- The combined SN-33 (Node Positive) and SN-34 (Node Negative) Intent-to-treat (ITT) population continued to demonstrate an excellent safety and efficacy profile.
- Phase 2 HER2 IHC 1+/2+ patients from SN-33 established the Phase 3 patient population. After establishing statistical significance at the 36-month Landmark Analysis, or the same endpoint as the ongoing Phase 3, 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%.
- Phase 3 PRESENT study is underway with an FDA-approved Special Protocol Assessment (SPA). To date, 70 sites are approved globally, with continued expansion to over 100 sites planned.
LAKE OSWEGO, Ore., Dec. 7, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, presented data from the completed SN-33 Trial and final results from the Phase 1/2 trials of NeuVax™ (nelipepimut-S or E75) at the 35th Annual CTRC-AACR San Antonio Breast Cancer Symposium. The event is being held December 4-8, 2012 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.
"New treatment options are needed to address unmet medical needs for breast cancer patients with HER2 low-to-intermediate expression or IHC 1+/2+ disease," stated COL George E. Peoples, MD, FACS and primary investigator for the studies. "I'm very pleased with the overall conduct of the Phase 1/2 adjuvant trials which have demonstrated the safety and efficacy of NeuVax to prevent recurrence, and want to thank the physicians and patients who participated in the studies. I'm excited to see the progress in the ongoing Phase 3 PRESENT trial."
THE COMBINED PHASE 1/2 NEUVAX CLINICAL TRIALS, SN-33 (NODE POSITIVE, NP) AND SN-34 (NODE NEGATIVE, NN), CONTINUE TO DEMONSTRATE AN EXCELLENT SAFETY AND EFFICACY PROFILE AT 60 MONTHS
Multiple clinical trials have shown NeuVax to be safe and effective at raising HER2 immunity. Trials SN-33 (NP) (n=97) and SN-34 (NN) (n=90) enrolled clinically eligible patients who were rendered disease-free after completion of standard of care multi-modality therapy (n=187). Treatment assignment was then based on HLA type, with HLA-A2/A3 patients vaccinated and HLA-A2/A3 negative patients followed prospectively as controls for recurrence. NeuVax exhibited an excellent safety and tolerability profile, and demonstrated a durable response out to 60 months:
- Maximum toxicity for all inoculations produced primarily Grade 1 and some Grade 2 toxicities, with injection site reactions and fatigue most common. No serious adverse events (SAEs) or cardiotoxicity were reported.
- 24-month Landmark Analysis: 94.3% of NeuVax patients were disease-free versus 86.8% of patients on the control arm (p=0.08).
- 60-month Landmark Analysis: 89.7% of NeuVax patients remain disease-free versus 80.3% of patients on the control arm (p=0.077)—a recurrence reduction of 47.7% among all patients at any dose. Multiple dose response analyses underscore the efficacy of the vaccine with statistical significance being achieved among the optimally-dosed and boosted patients.
PHASE 2 BOOSTED PATIENTS FROM SN-33 (NP) ESTABLISHED PHASE 3 PATIENT POPULATION
The target patient population for Galena's Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax™ Treatment) trial is based on the SN-33 trial. SN-33 was conducted in node positive patients, and was well balanced between the two arms: Vaccine HLA-A2/A3 positive (n=53) vs. Control HLA-A2/A3 negative (n=44). During the conduct of this trial, Herceptin® (trastuzumab; Genentech/Roche) became commercially available for HER2 IHC Positive (3+) patients, after which the trial was amended to allow these patients to receive Herceptin; however, this patient group was excluded from efficacy analysis.
The 60-month Landmark Analysis of the SN-33 trial shows that breast cancer recurrence was greatly reduced for patients treated with NeuVax and that these results are both clinically relevant and durable over time. SN-33 Intent-to-treat (ITT) population (n=97); NeuVax (n=53) vs. Control (n=44):
- 24-month Landmark Analysis: 90.6% of NeuVax patients were disease-free versus 79.5% of patients on the control arm.
- 60-month Analysis: 84.7% of NeuVax patients remain disease-free versus 77.1% of patients on the control arm.
SN-33 HER2 Negative (IHC 1+/2+) patients who received boosters (n=45) established the Phase 3 PRESENT study that is underway with a FDA-approved Special Protocol Assessment (SPA). NeuVax (n=18) vs. Control (n=27):
- 24-month Landmark Analysis: 0% recurrences for patients treated with NeuVax: statistically significant DFS for NeuVax at 100% vs. 77.8% Control (p=0.0358).
- 36-month Landmark Analysis: 0% recurrences for patients treated with NeuVax for a statistically significant DFS for NeuVax at 100% vs. 77.8% Control (p=0.035). Of note, no patients receiving booster inoculations had a recurrence through 36 months, which is the Phase 3 PRESENT study endpoint.
- 60-month Landmark Analysis: 5.6% recurrence rate with NeuVax versus 25.9% recurrence rate in the control arm. DFS for NeuVax at 94.4% vs. 74.1% Control—a recurrence reduction of 78.4% in the target patient population.
"At 60 months, the gold standard in cancer trials, NeuVax has maintained durable, improved disease-free survival," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "Importantly, 94.4% of the Phase 3 target patient population of HER2 low-to-intermediate IHC 1+/2+ patients remained disease-free. Based on these results, we continue to believe NeuVax may be a potential treatment option to prevent breast cancer recurrence for those women who currently have no HER2-directed treatment options."
About NeuVax™ (nelipepimut-S or E75)
NeuVax™ (nelipepimut-S) is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The Phase 3 trial is ongoing and additional information on the study can be found at the recently updated website www.neuvax.com.
According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50-60% of HER2-negative patients (IHC 1+/2+ or FISH <2.2) who achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit us at www.galenabiopharma.com.
The Galena Biopharma, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10647
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the possible clinical benefits, expectations, plans and prospects of the development of NeuVax and Galena's other new product candidates. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks that the anticipated benefits of the announced transactions are not achieved and that the proposed spin-off is delayed or is never completed, as well as the risks, uncertainties and assumptions relating to the development of Galena's new product candidates, including those identified under "Risk Factors" in Galena's most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings Galena periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.