Table 2.
Response to Treatment (Intention-to-Treat Population).*
| Response | Osimertinib (N = 279) |
Platinum-Pemetrexed (N = 140) |
Odds Ratio (95% CI)† |
P Value‡ |
|---|---|---|---|---|
| Type of response — no. (%) | ||||
| Complete | 4 (1) | 2 (1) | ||
| Partial | 193 (69) | 42 (30) | ||
| Stable disease for ≥6 wk | 63 (23) | 60 (43) | ||
| Progression | 18 (6) | 26 (19) | ||
| RECIST progression | 15 (5) | 22 (16) | ||
| Death | 3 (1) | 4 (3) | ||
| Could not be evaluated | 1 (<1) | 10 (7) | ||
| Objective response rate | 5.39 (3.47–8.48) | <0.001 | ||
| Percentage of patients | 71 | 31 | ||
| 95% CI | 65–76 | 24–40 | ||
| Disease control rate§ | 4.76 (2.64–8.84) | <0.001 | ||
| Percentage of patients | 93 | 74 | ||
| 95% CI | 90–96 | 66–81 | ||
| Time to response¶ | ||||
| Median no. of wk | 6.1 | 6.4 | ||
| 95% CI | NC-NC | 6.3–7.0 | ||
| ≤6 wk after randomization — no./total no. (%)‖ | 161/197 (82) | 29/44 (66) | ||
| Duration of response** | ||||
| Median no. of months | 9.7 | 4.1 | ||
| 95% CI | 8.3–11.6 | 3.0–5.6 | ||
| >6 mo — no./total no. (%) | 96/197 (49) | 12/44 (27) | ||
| >9 mo — no./total no. (%) | 56/197 (28) | 4/44 (9) | ||
| >12 mo — no./total no. (%) | 21/197 (11) | 1/24 (2) | ||
Tumor responses were assessed by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete response and partial response did not require confirmation, according to RECIST, version 1.1., guidance on randomized studies, since the control group served as an appropriate means of interpretation of data. CI denotes confidence interval, and NC could not be calculated.
Odds ratios were calculated with the use of logistic regression adjusted for Asian or non-Asian race. An odds ratio of more than 1 favors osimertinib.
P values were calculated by means of the likelihood ratio test, which compared two models (one model with race as the only covariate and the other model with both treatment factor and race as covariates).
The disease control rate is the proportion of patients who had a complete response, a partial response, or stable disease lasting at least 6 weeks before any disease-progression event.
The time to tumor response was calculated from the date of randomization to the date of the first documentation of a partial or complete response.
A 1-week window was allowed at approximately 6 weeks.
The duration of response was calculated with the use of the Kaplan–Meier method from the time of the first documented response until the date of progression or the last RECIST assessment for patients who did not have disease progression.