A. Bardia (Boston, MA, United States of America)
Massachusetts General Hospital Cancer CenterAuthor Of 2 Presentations
91O - Pooled analysis of patient (pt)-reported outcomes (PROs) in the MONALEESA (ML)-2, -3, and -7 trials: additional results and key subgroup findings (ID 240)
Abstract
Background
The phase III ML-2, -3, and -7 trials assessed ribociclib (RIB) with different endocrine therapy (ET) partners in pts with hormone receptor–positive, HER2-negative (HR+/HER2−) advanced breast cancer (ABC). Quality-of-life (QOL) results were previously reported for each ML trial and as a pooled analysis. Here, we report on individual dimensions of the EORTC QLQ-C30 PROs, including relevant pt subgroup data from a pooled analysis of the ML trials.
Methods
PROs were collected with EORTC QLQ-C30 questionnaires. QOL was assessed for all pts in ML-2, pts without prior ET for ABC in ML-3, and pts receiving RIB or placebo (PBO) + a nonsteroidal aromatase inhibitor in ML-7. A linear effects model was used to calculate the least-squares mean changes from baseline in global health status (GHS), nausea and vomiting, diarrhea, and anxiety/depression, and these were interpreted using minimally important differences. GHS was also assessed for pt subgroups including age, race, and molecular subtype by PAM50.
Results
A total of 1528 pts were included. Time to definitive deterioration (TDD) for diarrhea and anxiety/depression was prolonged for RIB vs PBO (Table). Diarrhea, anxiety/depression, and GHS across subgroups were improved or maintained from cycle 3 to end of treatment. Median TDD of GHS was longer for RIB vs PBO in pts regardless of age. Median TDD of GHS for RIB vs PBO was longer for White pts, similar for Asian pts, and shorter for pts of other races, although the n in the latter group was small. Median TDD of GHS for RIB vs PBO was longer in pts with luminal subtypes and was more than doubled for the HER2-enriched (HER2E; 30.4 vs 14.8 mo) subtype.
Conclusions
In this pooled analysis of the ML trials, RIB + ET showed delayed deterioration in QOL scores. TDD for GHS favored RIB vs PBO across most subgroups. These results support prior QOL analyses showing the value of RIB + ET in maintaining QOL for pts with HR+/HER2− ABC. aGHS by ≥10% NE, not estimable.
TDD, median mo RIB + ET (n=819) PBO + ET (n=709) HR (95% CI) All pts Nausea/vomiting ≥12 points 57.9 NE 1.04 (0.82-1.31) Diarrhea ≥10 points NE 55.2 0.76 (0.59-1.00) Anxiety/depression ≥30% 52.0 49.7 0.78 (0.63-0.96) Age (n)a <40 y (171) 35.9 23.0 0.78 (0.46-1.30) 40 - <55 y (531) 34.2 27.7 0.75 (0.57-0.99) ≥55 y (826) 42.6 35.9 0.82 (0.65-1.05) Race (n)a Asian (254) 35.9 35.8 0.94 (0.60-1.46) White (1131) 41.5 32.2 0.73 (0.59-0.89) Other (143) 33.2 46.9 1.11 (0.61-2.00) Molecular subtype (n)a Luminal A + B (628) 41.7 35.9 0.86 (0.65-1.14) HER2E (105) 30.4 14.8 0.59 (0.29-1.20) Basal-like (49) 16.5 22.4 0.84 (0.34-2.06) Normal-like (152) 47.2 50.6 0.74 (0.41-1.32)
Clinical trial identification
NCT01958021, NCT02422615, NCT02278120.
Editorial acknowledgement
This abstract was developed with editorial assistance provided by Casey Nielsen, PhD of MediTech Media, LLC. Editorial support was funded by Novartis Pharmaceuticals Corporation.
