Efficacy and safety of necitumumab (neci) in East Asian (EA) patients (pts) with stage IV squamous non-small-cell lung cancer (NSCLC): a subanalysis of the SQUIRE trial

Date

20 Dec 2015

Session

Poster presentation 2

Presenters

Keunchil Park

Citation

Annals of Oncology (2015) 26 (suppl_9): 125-147. 10.1093/annonc/mdv532

Authors

K. Park¹, E.K. Cho², M. Bello³, M.A. Ahn⁴, S. Thongprasert⁵, E. Song⁶, V. Soldatenkova⁷, H. Depenbrock⁸, T. Puri⁹, M. Orlando¹⁰

Author affiliations

¹ Samsung Medical Center, Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
² Gachon University Gil Medical Center, Namdong-gu, Incheon/KR
³ St. Luke's Medical Center, 1102, Quezon City/PH
⁴ Samsung Medical Center, Kangnam-Gu, Seoul/KR
⁵ Faculty Of Medicine, Maharaj Nakorn Chiang Mai, Chiang Mai University, Chiang Mai/TH
⁶ Chonbuk National University Hospital, Deokjin-gu, Jeon Ju/KR
⁷ Statistics Oncology, Lilly Deutschland GmbH, Bad Homburg/DE
⁸ Medical Oncology, Lilly Deutschland GmbH, 61352 - , Bad Homburg/DE
⁹ Eli Lilly And Company, Haryana, Gurgaon/IN
¹⁰ Eli Lilly Interamerica Inc., Tronador 4890, Buenos Aire/AR

Abstract 968

Aim/Background

The SQUIRE trial showed that neci added to gemcitabine + cisplatin (GC) improves overall survival (OS) in advanced squamous NSCLC pts. We report results of the EA subgroup.

Variable	EA		Non-EA
	Neci + GC	GC	Neci + GC	GC
Efficacy, median mos (95% CI)	n = 43	n = 41	n = 502	n = 507
OS	12.0 (7.3, 15.2)	12.2 (5.5, 14.7)	11.5 (10.5, 12.6)	9.8 (8.8, 11.1)
HR (95% CI)*	0.805 (0.484, 1.341)		0.839 (0.730, 0.964)
PFS	5.6 (4.7, 6.4)	5.3 (2.8, 5.6)	5.7 (5.6, 6.0)	5.5 (4.8, 5.6)
HR (95% CI)*	0.720 (0.439, 1.180)		0.862 (0.749, 0.993)
Safety, n (%)	n = 41	n = 39	n = 497	n = 502
Treatment- emergent AE	41 (100)	37 (94.9)	492 (99.0)	492 (98.0)
Neci related	30 (73.2)	0	378 (76.1)	0
SAE	27 (65.9)	20 (51.3)	230 (46.3)	183 (36.5)
Neci related	1 (2.4)	0	31 (6.2)	0
Grade ≥3	36 (87.8)	25 (64.1)	352 (70.8)	308 (61.4)
Neci related	5 (12.2)	0	84 (16.9)	0
With outcome death	7 (17.1)	3 (7.7)	59 (11.9)	54 (10.8)
Neci related	0 (0)	0	2 (0.4)	0

* neci + GC/GC.

Methods

Eligible pts were chemotherapy naive, ≥18 years, had stage IV squamous NSCLC, ECOG performance status 0-2, and unknown EGFR mutation status. Pts were randomly assigned to ≤ six 3-week cycles of G (1250 mg/m²) C (75 mg/m²) Â± neci (800 mg). OS (median [months], 95% CI) and progression-free survival (PFS) of pts from EA (Korea, Taiwan, Singapore, Thailand, and Philippines) and non-EA countries treated with neci + GC or GC were estimated using the Kaplan-Meier method. Hazard ratios (HR) and 95% CIs of neci + GC vs GC were estimated from stratified Cox proportional hazards models.

Results

Baseline characteristics were similar between EA groups. OS and PFS were improved in EA pts treated with neci + GC vs GC, and were similar for EA vs non-EA pts treated with neci + GC (Table). The percentages of serious adverse events (SAEs), AEs Grade ≥3, and AEs with outcome of death were higher in EA pts treated with neci + GC vs GC, and in EA vs non-EA pts treated with neci + GC (Table). The percentages of AEs causally related to neci only were similar in EA and non-EA pts (Table).

Conclusions

The efficacy of neci in EA pts with advanced squamous NSCLC was consistent with those in non-EA pts. The overall percentage of AEs with neci + GC was higher in EA pts than in non-EA pts; however, the AEs related to neci were similar.

Clinical trial identification

NCT00981058

Disclosure

K. Park: consulted/advised for Astellas, Astra-Zeneca, AVEO, and Boehringer Ingelheim. M.-J. Ahn: consulted/advised for Eli Lilly and Company. V. Soldatenkova, H. Depenbrock, T. Puri, M. Orlando: employee of Eli Lilly and Company and own shares in Eli Lilly Pty Ltd. All other authors have declared no conflicts of interest.

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