Kidney cancer drugs impress at ECC

There has been some overdue good news for patients with kidney cancer at the European Cancer Congress in Vienna, with not one but two new agents boosting survival in phase 3 trials.

The studies of Bristol-Myer Squibb’s checkpoint inhibitor Opdivo (nivolumab) and Exeleixis’ targeted multikinase inhibitor Cometriq (cabozantinib) were both shown to be more effective than the standard therapy everolimus in renal cell carcinoma (RCC), the most common form of kidney cancer.

The data also raises the intriguing possibility of combining the two drugs and further improving outcomes in a patient group that despite treatment advances in recent years still desperately need additional options. A phase I trial of the duo is already underway at the US National Cancer Institute.

Of the two drugs, Opdivo showed the strongest effect, boosting overall survival from 19.6 months on standard therapy to 25 months. Cometriq was able to show an increase in progression-free survival – from 3.8 months to 7.4 months – although data on overall survival are not ready yet. Both studies have been published in the New England Journal of Medicine.

The top-line data give the contest between to the two new drugs to BMS, but while this may translate into a market advantage the expectation is that both drugs will find their place in treatment.

An editorial accompanying the NEJM trial reports notes that the benefit of the two drugs compared to everolimus is “unequivocal” and “establish new efficacy benchmarks for this patient context.”

If detected in its early stages, the five-year survival rate for RCC is high; however, the five-year survival rate for patients with advanced or late-stage metastatic RCC is under 10 percent, and for patients in this situation having two additional options will be a massive step forward.

The editorial by David Quinn of the University of Southern California Norris Comprehensive Cancer Center and Primo Lara of the University of California Davis Comprehensive Cancer Centre does however raise some questions about the studies.

In particular they note that there was a low rate of complete remissions with each of the drugs that “begs for [patient] selection or combination approaches that expand the benefit spectrum.”

They also raise the thorny issue of affordability however, noting that effective treatments will only work if they are accessible to the patients they are designed to help. Given that around half the patients with RCC in the US receive treatment under Medicare, it makes no sense that the federal scheme is unable to negotiate on price.

Opdivo is already on the market for melanoma and non-small cell lung cancer (NSCLC), and BMS is expected to move ahead quickly with a filing in RCC. Exelixis said it planned to submit Cometriq in kidney cancer before the end of the year in the UK and in early 2016 in Europe. The drug is already sold to treat a form of thyroid cancer.

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