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
P.A. Fasching: Research grant/Funding (institution): BioNTech; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Celgene; Honoraria (self), Speaker Bureau/Expert testimony: Daiichi Sankyo; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Macrogenics; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy: Puma; Research grant/Funding (institution): Cepheid; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy: AstraZeneca. A. Bardia: Advisory/Consultancy, Leadership role, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech; Advisory/Consultancy, Leadership role, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Leadership role, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Leadership role, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Sanofi; Research grant/Funding (institution): Radius Health; Advisory/Consultancy, Leadership role, Research grant/Funding (institution), Travel/Accommodation/Expenses: Immunomedics/Gilead; Advisory/Consultancy, Research grant/Funding (institution): Biothernostics Inc.; Advisory/Consultancy, Travel/Accommodation/Expenses: Taiho; Advisory/Consultancy: Daiichi Pharma/AstraZeneca; Advisory/Consultancy: Puma; Advisory/Consultancy, Travel/Accommodation/Expenses: Phillips; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Foundation Medicine; Advisory/Consultancy: Mersana. A. Nusch: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Amgen. G. Jerusalem: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self): AbbVie; Honoraria (self): Daiichi Sankyo; Advisory/Consultancy: MedImmune; Advisory/Consultancy: Merck. N.S. El Saghir: Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Eli Lilly. E. Alba Conejo: Honoraria (self), Advisory/Consultancy: Genomic Health; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): NanoString; Travel/Accommodation/Expenses: Celgene; Research grant/Funding (institution): Sysmex. S-A. Im: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Hanmi; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy: Eisai; Advisory/Consultancy: Amgen; Advisory/Consultancy: MediPacto; Research grant/Funding (institution): Roche; Honoraria (self): Lilly; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: GSK; Research grant/Funding (institution): Daewoong Pharm. W. Janni: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis. D. Chandiwana, B.R. Lanoue, A. Thuerigen, E. Gu: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. N. Harbeck: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca. All other authors have declared no conflicts of interest.
LBA4 - Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate (ADC), for triple-negative breast cancer (TNBC): Preliminary results from an ongoing phase 1 trial (ID 321)
Abstract
Background
Dato-DXd is an ADC comprising a humanized anti-TROP2 IgG1 mAb conjugated to a potent topoisomerase I inhibitor payload (DXd) via a stable tetrapeptide-based cleavable linker. Results from the ongoing phase I TROPION-PanTumor01 (NCT03401385) study showed encouraging antitumor activity of Dato-DXd in heavily pretreated patients (pts) with metastatic (m) NSCLC. Reported here are preliminary results in mTNBC; recruitment is ongoing.
Methods
TROPION-PanTumor01 is a 2-part study evaluating Dato-DXd IV Q3W in previously treated pts with solid tumors. Based on the dose-escalation phase limited to NSCLC pts, this expansion phase evaluated 6 mg/kg in pts with mTNBC that relapsed/progressed with standard treatment (TX). The primary endpoint was safety/tolerability. Secondary endpoints included efficacy assessed by ORR per RECIST v1.1 by blinded independent central review (BICR).
Results
As of the Jan 8, 2021, data cutoff, 24 pts had ≥1 dose (6 mg/kg, n=22; 8 mg/kg, n=2 [treated prior to 6-mg/kg dose selection]), with 18 (75%) still on TX and 6 (25%) discontinued for PD. Median age was 57 y (range, 32-82 y); 71% had ≥3 prior lines of therapy. Prior therapies were taxanes (83%), platinum-based TX (50%), immunotherapy (33%), and sacituzumab govitecan (8%). Among 21 pts (6 mg/kg, n=19; 8 mg/kg, n=2) evaluable for response (≥1 postbaseline tumor assessment or discontinued TX), ORR by BICR was 43% (9 PRs), with 5 confirmed and 4 pending confirmation. The disease control rate was 95% (20/21 pts). Dose reductions due to AEs occurred in 6 pts (25%); no pts discontinued TX due to AEs. Any grade (Gr) and Gr ≥3 TEAEs regardless of causality occurred in 100% and 33% of pts, respectively. Most common TEAEs (any Gr [≥40%], Gr ≥3) were nausea (63%, 0%), stomatitis (63%, 13%), fatigue (42%, 4%), and vomiting (42%, 0%). No Gr ≥3 TEAEs of diarrhea or decreased neutrophil count/neutropenia were reported. No cases of TX-related ILD (adjudicated) were observed.
Conclusions
Preliminary results show that Dato-DXd had highly encouraging antitumor activity and a manageable safety profile in pts with refractory mTNBC; further confirmatory studies are warranted.
Clinical trial identification
TROPION-PanTumor01 (NCT03401385) study.
Editorial acknowledgement
Medical editorial assistance was provided by Allison Lytle, PhD, from ArticulateScience LLC, which was funded by Daiichi Sankyo, Inc.
Legal entity responsible for the study
Daiichi Sankyo Co, Ltd.
