Galena Biopharma (GALE) NeuVax Continues w/ Strong Safety Profile
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Galena Biopharma (Nasdaq: GALE), updated c (E75) results at a physician panel on Monday, June 5, 2012 during the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting in Chicago, Illinois.
THE COMBINED PHASE 1/2 NEUVAX CLINICAL TRIALS, SN-33 (NODE POSITIVE, NP) (N=97) AND SN-34 (NODE NEGATIVE, NN) (N=90), CONTINUE TO DEMONSTRATE AN EXCELLENT SAFETY AND EFFICACY PROFILE AT MEDIAN 60-MONTH FOLLOW-UP
Multiple clinical trials have shown NeuVax (E75 + GM-CSF) 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 had completed standard of care (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. Disease-Free Survival (DFS) at 24 months was the primary endpoint for the Landmark Analysis. Of note, the reported results are 60-month median follow-up, and the final few patients will complete five years of therapy later this year after which the final study report will be presented.
NeuVax continues to exhibit an excellent safety and tolerability profile. The combined SN-33 (NP) (n=97) and SN-34 (NN) (n=90) Intent-to-treat (ITT) population (n=187) continue to demonstrate a durable response.
The target patient population (TPP) for Galena's Phase 3 PRESENT 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, and the trial was modified accordingly to allow these patients to receive Herceptin, and exclude this patient group from future enrollment and analysis.
Below are the summary results from the SN-33 trial. This new, 60-month data analysis shows that breast cancer recurrence is greatly reduced for patients treated with NeuVax and that these results are both clinically relevant and durable over time. This five-year time point is noteworthy as it is often the mark where patients are considered cured of their disease.
SN-33 Intent-to-treat (ITT) population (n=97):
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THE COMBINED PHASE 1/2 NEUVAX CLINICAL TRIALS, SN-33 (NODE POSITIVE, NP) (N=97) AND SN-34 (NODE NEGATIVE, NN) (N=90), CONTINUE TO DEMONSTRATE AN EXCELLENT SAFETY AND EFFICACY PROFILE AT MEDIAN 60-MONTH FOLLOW-UP
Multiple clinical trials have shown NeuVax (E75 + GM-CSF) 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 had completed standard of care (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. Disease-Free Survival (DFS) at 24 months was the primary endpoint for the Landmark Analysis. Of note, the reported results are 60-month median follow-up, and the final few patients will complete five years of therapy later this year after which the final study report will be presented.
NeuVax continues to exhibit an excellent safety and tolerability profile. The combined SN-33 (NP) (n=97) and SN-34 (NN) (n=90) Intent-to-treat (ITT) population (n=187) continue to demonstrate a durable response.
- NeuVax is safe and effective at raising HER2 immunity. Of note, no serious adverse events (SAEs) or cardiotoxicity has been 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 Analysis: 89.7% of NeuVax patients remain disease-free versus 79.6% of patients on the control arm—a recurrence reduction of 49.5% among all patients at any dose.
The target patient population (TPP) for Galena's Phase 3 PRESENT 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, and the trial was modified accordingly to allow these patients to receive Herceptin, and exclude this patient group from future enrollment and analysis.
Below are the summary results from the SN-33 trial. This new, 60-month data analysis shows that breast cancer recurrence is greatly reduced for patients treated with NeuVax and that these results are both clinically relevant and durable over time. This five-year time point is noteworthy as it is often the mark where patients are considered cured of their disease.
SN-33 Intent-to-treat (ITT) population (n=97):
- 24-month Landmark Analysis: 90.6% of NeuVax patients (n=53) were disease-free versus 79.5% of patients on the control arm (n=44) (p=0.1155).
- 60-month Analysis: 84.5% of NeuVax patients (n=53) remain disease-free versus 77.1% of patients on the control arm (n=44).
- 24-month Landmark Analysis: 0% recurrences for patients treated with NeuVax: statistically significant DFS for NeuVax at 100% (n=18) vs 77.8% Control (n=27) (p=0.0358).
- 36-month Landmark Analysis: 0% recurrences for patients treated with NeuVax for a statistically significant DFS for NeuVax at 100% (n=18) vs 77.8% Control (n=27) (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 Analysis: 5.6% recurrence rate with NeuVax versus 25.9% recurrence rate in the control arm.
- DFS for NeuVax at 94.4% (n=18) vs 74.1% Control (n=27)—a recurrence reduction of 78.4% in the target patient population.
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