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Published on: September 25, 2018
Adjuvant MAGE-A3 immunotherapy in resected non-small-cell lung cancer: phase II randomized study results
Johan Vansteenkiste1, Marcin Zielinski, Albert Linder
1University HospitalKU Leuven, Leuven, Belgium. johan.vansteenkiste@uzleuven.be
Purpose:
The MAGE-A3 protein is expressed in approximately 35% of patients with resectable non-small-cell lung cancer (NSCLC). Several immunization approaches against the MAGE-A3 antigen have shown few, but often long-lasting, clinical responses in patients with metastatic melanoma.
Patients And Methods:
A double-blind, randomized, placebo-controlled phase II study was performed assessing clinical activity, immunologic response, and safety following immunization with recombinant MAGE-A3 protein combined with an immunostimulant (13 doses over 27 months) in completely resected MAGE-A3-positive stage IB to II NSCLC. The primary end point was disease-free interval (DFI).
Results:
Patients were randomly assigned to either MAGE-A3 immunotherapeutic (n = 122) or placebo (n = 60). After a median postresection period of 44 months, recurrence was observed in 35% of patients in the MAGE-A3 arm and 43% in the placebo arm. No statistically significant improvement in DFI (hazard ratio [HR], 0.75, 95% CI, 0.46 to 1.23; two-sided P = .254), disease-free survival (DFS; HR, 0.76; 95% CI, 0.48 to 1.21; P = .248), or overall survival (HR, 0.81; 95% CI, 0.47 to 1.40; P = .454) was observed. Corresponding analysis after a median of 70 months of follow-up revealed a similar trend for DFI and DFS. All patients receiving the active treatment showed a humoral immune response to the MAGE-A3 antigen, although no correlation was observed with outcome. No significant toxicity was observed.
Conclusion:
In this early development study with a limited number of patients, postoperative MAGE-A3 immunization proved to be feasible with minimal toxicity. These results are being investigated further in a large phase III study.
Insights
Postoperative MAGE-A3 immunization in resectable non-small-cell lung cancer (NSCLC) was feasible with minimal toxicity. The study did not show a significant improvement in disease-free interval or survival, but further investigation is ongoing.
Area of Science:
- Oncology
- Immunotherapy
- Cancer Vaccines
Background:
- MAGE-A3 protein is expressed in approximately 35% of resectable non-small-cell lung cancer (NSCLC) patients.
- Immunization strategies targeting MAGE-A3 have shown some durable responses in metastatic melanoma.
Purpose of the Study:
- To assess the clinical activity, immunologic response, and safety of MAGE-A3 protein combined with an immunostimulant in resectable NSCLC.
- To evaluate the MAGE-A3 immunotherapeutic's effect on disease-free interval (DFI) as the primary endpoint.
Main Methods:
- A double-blind, randomized, placebo-controlled phase II study.
- 182 patients with MAGE-A3-positive stage IB-II NSCLC received 13 doses over 27 months.
- Primary endpoint: disease-free interval (DFI).
Main Results:
- No statistically significant improvement in DFI, disease-free survival (DFS), or overall survival was observed between the MAGE-A3 arm (n=122) and placebo arm (n=60).
- Recurrence rates were 35% in the MAGE-A3 arm versus 43% in the placebo arm after 44 months median follow-up.
- All patients receiving MAGE-A3 showed a humoral immune response, but this did not correlate with outcomes. No significant toxicity was noted.
Conclusions:
- Postoperative MAGE-A3 immunization is feasible and well-tolerated in resectable NSCLC.
- The study did not meet its primary endpoint for improving DFI.
- Results warrant further investigation in a larger phase III study.