Funding
Daiichi Sankyo Co, Ltd.
Disclosure
A. Bardia: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Research grant/Funding (institution), Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Radius Health; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Immunomedics ; Advisory/Consultancy, Research grant/Funding (institution): Biotheranostics Inc.; Research grant/Funding (institution), Travel/Accommodation/Expenses: Taiho; Advisory/Consultancy: Daiichi Sankyo/AstraZeneca; Advisory/Consultancy: Puma; Advisory/Consultancy, Travel/Accommodation/Expenses: Phillips; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Foundation Medicine. D. Juric: Advisory/Consultancy: Novartis, EMD Serono, Eisai, Genentech, Ipsen, Syros Pharmaceuticals, MapKure, Vibliome Therapeutics, Petra Pharma; Research grant/Funding (institution): Novartis, Genentech, Eisai, EMD Serono, Placon, Amgen, Syros Pharmaceuticals, InventisBio, Infinity Pharmaceuticals, Takeda, Pfizer. T. Shimizu: Advisory/Consultancy: Daiichi-Sankyo, AbbVie, Takeda Oncology, The Consortium on Harmonization of Institutional Requirements for Clinical Research (CHAIR) Joint Scientific Committee Review Member and External IRB Member of Phase 1 Trials in Hong Kong, HKSAR, China; Research grant/Funding (self): Novartis, AbbVie, Daiichi-Sankyo, Takeda Oncology, Eli Lilly, Loxo Oncology, Bristol-Myers Squibb, Eisai, Pfizer, AstraZeneca, Incyte, Symbio Pharmaceuticals, Chordia Therapeutics, 3D-Medicine, Five Prime, PharmaMar, Astellas . A. Tolcher: Leadership role: NEXT Oncology; Advisory/Consultancy: SOTIO Biotechnology; Advisory/Consultancy: Axlmmune; Advisory/Consultancy: Bayer; Advisory/Consultancy: Immunomet Therapeutics, Inc.; Advisory/Consultancy: Menarini; Advisory/Consultancy: Mersana; Research grant/Funding (institution): Naivre Pharma, Inc.; Research grant/Funding (institution): 3's Biotherapeutics; Research grant/Funding (institution): PMV Pharmaceuticals; Research grant/Funding (institution): Apros Therapeutics Inc.; Research grant/Funding (institution): Codiak Biosciences; Research grant/Funding (institution): Merck Sharp & Dohme; Speaker Bureau/Expert testimony: Immunogen. A. Spira: Advisory/Consultancy: Amgen, Incyte, Mirati Therapeutics, Novartis; Shareholder/Stockholder/Stock options: Eli Lilly; Honoraria (self): Amgen, AstraZeneca/MedImmune, Bristol-Myers-Squibb, CytomX Therapeutics, Janssen Oncology, Merck, Novartis, Takeda; Research grant/Funding (self): Daiichi Sankyo. T. Mukohara: Research grant/Funding (self): Daiichi Sankyo, Inc., Sysmex, MSD, Pfizer, Sanofi, Seagen, AstraZeneca; Honoraria (self): Eisai, Pfizer, Novartis, Chugai, Eli Lilly, AstraZeneca. A.E. Lisberg: Spouse/Financial dependant, Employment, Stock: Boston Scientific; Honoraria (self): AstraZeneca, Bristol-Myers-Squibb, Leica Biosystems, Jazz Pharmaceuticals, Novocure, Pfizer, MorphoSys; Advisory/Consultancy: AstraZeneca, Bristol-Myers-Squibb, Leica Biosystems, Jazz Pharmaceuticals, Novocure, Pfizer, MorphoSys; Research grant/Funding (institution): Daiichi Sankyo, Calithera Biosciences, AstraZeneca, Dracen Pharmaceuticals, WindMIL. I. Krop: Honoraria (self): Daiichi Sankyo, Inc., Macrogenics, Novartis, Merck, Context Therapeutics, Taiho Oncology, Genentech/Roche, Seattle Genetics; Research grant/Funding (self): Genentech/Roche, Pfizer. K.P. Papadopoulos: Advisory/Consultancy: Bayer, ArQule, Basilea; Research grant/Funding (institution): AbbVie, MedImmune, Daiichi Sankyo, Regeneron, Sanofi, ARMO BioSciences, ArQule, Amgen, Calithera Biosciences, Incyte, Merck, Peloton