Advaxis (NASDAQ: ADXS) presented “extremely encouraging” data from the Phase I/II clinical study of ADXS-HPV plus chemoradiation in patients with HPV-associated locally advanced anal cancer. All patients have had a complete response with no evidence of recurrence to date. Is the 100% complete response rate meaningful? Not exactly, I couldn’t say yes.
Locally advanced anal cancer is a relatively easy-to-treat cancer that is extremely responsive to standard chemoradiation. In a 940-patient trial, 90.5% of patients in the mitomycin group and 89.6% patients in the cisplatin group had a complete response at 6 months.
Advaxis’ results are based on just 10 patients. The data are not enough to say ADXS-HPV plus chemoradiation is superior to chemoradiation alone. While Advaxis reported a 100% success rate, the trial didn’t create more value for the company. A large chemoradiation-controlled trial is warranted.
 Lancet Oncol. 2013, 14(6), 516-524.