ESMO2014摘要汇总

谢谢分享，学习。

我老公就是大细胞神经内分泌癌，手术病理检测EGFR，ALK虽然都阴性，但CMET扩增，RET阳性，医生让吃克药。看了这篇文章，明白了。

Biothera to Present Late-Breaking Data from its Phase 2
Randomized Immunotherapy Trial in Non-Small Cell Lung Cancer at ESMO 2014

EAGAN, MN — September 28, 2014 — Biothera will present today results on its investigational immunotherapy Imprime PGG® in combination with standard of care frontline chemotherapy and bevacizumab in patients with stage IV nonsquamous non-small cell lung cancer (NSCLC) at the European Society of Medical Oncology (ESMO) 2014 Congress in Madrid.

The addition of Imprime PGG to standard of care carboplatin, paclitaxel and bevacizumab achieved a 17 percentage point increase in objective response rate (ORR) and nearly doubled median response duration (from 5.6 to 10.3 months) in NSCLC patients, compared with standard of care treatment alone. In responding patients, there was continued regression of lesions on maintenance therapy with Imprime PGG and bevacizumab. Treatment with Imprime PGG was associated with a 4.5-month median increase in survival, and a 34% reduction in the risk of death. Results did not reach statistical significance in this proof of concept study but were deemed to be clinically meaningful. Adverse events mostly reflected expected toxicities with the backbone chemotherapy and bevacizumab or were complications of the patients’ lung cancer. Importantly, Imprime PGG was not associated with the immune-mediated adverse events reported for T-Cell modulators.

“We are excited about the promise Imprime PGG holds for patients living with non-small cell lung cancer,” said Ada Braun, M.D., Ph.D., Biothera chief medical officer. “These results reinforce the important untapped role of the innate immune system in contributing much-needed anti-tumor activity to antibody-based therapies.”

Imprime PGG is a novel innate immune cell modulator that primes neutrophils, monocytes and macrophages through a complement receptor 3 (CR3)-dependent mechanism to exert anti-tumor activity against tumor cells that have been opsonized with complement following targeting with anti-tumor antibodies.

Earlier this year Biothera presented promising results from an identically designed phase 2 trial of patients with stage IV NSCLC, which demonstrated that Imprime PGG in combination with carboplatin and paclitaxel chemotherapy plus an EGFR-targeted antibody (cetuximab) resulted in a 48% ORR compared to 23% ORR with chemotherapy plus cetuximab alone.

Late-Breaking Poster Discussion Session
Prof. Dr. Vansteenkiste from UZ Leuven will lead a poster discussion of the study between 1:00-2:00 pm CEST today in the Valencia Room. The abstract (#LBA32) is entitled, “Imprime PGG, A Novel Innate Immune Modulator, in the 1st-line Treatment of Stage IV NSCLC: Results From a Randomized, Controlled, Multicenter Phase 2 Study.”

Study Design
In this study, 92 patients with stage IV nonsquamous NSCLC were randomized 2:1 to receive Imprime PGG (4 mg/kg IV weekly) plus standard of care carboplatin and paclitaxel chemotherapy plus bevacizumab versus the same chemotherapy and bevacizumab alone. Chemotherapy was administered for 4 to 6 cycles at the investigator’s discretion; maintenance bevacizumab and Imprime PGG (or bevacizumab alone) were administered until disease progression or intolerable toxicity. The primary endpoint was ORR. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. Radiographic images (CT of chest and abdomen every 6 weeks) were assessed by blinded, independent central review. At the time of the primary analysis, all patients were to be followed for at least one year.

Study Results
A total of 60.4% of patients in the Imprime PGG treatment group achieved an objective response compared with 43.5% in the control group (p=0.21). The median DoR was 10.3 months for Imprime PGG group compared with 5.6 months for the control group. The median PFS was 11.9 months versus 10.2 months (HR=0.86; p=0.59) and the median OS was 16.1 months versus 11.6 months (HR=0.66; p=0.13) among subjects receiving Imprime PGG versus the control group, respectively. Overall, the incidence of adverse events (AEs) was similar across treatment groups. Adverse events were consistent with complications of the patients’ lung cancer and the standard of care therapy. The most common AEs deemed possibly or probably related to Imprime PGG by the investigator were infusion-related reactions (8.5% each). Overall, 37.3% of patients receiving Imprime PGG and 43.3% receiving control discontinued the study due to AEs.

About ESMO
The European Society of Medical Oncology is one of the most important oncology conferences worldwide, with over 16,000 participants from more than 100 countries and over 2,000 abstracts submitted.

About Imprime PGG
Imprime PGG is a novel innate immune cell modulator, consisting of soluble beta-1,3/1,6 glucan derived from a proprietary strain of yeast, that engages neutrophils, monocytes and macrophages in anti-tumor activity against complement opsonized tumor cells. In phase 2 clinical trials, Imprime PGG has been associated with objective tumor responses in multiple clinical trials forNSCLC,colorectal cancer and chronic lymphocytic leukemia. Imprime PGG is currently being investigated in a phase 3 clinical trial for advanced colorectal cancer and in phase 2 studies forNon-Hodgkin lymphoma andpancreas cancer. Website: www.biothera.com/pharmaceutical/.

About Biothera, the Immune Health Company

Biothera is a U.S. biotechnology company dedicated to improving immune health. The company is a pioneer in the field of cancer immunotherapy and the leader in innate immune modulation.

感谢楼主把英文翻译出来！

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