Dive Brief:
- Exelixis’s advanced kidney cancer drug Cabometyx (cabozantinib) scored a 31% reduced rate of disease progression or death in patients with previously untreated advanced renal cell carcinoma (RCC) in a Phase 2 clinical trial, compared to Pfizer’s Sutent (sunitinib), according to data presented at the European Society for Medical Oncology (ESMO) congress.
- Patients who received Cabometyx reached an average progression-free survival (PFS) of 8.2 months, versus 5.6 months for Sutent – a 46% improvement, the company said. These were patients with intermediate or poor-risk disease. The data outcomes show the potential for the drug as a first-line therapy for the most common kidney disease in adults. The San Francisco-based drugmaker’s Cabomeytx is currently approved only for patients who have received antiangiogenic therapy.
- Kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S. Clear cell RCC is the most common type of kidney cancer in adults. If detected early, the five-year survival rate is high, but for those with advanced or late stage renal cell carcinoma, the rate is only 12% with no identified cure. About 30,000 patients in the U.S. and 68,000 globally require treatment.
Dive Insight:
Exelixis’s Cabometyx has come a long way since 2014. Then, the company refocused the indication against kidney and liver cancer after previously failing a trial. And this past April, the FDA approved Cabometyx tablets for patients with advanced renal cell carcinoma who received prior anti-angiogenic therapy.
Now, Exelixis sees Cabometyx has a major player in the kidney cancer field following results it unveiled from its CABOSUN Phase 2 trial, stating it has delivered positive results directly against Sutent as a potential first-line therapy.
The clinical results unveiled at ESMO also showed objective response rates for patients taking Cabometyx against Sutent. The data showed 46% for Cabometyx, versus 18% for Sutent. With a median follow-up of 22.8 months, overall survival was 30.3 months for Cabometyx, versus 21.8 months for Sutent.
"The results presented today support the potential for Cabometyx to become a new therapeutic option for previously untreated patients following their diagnosis with advanced kidney cancer," said Toni K. Choueiri, of the Dana-Farber Cancer Center Institute and chair of the Cabometyx study.
With the latest results, Exelixis said it plans to submit a supplemental new drug application (sNDA) for Cabometyx.
Jefferies analyst Peter Welford characterized the Exelixis data as impressive, saying it bolstered the company's case for continued filings.
In March, Exelixis sold rights to cabozantinib for $200 million to the French drugmaker Ipsen, which gave Ipsen exclusive commercialization rights to the drug outside of the U.S., Canada and Japan.