Allogeneic vaccines |
Belagenpumatucel-L |
NSCLC II, IIIA, IIIB and IV |
II |
75 |
2006 |
Belagenpumatucel-L is well tolerated, and the survival advantage justifies further phase III evaluation. |
Non-significant. |
[12] |
|
|
NSCLC IV |
II |
21 |
2009 |
Overall survival was 562 days. |
Non-significant. |
[13] |
|
|
NSCLC III/IV |
III |
532 |
2015 |
No difference in survival between the arms. No differences in progression-free survival. |
No serious AEs. |
[30] |
|
Autologous or allogeneic NSCLC cells plus GM.CD40L-expressing K562 cells |
NSCLC IV |
I |
21 |
2007 |
There was no tumor regression after vaccination, but many patients had stable disease. |
No toxicity. |
[31] |
|
|
Refractory advanced stage |
II |
24 |
2013 |
The primary endpoint, inducing radiologic tumor regression, was not reached. Median OS was 7.9 months and median PFS was only 1.7 months. |
Common toxicities were headache and site reaction. |
[32] |
Peptide or protein vaccines |
CIMAvax-EGF |
IIIB/IV |
II |
80 |
2008 |
Good anti-EGF antibody response was obtained in 51.3% of vaccinated patients. |
Less than 25% of cases and were grade 1 or 2 |
[34] |
|
|
IIIB/IV |
III |
405 |
2016 |
Survival benefit was significant: Median survival time (MST) was 12.43 months for the vaccine arm versus 9.43 months for the control arm. MST was higher (14.66 months) for vaccinated patients with high EGF concentration at baseline. |
Long-term vaccination is safe. Most frequent adverse reactions were grade 1 or 2 injection-site pain, fever, vomiting, and headache. |
[35] |
|
MAGE-A3 |
IB, II, and IIIA MAGE-A3-positive NSCLC |
III (MAGRIT) |
13.849 |
2016 |
Adjuvant treatment with the MAGE-A3 immunotherapeutic did not increase disease-free survival. Further development of the MAGE-A3 immunotherapeutic for use in NSCLC has been stopped. |
The most frequently reported grade 3 or higher adverse events were infections and infestations, vascular disorders, and neoplasm. |
[38] |
|
Racotumomab (IE10) |
NSCLC IIIB/IV |
II/III |
176 |
2014 |
Median progression-free survival (PFS) in vaccinated patients was 5.33 versus 3.90 months for placebo. |
The most common adverse events in the racotumomab-alum arm were burning and pain at the injection site, bone pain, and asthenia. |
[43] |
|
BLP25 liposome vaccine |
NSCLC IIIB/IV |
IIB |
171 |
2005 |
The survival difference of 4.4 months observed with the vaccine did not reach statistical significance. |
Non-significant. |
[44] |
|
|
NSCLC III |
III (START) |
1239 |
2014 |
No significant difference in overall survival. |
Serious adverse events with a greater than 2% frequency with tecemotide were dyspnea, metastases to central nervous system and pneumonia. |
[45] |
DNA vaccines |
Elenagen |
Advanced solid tumors |
I/IIA |
27 |
2017 |
Most of the patients achieved stable disease for at least 8 weeks. |
No severe AEs. |
[46] |
Vector-based vaccines |
TG4010 |
Different solid tumors |
I |
13 |
2003 |
A total of 4 of the 13 patients achieved stable disease. One lung cancer patient who was initially progressing after the first injections later showed a marked decrease in the size of his metastases that lasted for 14 months. |
Injection site pain and influenza-like symptoms. |
[47] |
|
|
NSCLC III/IV |
II |
65 |
2008 |
The median overall survival was 12.7 months for arm 1 (combined TG4010 with chemotherapy) and 14.9 for arm 2 (vaccine alone). |
Mild–moderate injection site reactions, flu-like symptoms, and fatigue being the most frequent adverse reactions. |
[48] |
|
|
NSCLC IIIB/IV |
IIB |
148 |
2011 |
6-month progression-free survival (PFS) was 43.2% in the TG4010 plus chemotherapy group, and 35.1% in the chemotherapy alone group |
Common AEs include fever, abdominal pain, and injection-site pain. The most common grade 3–4 AEs were neutropenia, and fatigue. Anorexia and pleural effusion were grade 3–4 AEs that differed significantly between groups. |
[49] |
|
|
NSCLC IV |
IIB/III |
222 |
2016 |
The combination of TG4010 with chemotherapy seems to improve PFS relative to placebo plus chemotherapy. |
No grade 3–4 or serious AEs deemed to be related to TG4010 only; 4 (4%) patients presented grade 3 or 4 AEs related to TG4010 and other study treatments. The most frequent severe AEs were neutropenia, anemia, and fatigue. |
[50] |