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Denis Moro-Sibilot
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Mini Oral session II (ID 63)
- Event: ELCC 2019
- Type: Mini Oral session
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 4/11/2019, 16:40 - 17:40, Room C
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116O - Health-related quality of life (HRQoL) of non-small cell lung cancer (NSCLC) patients treated with nivolumab in real-life: The EVIDENS study (ID 271)
16:40 - 17:40 | Author(s): Denis Moro-Sibilot
- Abstract
- Presentation
Background
EVIDENS is an observational, prospective, multicenter cohort study following lung cancer patients initially treated with nivolumab between Oct 2016 and Nov 2017 in 146 French centers. Interim efficacy and safety results were consistent with those from nivolumab clinical trials. This analysis describes temporal changes in HRQoL.
a9ded1e5ce5d75814730bb4caaf49419 Methods
HRQoL was measured using the EQ-5D-3L, a 3-level version consisting of the 5 dimensions descriptive system (EQ-5D) and the visual analogue scale (VAS; 0–100 [worst–best health]). Outcomes for each dimension were described as the proportion of patients with no change, improvement or deterioration, and the utility index and VAS mean changes from baseline (minimally important difference [MID] = 0.08 and ±7 point change, respectively).
20c51b5f4e9aeb5334c90ff072e6f928 Results
Overall 1,394 NSCLC patients were followed-up for a median of 11.5 months. Baseline characteristics: median age 66.0 years, 69.2% men, 89.6% current/former smokers, 83.2% PS 0-1, 31.1% squamous (SQ) histology. Baseline completion rates for EQ-5D-3L/VAS were 80.2%/77.0%. At 9 and 12 months (276 and 78 patients at risk, respectively), they were 51.4%/48.9% and 69.2%/66.7%, respectively. The table summarizes HRQoL outcomes. Of note, mean change of VAS from baseline was statistically significant at 9 and 12 months regardless of histology and MID was achieved at 12 months for SQ (+7.6 [2.1 ; 13.1]).
fd69c5cf902969e6fb71d043085ddee6 Conclusions
Twelve months after initiating nivolumab, all the 5 dimensions measured by EQ-5D-3L were stable in at least half of NSCLC patients and a clinically meaningful improvement of VAS was observed in the SQ patients.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT03382496.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study
Bristol-Myers Squibb.
213f68309caaa4ccc14d5f99789640ad Funding
Bristol-Myers Squibb.
682889d0a1d3b50267a69346a750433d Disclosure
M. Pérol: Boards: Roche, Genentech, Eli Lilly, Pfizer, Boehringer Ingelheim, Clovis Onco, MSD, BMS, Novartis, Pierre Fabre, Takeda, AZ; Symposia: Eli Lilly, Roche, Pfizer, Amgen, Boehringer Ingelheim, BMS, Takeda, AstraZeneca. A. Dixmier: Advisory board: BMS, Roche, Novartis; Support for congress participation: BMS, Roche, AstraZeneca, Boehringer Ingelheim, MSD, Amgen, Lilly. F. Barlesi: Fees: AstraZeneca, BMS, Boehringer Ingelheim, Clovis Oncology, Eli Lilly Oncology, F. Hoffmann-La Roche Ltd, Novartis, Merck, MSD, Pierre Fabre, Pfizer, Takeda. D. Debieuvre: Consulting: Roche; Honoraria as speaker: AstraZeneca, Chugai, Lilly, Roche, Novartis, Pfizer, MSD, BMS; Grant for research: Roche, AstraZeneca, BMS, Boehringer Ingelheim, Chiesi, Chugai, Janssen, Pfizer, MSD, Novartis, GSK, Sandoz; Advisory boards : Roche, Boehringer Ingelheim, Pfizer, MSD, BMS, Novartis; Support for congress participation: Roche, Boehringer Ingelheim, Novartis, Pierre Fabre, Pfizer, Mundipharma, BMS. C. Raspaud: Fees: Novartis, Boehringer Ingelheim, GSK, Chiesi, BMS, MSD, AstraZeneca, SOSO2, AgirAdom, Lilly. J.B. Auliac: Advisory boards: AstraZeneca, Boehringer Ingelheim, BMS, Roche; Speakers bureau: AstraZeneca, Amgen, BMS, Roche, Lilly, Pfizer, MSD. N. Benoit : Fees: BMS, AstraZeneca. P. Bombaron: Fees: BMS, Novartis, Boehringer Ingelheim, Roche, Amgen. D. Moro-Sibilot: Fees: BMS, MSD, Roche, AstraZeneca, Pfizer, Lilly. B. Asselain: Speakers bureau: BMS. F-E. Cotté, P. Lamoureux, N. Karam, N. Ozan, C. Calvet, B. Bryan, V. Allan: Employee: BMS. C. Audigier Valette: Principal investigator : AstraZeneca, Boehringer Ingelheim, BMS, Novartis, Roche, MSD, Pfizer; Consulting: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, MSD, Pfizer, Roche AbbVie; Speaker: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Pfizer, Roche, MSD, AbbVie.
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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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): Denis Moro-Sibilot
- 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.
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.
