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Naoyuki Nogami
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Lunch & Poster Display session (ID 58)
- Event: ELCC 2019
- Type: Poster Display session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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122P - Osimertinib as first-line (1L) treatment for epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC): Final efficacy and safety results from two phase I expansion cohorts (ID 404)
12:30 - 13:00 | Author(s): Naoyuki Nogami
- Abstract
Background
Osimertinib is a 3rd-generation, CNS-active EGFR-tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR-TKI sensitising (EGFRm) and EGFR T790M resistance mutations. Earlier results from the Ph I AURA (NCT01802632) and Ph III FLAURA (NCT02296125) studies have established 1L osimertinib efficacy. We report final efficacy and safety data from two Ph I expansion cohorts who received 1L osimertinib 80 or 160 mg for advanced EGFRm NSCLC in AURA.
a9ded1e5ce5d75814730bb4caaf49419 Methods
Treatment-naïve pts with locally advanced/metastatic EGFRm NSCLC received osimertinib 80 or 160 mg once daily. Endpoints included objective response rate (ORR), progression-free survival (PFS) and safety evaluation. EGFRm status was confirmed via local and/or central laboratory testing. Key eligibility criteria included measurable disease and WHO performance status 0/1. Pts with stable asymptomatic CNS metastases were eligible. Data cutoff: 1 May 2018.
20c51b5f4e9aeb5334c90ff072e6f928 Results
Overall, 60 patients (pts) were enrolled at two doses (80 mg, n = 30; 160 mg, n = 30): 75% female; 72% Asian; 43% with EGFR ex19del; 48% with L858R. Five pts were EGFR T790M mutation-positive by central test at study entry. Median follow up: 19.1 mo. ORR (95% CI): 67% (47, 83) in the 80 mg cohort, 87% (69, 96) in the 160 mg cohort, 77% (64, 87) overall. Median duration of response (95% CI): 19.3 mo (12.2, 24.7) in the 80 mg cohort, 16.7 mo (9.7, 29.0) in the 160 mg cohort, 18.0 mo (12.5, 24.7) overall. Median PFS (95% CI): 22.1 mo (12.3, 30.2) in the 80 mg cohort, 19.3 mo (11.1, 26.0) in the 160 mg cohort, 20.5 mo (13.7, 26.1) overall (78% maturity). 42% (95% CI 29, 54) and 14% (95% CI 6, 26) of pts were progression free at 24 and 48 mo, respectively. Dose reductions occurred in 27% and 60% of pts at 80 mg and 160 mg, respectively. Most common adverse events overall: (% [Grade ≥3]) diarrhoea (80 mg, 63% [3%]; 160 mg, 87% [7%]), stomatitis (80 mg, 47% [0]; 160 mg, 53% [3%]), paronychia (80 mg, 37% [0]; 160 mg, 57% [10%]).
fd69c5cf902969e6fb71d043085ddee6 Conclusions
Consistent with previously reported results, 1L osimertinib for EGFRm advanced NSCLC results in prolonged PFS at both doses and better tolerability at the 80 mg dose.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT01802632 (25 February 2013).
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Medical writing support was provided by Natasha Cary BSc, from iMed Comms, an Ashfield Company and funded by AstraZeneca.
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
AstraZeneca.
213f68309caaa4ccc14d5f99789640ad Funding
AstraZeneca.
