- Shares in San Francisco-based Exelixis, Inc. surged upwards by more than 20% Monday morning, buoyed by news the biotech's main drug cabozantinib succeeded in a Phase 3 trial that could support an expanded label for the cancer treatment.
- An independent data monitoring committee recommended Exelixis' study, known as CELESTIAL, be stopped early due to cabozantinib's positive effect on overall survival versus placebo in patients with advanced hepatocellular carcinoma.
- Cabozantinib is already approved under the brand name Cabometyx to treat a common type of kidney cancer following anti-angiogenic therapy. Exelixis' prospects in that setting could soon get a boost, too — the company announced Monday that the Food and Drug Administration had granted priority review for approval of Cabometyx as a first-line agent.
Exelixis built two interim analyses into its CELESTIAL study, giving an opportunity to stop the trial early if Cabometyx showed a strong benefit.
While no data was disclosed, the biotech said treatment with Cabometyx lead to a statistically significant improvement in median overall survival compared to patients treated with placebo. CELESTIAL enrolled patients with advanced hepatocellcular carcinoma (HCC) who had previously received the chemotherapy sorafenib.
Seeing success, Exelixis now plans to submit a supplemental New Drug Application to the FDA in the first quarter of next year for approval in second-line HCC. An FDA OK for an expanded label would broaden the drug's reach beyond kidney cancer and likely give Exelixis further momentum.
The first quarter could now also see an approval for Cabometyx in first-line renal cell carcinoma (RCC), with a February 15 target action date for the FDA's decision on Exelixis' supplemental New Drug Application.
In the second quarter, Exelixis earned $88 million in net sales from its cabozantinib franchise, which also includes marketing of the drug under the brand name Cometriq for metastatic medullary thyroid cancer. That figure was up 28% from the first quarter and 178% higher than the same period one year ago, when Exelixis first launched Cabometyx in RCC.
Higher revenues have enabled the biotech to fund future growth from operations, supporting a June decision to pay down $124 million in debt early.