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Poster display session

2481 - Efficacy and safety of necitumumab and pembrolizumab combination therapy in patients with stage IV non-small cell lung cancer (NSCLC)

Date

09 Sep 2017

Session

Poster display session

Presenters

Benjamin Besse

Citation

Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380

Authors

B. Besse1, P. Garrido Lopez2, J. Puente3, A. Cortot4, M.E. Olmedo Garcia5, M. Perol6, M. Gil7, G. Chao8, J. Shahidi9, J. Bennouna10

Author affiliations

  • 1 Cancer Medicine, Institut de Cancérologie Gustave Roussy, 94805 - Villejuif/FR
  • 2 Medical Oncology, Hospital Universitario Ramón y Cajal, 28034 - Madrid/ES
  • 3 Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 4 Pneumology-oncology, Hospital Albert Calmette, 59000 - Lille/FR
  • 5 Medical Oncology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 6 Oncologie, Centre Léon Bérard, 69008 - Lyon/FR
  • 7 Medical Oncology, Eli Lilly Poland, 02-092 - Warsaw/PL
  • 8 Biometrics, Eli Lilly and Company, 08807 - Bridgewater/US
  • 9 Medical Oncology, Eli Lilly and Company, 08807 - Bridgewater/US
  • 10 Medical Oncology, CHU de Nantes, 44093 - Nantes/FR
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Resources

Abstract 2481

Background

Studies of EGFR-directed monoclonal antibody (mAb) necitumumab (neci) and anti-PD1 pembrolizumab (pembro) demonstrate activity of each agent in NSCLC.

Methods

This phase 1b, multicenter, single arm study of neci and pembro examined the safety, efficacy, and tolerability in pretreated patients with Stage IV NSCLC (NCT02451930). PDL1 was centrally assessed retrospectively using IHC 22C3 pharmDx assay (negative, weak positive, strong positive if 

Results

for 64 patients are reported. Part A completed without DLTs (9 patients; 2 squamous, 7 nonsquamous). Overall, 3 patients received neci 600 mg and 61 patients received neci 800 mg; all patients received pembro 200 mg. ORR (95% CI) was 23.4% (13.8, 35.7). Median PFS (95% CI) was 4.1 m (2.4, 6.9). Six-month OS rate (95% CI) was 74.7% (61.5, 83.9). Treatment-emergent adverse events occurring in ≥ 20% of all patients (n (%)) included dermatitis acneiform: 43 (67.2); asthenia: 24 (37.5); dry skin: 23 (35.9); hypomagnesemia: 21 (32.8); fatigue: 20 (31.3); decreased appetite and diarrhea (each): 17 (26.6); headache, pruritus, and stomatitis (each): 14 (21.9). Two neci 800 mg + pembro patients experienced grade 5 respiratory tract infection.

Conclusions

The results suggest modest activity of the combination in a NSCLC patient population with a relatively high proportion of PDL1 negative tumors (Table).Table:

1309P

Necitumumab 600 mg/800 mg + Pembrolizumab 200 mg
OverallSquamousNonsquamous
(N = 64)(n = 30)(n = 34)
Age, median (range), y65 (43, 81)67.5 (48, 81)61 (43, 75)
Male, n (%)46 (71.9)23 (76.7)23 (67.6)
Prior systemic therapy, n (%)
1 line36 (56.3)22 (73.3)14 (41.2)
2 lines15 (23.4)5 (16.7)10 (29.4)
≥3 lines13 (20.3)3 (10.0)10 (29.4)
Baseline ECOG PS, n (%)64 (100)30 (100)34 (100)
017 (26.6)3 (10.0)14 (41.2)
146 (71.9)26 (86.7)20 (58.8)
21 (1.6)1 (3.3)0
Tobacco use, n (%)64 (100)30 (100)34 (100)
Former41 (64.1)21 (70.0)20 (58.8)
Current14 (21.9)7 (23.3)7 (20.6)
Never9 (14.1)2 (6.7)7 (20.6)
Efficacy
ORR n (%) (95% CI)15 (23.4) (13.8, 35.7)6 (20.0) (7.7, 38.6)9 (26.5) (12.9, 44.4)
mPFS (months) (95% CI)4.1 (2.4, 6.9)2.8 (1.4, 5.5)6.9 (2.7, 12.3)
6-month OS rate (%) (95% CI)74.7 (61.5, 83.9)63.6 (42.8, 78.6)84.2 (66.0, 93.1)
PDL1 Status64 (100)30 (100)34 (100)
PDL1 negative32 (50.0)13 (43.3)19 (55.9)
ORR n (%) (95% CI)4 (12.5) (3.5, 29.0)1 (7.7) (0.2, 36.0)3 (15.8) (3.4, 39.6)
mPFS (m) (95% CI)2.69 (1.4, 4.1)
6-month OS rate (%) (95% CI)68.2 (47.7, 82.0)
PDL1 Weak positive12 (18.8)7 (23.3)5 (14.7)
ORR n (%) (95% CI)3 (25.0) (5.5, 57.2)1 (14.3) (0.4, 57.9)2 (40.0) (5.3, 85.3)
mPFS (m) (95% CI)5.4 (0.8, –)
6-month OS rate (%) (95% CI)83.3 (48.2, 95.6)
PDL1 Strong positive10 (15.6)5 (16.7)5 (14.7)
ORR n (%) (95% CI)4 (40.0) (12.2, 73.8)2 (40.0) (5.3, 85.3)2 (40.0) (5.3, 85.3)
mPFS (m) (95% CI)7.6 (1.0, 12.3)
6-month OS rate (%) (95% CI)80.0 (40.9, 94.6)
Unknown10 (15.6)5 (16.7)5 (14.7)
ORR n (%) (95% CI)4 (40.0) (12.2, 73.8)2 (40.0) (5.3, 85.3)2 (40.0) (5.3, 85.3)
mPFS (m) (95% CI)– (0.82, –)
6-month OS rate (%) (95% CI)78.8 (38.1, 94.3)

ECOG PS, Eastern Cooperative Oncology Group performance status; PDL1, programmed death ligand 1; ORR, overall response rate; mPFS, median progression-free survival; OS, overall survival; CI, confidence interval.

Clinical trial identification

NCT02451930

Legal entity responsible for the study

Eli Lilly and Company

Funding

Eli Lilly and Company

Disclosure

B. Besse: Research grants from Eli Lilly and Company and Merck, Sharp & Dohme. P. Garrido Lopez: Personal fees from BMS, Novartis, Pfizer, Roche, MSD, Guardant, and Abbvie; and grants and personal fees from BI. A. Cortot: Personal fees from Lilly and MSD; personal fees and non-financial support from Roche, Novartis, Astra-Zeneca, and Pfizer; and grants, personal fees, and non-financial support from Boehringer-Ingelheim. M. Perol: Personal fees from Eli Lilly and MSD. M. Gil: Employee of Eli Lilly and Company and owns Eli Lilly stock. Dr. Gil has a patent Combination Therapy for cancer pending to Eli Lilly. G. Chao: Employee of Eli Lilly and Company. J. Shahidi: Employee and stock owner of Eli Lilly and Company. J. Bennouna: Personal fees from Roche, Boehringer-Ingelheim, BMS, and Astra-Zeneca. All other authors have declared no conflicts of interest.

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