Not any reasonable number... FDA will approve Nuevax only if recurrence reduction is equal or better as herceptin trial many years ago which led to Herceptin FDA approval. (which is 30% recurrence reduction). that's a fact. anything below 30% approval will not happen.... also I would like to make it clear that based on current phase 3, only 10% of all cancer pts, will be eligible for NueVax ( lets assume 80% market penetration in North America, Europe, Australia peak sales 1.5-2 billion), unless NueVax/Herceptin combination will be approved down the road for HER2+ patients. (currently in phase 2).
The study concluded that in completed phase 1/2 trials of NeuVax, patients who exhibit robust in vitro IR have lower recurrence rates. This finding suggests that nelipepimut-specific CTL clonal expansion is a valid biomarker for CR in patients treated with NeuVax. In the SN-33 trial, the 60-month Landmark Analysis demonstrated a 5.6% recurrence rate with NeuVax vs. a 25.9% recurrence rate in the control arm—a recurrence reduction of 78.4%.
"NeuVax works by stimulating the body's own immune system, via cytotoxic T lymphocytes (CTLs), to seek out and destroy micrometastatic cancer cells that may be circulating or deposited in a patient's body after they are deemed clinically disease-free. The data presented today demonstrates there is a correlation between the these NeuVax-specifc CTLs stimulated by the vaccine, and a reduction in recurrence of breast cancer in the women tested," said COL George E. Peoples, MD, FACS, Director, Cancer Vaccine Development Program; Deputy Director, United States Military Cancer Institute; Professor (adjunct), Surgical Oncology, M.D. Anderson Cancer Center; Professor, Surgery, Uniformed Services University; Chief, Surgical Oncology, Brooke Army Medical Center.