Therapeutics, ADC Therapeutics, 3D Medicines, EMD Serono, Syros Pharmaceuticals, Mersana, OncoMed, MabSpace Biosciences, J. E. Hamilton: Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi Sankyo; Advisory/Consultancy, Travel/Accommodation/Expenses: Puma Biotechnology; Advisory/Consultancy, Research grant/Funding (institution): Mersana; Advisory/Consultancy, Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millennium, Taplmmune Inc., Medivation, Tesaro, H3 Biomedicine, Radius Health, Acerta Pharma, Takeda, Macrogenics, AbbVie, Immunomedics, F; Advisory/Consultancy: Astra Zeneca, Novartis, Silverback Therapeutics, Black Diamond Therapeutics, CytomX Therapeutics, Dantari, H3 Biomedicine, Merck, Novartis, Seattle Genetics, Eisai. S. Damodaran: Advisory/Consultancy: Tempus, Taiho Pharmaceutical, Pfizer; Travel/Accommodation/Expenses: Phillips Gilmore Oncology Communications; Honoraria (self): Novartis; Research grant/Funding (institution): EMD Serono, Guardant Health, Taiho Pharmaceutical, Novartis. J. Greenberg, W. Gu, F.M. Guevara, T. Jikoh: Full/Part-time employment: Daiichi Sankyo, Inc.; Shareholder/Stockholder/Stock options: Daiichi Sankyo, Inc. F. Kobayashi, Y. Kawasaki: Full/Part-time employment: Daiichi Sankyo, Inc. F. Meric-Bernstam: Full/Part-time employment: MD Anderson Cancer Center; Advisory/Consultancy: Inflection Biosciences; Speaker Bureau/Expert testimony: Chugai Pharma; Advisory/Consultancy, Research grant/Funding (institution): eFFECTOR Therapeutics; Travel/Accommodation/Expenses: Beth Israel Deaconess Medical Center; Honoraria (self): Mayo Clinic; Honoraria (self): Rutgers Cancer Institute of New Jersey; Research grant/Funding (institution): Novartis, AstraZeneca, Calithera Biosciences, Bayer, Aileron Therapeutics, Puma Biotechnology, CytomX Therapeutics, Jounce Therapeutics, Zymeworks, Curis, Pfizer, AbbVie; Guardant H; Research grant/Funding (institution), Travel/Accommodation/Expenses: Taiho Pharmaceutical; Advisory/Consultancy, Research grant/Funding (institution): Genentech; Advisory/Consultancy, Research grant/Funding (institution): Debiopharm Group; Advisory/Consultancy: Samsumg Bioepis; Advisory/Consultancy: Spectrum Pharmaceuticals; Advisory/Consultancy: Aduro Biotech; Advisory/Consultancy: Origimed; Advisory/Consultancy: Xencor; Advisory/Consultancy: Mersana; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Silverback Therapeutics; Advisory/Consultancy: Immunomedics.
Presenter Of 1 Presentation
LBA4 - Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate (ADC), for triple-negative breast cancer (TNBC): Preliminary results from an ongoing phase 1 trial (ID 321)
Abstract
Background
Dato-DXd is an ADC comprising a humanized anti-TROP2 IgG1 mAb conjugated to a potent topoisomerase I inhibitor payload (DXd) via a stable tetrapeptide-based cleavable linker. Results from the ongoing phase I TROPION-PanTumor01 (NCT03401385) study showed encouraging antitumor activity of Dato-DXd in heavily pretreated patients (pts) with metastatic (m) NSCLC. Reported here are preliminary results in mTNBC; recruitment is ongoing.
Methods
TROPION-PanTumor01 is a 2-part study evaluating Dato-DXd IV Q3W in previously treated pts with solid tumors. Based on the dose-escalation phase limited to NSCLC pts, this expansion phase evaluated 6 mg/kg in pts with mTNBC that relapsed/progressed with standard treatment (TX). The primary endpoint was safety/tolerability. Secondary endpoints included efficacy assessed by ORR per RECIST v1.1 by blinded independent central review (BICR).
