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M. Reck
Moderator of
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First line for non-oncogene addicted lung cancer (ID 4)
- Event: ELCC 2018
- Type: Educational session
- Track:
- Presentations: 4
- Moderators:M. Reck, S. Ramalingam
- Coordinates: 4/11/2018, 16:30 - 18:00, Room B
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First-line chemotherapy in NSCLC: Where do we stand? (ID 12)
16:30 - 18:00 | Presenting Author(s): R.A. Stahel
- Abstract
- Presentation
Abstract not provided
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First-line therapy in PS2 and elderly patients: Any new signals? (ID 14)
16:30 - 18:00 | Presenting Author(s): E. Quoix
- Abstract
- Presentation
Abstract not provided
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First-line therapy: What might we expect for the future? (ID 15)
16:30 - 18:00 | Presenting Author(s): G. Scagliotti
- Abstract
Abstract not provided
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Immunotherapy in the first-line setting: What have we achieved? (ID 13)
16:30 - 18:00 | Presenting Author(s): M. Reck
- Abstract
- Presentation
Abstract not provided
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Keynote lecture (ID 26)
- Event: ELCC 2018
- Type: Keynote Lecture
- Track:
- Presentations: 1
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Predictive biomarkers for immune checkpoints inhibitors (ID 108)
14:10 - 14:40 | Presenting Author(s): O. Michielin
- Abstract
- Presentation
Abstract not provided
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Author of
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First line for non-oncogene addicted lung cancer (ID 4)
- Event: ELCC 2018
- Type: Educational session
- Track:
- Presentations: 1
- Moderators:M. Reck, S. Ramalingam
- Coordinates: 4/11/2018, 16:30 - 18:00, Room B
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Immunotherapy in the first-line setting: What have we achieved? (ID 13)
16:30 - 18:00 | Presenting Author(s): M. Reck
- Abstract
- Presentation
Abstract not provided
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Immunotherapy and next-generation TKIs: From second to frontline treatment (ID 55)
- Event: ELCC 2018
- Type: Poster Discussion session
- Track:
- Presentations: 1
- Moderators:P. Garrido Lopez, S. Ekman, S. Ortiz-Cuaran, E. Wauters
- Coordinates: 4/12/2018, 07:45 - 09:00, Room A
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134PD - Primary PFS and safety analyses of a randomized phase III study of carboplatin + paclitaxel +/− bevacizumab, with or without atezolizumab in 1L non-squamous metastatic NSCLC (IMpower150) (ID 469)
07:45 - 09:00 | Presenting Author(s): M. Reck
- Abstract
Background:
Atezolizumab (atezo; anti–PD-L1) inhibits PD-L1 binding to PD-1 and B7.1, restoring anti-cancer immunity. Bevacizumab (bev) may further enhance atezo efficacy by inhibiting VEGF immunosuppression and promoting T-cell tumour infiltration. IMpower150 evaluates the addition of atezo to carboplatin (C) + paclitaxel (P) ± bev in chemo-naive patients (pts) with non-squamous (NSQ) mNSCLC.
Methods:
1202 pts received atezo 1200 mg + C AUC 6 + P 200 mg/m[2] (Arm A) or atezo + bev 15 mg/kg + C + P (Arm B) vs bev + C + P (Arm C) IV q3w for 4 or 6 cycles per investigator (INV) discretion, then maintenance atezo, atezo + bev or bev, respectively. Co-primary endpoints assessed at this data cutoff (15 Sep 2017; minimum follow up, 9.5 mo) were INV-assessed PFS in the ITT-WT (EGFR or ALK negative) population and in WT pts with expression of a tumour T-effector gene signature (Teff-WT; centrally assessed), and OS in the ITT-WT population, for the Arm B vs Arm C comparison. Due to pre-specified statistical testing hierarchy, Arm A vs Arm C has not been formally tested yet.
