Exelixis, Inc. (NASDAQ:EXEL) announced results from a phase 1 trial of cabozantinib in combination with nivolumab in patients with previously treated genitourinary tumors. The findings will be presented during a poster discussion session (Abstract #774PD) onOctober 9 at the European Society for Medical Oncology (ESMO) 2016 Congress, which is being held in Copenhagen, October 7 – 11, 2016.
“The treatment landscape for advanced, intractable cancers such as metastatic urothelial carcinoma is continuously evolving and the use of combination therapies may improve outcomes for patients in need of new options,” said Andrea Apolo, M.D., Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, the principal investigator of the trial. “Our previous correlative studies have demonstrated that cabozantinib has immunomodulatory properties that may counteract tumor-induced immunosuppression, providing the rationale for this trial.1,2 These promising early stage clinical findings support further investigation of cabozantinib in combination with nivolumab in a number of genitourinary tumors.”
Between July 2015 and September 2016, 24 patients were accrued with metastatic urothelial carcinoma (n=7), urachal adenocarcinoma (n=4), squamous cell carcinoma of the bladder or urethra (n=3), germ cell tumor (n=4), castration-resistant prostate cancer (n=4), renal cell carcinoma (n=1), or trophoblastic tumor (n=1) and were treated in Part I of the study, which evaluated the combination of cabozantinib and nivolumab at four dose levels. The median number of prior systemic therapies was 3, and 10 patients had received 4 or more prior therapies. The objective response rate was 43 percent among the 23 patients who were evaluable for response, with one complete response and nine partial responses. Four of six patients (67 percent) with urothelial cancer achieved a response. The recommended doses for the ongoing expansion cohorts were determined to be cabozantinib at 40 mg daily and nivolumab at 3 mg/kg once every 2 weeks. Part II of the phase 1 trial examining the use of the triplet combination of cabozantinib, nivolumab, and ipilimumab is also ongoing.
“Cabozantinib has demonstrated clinical activity as a single agent in several tumors, and we are interested in further examining its potential in combination with immunotherapies to treat a variety of genitourinary and other cancers,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We are encouraged by these preliminary phase 1 data and look forward to results from the ongoing expansion cohorts in this trial in patients with metastatic urothelial carcinoma and renal cell carcinoma.”
Common grade 1/2 adverse events observed in more than 30 percent of patients were fatigue, diarrhea, anorexia, dysgeusia, hoarseness, and oral mucositis. Grade 3 adverse events observed in more than 10 percent of patients, included neutropenia, fatigue, and thromboembolic events. There was one grade 4 adverse event of lipase elevation. No grade 5 toxicities were observed.
In addition to Part I, the study also has enrolled 15 patients in Part II, which is evaluating the triplet combination of cabozantinib, nivolumab, and ipilimumab. Expansion cohorts assessing cabozantinib and nivolumab are currently being accrued with bladder, renal and rare genitourinary cancer patients. Data from these patients will be reported at a later date. (Original Source)
Shares of Exelixis are currently trading at $13.21, up $0.03 or 0.23%. EXEL has a 1-year high of $15.58 and a 1-year low of $3.55. The stock’s 50-day moving average is $12.52 and its 200-day moving average is $8.03.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on October 3, Leerink Swann analyst Michael Schmidt reiterated a Buy rating on EXEL, with a price target of $15, which implies an upside of 14% from current levels. Separately, on September 16, William Blair’s John Sonnier reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Schmidt and John Sonnier have a total average return of 23.1% and 12.3% respectively. Schmidt has a success rate of 62% and is ranked #56 out of 4190 analysts, while Sonnier has a success rate of 48% and is ranked #484.
The street is mostly Bullish on EXEL stock. Out of 4 analysts who cover the stock, 3 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $15.00, which implies an upside of 14% from current levels.
Exelixis, Inc. is a biopharmaceutical company, which engages in the developing and commercializing small molecule therapies for the treatment of cancer. Its brands include COMETRIQ and cobimetinib. The company focuses on their proprietary resources and development and commercialization of cabozantinib.