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Martin Reck
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Boehringer Ingelheim - Industry Satellite Symposium (ID 27)
- Event: ELCC 2019
- Type: Industry Satellite symposium
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/11/2019, 18:00 - 19:00, Room A
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Recent changes and sequencing strategies in non-mutated, non-squamous advanced NSCLC (ID 629)
18:00 - 19:00 | Presenting Author(s): Martin Reck
- Abstract
Abstract not provided
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Bristol-Myers Squibb - Industry Satellite Symposium (ID 11)
- Event: ELCC 2019
- Type: Industry Satellite symposium
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 4/10/2019, 18:15 - 19:15, Room A
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Clinical practice today and future considerations (ID 618)
18:15 - 19:15 | Presenting Author(s): Martin Reck
- Abstract
- Presentation
Abstract not provided
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Moderator (ID 730)
18:15 - 19:15 | Presenting Author(s): Martin Reck
- Abstract
- Presentation
Abstract not provided
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ESMO-IASLC Best Abstracts (ID 62)
- Event: ELCC 2019
- Type: Proffered Paper session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 4/11/2019, 14:45 - 16:15, Room B
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103O_PR - Safety and efficacy of pembrolizumab (Pembro) monotherapy in elderly patients (Pts) with PD-L1–positive advanced NSCLC: Pooled analysis from KEYNOTE-010, -024, and -042 (ID 466)
14:45 - 16:15 | Author(s): Martin Reck
- Abstract
- Presentation
Background
Approximately 70% of newly-diagnosed NSCLC cases occur in the elderly, and more than half are locally advanced/metastatic. We present a pooled analysis of efficacy and safety in elderly pts (aged ≥75 y) enrolled in 3 randomized controlled trials of pembro monotherapy vs standard chemotherapy (chemo) for PD-L1–positive advanced NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Methods
Pts were aged ≥18 y with advanced NSCLC with PD-L1 tumor proportion score (TPS) ≥1% (KEYNOTE-010, -042) or TPS ≥50% (KEYNOTE-024). In KEYNOTE-010, pts were randomized to pembro 2 or 10 mg/kg Q3W or docetaxel, as second- or later-line therapy. In KEYNOTE-024 and -042, pts were randomized to first-line pembro 200 mg Q3W or platinum-based chemo. OS was estimated by the Kaplan-Meier method.
20c51b5f4e9aeb5334c90ff072e6f928 Results
The 3 trials included 264 pts aged ≥75 (range, 75–90) y with TPS ≥1%; 132 pts had TPS ≥50%. Independent of line of treatment, HRs (95% CI) for OS favored pembro vs chemo: 0.76 (0.56–1.02) in pts with TPS ≥1% and 0.40 (0.25–0.64) in pts with TPS ≥50%. Pembro also improved OS vs chemo in the pooled analysis of pts with TPS ≥50% who received first-line therapy (KEYNOTE-024 and -042): HR, 0.41 (95% CI, 0.23–0.73). Overall, fewer treatment-related AEs across various categories were observed with pembro vs chemo, in particular, grade 3–5 treatment-related AEs in pts aged ≥75 y (Table). Immune-mediated AEs and infusion reactions were more frequent with pembro vs chemo, with similar frequency in pts receiving pembro aged ≥75 y and <75 y (Table).
fd69c5cf902969e6fb71d043085ddee6 Conclusions
In this pooled analysis of pts aged ≥75 y with PD-L1–positive advanced NSCLC, pembro monotherapy improved OS vs chemo, both in pts with PD-L1 TPS ≥1% and PD-L1 TPS ≥50%. The safety profile of pembro was similar in pts aged ≥75 y and <75 y, with lower rates of grade 3–5 treatment-related AEs vs chemo.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT01905657 (KEYNOTE-010); NCT02142738 (KEYNOTE-024); NCT02220894 (KEYNOTE-042).
