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D. Kim
Author of
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Poster Display Session (ID 63)
- Event: ELCC 2017
- Type: Poster Display Session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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114P - Phase II study of nivolumab in patients with advanced non-small cell lung cancer (NSCLC) in Korea (ID 441)
12:30 - 12:30 | Author(s): D. Kim
- Abstract
Background:
Nivolumab (BMS-936558/ONO-4538), a fully human IgG4, PD-1 immune-checkpoint inhibitor antibody, has shown durable clinical activity in several tumor types. Recently, two phase III studies (CheckMate-017 and -057) demonstrated that nivolumab improved overall survival (OS) than docetaxel in second-line of squamous (SQ) and non-squamous (NSQ) Non-Small Cell Lung Cancer (NSCLC), respectively. Here, we report the results of a phase II study to evaluate the efficacy and safety of nivolumab in Korean patients (pts) with previously treated advanced SQ and NSQ NSCLC.
Methods:
This study requires pts aged ≥ 20 years with ECOG Performance Status (PS) of 0 or 1, stage IIIB/IV or recurrent NSCLC and at least one prior chemotherapy including platinum containing regimen. Pts received nivolumab 3 mg/kg IV Q2W until progression or unacceptable toxicity. The primary endpoint in this study was the objective response rate (ORR) (RECIST v1.1).
Results:
Nivolumab was administered to 100 NSCLC pts (SQ: 44, NSQ: 56), male/female: 78 (SQ: 44, NSQ: 34)/22 (SQ: 0, NSQ: 22); PS 0/1: 14 (SQ: 6, NSQ: 8)/86 (SQ: 38, NSQ: 48); aged 29 to 80 [median: 66.5] years (SQ: 40 to 80 [median: 69.5], NSQ: 29 to 77 [median: 63.5]); Stage IIIB/IV/recurrence: 6 (SQ: 5, NSQ: 1)/91 (SQ: 37, NSQ: 54)/3 (SQ: 2, NSQ: 1)). In SQ and NSQ NSCLC, ORR was 15.9% (7/44) and 23.2% (13/56), respectively. Median progression-free survival was 2.6 mo and 5.3 mo, respectively. Complete Response was observed in 2.3% (1/44) and 1.8% (1/56), respectively. Median OS was 12.3 mo and 16.3 mo, respectively. Median follow-up was 8.9 mo and 12.3 mo, respectively. Most common adverse drug reaction (ADR) was decreased appetite 15.9% (7/44), followed by pyrexia 9.1% (4/44) in SQ NSCLC, and decreased appetite 12.5% (7/56), followed by pruritus 10.7% (6/56), fatigue 8.9% (5/56), pyrexia 5.4% (3/56) and nausea 5.4% (3/56) in NSQ NSCLC. Grade 3-4 ADR was observed in 6.8% (3/44) and 10.7% (6/56) of SQ and NSQ NSCLC, respectively. No interstitial lung disease and no grade 5 ADRs were observed in this study.
Conclusions:
Nivolumab was considered to be effective and used safely in Korean pts with SQ and NSQ NSCLC as well as in non-Korean pts with SQ and NSQ NSCLC.
Clinical trial identification:
NCT02175017
Legal entity responsible for the study:
Ministry of Food and Drug Safety in Korea
Funding:
Ono Pharmaceutical
Disclosure:
J.H. Kang: Honoraria; Bristol-Myers Squibb, Boehringer Ingelheim Consulting or Advisory Role; Bristol-Myers Squibb, Amgen Research Funding; AstraZeneca, Lilly. K. Park: Consulting or Advisory Role; Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Clovis Oncology, Lilly, Hanmi, Kyowa Hakko Kirin, Novartis, Ono Pharmaceutical, Roche, Speakers\' Bureau; Boehringer Ingelheim Research Funding: AstraZeneca. All other authors have declared no conflicts of interest.
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97P - Brigatinib in crizotinib-refractory ALK+ NSCLC: Updates from the pivotal randomized phase 2 Trial (ALTA) (ID 247)
12:30 - 12:30 | Author(s): D. Kim
- Abstract
Background:
In a phase 1/2 trial (NCT01449461), the investigational next-generation anaplastic lymphoma kinase (ALK) inhibitor brigatinib (BRG) showed promising activity in crizotinib-treated ALK-positive non–small cell lung cancer (ALK+ NSCLC) patients (pts); because tumor responses and adverse events (AEs) varied with starting dose, two BRG regimens were evaluated in ALTA (NCT02094573).
Methods:
Pts with crizotinib-refractory advanced ALK+ NSCLC were stratified by presence of brain metastases and best response to prior crizotinib and randomized 1:1 to receive BRG at 90 mg qd in arm A or 180 mg qd with a 7-day lead-in at 90 mg in arm B. Investigator-assessed confirmed objective response rate (ORR) per RECIST v1.1 was the primary endpoint.
