LBA58 - Results of the randomized, placebo (PL)-controlled phase II study evaluating the efficacy and safety of regorafenib (REGO) in patients (pts) with relapsed advanced or metastatic chordoma, on behalf of the French Sarcoma Group (FSG) and Unicancer
- Florence Duffaud (Marseille, CEDEX 5, France)
Abstract
Background
REGOBONE is a non-comparative phase 2, double-blind, PL-controlled trial designed to evaluate the activity and safety of REGO, in 5 independent cohorts of sarcomas originating in bone. We report here the chordoma cohort results.
Methods
Eligibility criteria included histologically centrally confirmed diagnosis of chordoma, age ≥18 years, confirmed measurable progressive disease (PD) not amenable to curative-intent, with ≤ 2 prior lines of treatment, and ECOG 0-1. Eligible pts were randomized (2:1) to receive either REGO (160 mg/d, 21/28 d) or PL with optional cross-over at the time of centrally confirmed progressive disease (PD). 18 pts were planned in the REG arm to detect a 35% improvement (1-sided a=0.05, and 80% power) in the Progression-Free Rate (PFR) at 6 months (P0=40%), by central review per RECIST1.1. Main secondary endpoints were PFS, Response Rate, OS and safety.
Results
From March 2016 to February 2020, 27 chordoma pts were enrolled. Of 23 efficacy-evaluable pts (7 in PL arm and 16 in REG arm); 16 were men, median age was 66 (32-85) years. At 6 months, in REGO arm; one pt was not evaluable, 6/15 were non-progressive (PFR: 40.0%; one-sided CI95% = [19.1-[), and 4/15 discontinued REGO due to toxicity; and in PL arm; 2/5 were non-progressive (PFR: 40.0%; CI95% = [7.6-[), 2 pts were non evaluable. Median PFS was 8.2 (CI95% = 4.5-12.9) vs. 10.1 (CI95%= 0.8-NE) months for REGO and PL arms respectively. Median OS was 28.3 months on REGO but not reached in PL arm. Four out of 7 pts crossed-over to REGO after centrally-confirmed PD on PL. Of the 25 safety-evaluable pts, the most common ≥ Gr3 REGO-related AEs during the double blind period were hand-foot skin reaction (22%), hypertension (17%) and diarrhea (17%), with no toxic death.
Conclusions
This randomized non comparative study failed to show any signal of benefit for REGO in pts with advanced/metastatic incurable chordoma, with toxicities in REGO arm leading to early treatment discontinuation in this small group of patients.
Clinical trial identification
EudraCT 2013-003910-42; NCT02389244.
Legal entity responsible for the study
Unicancer.
Funding
Bayer.
Disclosure
F. Duffaud: Other, Attending oncology meetings: Léo Pharma; Other, Invited Speaker, Attenting to meetings (ESMO and ASCO meetings): PharmaMar. C.M. Chevreau: Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: LEO; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Ipsen; Financial Interests, Institutional, Principal Investigator: Karyopharm; Financial Interests, Institutional, Principal Investigator: Exelisis. A. Italiano: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Chugai; Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Advisory Board: Philips; Financial Interests, Personal, Advisory Board: Roche; Non-Financial Interests, Institutional, Principal Investigator: AstraZeneca; Non-Financial Interests, Institutional, Principal Investigator: Bayer; Non-Financial Interests, Institutional, Principal Investigator: Ipsen; Non-Financial Interests, Institutional, Principal Investigator: Merck; Non-Financial Interests, Institutional, Principal Investigator: MSD; Non-Financial Interests, Institutional, Principal Investigator: Roche. C. Perrin: Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Pfizer; Non-Financial Interests, Personal, Invited Speaker: Novartis; Non-Financial Interests, Personal, Invited Speaker: Pfizer; Non-Financial Interests, Personal, Invited Speaker: Roche. S. Piperno-Neumann: Financial Interests, Personal, Advisory Board: Immunocore. E. Kalbacher: Financial Interests, Institutional, Advisory Role: GSK Tesaro; Financial Interests, Institutional, Advisory Role: AstraZeneca; Financial Interests, Institutional, Advisory Role: Pharmamar; Financial Interests, Institutional, Advisory Role: Roche; Financial Interests, Institutional, Advisory Role: Leopharma; Financial Interests, Institutional, Advisory Role: Bayer; Financial Interests, Institutional, Advisory Role: Sanofi. J. Blay: Financial Interests, Personal, Leadership Role, Supervisory Board: Innate Pharma; Financial Interests, Personal, Other, Honoraria: Bayer; Financial Interests, Personal, Other, Honoraria: Roche; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: Deciphera; Financial Interests, Personal, Other, Honoraria: Pfizer; Financial Interests, Institutional, Other, Honoraria: Novartis; Financial Interests, Institutional, Other, Honoraria: Bayer; Financial Interests, Institutional, Other, Honoraria: Pfizer; Financial