What: Shares of Exelixis (NASDAQ:EXEL), a biotech company focused on the development of cancer therapeutics, have soared 45% thus far in 2016, according to data from S&P Global Market Intelligence. Both the company's METEOR results and its more recent CABOSUN study can be credited with pushing shares higher.
So what: Last year, Exelixis reported the top-line data from its phase 3 METEOR study for advanced second-line renal cell carcinoma. The study showed that cabozantinib (brand name Cabometyx) delivered a statistically significant improvement in progression-free survival against Afinitor, which met the primary endpoint of the study.
We'd also come to learn since then that Cabometyx hit the "trifecta" of being the first advanced RCC drug to provide statistically significant improvements in overall survival (21.4 months versus 16.5 months), progression-free survival (7.4 months versus 3.8 months), and response rate. This led to the FDA's April approval of Cabometyx -- an approval that was critical because it, along with Cotellic in combination with Roche's Zelboraf in metastatic melanoma, gives Exelixis new channels of revenue beyond just Cometriq for a rare form of aggressive thyroid cancer.
The other boost came from the recently released CABOSUN midstage study, which examined Cabometyx is a first-line advanced RCC setting in treatment-naïve patients. Head-to-head against Pfizer's standard-of-care treatment Sutent, Cabometyx provided a statistically significant improvement in progression-free survival. Exelixis' next step is to design a phase 3 study with the FDA to hopefully further expand Cabometyx's label.
As icing on the cake, in late February Exelixis and Ipsen (NASDAQOTH:IPSEY) entered into a global licensing agreement for Cabometyx to include all markets except for the U.S., Canada, and Japan. Exelixis wound up netting $200 million in upfront cash and has recently earned a $60 million milestone payment for Cabometyx's approval from Ipsen. More than a half-billion in possible milestones could still await Exelixis depending on Cabometyx's success in the CELESTIAL study for advanced liver cancer due in 2017, and net sales of the drug.
Now what: As a shareholder of Exelixis, I couldn't be more pleased with the way the past year has gone.
Despite its gains, I also realize the company still faces staunch competition from the likes of Bristol-Myers Squibb's (NYSE:BMY) cancer immunotherapy Opdivo, which beat Cabometyx to market in second-line RCC and has gobbled up a dominant slice of market share. Nonetheless, Cabometyx's treatment trifecta and its solid CABOSUN results should solidify it as a strong alternative or primary treatment in RCC. An early stage study is also under way in combination with Bristol-Myers' Opdivo that could have the combo of Opdivo and Cabometyx becoming the standard-of-care, which would also benefit Exelixis.
With no more near-term cash concerns, Cotellic getting off the ground, Cabometyx beginning to bring in sales, and the potential for future label expansion looking bright, Exlixis has me very excited for the future.
Sean Williams owns shares of Exelixis, but has no material interest in any other companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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