Results:
356 pts in Arm B and 336 pts in Arm C were enrolled in the ITT-WT. Median age was 63 y; 60% were previous smokers (both arms). 61% and 62% were male, and 39% and 43% had ECOG PS 0 in Arms B and C, respectively. The HRs for INV-assessed PFS in Arm B vs C were 0.62 (95% CI: 0.52, 0.74; P < 0.0001) in the ITT-WT and 0.51 (0.38, 0.68; P < 0.0001) in the Teff-WT populations. Median PFS in Arm B vs C was 8.3 mo vs 6.8 mo and 11.3 mo vs 6.8 mo in the ITT-WT and Teff-WT populations, respectively. PFS benefit was seen regardless of PD-L1 IHC status, including PD-L1–negative pts (TC0/IC0; HR, 0.77 [95% CI: 0.61, 0.99]). Landmark PFS and ORR are shown (Table). Arm B had a comparable safety profile to Arm C; treatment-related serious AEs were 25% vs 19%, respectively.Table:IMpower150 Primary PFS Analysis, Landmark PFS and ORR
HR, hazard ratio; ORR, objective response rate; PFS, progression-free survival; Teff, T-effector; WT, wild-type.aWT populations exclude patients with EGFR or ALK driver mutations.bUnconfirmed ORR.cn = 353 in Arm B and n = 331 in Arm C.dn = 153 in Arm B and n = 127 in Arm C.Arm C (bev + C + P; N = 400) Arm B (atezo + bev + C + P; N = 400) ITT-WT population[a] n = 336 n = 356 Median PFS (95% CI), mo 6.8 (6.0, 7.1) 8.3 (7.7, 9.8) HR (95% CI; P value) 0.62 (0.52, 0.74; P < 0.0001) ITT-WT landmark PFS (95% CI), % 6-month 56% (51, 62) 67% (62, 72) 12-month 18% (13, 23) 37% (31, 42) ORR[b,c] (95% CI), % 48% (43, 54) 64% (58, 68) Teff-WT population[a] n = 129 n = 155 Median PFS (95% CI), mo 6.8 (5.9, 7.4) 11.3 (9.1, 13.0) HR (95% CI; P value) 0.51 (0.38, 0.68; P < 0.0001) Teff-WT landmark PFS (95% CI), % 6-month 57% (48, 66) 72% (65, 79) 12-month 18% (10, 25) 46% (38, 54) ORR[b,d] (95% CI), % 54% (44, 62) 69% (61, 76)
Conclusions:
IMpower150 is the first Phase III study to show a statistically significant and clinically meaningful PFS benefit with atezo + bev + chemo vs bev + chemo in pts with 1L NSQ mNSCLC. Acknowledgement of contribution: G. Finley (Allegheny Cancer Center, Pittsburgh, PA, USA), R. Jotte (Rocky Mountain Cancer Centers, Denver, CO, USA), C. Kelsch, A. Lee, S. Coleman, Y. Shen, M. Kowanetz, A. Lopez-Chavez, A. Sandler (Genentech, Inc., South San Francisco, CA, USA).
Clinical trial identification:
NCT02366143
Legal entity responsible for the study:
F. Hoffmann-La Roche Ltd/Genentech, Inc
Funding:
F. Hoffmann-La Roche Ltd/Genentech, Inc
Disclosure:
M. Reck: Consulting or Advisory Role: Lilly, F.Hoffmann‐La Roche, BI, BMS, MSD, AstraZeneca, Merck, Novartis, Pfizer, Celgene. Speakers’ Bureau: F. Hoffmann‐La Roche, Lilly, Pfizer, BI, AstraZeneca, MSD, BMS, Merck, Novartis, Pfizer, Celgene. M. A. Socinski: Honoraria: Genentech, Speakers Bureau: Genentech, Research Funding: Genentech. F. Cappuzzo: Participation in advisory boards for Roche, AZ, BMS, Takeda, MSD, Lilly, Pfizer. F. Orlandi: Research grants from Astrazeneca, MSD, Genetech-Roche, Advisory tasks for AstraZeneca, Roche, Boehringer Ingelheim, Pfizer. N. Nogami: Honoraria: Meiji Seika Pharma Co., Ltd., AstraZeneca, Pfizer Inc., Bristol‐Myers Squibb, ONO Pharmaceutical CO., LTD., Kyowa Hakko Kirin, Taiho Phamaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd, Eli Lilly Japan, Boehringer Ingelheim. D. Rodríguez-Abreu: Honoraria for lectures and Advisory Board from Bristol-Myers-Squibb, Merck Sharp & Dohme and Hoffmann-La Roche. D. Moro-Sibilot: Advisory boards for Roche, MSD, Pfizer, Novartis, BMS, Astra Zeneca, Lilly. F. Barlesi: Honarium from Genentech & Roche. G. Finley: Promotional speaking on behalf of Bristol Meyers, Boehringer Ingleheim, and Astellas Medivation, and Merck. C. Kelsch: Genentech Employee with Roche Stock. A. Lee: Genentech Employee with Roche Stock. S. Coleman: Genentech Employee with Roche Stock. Y. Shen: Genentech Employee with Roche Stock. M. Kowanetz: Genentech Employee with Roche Stock. A. Lopez-Chavez: Genentech Employee with Roche Stock. A. Sandler: Genentech Employee with Roche Stock. All other authors have declared no conflicts of interest.