Interests, Institutional, Other, Honoraria: Deciphar; Financial Interests, Institutional, Other, Honoraria: Roche; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: GSK; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Deciphera; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: GSK; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Deciphera; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Personal, Research Grant, Medical writing: F Hoffmann-La Roche Ltd. O. Mir: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Blueprint Medecines; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Eli-Lilly; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Servier; Financial Interests, Institutional, Other, Local PI: Bayer; Financial Interests, Institutional, Other, Local PI: Blueprint Medecines; Financial Interests, Institutional, Other, Local PI: Eli Lilly; Financial Interests, Institutional, Other, Local PI: Epizyme. All other authors have declared no conflicts of interest.
LBA59 - LMS-04 study: A randomised, multicenter, phase III study comparing doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin in non-progressive patients as first-line therapy, in patients with metastatic or unresectable leiomyosarcoma - A French Sarcoma Group study
- Patricia Pautier (Villejuif, CEDEX, France)
Abstract
Background
Doxorubicin (Dox) alone remains the standard 1st-line treatment for unresectable or metastatic (met) leiomyosarcoma (LMS). The LMS02 study reported very encouraging results of a doxorubicin + trabectedin (Dox+Trab) combination in 1st-line therapy for met LMS with median progression-free survival (PFS) of 10.1 months (mo), and median overall survival (OS) of 34.4 mo.
Methods
The LMS-04 trial compared, as 1st-line treatment for patients (pts) with met or unresectable LMS, up to 6 cycles (cy) of Dox (75 mg/m2) (arm A)
Results
Between January 2017 and March 2019, 150 pts with LMS (U-LMS: n=67; ST-LMS: n=83) with a median age of 61 years (range 30-86) and mostly metastatic diseases (90%) were enrolled: 76 in arm A and 74 in arm B. Median follow-up in August 2021 was 37 months (mo); 74% of arm B pts received at least 1 cy of Trab in maintenance. Grade 3-4 toxicities were reported in 46% of arm A pts
Conclusions
Dox+Trab combination in 1st-line therapy increases significantly the PFS of met LMS compared to Dox alone, though at the cost of additional expected and manageable toxicity. Benefit in ORR and OS is also observed.
Clinical trial identification
NCT02997358.
Legal entity responsible for the study
Institut Gustave-Roussy.
Funding
PharmaMar.
Disclosure
P. Pautier: Financial Interests, Personal, Advisory Board, 2015: PharmaMar; Financial Interests, Institutional, Advisory Board, 2020: Roche; Financial Interests, Institutional, Advisory Board, 2021: AstraZeneca; Financial Interests, Personal, Advisory Board, 2019-2020: AstraZeneca; Financial Interests, Institutional, Advisory Board, 2020: Clovis; Financial Interests, Institutional, Advisory Board: GSK; Financial Interests, Personal, Advisory Board, 2018-2019: Roche. S. Piperno-Neumann: Non-Financial Interests, Personal, Other, travel grantsnts: PharmaMar; Financial Interests, Personal, Advisory Board: ImmunoCore. C.M. Chevreau: Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: LEO; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Ipsen; Financial Interests, Institutional, Research Grant: Karyopharm; Financial Interests, Institutional, Research Grant: Exelixis. N. Penel: Financial Interests, Institutional, Research Grant: Bayer HealthCare. P. Boudou Rouquette: Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Personal, Advisory Board: BMS; Other, Personal, Other, Travel fees: Takeda. C. Balleyguier: Financial Interests, Personal, Other, radiological review: EISAI; Financial Interests, Personal, Other, radiological review: Bracco; Financial Interests, Personal, Other, radiological review: GE Healthcare; Financial Interests, Personal, Other, radiological review: Samsung. J. Blay: Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Institutional, Research Grant: PharmMar. E. Kalbacher: Financial Interests, Institutional, Advisory Board: GSK-Tesaro; Non-Financial Interests, Other, travel grantsnts: GSK-Tesaro; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Advisory Board: PharmaMar; Financial Interests, Institutional, Advisory Board: Roche; Financial Interests, Institutional, Advisory Board: LeoPharma; Financial Interests, Institutional, Advisory Board: Bayer; Financial Interests, Institutional, Advisory Board: Sanofi. F. Duffaud: Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Advisory Board: Roche; Other, Personal, Other, Attending to oncology meeting: LeoPharma; Other, Personal, Other, Attending to oncology meeting: PharmaMar. All other authors have declared no conflicts of interest.