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Medical writing and editorial assistance was provided by Michael S. McNamara, MS, of C4 MedSolutions, LLC (Yardley, PA), a CHC Group company and 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
K. Nosaki: Honoraria: AstraZeneca, Chugai Pharmaceutical, Eli Lilly, MSD; Institutional research funding: MSD. Y. Hosomi: Personal fees: MSD, AstraZeneca, Eli Lilly Japan, Taiho Pharmaceutical, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb. H. Saka: Grants/research support: AstraZeneca, MSD, Ono Pharmaceutical; Honoraria: AstraZeneca, MSD, Ono Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, Kyorin Pharmaceutical. P. Baas: Consulting role: Genentech/Roche, Merck, Bristol-Myers Squibb, Pfizer; Research support: Bristol-Myers Squibb, Roche, Merck. G. de Castro Jr: Consulting/advisory role: AstraZeneca, MSD, BMS, Roche, Novartis, Boehringer Ingelheim; Speakers’ bureau: MSD, BMS, Novartis, AstraZeneca; Travel/accommodation expenses: MSD, BMS, Roche, Bayer, Novartis, Boehringer Ingelheim, AstraZeneca. M. Reck: Personal fees: Amgen, Hoffmann-La Roche, Lilly, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, MSD, Merck, Novartis, Pfizer, AbbVie. Y-L. Wu: Honoraria: AstraZeneca, Eli Lilly, Roche, Pierre Fabre, Pfizer, Sanofi; Consulting/advisory role: AstraZeneca, Roche, Merck, Boehringer Ingelheim; Research funding to institution: Boehringer Ingelheim, Roche. J.R. Brahmer: Grant, personal fees, Advisory boards, consulting: Merck; Uncompensated advisor and consultant: Bristol-Myers Squibb; Grants: Bristol-Myers Squibb, MedImmune/AstraZeneca; Personal fees: Amgen, Celgene, Lilly. E. Felip: Consulting, advisory role, speaker’s bureau: AbbVie, AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Guardant Health, Janssen, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda; Research funding: Fundación Merck Salud; Grant for Oncology Innovation EMD Serono. T. Sawada, K. Noguchi, S.R. Han: Employee: MSD K.K., Tokyo, Japan. B. Piperdi, D.A. Kush: Employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. G. Lopes: Research funding to institution: Merck & Co., Inc., EMD Serono, AstraZeneca.
cffcb1a185b2d7d5c44e9dc785b6bb25Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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LBA1_PR - Nivolumab (nivo) plus ipilimumab (ipi), nivo, or placebo (pbo) as maintenance therapy in patients (pts) with extensive disease small cell lung cancer (ED-SCLC) after first-line (1L) platinum-based chemotherapy (chemo): Results from the double-blind, randomized phase III CheckMate 451 study (ID 683)
14:45 - 16:15 | Author(s): Martin Reck
- Abstract
- Presentation
Background
In pts with ED-SCLC, response rates to 1L platinum-based chemo are high but lack durability. Treatments (txs) that prolong response duration and improve survival are needed. CheckMate 451 (NCT02538666) is a global, double-blind, phase 3 study of nivo+ipi or nivo vs pbo as maintenance therapy in pts with ED-SCLC who did not progress on 1L platinum-based chemo.
a9ded1e5ce5d75814730bb4caaf49419 Methods
Pts (N = 834) with ED-SCLC, ECOG performance status (PS) ≤ 1 and response or stable disease after 4 cycles of 1L platinum-based chemo were randomized 1:1:1 (3–9 weeks from last dose of 1L chemo or 3–11 weeks for pts who received prophylactic cranial irradiation [PCI]) to nivo 1 mg/kg + ipi 3 mg/kg Q3W intravenously (IV; 4 doses followed by nivo 240 mg Q2W IV; n = 279), nivo 240 mg Q2W IV (n = 280), or pbo (n = 275), stratified by PS, sex and prior PCI. Pts were treated up to 2 years or until progression or unacceptable toxicity. Primary endpoint was overall survival (OS) for nivo+ipi vs pbo. Secondary endpoints included OS for nivo vs pbo and progression-free survival (PFS) per blinded independent central review for nivo+ipi vs pbo and nivo vs pbo.
