Heron Therapeutics Reports Positive Phase 3 Results For Cancer Nausea Study
Shares of Heron Therapeutics (HRTX) are up 40% in after-hours trade after the company reported positive results in its phase 3 study. The phase 3 study known as MAGIC recruited up to 900 patients that were undergoing highly emetogenic chemotherapy -- HEC -- agents for various types of tumors. Each patient either received Heron's SUSTOL drug together as part of a three-part regimen with IV fosaprepitant 150 mg plus IV dexamethasone 12 mg or a comparator arm three part regimen that included standard-of-care -- ondansetron 0.15 mg/kg plus IV fosaprepitant 150 mg and IV dexamethasone 12 mg.
One thing to note is that this study was looking for the primary endpoint of complete response rate of SUSTOL as compared to the placebo arm. The complete response rate was defined as the patient not requiring any other rescue medication during the delayed-onset phase of chemotherapy induced nausea and vomiting -- CINV -- that occurs 24 hours to 120 hours following HEC agents. Basically the patient would feel reduced nausea side effects associated with HEC treatments as compared to placebo.
The company met the primary endpoint as the patients in the SUSTOL group achieved a better complete response rate compared to the placebo group. The SUSTOL group was at 64.7% versus the placebo group that only obtained 56.6% complete response rate. The 10% improvement in the SUSTOL group gives the drug a p-value of p = 0.014 which means the primary endpoint was right on the line of being statistically significant. These results are great because Heron is the only phase 3 study to-date that used its drug SUSTOL to compare with a standard-of-care in the HEC agent population. There were no severe side effects in the SUSTOL group that overshadowed safety from the comparator group making this drug a great way to make these CINV patients more comfortable with HEC agents.
Disclosure: No positions mentioned.
I see Huron ended the day up 60% on Friday, wonder if it has more room to go up from here?
I was also wondering how HRTX compares to its closest competitors:
ALKS - Alkermes plc
DEPO - DepoMed Inc.
DRRX - DURECT Corporation