NCCN Updates Guidelines for Kidney Cancer

The National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines for kidney cancer, including the recommendation for frontline Cabometyx (cabozantinib) to treat previously untreated patients with advanced kidney disease.

“It is a very exciting time in renal cell carcinoma, with new treatments,” Eric Jonasch, M.D., from the Department of Genitourinary Medical Oncology in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, said at the NCCN’s 23rd Annual Conference. “Most new treatments are for clear cell carcinoma.”

The NCCN Clinical Practice Guidelines — developed through review of evidence and recommendations from physicians and oncology researchers – are the recognized standard for clinical policy in cancer care.

Two new options were included for the first-line treatment of advanced renal cell carcinoma:

• The combination of Yervoy (ipilimumab) plus Opdivo (nivolumab) for poor- and intermediate-risk patients; and
• Cabometyx was added as a first-line option for poor- and intermediate-risk patients with relapsed renal cell carcinoma or stage 4 unresectable advanced renal cell carcinoma.

In addition, adjuvant Sutent (sunitinib malate) was added as an option for patients with stage 2 and 3 clear cell carcinoma, joining clinical trial or surveillance. Of note, this recommendation did come with a category 2B ranking — meaning this was based on lower-level evidence. Jonasch noted this recommendation may change in the future as more trial data emerge.

Cabometyx Tablets

As part of the guidelines, the NCCN recommended Cabometyx for the treatment of advanced renal cell carcinoma regardless of patient risk status, including favorable-, intermediate- and poor-risk.

“CABOMETYX is the only TKI indicated for the treatment of advanced kidney cancer with NCCN-preferred status for intermediate- and poor-risk groups in the first-line setting and the only TKI with preferred status for patients who have progressed on prior therapy,” Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis, the manufacturer of Cabometyx, said in a press release.

“We welcome these updated recommendations, which recognize the significance of the CABOSUN trial data included in our label as an important advance in the care of patients with this disease,” he added.

The recommendation included results from the randomized, open-label, active-controlled phase 2 CABOSUN study — designed to evaluate Cabometyx compared with Sutent in patients with advanced intermediate- or poor-risk renal cell carcinoma as determined by investigator assessment. Secondary endpoints included overall survival, objective response rate and safety.

The study included 157 patients with advanced kidney cancer determined to be intermediate- or poor-risk, who were randomized 1:1 to receive 60 mg of Cabometyx once daily or 50 mg of Sutent once daily for four weeks on followed by two weeks off.

In May 2016, the trial met its primary endpoint of a statistically significant and clinically meaningful improvement in progression-free survival.

In addition, a blinded independent radiology review committee confirmed that Cabometyx provided a clinically meaningful and statistically significant improvement in the primary efficacy endpoint of investigator-assessed progression-free survival in June 2017.