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Barbara Gonzalez
Author of
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P2.01 - Advanced NSCLC (ID 159)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.01-92 - Cimavax-EGF in Combination with First-Line Chemotherapy in III Stage NSCLC (Now Available) (ID 2232)
10:15 - 18:15 | Author(s): Barbara Gonzalez
- Abstract
Background
A Cuban therapeutic cancer vaccine composed by human recombinant Epidermal Growth Factor (EGF) conjugated to a carrier protein, P64K from Neisseria Meningitides (CimaVax-EGF) induces antibodies against self EGF that decrease its concentration and affect EGF-EGFR interaction. Cimavax EGF was registered in Cuba as switch maintenance therapy for advanced stage NSCLC.
Objective: Evaluate the safety an immunogenicity of the combination of cimavax and first-line chemotherapy in patients with inoperable stage IIIa non-small cell lung cancer
Method
A phase I clinical trial was conducted in two hospitals in Cuba, with the approval of Ethic Committee of each one. Cimavax EGF was administered by intramuscular injection in four sites of administration (4 subdoses of 0.25 ml), every 2 weeks the first 4 doses and after this induction phase monthly reinmunizations were given. First-line platinum-based chemotherapy was administered concomitantly, four to six cycles platinum-based ChT every 21 days.
Result
Thirty patients entered the study. Most frequently adverse events registered with the combined treatment were: injection-site reaction (7.8 %), cough (7.3%), anemia (6.1%), fever (5.3%), asthenia (4.9%) and anorexia (4.9%). Most of them were classified as grade1 -2 according CTCAE version 3. There were no deaths related to the combined treatment. Antibody response against EGF was repeatedly measured in 24 patients. More than 90% of patients (n = 23; 95,8%) were classified as good antibody responders (GAR). It was observed an inverse correlation between EGF concentrations and anti-EGF antibody titers, as previously Cimavax EGF trials have reported. Anti-EGF antibody titers continue increasing until day 76 during the chemotherapy course and was maintained until the end of the treatment. In fact, there were high anti-EGF antibodies post-chemotherapy than before. The median overall survival (mOS) time for all included patients was 9.4 months.
Conclusion
Cimavax EGF vaccine in combination with first-line platinum-based chemotherapy was a safe treatment option for NSCLC patients with IIIa stage NSCLC. Immune response was not affected with the administration of chemotherapy. This was the first combined study of Cimavax in locally advanced NSCLC.