Results
As of the Jan 8, 2021, data cutoff, 24 pts had ≥1 dose (6 mg/kg, n=22; 8 mg/kg, n=2 [treated prior to 6-mg/kg dose selection]), with 18 (75%) still on TX and 6 (25%) discontinued for PD. Median age was 57 y (range, 32-82 y); 71% had ≥3 prior lines of therapy. Prior therapies were taxanes (83%), platinum-based TX (50%), immunotherapy (33%), and sacituzumab govitecan (8%). Among 21 pts (6 mg/kg, n=19; 8 mg/kg, n=2) evaluable for response (≥1 postbaseline tumor assessment or discontinued TX), ORR by BICR was 43% (9 PRs), with 5 confirmed and 4 pending confirmation. The disease control rate was 95% (20/21 pts). Dose reductions due to AEs occurred in 6 pts (25%); no pts discontinued TX due to AEs. Any grade (Gr) and Gr ≥3 TEAEs regardless of causality occurred in 100% and 33% of pts, respectively. Most common TEAEs (any Gr [≥40%], Gr ≥3) were nausea (63%, 0%), stomatitis (63%, 13%), fatigue (42%, 4%), and vomiting (42%, 0%). No Gr ≥3 TEAEs of diarrhea or decreased neutrophil count/neutropenia were reported. No cases of TX-related ILD (adjudicated) were observed.
Conclusions
Preliminary results show that Dato-DXd had highly encouraging antitumor activity and a manageable safety profile in pts with refractory mTNBC; further confirmatory studies are warranted.
Clinical trial identification
TROPION-PanTumor01 (NCT03401385) study.
Editorial acknowledgement
Medical editorial assistance was provided by Allison Lytle, PhD, from ArticulateScience LLC, which was funded by Daiichi Sankyo, Inc.
Legal entity responsible for the study
Daiichi Sankyo Co, Ltd.
Funding
Daiichi Sankyo Co, Ltd.
Disclosure
A. Bardia: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Research grant/Funding (institution), Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Radius Health; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Immunomedics ; Advisory/Consultancy, Research grant/Funding (institution): Biotheranostics Inc.; Research grant/Funding (institution), Travel/Accommodation/Expenses: Taiho; Advisory/Consultancy: Daiichi Sankyo/AstraZeneca; Advisory/Consultancy: Puma; Advisory/Consultancy, Travel/Accommodation/Expenses: Phillips; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Foundation Medicine. D. Juric: Advisory/Consultancy: Novartis, EMD Serono, Eisai, Genentech, Ipsen, Syros Pharmaceuticals, MapKure, Vibliome Therapeutics, Petra Pharma; Research grant/Funding (institution): Novartis, Genentech, Eisai, EMD Serono, Placon, Amgen, Syros Pharmaceuticals, InventisBio, Infinity Pharmaceuticals, Takeda, Pfizer. T. Shimizu: Advisory/Consultancy: Daiichi-Sankyo, AbbVie, Takeda Oncology, The Consortium on Harmonization of Institutional Requirements for Clinical Research (CHAIR) Joint Scientific Committee Review Member and External IRB Member of Phase 1 Trials in Hong Kong, HKSAR, China; Research grant/Funding (self): Novartis, AbbVie, Daiichi-Sankyo, Takeda Oncology, Eli Lilly, Loxo Oncology, Bristol-Myers Squibb, Eisai, Pfizer, AstraZeneca, Incyte, Symbio Pharmaceuticals, Chordia Therapeutics, 3D-Medicine, Five Prime, PharmaMar, Astellas . A. Tolcher: Leadership role: NEXT Oncology; Advisory/Consultancy: SOTIO Biotechnology; Advisory/Consultancy: Axlmmune; Advisory/Consultancy: Bayer; Advisory/Consultancy: Immunomet Therapeutics, Inc.; Advisory/Consultancy: Menarini; Advisory/Consultancy: Mersana; Research grant/Funding (institution): Naivre Pharma, Inc.; Research grant/Funding (institution): 3's Biotherapeutics; Research grant/Funding (institution): PMV Pharmaceuticals; Research grant/Funding (institution): Apros Therapeutics Inc.; Research grant/Funding (institution): Codiak Biosciences; Research grant/Funding (institution): Merck Sharp & Dohme; Speaker Bureau/Expert testimony: Immunogen. A. Spira: Advisory/Consultancy: Amgen, Incyte, Mirati