20c51b5f4e9aeb5334c90ff072e6f928 Results
Minimum study follow-up was 9 months. Baseline characteristics were balanced between arms. OS was not significantly prolonged with nivo+ipi vs pbo (HR, 0.92; 95% CI 0.75–1.12; P = 0.3693). OS was also not prolonged for nivo vs pbo (HR, 0.84; 95% CI 0.69–1.02), although not formally tested due to statistical hierarchy. PFS HRs vs pbo were: nivo+ipi, 0.72 (0.60–0.87); nivo, 0.67 (0.56–0.81). Rates of all-grade (grade 3–4) tx-related adverse events were: nivo+ipi, 86% (52%); nivo, 61% (12%); pbo, 50% (8%). Rates of discontinuation due to tx toxicity were: nivo+ipi, 31%; nivo, 9%; pbo, <1%. Tx-related deaths were: nivo+ipi, 7 (2.5%); nivo, 1 (<1%); pbo, 1 (<1%).
fd69c5cf902969e6fb71d043085ddee6 Conclusions
In CheckMate 451, maintenance therapy with nivo+ipi (primary endpoint) or nivo did not prolong OS vs pbo for ED-SCLC patients who did not progress on 1L chemo. Safety profiles of nivo+ipi and nivo were consistent with previous reports at this dose/schedule in SCLC.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT02538666; Release date: 2 September 2015.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement
Writing and editorial assistance was provided by Cristina Tomas, PhD, of Caudex and funded by Bristol-Myers Squibb.
934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study
Bristol-Myers Squibb.
213f68309caaa4ccc14d5f99789640ad Funding
Bristol-Myers Squibb.
682889d0a1d3b50267a69346a750433d Disclosure
T.K. Owonikoko: Research support: AbbVie, Adaptimmune, Amgen, AstraZeneca, Bristol-Myers Squibb, Corvus, G1 Therapeutics, Novartis, Pfizer, Regeneron/Sanofi; Advisory board: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Lilly/Armo, PharmaMar, Xcovery; IRC/DSMB: EMD Serono, Roche/Genentech; Co-founder: Cambium Oncology. H.R. Kim: Speakers bureau, honoraria: AstraZeneca, ONO/Bristol-Myers Squibb; Consultant: Roche. R. Govindan: Consultant/advisory committees: AbbVie, Adaptimmune, AstraZeneca, Celgene, Ignyta, Inivata, Merck, Nektar, Pfizer, Roche. N. Ready: Advisor: AbbVie, G1 therapeutics, Merck, Novartis; Advisor/speaker: Bristol-Myers Squibb, Celgene; Education: AstraZeneca, EMD Serrano, Tesaro. M. Reck: Honoraria for lectures and consultancy: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Lilly, Merck, MSD, Novartis, Pfizer, Roche. S. Peters: Honoraria, education grants, consultancy, attended advisory boards, and/or provided lectures: AbbVie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche, Foundation Medicine, Illumina, Janssen, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, PharmaMar, Pfizer, Regeneron, Sanofi, Seattle Genetics, Takeda. A. Navarro: Advisory role: Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Roche; Safety committee member: Oryzon Genomics; Travel support: Boehringer Ingelheim, Pfizer. J. Rodriguez-Cid: Investigational resources: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, MSD, Novartis, Roche, Takeda; Advisory role: AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, MSD, Novartis, Pfizer, Roche, Takeda; Speaker role: AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, Takeda. M. Schenker: For clinical trial participation (as PI/SI) my institution and I have received funds from: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Bioven, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, Merck Serono, MSD, Mylan, Nano Carrier, Novartis, Pfizer, PharmaMar, Regeneron, Roche, Samsung D. Morgensztern: Advisory board: AbbVie, Bristol-Myers Squibb, PharmaMar, Takeda. J. Fairchild: Stock ownership: Bristol-Myers Squibb. C. Baudelet: Employee: Bristol-Myers Squibb. K. Park: Advisor: Bristol-Myers Squibb. All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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Immunotherapy in stage IV (ID 13)
- Event: ELCC 2019
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/11/2019, 09:00 - 10:30, Room B
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I-O monotherapy (ID 33)
09:00 - 10:30 | Presenting Author(s): Martin Reck
- Abstract
- Presentation
Abstract not provided
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Lunch & Poster Display session (ID 58)
- Event: ELCC 2019
- Type: Poster Display session
- Track:
- Presentations: 3
- Moderators:
- Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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125P - Elderly patients treated with afatinib in clinical practice: Results from the prospective non-interventional study GIDEON (ID 294)
12:30 - 13:00 | Author(s): Martin Reck
- Abstract
Background
Elderly patients are often underrepresented in clinical trials, leading to uncertainties in the treatment of these patients in the clinical routine.
a9ded1e5ce5d75814730bb4caaf49419 Methods
The prospective non-interventional study GIDEON allows analyzing a German real world patient collective treated with afatinib according to label. This analysis focusses on patients older than 70 years.
