AdventHealth Cancer Institute, Orlando, FL
Mark A. Socinski , Robert M. Jotte , Federico Cappuzzo , Tony S. K. Mok , Howard West , Makoto Nishio , Vassiliki Papadimitrakopoulou , Francisco J Orlandi , Daniil Stroyakovskiy , Christian A. Thomas , Naoyuki Nogami , Fabrice Barlesi , Anthony Lee , Geetha Shankar , Wei Yu , Marcus Ballinger , Ilze Bara , Alan Sandler , Martin Reck
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). 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. 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. Clinical trial information: NCT02366143
Presence of liver mets | mPFS, mo | HR (95% CI) | |||
---|---|---|---|---|---|
ABCP | ACP | BCP | ABCP vs BCP | ACP vs BCP | |
Yes | 8.2 | 5.4 | 5.4 | 0.41 | 0.81 |
n = 52 | n = 53 | n = 57 | (0.26, 0.62) | (0.55, 1.21) | |
No | 8.4 | 6.9 | 7.0 | 0.61 | 0.90 |
n = 348 | n = 349 | n = 343 | (0.52, 0.73) | (0.77, 1.06) | |
mOS, mo | HR (95% CI) | ||||
Yes | 13.3 | 8.9 | 9.4 | 0.52 | 0.87 |
n = 52 | n = 53 | n = 57 | (0.33, 0.82) | (0.57, 1.32) | |
No | 20.4 | 21.0 | 17.0 | 0.82 | 0.84 |
n = 348 | n = 349 | n = 343 | (0.66, 1.02) | (0.68, 1.04) | |
ORR, %a | Difference (95% CI), % | ||||
Yes | 60.8 | 26.9 | 41.1 | 19.7 | -14.2 |
n = 51 | n = 52 | n = 56 | (-0.75, 40.18) | (-33.65, 5.35) | |
No | 55.8 | 42.7 | 40.1 | 15.7 | 2.6 |
n = 346 | n = 349 | n = 337 | (8.03, 23.4) | (-5.03, 10.29) | |
mDOR, mo | HR (95% CI) | ||||
Yes | 10.7 | 5.6 | 4.6 | 0.39 | 0.59 |
n = 31 | n = 15 | n = 23 | (0.21, 0.73) | (0.29, 1.23) | |
No | 11.5 | 9.2 | 6.5 | 0.43 | 0.52 |
n = 193 | n = 149 | n = 138 | (0.33, 0.55) | (0.40, 0.69) |
a Pts with measurable disease at BL
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Abstract Disclosures
2024 ASCO Annual Meeting
First Author: Yasutaka Watanabe
2018 ASCO Annual Meeting
First Author: Mark A. Socinski
2022 ASCO Annual Meeting
First Author: Naoki Furuya
2021 ASCO Annual Meeting
First Author: Mark A. Socinski