Polynoma Launches Phase III Melanoma Vaccine Trial

January 30, 2015

A multicenter, double-blind, placebo-controlled, phase III vaccine trial is now underway for post-resection melanoma patients with a high risk of recurrence.

A multicenter, double-blind, placebo-controlled, phase III vaccine trial is now underway for post-resection melanoma patients with a high risk of recurrence.

Polynoma, a small biotech conducting the trial, has currently enrolled approximately 1,100 melanoma patients to test their vaccine. The hope is that their polyvalent vaccine-a vaccine that immunizes more than one antigen-will be more successful compared to others in the past.

Creating a melanoma vaccine that can successfully provoke an immune response is difficult. That's why the researchers at Polynoma developed a vaccine that includes hundreds of antigens taken from three lines of melanoma cells. They are looking to stimulate a more robust immune response against melanoma compared to those vaccines with a smaller number of antigens.

In one trial, 42 melanoma patients that received the vaccine had an average of 36.5 months of recurrence-free survival (RFS). When compared to the placebo arm, the RFS was 11 months in 29 of the patients. Also, 45 patients who received an ineffective version of the vaccine containing four cell lines, the average RFS was 13.2 months-not much different from the placebo arm.

"We think that trying to pick antigens that we think are going to produce an immune response is folly," said Paul Hopper, a company board member. "The reality is we don't know which antigens are going to produce an immune response strong enough to reduce the tumor."

The vaccine trial will be offered at 88 cancer centers in the United States for those patients with stage II or III melanoma who have already had surgery--in addition to the following inclusion and exclusion criteria:

Inclusion Criteria:

  • Histologically confirmed Stage IIb, IIc, III melanoma
  • Surgical resection within 90 days of first dosing
  • Persons with positive sentinel nodes must have a complete lymphadenectomy
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Any prior melanoma treatment other than surgery or regional irradiation
  • Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
  • Use of biologic response modifiers within 60 days of first dosing
  • Subjects with history of other malignancy within past 5 years (with exceptions)

References:

U-T San Diego. (2015). Local biotech testing melanoma vaccine.