, and urothelial carcinoma. Clear cell carcinoma, accounts for approximately 70% of all RCC cases, with an estimated 73,820 new cases of kidney cancer expected to be diagnosed in the US in 2019.

Tivozanib, Still Seeking FDA Approval, Scores Favorable Results in Phase 3
Tivozanib, a tyrosine kinase inhibitor with a troubled history at the FDA despite its approval in Europe, is making progress in a Phase 3 trial that may yet set the stage for the drug to become a part of treatment selection in the US.

Patients with refractory metastatic renal cell carcinoma (mRCC) have better outcomes when treated with tivozanib compared with sorafenib, according to study findings pre­sented at the 2019 Genitourinary Cancers Symposium. In the TIVO-3 phase 3 trial (ClinicalTrials.gov Identifier: NCT02627963), which compared the drugs in patients with mRCC who had received 2 or 3 prior systematic therapies that failed, median progression-free survival (PFS) was 5.6 months (95% CI, 7.3-5.3) among patients who received tivozanib compared with 3.9 months (95% CI, 5.6-3.7) for patients treated with sorafenib, lead investigator Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, reported. Tivozanib treatment was associated with a signifi­cant 27% decreased risk of disease progression (hazard ratio 0.73; P =.02) compared with sorafenib therapy. In addi­tion, the PFS rate at 2 years was higher in the tivozanib compared with the sorafenib arm (18% vs 5%). Further­more, tivozanib-treated patients had a higher objective response rate compared with sorafenib recipients (18% vs 8%).

Grade 3 treatment-related adverse events occurred in 44% of patients in the tivozanib group and 55% of the sorafenib arm. In addition, a smaller proportion of patients in tivozanib group required a dose reduction compared with the sorafenib group (24% vs 38%) or interruption of treatment (48% vs 63%) due to an adverse event. Tivozanib-treated patients also were less likely to discontinue treat­ment (21% vs 29%).

Tivozanib has been included as a first-line treatment recommendation for advanced RCC in new European Soci­ety of Medical Oncology (ESMO) clinical practice guidelines for RCC, published last month. Tivozanib is recommended as a first-line treatment option for people with advanced clear cell RCC of good (favorable) risk or intermediate risk.

After the CARMENA Trial: Do Patients Still Want a Nephrectomy? The Answer Is Yes
Conducted over eight years, enrolling 450 patients at multiple centers in Europe, the CARMENA (Cancer du Rein Metastatique Nephrectomie et Antiangiongeniques) trial demonstrated that systemic therapy using sunitinib alone is not worse than cytoreductive nephrectomy (CN) plus sunitinib in metastatic RCC in an intention to treat analysis (hazard ratio HR): 0.89, 95% confidence interval (CI), 0.71-1.10) But what do patients think? Are their concerns in line with the physicians who manage their disease?

The Kidney Cancer Research Alliance (KCCure) con­ducted a survey among kidney cancer patients. The short survey was disseminated in various patient communities using social media and was posted to the KCCure website in June 2018 after the presentation of the CARMENA trial. Patients were asked “The CARMENA trial presented recently at ASCO found that for kidney cancer patients diagnosed with metastatic disease, there is no overall survival benefit of having a nephrectomy prior to starting systemic therapy. Knowing that information, would you still want to have a nephrectomy at diagnosis if you were metastatic?”

Patients were also asked whether they had already had a nephrectomy and their stage at diagnosis and whether they were on systemic therapy. On the question of whether they would want nephrectomy 75.2% of the patients indi­cated they would still prefer nephrectomy. Of the patients with primary metastatic disease and the tumor in place treated with systemic therapy, 20.1% wanted their kidney tumor to be removed. There was no statistically significant difference between patients who had experience with systemic therapy and those who hadn’t, and answers were also consistent regardless of gender and age. The conclu­sion of the authors: Overall survival should not be overesti­mated as the most important aim in an end-stage patient population. Patients might think differently about benefits, risks and value of surgical procedures than physicians. KCJ