682889d0a1d3b50267a69346a750433d Disclosure
J.C-H. Yang: Honoraria: BI, Roche, MSD, AstraZeneca, Novartis; Consulting/advisory: BI, Novartis, AstraZeneca, Roche/Genentech, Clovis Oncology, Lilly, MSD, Merck Serono, Celgene, Astellas Pharma, Bayer, Pfizer, Ono Pharmaceutical, Bristol-Myers Squibb, Yuhan, Hansoh. S.S. Ramalingam: Advisory boards: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Genentech, Lilly, Merck, Roche, Nektar, Loxo, Takeda; Research grants: Merck, Tesaro. C.K. Lee: Advisory boards: AstraZeneca, Roche, Norvatis, Pfizer. Research funding to institution: AstraZeneca for the trials in which I am currently involved. T. Kurata: Research grants: AstraZeneca, MSD; Honoraria: AstraZeneca, MSD, Ono, Bristol-Myers Squibb, Chugai, Eli Lilly. D-W. Kim: Advisory board membership, personal expenses: Novartis. T. John: Consultancy: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Takeda, Pfizer, Novartis, Merck, Roche. N. Nogami: Honoraria: AstraZeneca, Chugai Pharmaceutical, Eli Lilly Japan K.K., MSD, ONO Pharmaceutical, Pfizer Japan Inc., Taiho Pharmaceutical. Y. Ohe: Honoraria, consulting, research funding: AstraZeneca, Chugai, Dainippon Lilly, Ono, BMS Japan, Daiichi Sankyo, BI, Bayer, Ignyta, Pfizer, MSD, Taiho, Novartis, Kyorin, Kyowa Hakko Kirin, Takeda, Celltrion. Y. Rukazenkov: Employee and shareholder: AstraZeneca. P.A. Jänne: Consultancy: AstraZeneca, BI, Pfizer, Merrimack, Roche/Genentech, Chugai, AceaBiosciences, ARIAD Pharma, Ignyta, LOXO Oncology; Stock ownership: Gatekeeper Pharma; Research funding: Astellas, AstraZeneca; IP: EGFR mutations licensed to Lab Corp. All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25 -
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151P - Safety and tolerability of pembrolizumab or placebo plus pemetrexed and platinum as first-line therapy in Japanese patients (PTS) with metastatic non-squamous non-small cell lung cancer (NSCLC) enrolled in the phase III KEYNOTE-189 study (ID 484)
12:30 - 13:00 | Author(s): Naoyuki Nogami
- Abstract
Background
The global, randomized, double-blind, phase 3 KEYNOTE-189 study (NCT02578680) showed significantly improved OS and PFS with pembrolizumab (pembro) + pemetrexed (pem) + platinum compared with placebo + pem + platinum with a manageable safety profile in pts with previously untreated metastatic nonsquamous NSCLC without targetable EGFR/ALK aberrations|. We present safety and tolerability data from Japanese pts enrolled in KEYNOTE-189.
a9ded1e5ce5d75814730bb4caaf49419 Methods
Eligible pts enrolled in Japan during the global or extension study of KEYNOTE-189 were randomized 2:1 to pembro 200 mg Q3W or placebo for up to 35 cycles (∼2 y); all pts received pem 500 mg/m2 (until progressive disease or intolerable toxicity) and 4 cycles of carboplatin AUC 5 or cisplatin AUC 75 mg/m2. Safety and tolerability were assessed by clinical review of all relevant parameters; adverse events (AEs) and laboratory abnormalities were graded per NCI CTCAE v4.0.
20c51b5f4e9aeb5334c90ff072e6f928 Results
Of 40 pts enrolled in Japan (global study, n = 10; extension study, n = 30), 25 were randomized to the pembro arm, and 15 to the placebo arm. There were no meaningful differences in baseline characteristics, apart from a smaller proportion of pts with brain metastases (16% vs 33%), and larger proportion with PD-L1 TPS <1% (56% vs 40%) and cisplatin recipients (72% vs 53%) in the pembro vs placebo arm, respectively. The median (range) follow-up was 5.6 (2.4–12.9) mo and 7.0 (2.4–19.8) mo in the pembro and placebo arms, respectively. There were no deaths due to AEs. Grade 3/4 AEs occurred in 13 pts (52%) in the pembro arm and 8 (53%) in the placebo arm. 6 (24%) vs 3 pts (20%) had immune-mediated AEs and infusion reactions, with no events of pneumonitis reported in the pembro arm vs 2 (13.3%) in the placebo arm. Overall, AEs led to treatment discontinuation in 4 (16%) pts in the pembro vs 3 (20%) pts in the placebo arm.