Results:
222 pts were enrolled (112 in arm A, 110 in arm B); median age was 54 years, 57% were female, 74% had received chemotherapy, and 69% had brain metastases. As of 29 February 2016, 57%/69% of pts in arms A/B were receiving BRG, with 7.8/8.3-month median follow-up. Investigator-assessed efficacy by arm and subgroup is shown below. Per independent review committee, as of 16 May 2016, confirmed ORR was 48%/53% and median PFS was 9.2/15.6 months in arms A/B. Treatment-emergent AEs with ≥25% overall frequency (A/B, n = 109/n=110 treated) were nausea 33%/40%, diarrhea 19%/38%, headache 28%/27%, and cough 18%/34%; grade ≥3 events with ≥3% frequency were hypertension 6%/6%, increased blood creatine phosphokinase 3%/9%, pneumonia 3%/5%, and increased lipase 4%/3%. A subset of pulmonary AEs with early onset (median onset: Day 2) occurred in 14/219 (6%) treated pts (3%, grade ≥3); no such events occurred after escalation to 180 mg in arm B, and 7/14 pts were successfully retreated.
Conclusions:
BRG yielded substantial efficacy, with an acceptable safety profile, in both arms. 180 mg with 90 mg lead-in showed an improvement in efficacy endpoints, particularly PFS, with no increase in early pulmonary AEs, compared with 90 mg. Investigator-Assessed Efficacy by Subgroup.rnTable: 97PDrnrn
rnCR = complete response, ORR = objective response rate, PFS = progression-free survival, PR = partial responsernaPrimary endpointrnrn Arm A n = 112 rnArm B n = 110 rnTotal N = 222 rnrn rnConfirmed ORR, n/N (%) rnrn rn rn rn rnAll pts[a] rn50/112 (45) rn59/110 (54) rn109/222 (49) rnrn rnRace rnrn rn rn rn rnAsian rn18/39 (46) rn18/30 (60) rn36/69 (52) rnrn rnNon-Asian rn32/73 (44) rn41/80 (51) rn73/153 (48) rnrn rnPrior chemotherapy rnrn rn rn rn rnYes rn35/83 (42) rn44/81 (54) rn79/164 (48) rnrn rnNo rn15/29 (52) rn15/29 (52) rn30/58 (52) rnrn rnBest response to prior crizotinib rnrn rn rn rn rnCR or PR rn36/71 (51) rn47/73 (64) rn83/144 (58) rnrn rnOther rn14/41 (34) rn12/37 (32) rn26/78 (33) rnrn rnBaseline brain metastases rnrn rn rn rn rnYes rn31/80 (39) rn43/74 (58) rn74/154 (48) rnrn rnNo rn19/32 (59) rn16/36 (44) rn35/68 (51) rnrn rnMedian PFS, months rnrn rn rn rn rnAll pts rn9.2 rn12.9 rn11.1 rnrn rnRace rnrn rn rn rn rnAsian rn8.8 rn11.1 rn11.1 rnrn rnNon-Asian rn9.2 rn12.9 rn11.8 rnrn rnPrior chemotherapy rnrn rn rn rn rnYes rn8.8 rn12.9 rn11.8 rnrn rnNo rn9.2 rn8.1 rn9.2 rnrn rnBest response to prior crizotinib rnrn rn rn rn rnCR or PR rn11.1 rn15.6 rn15.6 rnrn rnOther rn7.4 rn12.9 rn9.2 rnrn rnBaseline brain metastases rnrn rn rn rn rnYes rn9.2 rn11.8 rn11.1 rnrn rnrnNo rn7.4 rn15.6 rn15.6 rn
Clinical trial identification:
NCT02094573
Legal entity responsible for the study:
ARIAD Pharmaceuticals, Inc.
Funding:
ARIAD Pharmaceuticals, Inc.
Disclosure:
M. Tiseo: Consulting or advisory role (AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Novartis, Otsuka, Pierre Fabre), research funding (ARIAD). K.L. Reckamp: Consulting or advisory role (ARIAD), research funding (ARIAD). H.L. West: Consulting or advisory role (ARIAD, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Merck, Novartis, Pfizer, Roche/Genentech, Trovagene), speakers’ bureau (ARIAD, Eli Lilly, Roche/Genentech). H.J. Groen: Consulting or advisory role (Eli Lilly, MSD, Novartis, Pfizer, Roche). C.J. Langer: Honoraria (BMS, Lilly/ImClone, Roche/Genentech), consulting or advisory role (Abbott, ARIAD, AstraZeneca, Bayer/Onyx, BMS, Cancer Support Community, Celgene, Clarient, Clovis Oncology, Lilly/ImClone, Merck, Millennium, Roche/Genentech), research funding (Advantagene, ARIAD, Celgene, Clovis Oncology, GSK, Inovio, Merck, Roche/Genentech). W. Reichmann, D. Kerstein: Employment, stock and other ownership interests (ARIAD). D.R. Camidge: Honoraria (ARIAD), research funding (ARIAD). All other authors have declared no conflicts of interest.
