Galena Biopharma Presents Positive Interim Safety Data on the NeuVax™ (nelipepimut-S) Clinical Trial in Combination with Trastuzumab in High-Risk HER2 3+ Patients at the AACR Annual Meeting 2017
- Category: Vaccines
- Published on Tuesday, 04 April 2017 14:38
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SAN RAMON, CA, USA I April 04, 2017 I Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs, today announced a poster was presented on the Company’s NeuVax™ (nelipepimut-S) investigator-sponsored Phase 2 clinical trial (IST) in high-risk, HER2 3+ patients at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, DC. The Phase 2 trial is a multi-center, prospective, randomized, single-blinded, placebo-controlled trial combining NeuVax and trastuzumab in the adjuvant setting to prevent recurrence in HER2-positive (HER2 3+) breast cancer patients.
The poster, entitled, “Pre-specified interim analysis in a prospective, randomized phase II trial of trastuzumab vs trastuzumab + NeuVax to prevent breast cancer recurrence in HER2+ breast cancer patients,” presented the interim safety analysis that was initiated after enrollment of the 50th patient in the trial (vaccine group (VG) n=22, control group (CG) n=28). The analysis demonstrated that the agent is well tolerated with no increased cardiotoxicity associated with giving NeuVax in combination with trastuzumab.
In the trial, there were no significant clinicopathologic differences between groups. The vast majority of toxicities were grade 1 and there were no related grade 4 or 5 toxicities and no differences in related toxicities between the VG and CG (Grade 1: 96% vs 98.5%; Grade 2: 3.2% vs 1.5%; Grade 3: 0.8% vs 0%, p=0.14). There was no significant reduction in cardiac ejection fraction (EF) pre- to post-treatment in either group (VG: 61.1±5.4% vs 60.1±4.8%, p=0.55; CG: 62.3±5.7% vs 61.9±4.0%, p=0.74) and no notable difference in EF was observed between the baseline (pre-treatment) and the follow-up (post treatment) within the vaccine and control groups (p=0.54).
“As we reported in February, this data was the basis for the Data Safety Monitoring Board (DSMB) to perform a futility analysis and recommend the study continue as planned. Additionally, the DSMB determined that there were no safety concerns,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “The poster presented at AACR provides a more detailed safety analysis of the ongoing IST with NeuVax in combination with trastuzumab in HER2 positive breast cancer patients. We are pleased that the combination of agents are well tolerated and that there is no additive cardio toxicity.”
Dr. Nejadnik continued, “The Phase 2 trial is expected to complete enrollment by the end of this year with immunologic and clinical outcomes data to be reported via the planned primary analysis after 24-months follow-up. This trial in HER2 3+ patients complements our other ongoing IST with NeuVax in combination with trastuzumab in HER2 1+/2+ patients with an interim data analysis also expected by the end of the year.”
The trial is enrolling HLA-A2 and HLA-A3 positive breast cancer patients with stage I-III HER2 positive disease at high risk for recurrence, which is defined as patients not achieving a complete response after trastuzumab-containing neoadjuvant therapy or those undergoing up-front surgery with any node-positive disease (if ER/PR- or ≥4 positive nodes if ER/PR+). Patients are enrolled after surgery, radiation and neo-adjuvant/adjuvant chemotherapy with an approved trastuzumab-containing regimen. Patients are randomized to receive trastuzumab + NeuVax in the VG or trastuzumab + GM-CSF only in the CG. Patients receive vaccinations of NeuVax or GM-CSF intradermally every 3 weeks for 6 total vaccinations (primary vaccine series, PVS) starting with the third dose of trastuzumab maintenance therapy. Starting 6 months after the completion of the PVS, patients receive 4 booster inoculations, one every 6 months. EF is assessed by either echo or MUGA at baseline and serially during treatment. For this analysis, demographic and safety data were collected and analyzed, and the interim safety analysis was initiated after enrollment of the 50th patient.
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA 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-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. In clinical studies, NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).
NeuVax is currently in two breast cancer studies in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698). A Phase 2 clinical trial is also ongoing with NeuVax in patients with ductal carcinoma in situ (DCIS) (clinicaltrials.gov identifier: NCT02636582), and a Phase 2 trial is planned in patients with gastric cancer.
About Breast Cancer1
New cases of breast cancer occur at an annual rate of 125 per 100,000 women in the U.S., with an estimated 246,660 new cases and 40,450 deaths in 2016. Approximately 89.7% of breast cancer patients are expected to survive five years after diagnosis. Approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime (2011 – 2013 data). The prevalence data from 2013 showed an estimated 3,053,450 women living with breast cancer in the United States.
1National Cancer Institute Surveillance, Epidemiology, and End Results Program
About Galena Biopharma
Galena Biopharma, Inc. is a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs. Galena’s pipeline consists of multiple mid-to-late-stage clinical assets led by its hematology asset, GALE-401, and its novel cancer immunotherapy programs including NeuVax™ (nelipepimut-S) and GALE-301/GALE-302. For more information, visit www.galenabiopharma.com.
SOURCE: Galena Biopharma