The Sirtex Medical Limited (ASX: SRX) share price is under pressure today after it returned to the ASX boards on revealing the highly-anticipated results from its SARAH clinical trial.
The trial was setup to compare whether patients with an advanced type of liver cancer known as hepatocellular carcinoma were better off receiving the company's specialised selective internal radiation therapy (SIRT) treatment or Sorafenib as a rival treatment more widely used by medical oncologists.
As with the SIRFLOX trials previously the results look set to leave the analyst and investing community scratching their heads as to what the results actually mean for the future of the company and its product's sales growth trajectory.
The key takeaway is that the trial's primary endpoint failed as it did not show on an Intention to Treat (ITT) basis that overall survival in patients was higher than in the sorafenib group. On the contrary, it was reported that the overall survival for patients treated with sorafenib was 9.9 months versus 8 months for those with SIRT.
However, the company also reported that on a "Per Protocol" (PP) analysis basis that overall survival was identical to sorafenib with the difference being explained by two slightly different methods of patient allocation in conducting the trials.
This kind of "alternative facts" scenario in comparing the ITT to PP clinical results is likely to confuse investors, although it seems that the bottom line is that it's going to be hard for the company to argue that SIR-Spheres should be promoted in the treatment line given the ITT data suggests that Sorafenib remains the superior treatment in terms of overall survival.
The SIRT treatment did reportedly show less side effects on patients in terms of toxicity and tolerability benefits which is a positive in the company's favour if it's able to persuade the oncologist community and regulators such as the U.S. FDA of the worth of the PP results.
Outlook
Sirtex is a former market darling supported by its cheerleaders in the fund manager community such as Hunter Hall that has hit the rocks recently after announcing a big downgrade to forecasts just months after its former CEO sold $2 million worth of shares.
It's not hard to make the positive investment case for this company, although it's not hard to paint a bearish picture either with sales growth slowing down sharply and the company at risk of losing market share to competitors such as BTG's TheraSpheres.
It's also worth remembering it's something of a one-trick pony at the bottom of the treatment spectrum in the fast-evolving medical oncology space where it's vulnerable to being disrupted quickly. For those reasons, I'm not a buyer of its shares, although it does have more clinical trial results due for release later this year which may help provide the evidence needed to promote its sales growth and give the product a more secure position into the future.
