98; 95% CI (9.6, 13.6) (5.4, 8.2)
HR (95% CI) 0.58 (0.43, 0.78)
Stratified Log-Rank Test P-value* <0.001
Overall Survival
Number of Deaths, N (%) 116 (50.4%) 59 (51.2%)
Median Overall Survival (months) 28.1 28.2
95% CI (24.6, 33.0) (20.7, 33.2)
HR (95% CI) 0.91 (0.66, 1.25)
Stratified Log-Rank Test P-value* 0.55
Objective Response Rate (CR + PR)
N (%) 116 (50.4%) 22 (19.1%)
Response Duration
Median (months) 12.5 6.7
*Stratified by EGFR mutation status and race.CR=complete response; PR=partial response
Subgroup analyses were conducted based on the stratification factor of EGFR mutation status (Del19, L858R, other) and mutation category (common [Del19, L858R] vs uncommon [other]). See Figure 2.
There were 26 GILOTRIF-treated patients in the “other” (uncommon) EGFR mutations subgroup with nine unique mutation patterns. None of these 26 patients achieved a complete response, while four achieved a partial response (see Table 4 below). No responses were seen in GILOTRIF-treated patients with the following mutations: T790M alone (n=2), deletion 19 and T790M (n=3), G719X and T790M (n=1), exon 20 insertion (n=6), and L861Q alone (n=3). There were 11 chemotherapy-treated patients in the “other” uncommon EGFR mutation subgroup; of these, four (36%) achieved a partial response.
Table 4 Objective Tumor Responses in GILOTRIF-Treated Patients Based on Investigator Assessment in the “Other” (Uncommon) EGFR Mutation Subgroup
EGFR Mutations Number of GILOTRIF-Treated Patients Number of Patients with Partial Responses Duration of Response
L858R and T790M 5 1 6.9 months
L858R and S768I 2 1 12.4+ months
S768I 1 1 16.5+ months
G719X 3 1 9.6 months
16 HOW SUPPLIED/STORAGE AND HANDLINGGILOTRIF tablets are available as follows:
40 mg: light blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T40” on one side and the Boehringer Ingelheim company symbol on the other side.
Unit of use bottles of 30 NDC: 0597-0138-30
30 mg: dark blue, film-coated, round, biconvex, bevel-edged tablets debossed with “T30” on one side and the Boehringer Ingelheim company symbol on the other side.
Unit of use bottles of 30 ̳