Invited Discussant LBA58 and LBA59
- Robin L. Jones (London, United Kingdom)
Q&A and live discussion
- Robin L. Jones (London, WA, United Kingdom)
1520O - REGISTRI: Regorafenib in first-line of KIT/PDGFR wild type advanced GIST: Capatalize the A Spanish (GEIS), Italian (ISG) and French Sarcoma Group (FSG) phase II trial
- Javier Martin-Broto (Madrid, Spain)
Abstract
Background
Around 15% of adult GIST are wild type for
Methods
Patients (pts) >18, with advanced non pretreated KPWT GIST were eligible after central confirmation by next-generation sequencing (NGS). Eligible pts received RE at 160mg/d for 21/28d cycles. Primary end-point was disease control rate (DCR) at 12 weeks (RECIST 1.1 ) by central radiological assessment (CRA). Secondary objectives were PFS, OS, ORR (RECIST,Choi), safety and QoL. An amendment allowed previous IM (adjuvant). Statistical assumptions [H0 73% and H1 90% (α 0.1 and β 0.2)], defined a sample size of 20 pts.
Results
From May 2016 to October 2020, 30pts with KPWT GIST (by Sanger) underwent central molecular screening. Among the 15 non-eligible pts, 8 harbored KIT exon 11 mutations, 3 exon 9 and 3 PDGFRA exon 18 by NGS. The remaining 16 (53.3%) molecularly eligible pts were enrolled and started RE except one pt due to COVID-19 pandemic. The trial was prematurely closed due to low recruitment, especially after COVID outbreak. Demographics and treatment details in the table. Based on CRA, 12w-DCR was 86.7%. With a median (m) FU of 26 (5-44) months (mo), 10/15 pts progressed, with a mPFS of 10.8 mo (95% CI 6.9-14.8). 6 mo, 9 mo and 12 mo PFS rates were 65%, 48% and 29% respectively. 2 pts were PD-free at 25 and 43 mo from start of RE. 6/15 pts died, with a mOS of 33.5 mo (95% CI NR).
CHARACTERISTIC n (%) Age, median (range) 57 (17-72) Gender Female Male 8 (53) 7 (47) SDH complex activity Preserved Deficient Not evaluable 3 (20) 10 (66) 2 (13) Stage at treatment initiation Locally advanced unresectable Metastasic 2 (13) 13 (87) Previous imatinib Yes No 5 (33) 10 (66) Median cycles of regorafenib (range) 7.8 (0.3-39) Treatment reductions No Yes 7 (47) 8 (53) Treatment interruptions No Yes 1 (7) 14 (93) G3-4 toxicities GOT/GPT increase Palmo-plantar erythrodysesthesia Skin disorders Anemia Diarrhea Hypertension Pruritus 3 (20) 2 (13) 2 (13) 1 (7) 1 (7) 1 (7) 1 (7) Best RECIST response CR PR SD PD NE 0 1 (7) 12 (84) 1 (7) 1 (7)
Conclusions
The study results approach the prespecified activity threshold. The low recruitment rate could have affected this attainment. Other analysis of secondary endpoints are ongoing. The high percentage of overlooked mutant GIST by Sanger raises the need of NGS in presumed KPWT GIST.
Clinical trial identification
NCT02638766.
Legal entity responsible for the study
Spanish Group for Research on Sarcoma (GEIS).
Funding
Bayer.