20c51b5f4e9aeb5334c90ff072e6f928 Results
Patients older than 70 years account for 44% of the GIDEON study population (n = 67). Main EGFR mutation in this population was Del.19 (n = 43, 64%), followed by L858R und rare mutations (both n = 12, 18%). Brain metastases at baseline were detected in 22% of patients (n = 15). Afatinib dose was reduced in 55% (n = 37) of all patients older than 70 years and in 58% of patients younger than 70 years. The percentage of patients who received a starting dose of afatinib lower than 40mg was higher in the elderly population (n = 25, 37%) compared to patients younger than 70 years (18%). Main Afatinib related side effects of grade 3 or higher were independent of age, with diarrhea (18% in patients <70 years and 15% in patients ≥70 years) as the most frequent adverse drug reactions. Overall response rate was 78% and disease control rate was 93% in the elderly population. PFS rate at one year was 62%.
fd69c5cf902969e6fb71d043085ddee6 Conclusions
With 44% of the whole study population, elderly patients (>70 years) are well represented in GIDEON. Therefore, these data provide important information for the routine clinical use of afatinib in these patients. With an overall response rate of 78% and a PFS-rate of 62% after one year, these data support the use of afatinib in elderly patients. Adverse drug reactions of grade 3 or more were not significantly higher in the elderly group.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT02047903.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study
Boehringer Ingelheim.
213f68309caaa4ccc14d5f99789640ad Funding
Boehringer Ingelheim.
682889d0a1d3b50267a69346a750433d Disclosure
W. Brückl: Fees for consulting and/or lectures: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Chugai, Lilly, MSD, Pfizer, Roche, Stratifyer. M. Reck: Honoraria for lectures and consultancy: Hoffmann-La Roche, Lilly, Amgen, Boehringer Ingelheim, Abbot, AstraZeneca, Celgene, BMS, MSD, Merck, Novartis, Pfizer. A. Maerten, C. Hoffmann: Employee: Boehringer Ingelheim. All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25 -
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66P - Treatment (tx) characteristics and clinical outcomes in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) treated with carboplatin (carbo) or cisplatin (cis) in combination with etoposide (etop) in US clinical practice (ID 309)
12:30 - 13:00 | Author(s): Martin Reck
- Abstract
Background
For pts with ES-SCLC, guidelines recommend carbo or cis + etop as first-line (1L) tx. However, real-world data (RWD) on tx patterns and outcomes are limited. Here, we describe pt characteristics, tx duration and clinical outcomes associated with these 2 regimens.
a9ded1e5ce5d75814730bb4caaf49419 Methods
Pts with ES-SCLC diagnosis (or limited-stage [LS] SCLC who initiated second-line [2L] tx) between 1 Jan 2013 and 31 Aug 2017 (follow-up to 31 Aug 2018) were identified from the US-based Flatiron Health electronic health record–derived database. Pts receiving tx with either carbo + etop or cis + etop were included in the analysis.
20c51b5f4e9aeb5334c90ff072e6f928 Results
RWD on 2161 pts from 156 tx centres were included; 84% of pts received carbo + etop. See table below for pt characteristics. The median tx duration was 3.4 mo (95% CI: 3.4, 3.4) with carbo + etop and 3.0 mo (95% CI: 2.8, 3.4) with cis + etop. The distribution of tx cycles administered was similar between carbo and cis, with 20% and 28% of pts completing 4 or 6 cycles, respectively. Median overall survival (OS) was 8.3 mo (95% CI: 8.1, 8.7) with carbo + etop and 9.7 mo (95% CI: 9.3, 11.0) with cis + etop. The 1-yr OS rates were 30% (95% CI: 28, 33) and 41% (95% CI: 36, 47), respectively. In pts with Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 and ≥ 2, median OS was 9.3 mo (95% CI: 8.6, 9.9) and 7.1 mo (95% CI: 6.3, 8.3), respectively. Pts with unknown ECOG PS had a median OS of 8.4 mo (95% CI: 8.0, 8.9).
