October 17, 2016
By Mark Terry, BioSpace.com Breaking News Staff
At the recent European Society for Medical Oncology (ESMO) meeting, Exelixis announced results from its CABOSUN Phase II trial of cabozantinib in previously treated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease. The drug was compared to patients receiving Pfizer ’s Sutent (sunitinib). And it was bad news for Pfizer, and probably Bristol-Myers Squibb . Keith Speights, writing for The Motley Fool, takes a look.
The median progression-free survival (PFS) for patients on cabozantinib was 8.2 months. The PFS for patients on sunitinib was 5.6 months. The results demonstrated a 31 percent decrease in disease progression or death in patients on cabometyx compared to patients on Sutent.
At the moment, Cabometyx is approved only in patients who have previously received therapy. Sutent is approved as a first-line treatment. It is also approved in the U.S. to treat gastrointestinal (GI) stromal tumors and pancreatic neuroendocrine tumors. As a result, Exelixis is planning to submit to the U.S. Food and Drug Administration (FDA) for cabozantinib to treat first-line advanced renal cell carcinoma.
Side effects for the two drugs appear to be about the same.
In 2015, Pfizer’s Sutent brought in $1.12 billion, and in the first half of this year sales were up about 10 percent year over year, although those figures include the GI stromal tumor and pancreatic cancer indications. If Exelixis can gets its drug approved for first-line treatment, it’ll capture a chunk of that money.
Bristol-Myers Squib, on the other hand, received FDA approval for Opdivo as a second-line treatment for advanced kidney cancer in 2015. It’s undergoing a Phase III trial with Yervoy as a first-line advanced kidney cancer treatment. And in that trial, the drugs are being compared to Pfizer’s Sutent.
That trial isn’t projected to be finished until 2019. Speights writes, “However, Exelixis will have a head start if Cabometyx is approved as a first-line treatment for kidney cancer. Therefore, the Opdivo regimen will probably need to outperform Sutent by more than Cabometyx did to be as successful as Bristol hopes it will be.”
So although both Pfizer and Bristol-Myers Squibb may—probably—face some stiff competition from Exelixis, they’re probably not panicking. As Speights writes, “Neither of the two big drugmakers will be hurt too badly if Exelixis’ drug gains approval and does as well as expected. Both Sutent and Opdivo are approved for multiple indications (with possibly more on the way).”
Exelixis, on the other hand, is probably ecstatic. In the second quarter of this year, Cabometyx generated $31.6 million. That’s a very long way from $1.12 billion, and it may not take all of Pfizer’s Sutent revenue, but a big increase is very likely. The company’s total 2015 revenue was $37.172 million. Any growth at this point will be good growth.
Exelixis is currently trading up at $11.65. Five analysts have given a consensus Average Revenue Estimate for this year at $43.15 million, with an estimated low of $32 million and an estimated high of $58.62 million. Three analysts have given the stock a “strong” buy, one a “buy” and one a “hold.”
