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.
BACKGROUND
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.


METHODS
Twenty-two patients received L-BLP25 1000 µg 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 [18%], 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%).


CONCLUSIONS
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.
Cross Cancer Institute, Edmonton, AB, Canada. charlesb@cancerboard.ab.ca
Charles
C
Butts
R Nevin
RN
Murray
Colum J
CJ
Smith
Peter M
PM
Ellis
Kevin
K
Jasas
Andrew
A
Maksymiuk
Glenwood
G
Goss
Guy
G
Ely
Frank
F
Beier
Denis
D
Soulières
D000368:Aged; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D002289:Carcinoma, Non-Small-Cell Lung / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008081:Liposomes; D008175:Lung Neoplasms / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008562:Membrane Glycoproteins / Q000008:administration & dosage / Q000009:adverse effects*; D008875:Middle Aged; D018396:Mucin-1 / Q000276:immunology; D015996:Survival Rate; D013997:Time Factors
D019496:Cancer Vaccines; C518273:L-BLP25; D008081:Liposomes; D008562:Membrane Glycoproteins; D018396:Mucin-1