fd69c5cf902969e6fb71d043085ddee6 Conclusions
Tx duration was similar between the 2 regimens. Pts who received cis + etop had numerically increased OS vs pts who received carbo + etop, as did pts with ECOG PS 0-1. However, these findings may be due to pts receiving cis + etop being fitter (younger and lower ECOG PS) at baseline.
b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement
Medical writing assistance for this abstract was provided by Steffen Biechele, PhD, 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. Sebastian: Honoraria, consulting: AZ, BI, BMS, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche; Honoraria: Pierre Fabre; Consulting: Celgene. F. Barlesi: Personal fees/clinical trials (inst.): AZ, BMS, BI, Lilly, Roche, Novartis, Merck, MSD, Pierre Fabre, Pfizer, Takeda; Clinical trials (inst.): AbbVie, ACEA, Amgen, Bayer, Eisai, Genentech, Ipsen, Ignyta, Innate Pharma, Loxo, Medimmune, Sanofi-Aventis. R. Califano: Honoraria/consult: BI; Stock: Christie Private Care; Grants/nonremunerated activities: Clovis, AbbVie; Leadership (nonrem): ESMO; Nonrem membership: EORTC; Honoraria/consult/grants/nonrem activities: AZ, Roche, Pfizer, Lilly, MSD, Takeda, Novartis, BMS. A.S. Mansfield: Research funding (inst.): Novartis, Verily; Honoraria/Ad board (inst.): Genentech, AbbVie, BMS Mesothelioma Applied Research Foundation; Board member (non-rem.) ASCO; Lung Cancer Education Committee member (non-rem). F.H. Blackhall: Grant/research: Roche, BI, AZ, Cellmedica, AbbVie, Pfizer; Advisory board: AZ, Cellmedica, AbbVie, Ipsen, Takeda, Roche; Consulting/speakers: Takeda; Honoraria: Takeda, Roche, AbbVie, Ipsen; Study, editorial support: Roche. E.M. Flahavan: Employee: Roche; Stock: Lilly, Roche; support of parent study and funding of editorial support: Roche. J. Davies: Employee: Roche. P. Arnold: Employee: Roche; Stock: Novartis Pharma AG. S. Morris: Employee, Stock: Roche. M. Reck: Support of parent study, funding of editorial support: Roche; Honoraria for lectures and consulting: Amgen, AbbVie, BI, BMS, Celgene, Merck-Serono, MSD, Lilly, Novartis, Pfizer, Roche.
cffcb1a185b2d7d5c44e9dc785b6bb25Characteristics
Carbo + Etop Cis + Etop Pts, n 1815 346 Age, median (IQR), y 68 (61-74) 64 (58-69) 35-64, n (%) 663 (37) 189 (55) 65-69, n (%) 357 (20) 77 (22) ≥ 70, n (%) 795 (44) 80 (23) Male, n (%) 919 (51) 184 (53) White race, n (%) 1383 (76) 259 (75) Baseline ECOG PS, n (%) 0-1 716 (39) 144 (42) ≥ 2 296 (16) 29 (8) Not provided 803 (44) 173 (50) Type of ES-SCLC, n (%) 1L tx of ES-SCLC 1757 (97) 335 (97) 2L tx of LS-SCLC 58 (3) 11 (3) IQR, interquartile range.