fd69c5cf902969e6fb71d043085ddee6 Conclusions
Pembro + pem + platinum demonstrated a tolerable and manageable safety profile in Japanese pts, generally consistent with the overall pt population in the global KEYNOTE-189 study. No new safety concerns were identified in Japanese pts.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT02578680.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Medical writing assistance was provided by Shilpa Aggarwal, PhD, of C4 MedSolutions, LLC (Yardley, PA, USA), a CHC Group company and was funded by funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
213f68309caaa4ccc14d5f99789640ad Funding
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
682889d0a1d3b50267a69346a750433d Disclosure
H. Horinouchi: Corporate-sponsored research: MSD, Eli Lilly, BMS. N. Nogami: Honoraria: Pfizer Inc., Chugai Pharmaceutical Co. Ltd, Eli Lilly, Taiho Pharmaceutical Co. Ltd., AstraZeneca, Kyowa Hakko Kirin, Ono Pharmaceutical Co. Ltd., MSD. H. Saka: Grants/research support: AstraZeneca, MSD, Ono Pharmaceutical; Honoraria: AstraZeneca, MSD, Ono Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, Kyorin Pharmaceutical. M. Nishio: Grants and personal fees: Ono Pharmaceutical, Bristol-Myers Squibb, Pfizer, Chugai Pharmaceutical, Eli Lilly, Taiho Pharmaceutical, AstraZeneca, Boehringer-Ingelheim, MSD, Novartis; Personal fees: Daiichi Sankyo Healthcare, Merck Serono; Grants: Astellas, outside the submitted work. T. Tokito: Honoraria: AstraZeneca, MSD, Ono, Chugai. T. Takahashi: Grants, personal fees: Ono Pharmaceutical Co., Ltd., MSD K.K., AstraZeneca KK, Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K.; Grants: Pfizer Japan Inc.; Personal fees: Boehringer Ingelheim Japan, Inc, Roche Diagnostics K.K. K. Kasahara: Grants, honoraria: Boehringer Ingelheim; Honoraria: Pfizer, Chugai Pharmaceutical, Eli Lilly, Taiho Pharmaceuticals, AstraZeneca, MSD. Y. Hattori: Research funding: MSD, Ono; Honoraria: AstraZeneca, Boehringer Ingelheim, Chugai, Eli Lilly, MSD, Novartis, Ono, Taiho. E. Ichihara: Research grants: Eli Lilly, MSD. N. Adachi, T. Sawada, T. Shimamoto, K. Noguchi: Employee: MSD K.K., Tokyo, Japan. M.C. Pietanza: Employee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. T. Kurata: Research grants: AstraZeneca, MSD; Honoraria: AstraZeneca, MSD, Ono, Bristol-Myers Squibb, Chugai, Eli Lilly.
cffcb1a185b2d7d5c44e9dc785b6bb25
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Proffered Paper session III (ID 64)
- Event: ELCC 2019
- Type: Proffered Paper session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/12/2019, 08:30 - 10:00, Room A
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104O - IMpower150: An exploratory analysis of efficacy outcomes in patients with EGFR mutations (ID 184)
08:30 - 10:00 | Author(s): Naoyuki Nogami
- Abstract
- Presentation
Background
Atezolizumab (atezo; anti–PD-L1) inhibits PD-L1 to restore anticancer immunity; bevacizumab (bev) may enhance atezo efficacy by inhibiting VEGF immunosuppression and promoting T-cell tumour infiltration. Atezo + bev + chemotherapy (chemo) prolonged PFS and OS vs bev + CP in pts with first-line nonsquamous NSCLC in the randomised Ph III IMpower150 study, including pts with EGFR or ALK genomic alterations. The purpose of this analysis is to focus on the efficacy of atezo and/or bev with chemo in pts with EGFR mutations (EGFR-mt).
a9ded1e5ce5d75814730bb4caaf49419 Methods
The 1202 enrolled pts received atezo (A) 1200 mg + bev (B) 15 mg/kg + carboplatin (C) AUC 6 + paclitaxel (P) 200 mg/m2 (ABCP) or A + C + P (ACP) or B + C + P (BCP) by IV q3w for 4 or 6 cycles per investigator (INV) decision, then q3w maintenance with atezo + bev, atezo or bev, respectively. Primary endpoints were OS and INV-assessed PFS in the ITT–wild-type population (pts with no EGFR or ALK genomic alterations). Exploratory analyses included OS and INV-assessed PFS in pts with EGFR-mt disease, pts with sensitising EGFR-mt and pts with EGFR-mt disease with prior TKI therapy.
