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DOI: 10.1055/s-0039-3403148
IMpower150: analysis of efficacy in patients (pts) with liver metastases (mets)
Publication History
Publication Date:
28 February 2020 (online)
Background: Atezolizumab (atezo) + bevacizumab (bev) + chemo (carboplatin + paclitaxel [CP]; ABCP) showed improved PFS and OS vs. bev + CP (BCP) in pts with chemo-naive NSCLC (IMpower150). Benefit with ABCP vs. BCP extended to key subgroups, including pts with baseline (BL) liver mets, which is a poor prognostic factor in metastatic NSCLC. Similar outcomes were not seen with atezo + chemo (IMpower150 [atezo + CP; ACP]; IMpower130; IMpower132), suggesting that the addition of bev to atezo + chemo is important for conferring clinical benefit in these pts. Here we further explore characteristics and responses of pts with BL liver mets in IMpower150.
Methods: 1202 ITT pts were randomized 1 : 1 : 1 to receive ABCP, ACP or BCP. Doses were: A, 1200 mg; B, 15 mg/kg; C, AUC 6 mg/mL/min; P, 200 mg/m2. Coprimary endpoints were OS and investigator-assessed PFS in ITT-wild-type pts. Exploratory analyses included efficacy and safety in pts with liver mets.
Results: The data capture ≥ 20-mo follow-up in ITT pts (data cutoff: Jan 22, 2018). 162 pts had BL liver mets (ABCP, n = 52; ACP; n = 53; BCP, n = 57), with a median of 3 metastatic sites and median BL tumor SLD of 109 mm (range, 10 – 249). BL characteristics in these pts were generally balanced across study arms. PFS and OS were improved with ABCP vs. BCP ([Table 1]). Gr 3 – 4 treatment-related AEs occurred in 52.1%, 36.5% and 54.5% of pts with liver mets in the ABCP, ACP and BCP arms, respectively.
Presence of liver mets |
mPfS, mo |
HR (95% CI) |
|||
---|---|---|---|---|---|
ABCP |
ACP |
BCP |
ABCP vs. BCP |
ACP vs. BCP |
|
a Pts with measurable disease at BL. |
|||||
Yes |
8.2 (n = 52) |
5.4 (n = 53) |
5.4 (n = 57) |
0.41 (0.26, 0.62) |
0.81 (0.55, 1.21) |
No |
8.4 (n = 348) |
6.9 (n = 349) |
7.0 (n = 343) |
0.61 (0.52, 0.73) |
0.90 (0.77, 1.06) |
mOS, mo |
HR (95% CI) |
||||
Yes |
13.3 (n = 52) |
8.9 (n = 53) |
9.4 (n = 57) |
0.52 (0.33, 0.82) |
0.87 (0.57, 1.32) |
No |
20.4 (n = 348) |
21.0 (n = 349) |
17.0 (n = 343) |
0.82 (0.66, 1.02) |
0.84 (0.68, 1.04) |
ORR, %a |
Difference (95% CI), % |
||||
Yes |
60.8 (n = 51) |
26.9 (n = 52) |
41.1 (n = 56) |
19.7 (− 0.75, 40.18) |
− 14.2 (− 33.65, 5.35) |
no |
55.8 (n = 346) |
42.7 (n = 349) |
40.1 (n = 337) |
15.7 (8.03, 23.4) |
2.6 (− 5.03, 10.29) |
mDOR, mo |
HR (95% CI) |
||||
Yes |
10.7 (n = 31) |
5.6 (n = 15) |
4.6 (n = 23) |
0.39 (0.21, 0.73) |
0.59 (0.29, 1.23) |
No |
11.5 (n = 193) |
9.2 (n = 149) |
6.5 (n = 138) |
0.43 (0.33, 0.55) |
0.52 (0.40, 0.69) |
Conclusions: ABCP reduced the risk of death in pts with liver mets by 48% vs. BCP and may represent an important new treatment option for this population.
NCT02366143
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