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New approaches in rare thoracic tumors (ID 60)
- Event: ELCC 2018
- Type: Proffered Paper session
- Track:
- Presentations: 1
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213O - Nintedanib + pemetrexed/cisplatin in malignant pleural mesothelioma (MPM): Phase II biomarker data from the LUME Meso study (ID 206)
11:00 - 12:30 | Author(s): M. Reck
- Abstract
- Presentation
Background:
The randomised Phase II/III LUME-Meso study is evaluating nintedanib + pemetrexed/cisplatin versus placebo + pemetrexed/cisplatin (≤6 cycles), followed by nintedanib or placebo maintenance, in chemo-naïve MPM. In the Phase II part, nintedanib treatment led to improved progression-free survival (PFS; hazard ratio [HR] = 0.54; p = 0.010) and a trend for longer overall survival (OS; HR = 0.77; p = 0.319) compared with placebo. Patients with epithelioid tumours derived greatest benefit. Plasma angiogenic factors and genomic markers were explored for potential associations with treatment outcome in the Phase II epithelioid population.
Methods:
Baseline plasma levels of 58 angiogenic factors were analysed by multiplex immunoassay (Human AngiogenesisMAP®, Myriad RBM). Genes implicated in the nintedanib mode of action and/or mesothelioma pathophysiology (VEGFR1, VEGFR3 and mesothelin) were evaluated for known single-nucleotide polymorphisms (SNPs). Biomarker associations with PFS/OS treatment effects were analysed by Cox regression and interaction tests with false-discovery rate (FDR) adjustment. Analyses were exploratory and hypothesis generating.
Results:
Angiogenic factor and genomic data were available for 71 and 67 patients, respectively, in the epithelioid population (n = 77). Of the angiogenic factors evaluated, only endoglin showed a possible trend for association with both PFS and OS improvement, with potentially greater benefit in patients with low plasma levels. Major homozygous genotypes for two VEGFR3 SNPs (rs307821 G/G and rs307826 A/A) showed weak association with OS effect, while the VEGFR1 SNP rs9582036 A/A genotype was potentially correlated with PFS benefit. However, all biomarker treatment associations were limited by small subgroup size (especially for minor genotypes) and FDR-adjusted interaction tests were not significant.
Conclusions:
These first biomarker results for nintedanib-treated MPM showed potential signals for greater PFS/OS benefits in patients with low plasma endoglin and major homozygous VEGFR1/3 genotypes, but no biomarkers showed clear and significant association with nintedanib efficacy.
Clinical trial identification:
NCT01907100
Legal entity responsible for the study:
Boehringer Ingelheim
Funding:
Boehringer Ingelheim
Disclosure:
N. Pavlakis: Advisory Boards: Boehringer Ingelheim, MSD, Merck, BMS, Astra Zeneca, Takeda, Bayer, Novartis, Pfizer, Roche, Ipsen Speaking Honoraria: Boehringer Ingelheim, Bayer, Novartis, Pfizer, Roche Travel Support: BMS, Astra Zeneca, Roche. N. Steele: Honoraria: Pfizer, Novartis Consulting/advisory role: MSD, Boehringer Ingelheim, BMS Research funding: Merck Serono, AstraZeneca, Boehringer Ingelheim, BMS, Novartis, Roche Travel, accommodation, expenses: Pfizer, MSD Oncology, Boehringer Ingelheim. A. Nowak: Consulting/ Advisory Role: Aduro Biotech, Morphotek, Bayer, AstraZeneca, Sellas Life Sciences, Trizell, Boehringer Ingelheim, Epizyme, Roche Research Funding: Boehringer Ingelheim, AstraZeneca Travel and expenses: Amgen, AstraZeneca, Boehringer Ingelheim. S. Novello: Speakers’ Bureau: AstraZeneca, MSD, Bristol-Myers Squibb, Roche, Pfizer, Eli Lilly. S. Popat: Honoraria: Pfizer, Boehringer Ingelheim, Eli Lilly, AstraZeneca, Novartis, Roche Consulting/advisory role: Boehringer Ingelheim, Eli Lilly, Pfizer, Novartis, Roche Research funding: Boehringer Ingelheim, Epizyme, BMS, Clovis Oncology, Eli Lilly, Roche. L. Greillier: Honoraria: Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca, Novartis Pharma, Roche Consulting/advisory role: Boehringer Ingelheim, Bristol-Myers Squibb, Roche Research funding: Roche. M. Reck: Honoraria: Boehringer Ingelheim, Proacta, BMS, MSD, Pfizer, Eli Lilly, AstraZeneca, Merck Inc., Celgene, Novartis Consulting/advisory role: Boehringer Ingelheim, Eli Lilly, BMS, MSD, Pfizer, AstraZeneca, Merck Inc., Celgene, Novartis, Roche Speaker's bureau: Roche, Eli Lilly, MSD Oncology, Merck, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Pfizer, Novartis. T. Kitzing: Employment: Boehringer Ingelheim. G. Scagliotti: Honoraria: Eli Lilly, Pfizer, MSD, AstraZeneca, Roche Consulting/Advisory role: Eli Lilly Speakers’ Bureau: Eli Lilly, MSD. All other authors have declared no conflicts of interest.
