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4 months (95% confidence interval [CI] 6.5, 8.8) with abemaciclib and 7.8 months (95% CI 6.4, 9.5) with erlotinib (hazard ratio [HR] = 0.968 [95% CI 0.768, 1.219]; p = .77). Median PFS was 3.6 months (95% CI 2.8, 3.8) with abemaciclib and 1.9 months (95% CI 1.9, 2. with erlotinib (HR = 0.583 [95% CI 0.470, 0.723]; p .000001). ORR was 8.9% and 2.7% (p = .01, and the disease control rate was 54.4% and 31.7% (p .001) with abemaciclib and erlotinib, respectively. Safety results reflected the known safety profiles of abemaciclib