April 12, 2017
By Mark Terry, BioSpace.com Breaking News Staff
South San Francisco-based Exelixis has been having an unusually good year. Its stock has grown more than 415 percent from its low point. Let’s take a look at what’s going on.
The company’s Cabometyx was approved by the U.S. Food and Drug Administration (FDA) for advanced renal cell carcinoma last year and launched in the second quarter of 2016. In 2016, it managed to pick up about a third of the market for that indication, and most analysts think it’s likely to receive label expansion approval.
On March 6, the FDA granted Cabometyx orphan drug designation to treat hepatocellular carcinoma (HCC). A Phase III clinical trial is ongoing. Data from that trial is expected sometime this year.
The CELESTIAL trial will enroll 760 patients with advanced HCC who received sorafenib previously. The patients will be randomized 2:1 to receive 60 mg of Cabometyx daily or a placebo. The primary endpoint is overall survival. Secondary endpoints include objective response rate and progression-free survival. The trial is being performed at more than 100 locations in 19 countries.
Rich Duprey, writing for The Motley Fool, notes, “As it turns out, Exelixis’ Cabometyx is the one taking market share, and tracking toward a $200 million run rate in sales. Exelixis is also planning for the next phase, when it seeks to expand Cabometyx’s addressable market by preparing to file an application to be able to treat previously untreated patients with advanced renal cell carcinoma. Additionally, Cometriq, a treatment for advanced medullary thyroid cancer, generated $42 million in sales for 2016.”
Partly as a response to this success, many analysts believe Exelixis may be acquired this year. They wouldn’t be the first rumors, though. There’s been speculation of an Exelixis takeover for years.
In February, Exelixis announced it was collaborating with Roche on a Phase Ib dose escalation trial to evaluate the safety and tolerability of Cabometyx in combination with Roche’s anti-PD-L1 drug, atezolizumab, in patients with locally advanced or metastatic solid tumors. Enrollment is expected to start mid-2017.
“We are pleased to collaborate with Roche to study the potential of atezolizumab in combination with cabozantinib, our lead medicine that is the subject of a broad development program across a variety of cancers,” said Michael Morrissey, Exelixis’ president and chief executive officer, in a statement. “Although several therapies have recently received regulatory approval to treat advanced kidney and bladder cancers, survival continues largely to be measured in months, not years. Evaluating how cobazantinib may positively impact treatment when paired with immunotherapy is central to our goal of improving therapeutic outcomes for patients with these and other cancers.”
And also in February, Exelixis announced a collaboration with Bristol-Myers Squibb . Cabometyx will be evaluated with BMY’s Opdivo either alone or in combination with Yervoy. The development program, co-funded by the two companies, is to include a Phase III pivotal trial in first-line renal cell carcinoma, with more trials planned in bladder cancer, hepatocellular carcinoma (HCC) and other tumor types.
“Combining our Immuno-Oncology portfolio with promising agents which target different and complementary pathways is a key component of our strategy to improve treatment outcomes for patients,” said Fouad Namouni, head of Development, Oncology, for Bristol-Myers Squibb, in a statement. “We look forward to working with Exelixis, bringing together our knowledge and experience in oncology, to evaluate the potential clinical value of combining these therapies to treat multiple tumors.”
Exelixis is currently trading for $20.46. On April 12, 2016 it traded for $4.34. As Duprey notes, if you have invested $5,000 into the company a year ago, it would now be worth over $20,700.
