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Who's Watching Exelixis Now?

PART:
1 2 3 4
Part 4
Who's Watching Exelixis Now? PART 4 OF 4

Could Cabometyx Be Exelixis’s Long-Term Growth Driver?

Recent regulatory submissions

In August 2017, Exelixis (EXEL) submitted an sNDA (supplemental new drug application) to the FDA (U.S. Food & Drug Administration) for Cabometyx as a treatment for previously untreated individuals with advanced renal cell carcinoma (or RCC). Exelixis’s NDA for Cabometyx was based on the results of the Phase 2 CABOSUN trial, which evaluated the safety and efficacy of Cabometyx in previously untreated patients with advanced or metastatic RCC.

Could Cabometyx Be Exelixis’s Long-Term Growth Driver?

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CABOSUN trial

In the Phase 2 CABOSUN trial, Cabometyx met the primary endpoint by demonstrating statistically significant and clinically beneficial improvement in progression-free survival (or PFS) compared to advanced RCC patients receiving sunitinib.

In June 2017, the Independent Radiology Committee Review confirmed the results of the Phase 2 CABOSUN trial. In the trial, patients on Cabometyx demonstrated median PFS of 8.2 months compared to 5.6 months for patients on sunitinib therapy. Patients in the Cabometyx therapy arm had an objective response rate (or ORR) of 46.0% compared to 18.0% for patients in the sunitinib therapy arm.

CELESTIAL trial

Currently, Exelixis is conducting a pivotal Phase 3 CELESTIAL trial for the evaluation of the safety and efficacy of cabozantinib compared to a placebo for the treatment of individuals with advanced hepatocellular cancer (or HCC). Exelixis anticipates a second interim analysis this year and plans to submit an sNDA by 1Q18. In March 2017, the FDA granted cabozantinib orphan drug designation for the treatment of HCC.

Exelixis is also conducting various other clinical trials for the label expansion of Cabometyx. In February 2017, Exelixis presented the results from the Phase 1 trial, which evaluated the safety and efficacy of cabozantinib in combination with nivolumab with or without ipilimumab in refractory metastatic urothelial carcinoma. In the Phase 1 trial, 30.0% of the patients achieved ORR, 7.0% of patients achieved complete response, and 23.0% of patients achieved a partial response. The study reported stable disease in 56.0% of patients.

Exelixis’s peers in the RCC drugs market include Pfizer (PFE), Bristol-Myers Squibb (BMY), Novartis (NVS), and Roche. The Vanguard Small-Cap Growth ETF (VBK) invests ~0.45% of its total portfolio holdings in Exelixis.

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