Therapeutics, Novartis; Shareholder/Stockholder/Stock options: Eli Lilly; Honoraria (self): Amgen, AstraZeneca/MedImmune, Bristol-Myers-Squibb, CytomX Therapeutics, Janssen Oncology, Merck, Novartis, Takeda; Research grant/Funding (self): Daiichi Sankyo. T. Mukohara: Research grant/Funding (self): Daiichi Sankyo, Inc., Sysmex, MSD, Pfizer, Sanofi, Seagen, AstraZeneca; Honoraria (self): Eisai, Pfizer, Novartis, Chugai, Eli Lilly, AstraZeneca. A.E. Lisberg: Spouse/Financial dependant, Employment, Stock: Boston Scientific; Honoraria (self): AstraZeneca, Bristol-Myers-Squibb, Leica Biosystems, Jazz Pharmaceuticals, Novocure, Pfizer, MorphoSys; Advisory/Consultancy: AstraZeneca, Bristol-Myers-Squibb, Leica Biosystems, Jazz Pharmaceuticals, Novocure, Pfizer, MorphoSys; Research grant/Funding (institution): Daiichi Sankyo, Calithera Biosciences, AstraZeneca, Dracen Pharmaceuticals, WindMIL. I. Krop: Honoraria (self): Daiichi Sankyo, Inc., Macrogenics, Novartis, Merck, Context Therapeutics, Taiho Oncology, Genentech/Roche, Seattle Genetics; Research grant/Funding (self): Genentech/Roche, Pfizer. K.P. Papadopoulos: Advisory/Consultancy: Bayer, ArQule, Basilea; Research grant/Funding (institution): AbbVie, MedImmune, Daiichi Sankyo, Regeneron, Sanofi, ARMO BioSciences, ArQule, Amgen, Calithera Biosciences, Incyte, Merck, Peloton Therapeutics, ADC Therapeutics, 3D Medicines, EMD Serono, Syros Pharmaceuticals, Mersana, OncoMed, MabSpace Biosciences, J. E. Hamilton: Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi Sankyo; Advisory/Consultancy, Travel/Accommodation/Expenses: Puma Biotechnology; Advisory/Consultancy, Research grant/Funding (institution): Mersana; Advisory/Consultancy, Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millennium, Taplmmune Inc., Medivation, Tesaro, H3 Biomedicine, Radius Health, Acerta Pharma, Takeda, Macrogenics, AbbVie, Immunomedics, F; Advisory/Consultancy: Astra Zeneca, Novartis, Silverback Therapeutics, Black Diamond Therapeutics, CytomX Therapeutics, Dantari, H3 Biomedicine, Merck, Novartis, Seattle Genetics, Eisai. S. Damodaran: Advisory/Consultancy: Tempus, Taiho Pharmaceutical, Pfizer; Travel/Accommodation/Expenses: Phillips Gilmore Oncology Communications; Honoraria (self): Novartis; Research grant/Funding (institution): EMD Serono, Guardant Health, Taiho Pharmaceutical, Novartis. J. Greenberg, W. Gu, F.M. Guevara, T. Jikoh: Full/Part-time employment: Daiichi Sankyo, Inc.; Shareholder/Stockholder/Stock options: Daiichi Sankyo, Inc. F. Kobayashi, Y. Kawasaki: Full/Part-time employment: Daiichi Sankyo, Inc. F. Meric-Bernstam: Full/Part-time employment: MD Anderson Cancer Center; Advisory/Consultancy: Inflection Biosciences; Speaker Bureau/Expert testimony: Chugai Pharma; Advisory/Consultancy, Research grant/Funding (institution): eFFECTOR Therapeutics; Travel/Accommodation/Expenses: Beth Israel Deaconess Medical Center; Honoraria (self): Mayo Clinic; Honoraria (self): Rutgers Cancer Institute of New Jersey; Research grant/Funding (institution): Novartis, AstraZeneca, Calithera Biosciences, Bayer, Aileron Therapeutics, Puma Biotechnology, CytomX Therapeutics, Jounce Therapeutics, Zymeworks, Curis, Pfizer, AbbVie; Guardant H; Research grant/Funding (institution), Travel/Accommodation/Expenses: Taiho Pharmaceutical; Advisory/Consultancy, Research grant/Funding (institution): Genentech; Advisory/Consultancy, Research grant/Funding (institution): Debiopharm Group; Advisory/Consultancy: Samsumg Bioepis; Advisory/Consultancy: Spectrum Pharmaceuticals; Advisory/Consultancy: Aduro Biotech; Advisory/Consultancy: Origimed; Advisory/Consultancy: Xencor; Advisory/Consultancy: Mersana; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Silverback Therapeutics; Advisory/Consultancy: Immunomedics.