A Multicenter Open-Label Study to Assess the Safety of a New Formulation of BLP25 Liposome Vaccine in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

被引:49
作者
Butts, Charles [1 ]
Murray, R. Nevin [2 ]
Smith, Colum J. [3 ]
Ellis, Peter M. [4 ]
Jasas, Kevin [5 ]
Maksymiuk, Andrew [6 ]
Goss, Glenwood [7 ]
Ely, Guy [8 ]
Beier, Frank [8 ]
Soulieres, Denis [9 ]
机构
[1] Cross Canc Inst, Edmonton, AB T6M 2L7, Canada
[2] Vancouver Canc Ctr, Vancouver, BC, Canada
[3] Tom Baker Canc Clin, Calgary, AB, Canada
[4] Juravinski Canc Ctr, Hamilton, ON, Canada
[5] Sir Charles Gairdner Hosp, Nedlands, WA 6009, Australia
[6] CancerCare Manitoba, Winnipeg, MB, Canada
[7] Ottawa Hosp, Ctr Canc, Ottawa, ON, Canada
[8] Merck KGaA, Darmstadt, Germany
[9] CHUM Hop Notre Dame, Montreal, PQ, Canada
关键词
Immunotherapy; Lipid A; MUC1; Phase II study; PHASE-III; CONCURRENT CHEMORADIOTHERAPY; TUMOR CHARACTERISTICS; EXPRESSION PATTERN; MUC1; EMA; IMMUNOTHERAPY; TRIAL; CONSOLIDATION; DOCETAXEL; CISPLATIN;
D O I
10.3816/CLC.2010.n.101
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Introduction: BLP25 liposome vaccine (L-BLP25) is an innovative therapeutic cancer vaccine designed to induce an immune response resulting in elimination of tumor cells expressing the MUC1 antigen, which is overexpressed in non small-cell lung cancer (NSCLC). Manufacturing modifications have produced subtle changes to the lipid A acyl chain composition of L-BLP25. This open-label phase II study was conducted to evaluate the safety of the new formulation in patients with unresectable stage IIIA/IIIB NSCLC. Patients and Methods: Twenty-two patients received L-BLP25 1000 mu g every week for 8 weeks plus best supportive care. Maintenance vaccinations were given every 6 weeks, commencing at week 13, until disease progression. Results: Median treatment duration was 9.9 months (range, 1-30 months), 9 patients remain on treatment, and 8 have received treatment for > 2 years. Fifteen patients (68%) had adverse events considered to be related to L-BLP25: these were all grade 1/2, except for 1 grade 3 event (pneumonia). The most common adverse events were injection-site reactions (bruising [23%], erythema El 8 4 pain [14%], fatigue [18%], and influenza-like illness [14%]). After a median follow-up of 26.7 months, the 1-year survival rate was 82% (95% CI, 66%-98%), and the 2-year survival rate was 64% (95% CI, 44%-84%). Conclusion: The results suggest that the new formulation of L-BLP25 has a safety profile similar to the original formulation and is safe to use in the phase III clinical development program.
引用
收藏
页码:391 / 395
页数:5
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