Disclosure
J. Martin Broto: Financial Interests, Personal, Expert Testimony, Honoraria: Lilly; Financial Interests, Personal, Expert Testimony, Honoraria: PharmaMar; Financial Interests, Personal, Expert Testimony, Honoraria: Eisai; Financial Interests, Personal, Expert Testimony, Honoraria: Bayer; Financial Interests, Personal, Invited Speaker: PharmaMar; Financial Interests, Institutional, Invited Speaker: PharmaMar; Financial Interests, Institutional, Invited Speaker: Eisai; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: IMMIX Biopharma; Financial Interests, Institutional, Invited Speaker: Lixte; Financial Interests, Institutional, Invited Speaker: Karyopharm; Financial Interests, Institutional, Invited Speaker: Bayer; Financial Interests, Institutional, Invited Speaker: Celgene; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: BMS; Financial Interests, Institutional, Invited Speaker: Blueprint; Financial Interests, Institutional, Invited Speaker: Deciphera; Financial Interests, Institutional, Invited Speaker: Nektar; Financial Interests, Institutional, Invited Speaker: FORMA; Financial Interests, Institutional, Invited Speaker: Amgen; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: Lilly; Financial Interests, Institutional, Invited Speaker: AROG; Financial Interests, Institutional, Invited Speaker: Adaptimmune; Financial Interests, Institutional, Invited Speaker: GSK. N. Hindi: Financial Interests, Personal, Invited Speaker: PharmaMar; Financial Interests, Personal, Advisory Board: PharmaMar; Financial Interests, Institutional, Research Grant: PharmaMar; Financial Interests, Institutional, Sponsor/Funding: PharmaMar; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Immix Bio; Financial Interests, Institutional, Sponsor/Funding: Bayer; Financial Interests, Institutional, Sponsor/Funding: Deciphera; Financial Interests, Institutional, Sponsor/Funding: Daychii; Financial Interests, Institutional, Sponsor/Funding: Blueprint; Financial Interests, Institutional, Sponsor/Funding: Adaptimmune; Financial Interests, Institutional, Sponsor/Funding: GSK; Financial Interests, Institutional, Sponsor/Funding: Karyopharm; Financial Interests, Institutional, Sponsor/Funding: Celgene; Financial Interests, Institutional, Sponsor/Funding: AROG. J. Lavernia: Financial Interests, Personal, Invited Speaker: PharmaMar; Financial Interests, Personal, Invited Speaker: BMS. C. Serrano: Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Institutional, Research Grant: Bayer. D. Moura: Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: PharmaMar; Financial Interests, Institutional, Research Grant: Immix Bio. J. Blay: Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Research Grant: Deciphera; Financial Interests, Personal, Research Grant: Deciphera. E.R. Fumagalli: Financial Interests, Institutional, Research Grant: Bayer. All other authors have declared no conflicts of interest.
1521O - A phase II biomarker-driven study evaluating the clinical efficacy of an MDM2 inhibitor, milademetan, in patients with intimal sarcoma, an ultra-rare cancer with highly life-threatening unmet medical needs (NCCH1806/MK004)
- Yuki Kojima (Chuo-ku, Aichi, Japan)
Abstract
Background
Intimal sarcoma is an ultra-rare, high-grade malignant neoplasm arising in the intima of large blood vessels, most frequently the pulmonary arteries and aorta. As murine double minute 2 (
Methods
Between December 2018, and January 2021, we conducted an open-label phase 2 trial in patients with
Results
A total of 11 patients, age: 20-72 (median:33.0), were enrolled and treated. One patient was excluded from response assessment due to detection of
Conclusions
Milademetan showed acceptable safety profile with some clinical activity in patients with intimal sarcoma with
Clinical trial identification
JMA-IIA00402.
Legal entity responsible for the study
The authors.
Funding
Daiichi Sankyo.