20c51b5f4e9aeb5334c90ff072e6f928 Results
These data represent ≥ 20-mo follow-up (data cutoff: 22 Jan 2018) in the ITT population. 124 pts were EGFR-mt; 91 with a sensitising mutation. Baseline characteristics of EGFR-mt pts across treatment arms were generally comparable to the ITT population. OS was improved with ABCP vs BCP in EGFR-mt pts, especially in pts with sensitising EGFR-mts (HR, 0.31 [95% CI: 0.11, 0.83]). This benefit extended to PFS (HR, 0.41 [95% CI: 0.23, 0.75]). See table for full efficacy results. Safety was similar between the EGFR-mt and ITT populations.
fd69c5cf902969e6fb71d043085ddee6 Conclusions
IMpower150 is the first randomised Ph III trial of a checkpoint inhibitor to show a benefit in pretreated EGFR-mt pts. Adding atezo to standard-of-care bev and chemo provided survival benefit in EGFR-mt pts who have failed TKIs, for whom this regimen may represent a new treatment option.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT02366143.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Medical writing assistance for this abstract was provided by Jessica Men, PharmD, of Health Interactions and funded by F. Hoffmann-La Roche, Ltd.
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
F. Hoffmann-La Roche, Ltd.
213f68309caaa4ccc14d5f99789640ad Funding
F. Hoffmann-La Roche, Ltd.
682889d0a1d3b50267a69346a750433d Disclosure
M. Reck: Speakers bureau, consulting, advisory role: Roche, Lilly, Pfizer, BI, AZ, MSD, BMS, Merck, Novartis, Celgene; Other (support of parent study, funding of editorial support): Roche. R. Jotte: Speakers bureau; travel, accommodations, expenses: Bristol-Myers Squibb; Other (support of parent study, funding of editorial support): Roche. T.S.K. Mok: Honoraria, consult/ad role, research: AZ, BI, BMS, Merck, NVS, Pfizer, Roche/GNE; Honoraria, consult/ad role: LLY; Consult/Ad Role: ACEA, Celgene, geneD, Ignyta, OGXI, Vertex; Consult/ad role, research: Clovis, SFJ; Research: Eisai, Taiho; Stock: Sanomics, Hutch. D.W-T. Lim: Honoraria: AZ, BI, Novartis, MSD, Pfizer, Roche, Takeda, Taiho; Research grants (institution): BMS; Stock: Clearbridge Biomedics Pte Ltd, Mesh Bio Pte Ltd; Other (support of parent study, funding of editorial support): Roche. F. Cappuzzo: Speakers/Advisory board: Roche, AZ, BMS, Pfizer, MSD, Takeda; Other (support of parent study, funding of editorial support): Roche. F. Orlandi: Consult/ad role: AZ, Lilly; Consult/ad role, travel, research: Roche, BMS, MSD; Consult/ad role, travel: Pfizer; Speaker, travel, research: MedImm; Research: Amgen, BI, Astellas, Celltrion. D. Stroyakovskiy, C.A. Thomas: Support of parent study, funding of editorial support: Roche. N. Nogami: Honoraria: AZ, Pfizer, Ono Pharmaceutical, Kyowa Hakko Kririn, Taiho, Chugai, Eli Lilly, BI, MSD; Other (support of parent study and funding of editorial support): Roche. D. Rodríguez-Abreu: Speakers bureau: MSD, Roche, BMS, AZ, Pfizer; Other (support of parent study and funding of editorial support): Roche. D. Moro-Sibilot: Honoraria; Consulting/advisory role, travel, accommodations, expenses: Roche, MSD, Pfizer, BMS, AZ; Honoraria, consulting/advisory role: Novartis, Lilly; Other (support of parent study, funding of editorial support): Roche. F. Barlesi: Support of parent study, funding of editorial support: Roche; Personal fees: AZ, BMS, BI, Clovis, Lilly, Roche, Novartis, Merck, MSD, Pierre Fabre, Pfizer, Takeda; Consulting/advisory: MSD, Takeda. G. Finley: Speakers: BMS, BI, Astellas Medivation, Merck; Support of parent study, funding of editorial support: Roche. M. Nishio: Speakers/Ad board, research grant: Ono Pharma, BMS, Pfizer, Chugai, Lilly, Taiho, AZ, MSD, Novartis; Speakers/Ad board: BI, Sankyo, Merck; Research Grant: Astellas; Support of parent study, funding of editorial support: Roche. A. Lee: Employee/Stock: Genentech; Support of parent study, funding of editorial support: Roche. G. Shankar, W. Yu: Employee: Genentech; Support of parent study, funding of editorial support: Roche. M.A. Socinski: Honoraria/speakers bureau/research funding: Genentech; Support of parent study, funding of editorial support: Roche.
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