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The target sample size was 100 participants per group with the assumption that approximately 5% of participants would not be evaluable for immunogenicity endpoints.
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The expected precision of the relative immune response estimation was presented for 190 evaluable participants in each group (assuming that about 5% of subjects would not be evaluable for the immunogenicity endpoints).
531 subjects received all vaccine doses as scheduled and 521 were evaluable for the ATP cohort for immunogenicity.
All patients were evaluable for safety analysis and efficacy evaluation.
The analysis of robatumumab immunogenicity included 42 patients who tested negative for anti-robatumumab antibody at baseline and were evaluable for anti-robatumumab antibody titer in P2.
All patients were evaluable for safety.
14 patients were evaluable for pharmacokinetic analysis.
All patients were evaluable for toxicity and 31 (78%) were evaluable for response.
infusion every 4 weeks) and were evaluable for toxicity and 18 (15 NSCLC, 3 SCLC) were evaluable for efficacy.
Seventy-nine patients were evaluable for safety, and data from 70 patients were used for efficacy analysis.
Results: Ten patients were enrolled, and 9 were evaluable for response.
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