Disclosure
T. Shimizu: Financial Interests, Personal, Speaker’s Bureau: AbbVie; Financial Interests, Personal, Speaker’s Bureau: Daiichi-Sankyo; Financial Interests, Personal, Speaker’s Bureau: Eisai; Financial Interests, Personal, Speaker’s Bureau: Takeda Oncology; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Advisory Board: Daiichi-Sankyo; Financial Interests, Personal, Advisory Board: AbbVie; Financial Interests, Personal, Advisory Board: akeda Oncology; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: AbbVie; Financial Interests, Institutional, Research Grant: Daiichi-Sankyo; Financial Interests, Institutional, Research Grant: Takeda Oncology; Financial Interests, Institutional, Research Grant: Eli Lilly; Financial Interests, Institutional, Research Grant: LOXO Oncology; Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Incyte; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Chordia Therapeutics; Financial Interests, Institutional, Research Grant: ymbio Pharmaceuticals; Financial Interests, Institutional, Research Grant: 3D-Medicine; Financial Interests, Institutional, Research Grant: Five Prime; Financial Interests, Institutional, Research Grant: Five Prime; Financial Interests, Institutional, Research Grant: Astellas; Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Institutional, Principal Investigator: AbbVie; Financial Interests, Institutional, Principal Investigator: Daiichi-Sankyo; Financial Interests, Institutional, Principal Investigator: Takeda Oncology; Financial Interests, Institutional, Principal Investigator: Eli Lilly; Financial Interests, Institutional, Principal Investigator: LOXO Oncology; Financial Interests, Institutional, Principal Investigator: Bristol-Myers Squibb; Financial Interests, Institutional, Principal Investigator: Eisai; Financial Interests, Institutional, Principal Investigator: Incyte; Financial Interests, Institutional, Principal Investigator: AstraZeneca; Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Institutional, Principal Investigator: Chordia Therapeutics; Financial Interests, Institutional, Principal Investigator: Symbio Pharmaceuticals; Financial Interests, Institutional, Principal Investigator: 3D-Medicine; Financial Interests, Institutional, Principal Investigator: Five Prime; Financial Interests, Institutional, Principal Investigator: PharmaMar; Financial Interests, Institutional, Principal Investigator: Astellas. K. Yonemori: Financial Interests, Personal, Advisory Board: Astrazeneca; Financial Interests, Personal, Speaker’s Bureau: Chugai; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Eisai; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Astrazeneca; Financial Interests, Personal, Speaker’s Bureau: Takeda Oncology; Financial Interests, Personal, Advisory Board: Takeda Oncology; Financial Interests, Personal, Advisory Board: Eisai. T. Koyama: Financial Interests, Personal, Speaker’s Bureau: Sysmex; Financial Interests, Personal, Speaker’s Bureau: Chugai; Financial Interests, Institutional, Principal Investigator: PACT. N. Yamamoto: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Chugai; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Advisory Board: Cimic; Financial Interests, Personal, Invited Speaker: Daiichi-Sankyo; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: ONO; Financial Interests, Personal, Advisory Board: Otsuka; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Sysmex; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Institutional, Principal Investigator: AbbVie; Financial Interests, Institutional, Principal Investigator: Astellas; Financial Interests, Institutional, Principal Investigator: Bayer; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: Boehringer Ingelheim; Financial Interests, Institutional, Principal Investigator: Chiome Bioscience; Financial Interests, Institutional, Principal Investigator: Chugai; Financial Interests, Institutional, Principal Investigator: Daiichi-Sankyo; Financial Interests, Institutional, Principal Investigator: Eisai; Financial Interests, Institutional, Principal Investigator: Eli Lilly; Financial Interests, Institutional, Principal Investigator: GSK; Financial Interests, Institutional, Principal Investigator: Janssen Pharma; Financial Interests, Institutional, Principal Investigator: Kyowa-Hakko Kirin; Financial Interests, Institutional, Principal Investigator: MERCK; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Institutional, Principal Investigator: ONO; Financial Interests, Institutional, Principal Investigator: Otsuka; Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Institutional, Principal Investigator: Sumitomo Dainippon; Financial Interests, Institutional, Principal Investigator: Taiho; Financial Interests, Institutional, Principal Investigator: Takeda. Y. Fujiwara: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Chugai; Financial Interests, Personal, Speaker’s Bureau: Daiichi-Sankyo; Financial Interests, Personal, Speaker’s Bureau: Bristol-Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: SRL inc; Financial Interests, Personal, Speaker’s Bureau: Santen Pharmaceutical. All other authors have declared no conflicts of interest.
Invited Discussant 1520O and 1521O
- Sebastian Bauer (Essen, Germany)
Q&A and live discussion
- Sebastian Bauer (Essen, Germany)