Asians on docetaxel alone generally have higher mOS to begin with. Bavituximab 3mg/kg 11.7 months mOS in ph2 is a relatively high number if you compare to a western population on docetaxel alone, but compare to a 2nd line NSCLC trial conducted in Asia on docetaxel alone, it's like nothing. Here is one from Korea with 12.2 months. There are so many with even higher than this number.
Imbalance that skews a trial result works like this, I'll use an extreme example where patient population is 100% imbalanced. Docetaxel plus placebo vs docetaxel in 100% Asian population vs 100% western population, trial yields mOS=12.2 vs 9.4 months. Can you say placebo added to Asian population arm caused 2.8 months improvement in overall survival? The answer is no, the 2.8 months difference is due to imbalance of patient population, not due to placebo.
Now, randomly move 20% Asian to Western, move 20% Western to Asian, result 80% Asian 20% Western vs 20% Asian 80% Western, still docetaxel plus placebo vs docetaxel, trials yield 11.8 vs 9.8 months, you still can't say placebo caused the 2 months difference. However, the difference is smaller than previous extreme example because population is slightly LESS imbalanced.
Now, randomly move 50% from each arm, trial yields say 10.8 vs 10.8 months, difference is zero from a now balanced arms, conclusion, placebo has no real effect.
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