The Oncolytics Biotech (ONCY) study of Reolysin in head and neck cancer patients failed. The company issued a press release Thursday claiming the Reolysin study results were positive, but CEO Brad Thompson is shading the truth.
It's easy to be confused because Oncolytics throws out a bunch of numbers in this morning's announcement to make Reolysin appear effective. It's smoke and mirrors, so let's cut through the B.S.
For starters, a brief recap of the study design. Oncolytics enrolled 167 patients with advanced head and neck cancer and randomized them to receive either 1) Reolysin plus carboplatin and paclitaxel or 2) placebo plus carboplatin and paclitaxel. The primary endpoint of the study was overall survival, with progression-free survival (PFS) and overall response rate important secondary endpoints. A description of the study can be found at ClinicalTrials.gov.
This morning, Oncolytics reported results from an "intent-to-treat" analysis of 118 patients with "loco-regional head and neck cancer with or without distant metastases."
The first red flag: An "intent-to-treat" analysis cannot be conducted on a subgroup of patients. Oncolytics is omitting from its analysis 49 head and neck cancer patients with distant metastatic disease.
Why is Oncolytics dividing up patients in the study? Last year, the company claimed patients with localized disease (tumors primarily restricted to the head and neck) were responding differently to Reolysin compared to patients with cancer that had spread to distant parts of the body. How Oncolytics came to this conclusion while remaining blinded to study data has never been explained, but nonetheless, the company insisted on splitting the study into two parts, with loco-regional and distant metastatic patients analyzed separately.