ASCO: Biothera to present Phase 2 study data on the predictive serum biomarkers for NSCLC -
Biothera will present research at American Society of clinical Oncology (ASCO) annual meeting between a predictive serum biomarker potential clinical response to PGG ® immunotherapy in a recent phase 2 study in non-small patients of lung cancer of cell. The meeting begins today and 3 June in Chicago.
PGG Biothera is a β-glucan soluble yeast derivative that primes the cells of innate immunity, such as neutrophils and macrophages to kill cancer cells targeted antibody through a complement receptor 3 (CR3) dependent mechanism. In humans, naturally occurring anti-p-glucan antibodies (ABA) are required for binding to CR3 PGG and subsequent activation of innate immune cells.
In a study in healthy volunteers, the ABA serum levels above a cut-off threshold level was predictive of the binding PGG higher neutrophil and improved functional activities, including activation addition, complete expression of the receptor, modulating activation marker, and production of selective chemokine.
The potential of serum levels of ABA as a biomarker clinical response to PGG was then evaluated in a Phase 2 clinical trial of retrospectively between subjects in populations at or above the ABA threshold established independently (positive biomarker; BM +) or below the ABA threshold (negative biomarker; BM -).
In this randomized phase 2 NSCLC patients with stage IV received cetuximab, carboplatin and paclitaxel without (control) or with PGG 4 mg / kg on days 1, 8 and 15 each 3-week treatment cycle for the first 4 to 6 cycles. The maintenance therapy with cetuximab alone or in combination with PGG was continued until disease progression
Overall, the objective response rate (ORR, primary endpoint). 23% in the control group (6/26), and 48% in the PGG group (22/46;>
"in patients with NSCLC, the addition of PGG to carboplatin, paclitaxel and treatment with cetuximab resulted in a significant improvement in objective response rate, "said Ada Braun, MD, Ph.D., Biothera chief medical officer." in patients with levels of ABA above the predetermined threshold threshold, the objective response rate almost tripled compared to control and there was a trend toward improved survival. "
Median overall survival was 11.3 months in the control group, 12.4 months in the whole group PGG.
serum levels of ABA can be a predictive biomarker of PGG activity. further research to characterize the predictive importance of the biomarker is underway.
"Creating a predictive biomarker for PGG will enrich future clinical trials and, ultimately, provide oncologists with additional tools to evaluate treatment options for their patients," said Dan Conners, president of Biothera Pharmaceutical Group
Biothera ASCO presentation Details
Biothera presentation will be part of the session of the General appears on Developmental Therapeutics -. Immunotherapy. The presentation is scheduled for 8: 00-11: 45 pm on Monday, June 1, at McCormick Place, S Hall A2. The presentation is Biothera # 112 entitled "anti-β-glucan antibodies as potential predictive biomarker for clinical endogenous response to PGG Immunotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients" Abstract ID. 3045.
The research is a collaboration Biothera and :.
- Thoraxklinik, University of Heidelberg, Heidelberg translational Lung research Centre, Heidelberg, Germany
- Johannes Wesling Klinikum Minden, Minden, Germany.
- Polyclinic of Klinikum rechts der Isar, technical University of Munich, Muenchen, Germany.
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