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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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188P - Treatment switching–adjusted overall survival (OS) in KEYNOTE-024: First-line pembrolizumab versus chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) (ID 622)
12:30 - 13:00 | Presenting Author(s): M. Reck
- Abstract
Background:
In KEYNOTE-024, pembrolizumab was superior to chemotherapy for advanced untreated NSCLC with PD-L1 tumor proportion score (TPS) ≥50% and no sensitizing EGFR mutations/ALK translocations. We present OS adjusted for the potential bias introduced by switching treatment from chemotherapy to pembrolizumab after a median of 25.2 months of follow-up.
Methods:
Patients were randomized to pembrolizumab 200 mg every 3 weeks or investigator-choice platinum-doublet chemotherapy with optional pemetrexed maintenance for patients with nonsquamous histology. Patients in the chemotherapy arm could switch to pembrolizumab (prior to the second interim analysis that revealed superiority, only patients with progressive disease confirmed by blinded, independent central radiology review were eligible). Three statistical methods were applied to adjust for treatment switching: the simplified 2-stage method, the rank preserving structural failure time (RPSFT) method, and the inverse probability of censoring weighting (IPCW) method.
Results:
305 patients were randomized; all but 1 patient in the chemotherapy arm received protocol-specified treatment. 82 (54%) patients had switched from chemotherapy to pembrolizumab per protocol. OS results per the intent-to-treat (ITT) analysis and the 3 adjustment methods are listed in the Table. The 3 methods adjusting for treatment switching in the chemotherapy arm provided larger treatment estimates (lower HRs) than the ITT estimate. As there was some evidence towards a deviation from the common treatment effect assumed in the RPSFT method, and the IPCW method is more prone to bias in the presence of relatively small sample sizes, the simplified 2-stage method was the favored method in this study. Results obtained with the RPSFT and IPCW methods were consistent with those from the 2-stage analyses.Table: (Abstract: 188P)Treatment switching–adjusted OS in KEYNOTE-024 after median follow-up of 25.2 monthsMedian OS, months (95% CI) Pembrolizumab(n = 154) Chemotherapy(n = 151) HR (95% CI) ITT analysis 30.0 (18.3–not reached) 14.2 (9.8–19.0) 0.63 (0.47–0.86) 2-sided log-rank P = 0.003 2-stage method N/A 8.7 (7.3–11.5) 0.49 (0.34–0.69) RPSFT method N/A 11.8 (8.7–not reached) 0.52 (0.33–0.75) IPCW method N/A 11.8 (8.7–21.3) 0.52 (0.33–0.80)
Conclusions:
In this study, pembrolizumab demonstrated an OS advantage compared to chemotherapy as first-line therapy, which becomes more pronounced when utilizing treatment switching analyses that adjust for bias introduced when switching from chemotherapy to pembrolizumab. Pembrolizumab remains a standard-of-care first-line therapy for patients with advanced NSCLC expressing PD-L1 TPS ≥50%.