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82TiP - IMpower030: Phase III study evaluating neoadjuvant treatment of resectable stage II-IIIB non-small cell lung cancer (NSCLC) with atezolizumab (atezo) + chemotherapy (ID 183)
12:30 - 13:00 | Author(s): Martin Reck
- Abstract
Background
A standard of care for resectable early-stage NSCLC is surgery alone or in combination with adjuvant or neoadjuvant platinum-based doublet chemotherapy (PT-DC). Still, 30%-70% of patients develop recurrence and die from disease progression, highlighting the need for more effective treatments. Atezo, an anti–programmed death-ligand 1 (PD-L1) antibody that restores anti-tumour immunity, has shown promising efficacy as monotherapy and in combination with chemotherapy in advanced NSCLC. It is hypothesised that the combination of atezo and PT-DC may provide clinical benefit in the neoadjuvant setting by enhancing cancer cell killing and eradicating micrometastases, reducing the risk of disease recurrence. The objective of IMpower030 (NCT03456063) is to evaluate the efficacy and safety of atezo in combination with PT-DC as neoadjuvant treatment for patients with resectable early-stage NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Trial design
IMpower030 is a global, Phase III, double-blind, randomized study in patients with histologically or cytologically confirmed, resectable stage II, IIIA, or select IIIB (T3N2) NSCLC (per AJCC/UICC, 8th ed). Study inclusion requires measurable disease per RECIST v1.1, ECOG PS of 0/1 and eligibility for R0 resection with curative intent and PT-DC. Patients who had received prior therapy for lung cancer or present with nonsquamous NSCLC with activating EGFR mutations or ALK translocation are excluded. Patients will be randomized to receive 4 cycles of neoadjuvant atezo (1200 mg Q3W, Arm A) or placebo (Arm B) in combination with an investigator-selected PT-DC regimen. Following unblinding, patients in Arm A will receive adjuvant atezo treatment for ≤ 16 cycles or until disease recurrence or unacceptable toxicity, and patients in Arm B will receive best supportive care and scheduled observational follow-up. Endpoints will include major pathological response (≤ 10% residual viable tumour tissue at time of resection), investigator-assessed event-free survival and disease-free survival per RECIST v1.1, OS, ORR, pathological complete response and patient-reported outcomes. Exploratory biomarkers will also be evaluated.
d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification
NCT03456063.
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
S. Peters: Ad board, honoraria: Daiichi, Debiopharm, FoundMed, Janssen, Merrimack, PharmaMar, Regeneron, Sanofi, Seattle Genetics; Ad boad, honoraria, talk: Lilly, Takeda; Talk, honoraria, investigation in trials: AZ, BI, BMS, Clovis; Ad board, honoraria, talk, investigation in trials: Roche, Merck, Novartis, Pfizer; Ad board, honoraria, investigation in trials: Illumina. A.W. Kim: Full-time employee: University of Southern California; Advisory board: Medtronic, Genentech; Other (support of parent study, funding of editorial support): F. Hoffmann-La Roche. B. Solomon: Support of parent study, funding of editorial support: Roche. D.R. Gandara: Research grants: AstraZeneca, Genentech, Novartis, Merck; Consultant/Advisory board: AstraZeneca, Celgene, CellMax, Genentech, Guardant Health, Inivata, IO Biotech, Lilly, Liquid Genomics, Merck, Samsumg Bioepis; Parent study, medical writing support: Roche. R. Dziadziuszko: Advisor/Board member: Roche, Novartis, Pfizer, Boehringer Ingelheim, AstraZeneca, Bristol-Myers Squibb; Speaker’s Bureau: Roche, Pfizer, Foundation Medicine; Support of parent study, funding of editorial support: Roche. A. Brunelli: Support of parent study, funding of editorial support: F. Hoffmann-La Roche. M.C. Garassino: Grants/research support: MSD, BMS, AZ, Roche, Celgene, Medimmune; Advisory board/Speakers’ bureau: MSD, BMS, AZ, Roche, Celgene, Medimmune, Incyte, Ignyta; Other (support of parent study, funding of editorial support): Roche. 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. L. Wang, I. To, S.W. Sun, B.J. Gitlitz: Employee: Genentech; Other (support of parent study, funding of editorial support): Roche. A. Sandler: Employee: Genetech; Stock: Roche; Other (support of parent study, funding of editorial support): Roche. N. Rizvi: Consulting: AbbVie, AstraZeneca, BMS, EMD Sorono, Genentech, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron; Advisory boards: Bellicum, Brooklyn Immunotherapeutics, Neogenomics, Gritstone; Equity: Bellicum, Brooklyn Immunotherapeutics, Gritstone, ARMO Board of Director (2017-2018) with Stock options vested with company acquisition by Lilly (June 25, 2018); Royalties: Personal Genome Diagnostics: Royalties related to patent filed by MSKCC, Determinants of cancer response to immunotherapy (PCT/US2015/062208); Research funding: BMS, Merck; Institutional financial interests: Clinical research: AstraZeneca, BMS, Genentech, GSK, Merck, Regeneron.
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 | Presenting Author(s): Martin Reck
- 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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