Shares of Exelixis Inc. (NASDAQ: EXEL) saw a handy gain early Monday morning after the company reported positive results from its mid-stage trial for the treatment of renal cell carcinoma. Specifically, the Cabosun Phase 2 trial of cabozantinib demonstrated a clinically meaningful and statistically significant 31% reduction in the rate of disease progression or death in patients within the study.
This stock has made a massive run in 2016, up about 130% year to date. If Exelixis continues to hit the ball out of the park like this, some analysts are saying the stock could run another 15%.
As we have said time and time again, clinical trials and FDA decisions have the potential to make or break companies in this industry. For the month of October, a few of these companies have been on the move, and a few more are expecting results or decisions later this month.
The objective response rate (ORR) in the Cabosun trial was also significantly improved, at 46% for cabozantinib versus 18% for sunitinib. With a median follow up of 22.8 months, median overall survival was 30.3 months for cabozantinib, versus 21.8 months for sunitinib.
Ultimately, based on these results, the company intends to submit a Supplemental New Drug Application (sNDA) for cabozantinib as a treatment of first-line advanced renal cell carcinoma, and it is working with the Alliance for Clinical Trials in Oncology to transfer the complete Cabosun clinical database to Exelixis.
Toni K. Choueiri, M.D., Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and chair of the Cabosun study, commented:
The results presented today support the potential of cabozantinib to become a new therapeutic option for previously untreated patients following their diagnosis with advanced kidney cancer. Not only has cabozantinib surpassed sunitinib, the current standard of care, in progression-free survival and objective response rate, cabozantinib’s effects on progression-free survival were also consistently favorable across patient stratification subgroups including IMDC intermediate versus poor-risk groups and presence or absence of bone metastases.
Shares of Exelixis most recently closed at $12.95, with a consensus analyst price target of $12.67 and a 52-week trading range of $3.55 to $15.58. Following the announcement, the stock was up about 7% at $13.90 in early trading indications Monday.