Clinical trial identification:
NCT02142738
Legal entity responsible for the study:
Merck & Co., Inc., Kenilworth, NJ, USA
Funding:
This study and medical writing assistance were funded by Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure:
M. Reck: Advisory board member for Roche, Lilly, AstraZeneca, BMS, MSD, Merck, Boehringer-Ingelheim, Celgene, Pfizer, and Novartis; Speakers’ bureaus for Roche, Lilly, AstraZeneca, BMS, MSD, Merck, Boehringer-Ingelheim, Celgene, Pfizer, and Novartis; Research funding from Boehringer-Ingelheim. A.G. Robinson: Honoraria from Merck & Co., Inc., Kenilworth, NJ; his institution has received research funding from AstraZeneca, Merck & Co., Inc. (Kenilworth, NJ USA), Bristol-Myers Squibb, and Roche Canada. R. Hui: Honoraria from MSD, BMS, AstraZeneca, Boehringer-Ingelheim, and Pfizer; Consulting or Advisory role for MSD, AstraZeneca, Pfizer, and Novartis. K. Vandormael: Employee of MSD Europe. W. Malbecq: Employee of and owns stock in MSD Europe. M.C. Pietanza: Employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA. J. Brahmer: Advisory board member for BMS (uncompensated), Celgene, Eli Lilly, Merck; Research funding from BMS, MedImmune/AstraZeneca, Merck. All other authors have declared no conflicts of interest.
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194TiP - eXalt3: Phase 3 randomized study comparing ensartinib to crizotinib in anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) patients (ID 644)
12:30 - 13:00 | Author(s): M. Reck
- Abstract
Background:
Ensartinib (X-396) is a novel, potent ALK small molecule tyrosine kinase inhibitor (TKI) with additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1 and SLK. Ensartinib is well-tolerated and has shown promising activity in NSCLC patients in a phase 1/2 study in patients that were both ALK TKI naïve and patients that received prior crizotinib, as well as those with CNS metastases. The safety profile of ensartinib appears to be different than other ALK TKIs.
Trial design:
In this global, phase 3, open-label, randomized study, approximately 270 patients with ALK+ NSCLC who have received no prior ALK TKI and up to one prior chemotherapy regimen will be randomized with stratification by prior chemotherapy (0/1), performance status (0 − 1/2), brain metastases at screening (absence/presence), and geographic region (Asia/other), to receive oral ensartinib (225 mg, once daily) or crizotinib (250 mg, twice daily) until disease progression or intolerable toxicity.Eligibility also includes patients ≥ 18 years of age, stage IIIB or IV ALK+ NSCLC. Patients are required to have measurable disease per RECIST 1.1, adequate organ function, and an ECOG PS of ≤ 2. Adequate tumor tissue (archival or fresh biopsy) must be available for central testing. The primary endpoint is progression-free survival assessed by independent radiology review based on RECIST v. 1.1 criteria. Secondary efficacy endpoints include overall survival, response rates (overall and central nervous system [CNS]), PFS by investigator assessment, time to response, duration of response, and time to CNS progression. The study has > 80% power to detect a superior effect of ensartinib over crizotinib in PFS at a 2-sided alpha level of 0.05.Phase 3 recruitment began in June, 2016 and currently has 98 active sites in 20 countries. The duration of recruitment will be approximately 24 months.
Clinical trial identification:
NCT02767804
Legal entity responsible for the study:
Xcovery Holding Corporation
Funding:
Betta Pharmaceuticals
Disclosure:
L. Horn: Consulting for Xcovery Holding Company, BMS, BI, Abbvie, Genentech, Merck. Y-L. Wu: Speaker fees from AstraZeneca, Roche, Eli Lily. M. Reck: Honoraria for lectures and consultancy: Hoffman-La Roche, Lily, BMS, MSD, AstraZeneca, Merck, Celgene, Boehringer-Ingelheim, Pfizer, Novartis. C. Liang, K. Harrow, V. Oertel, G. Dukart: Full-Time Employee: Xcovery Holding Corporation, F. Tan: Manager: Xcovery Holding Company Chief Medical Officer: Betta Pharmaceuticals. T.S.K. Mok: Grant/Research Support from AstraZeneca, BI, Pfizer, Novartis, SFJ, Roche, MSD, Clovis Oncology, BMS, Eisai, Taiho; Speaker's fees with: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, MSD, Novartis, BMS, Taiho; Major Stock Shareholder in: Sanomics Ltd.; Advisory Board for: AstraZeneca, Roche/Genentech, Pfizer, Eli Lilly, BI, Clovis Oncology, Merck Serono, MSD, Novartis, SFJ Pharmaceutical, ACEA Biosciences, Inc., Vertex Pharmaceuticals, BMS, geneDecode Co., Ltd., OncoGenex Technologies Inc., Celgene, Ignyta, Inc.; Board of Directors: IASLC, Chinese Lung Cancer Research Foundation Ltd., Chinese Society of Clinical Oncology (CSCO), Hong Kong Cancer Therapy Society (HKCTS).
