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Proffered Paper session - Developmental therapeutics

513O - A phase I/II multicenter, first-in-human study of DS-7300 (B7-H3 DXd-ADC) in patients (pts) with advanced solid tumors

Date

17 Sep 2021

Session

Proffered Paper session - Developmental therapeutics

Topics

Tumour Site

Lymphomas

Presenters

Melissa Johnson

Citation

Annals of Oncology (2021) 32 (suppl_5): S583-S620. 10.1016/annonc/annonc699

Authors

M.L. Johnson1, T. Doi2, S.A. Piha-Paul3, S. Sen4, T. Shimizu5, B. Cheng6, N. Yoshizuka6, N. Okamoto7, Y. Okuda7, X. Qian6, G. Serbest6, T. Hammett8, W.E. Brady8, M.R. Patel9, J.C. Bendell10

Author affiliations

  • 1 Medical Oncology Department, Sarah Cannon Research Institute, Nashville, TN; Tennessee Oncology, PLLC, 37203 - Nashville/US
  • 2 Experimental Therapeutics Dept., National Cancer Center Hospital East, 277-8577 - Chiba/JP
  • 3 Department Of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 4 Drug Development Unit, Sarah Cannon Research Institute at HealthOne, 80218 - Denver/US
  • 5 Experimental Therapeutics Dept., National Cancer Center Hospital, 154-0016 - Tokyo/JP
  • 6 Oncology R&d, Daiichi Sankyo, Inc., 07920 - Basking Ridge/US
  • 7 Oncology R&d, Daiichi Sankyo, Co., Ltd, 154-0016 - Tokyo/JP
  • 8 Drug Development Unit, Sarah Cannon Research Institute, 37203 - Nashville/US
  • 9 Drug Development Unit, Sarah Cannon Research Institute, Nashville, TN; Florida Cancer Specialists, 34236 - Sarasota/US
  • 10 Drug Development Unit, Sarah Cannon Research Institute, Nashville, TN; Tennessee Oncology, PLLC, 37203 - Nashville/US

Resources

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Abstract 513O

Background

B7-H3 overexpression is associated with poor prognosis in various cancers. DS-7300 is an antibody drug conjugate composed of an anti–B7-H3 IgG1 monoclonal antibody conjugated to an exatecan derivative payload with a drug to antibody ratio of ∼4. It has shown potent preclinical antitumor activity. Here, we report preliminary results from a phase 1/2 trial of DS-7300 in pts with advanced solid tumors.

Methods

This dose-escalation (part 1) and -expansion (part 2) study is recruiting adult pts with 11 selected tumor types in the US and Japan. DS-7300, from 0.8 to 16 mg/kg IV, is administered every 3 wk. Part 1 assesses safety, tolerability, and maximum tolerated or recommended dose for expansion; additional pts were enrolled to examine safety and efficacy. Part 2 assesses safety and prospective efficacy.

Results

Part 1 results are presented. At data cutoff (Apr 9, 2021), 56 pts had enrolled: Median treatment duration, 12 wk (range, 3.0-47.9 wk), with 26 pts (46%) ongoing; median age, 65 y (range, 35-77 y); 42 pts (75%) were male. Baseline B7-H3 expression was highly prevalent in the study population. No DLTs were observed. Treatment-emergent adverse events (TEAEs) occurred in 55 pts (98%). The most common (≥20%) all-grade (Gr) TEAEs were nausea (48%), infusion-related reactions (IRRs; 36%), decreased appetite and vomiting (27% each). Gr ≥3 TEAEs occurred in 11 pts (20%); the most common was anemia (11%). One Gr 3 treatment-related AE (TRAE), neutropenia, occurred. No serious TRAEs occurred. IRRs were Gr 1/2 and manageable with supportive care. Due to TEAEs, 2 pts each (4%) had a dose interruption or reduction, and no dose discontinuations occurred. Two pts died due to disease progression. Among 56 pts enrolled, 9 partial responses (PRs; 5 confirmed PRs [2 CRPC, 1 esophageal SCC (ESCC), 1 sqNSCLC, 1 SCLC], and 4 unconfirmed PRs [1 CRPC, 1 ESCC, 1 SCLC, and 1 endometrial cancer]) were observed, with 6 PRs ongoing; 28 pts had stable disease.

Conclusions

DS-7300 was generally well tolerated with early signs of clinical activity, including objective responses, in pts with pretreated advanced solid tumors. Expansion cohorts are currently enrolling to evaluate DS-7300 in selected tumor types.

Clinical trial identification

NCT04145622. Release date: October 30, 2019.

Editorial acknowledgement

Medical writing support was provided by Neil Gillette, PharmD, of SciMentum, a Nucleus Global company, and was funded by Daiichi Sankyo, Inc.

Legal entity responsible for the study

Daiichi Sankyo, Inc.

Funding

Daiichi Sankyo, Inc.

Disclosure

M.L. Johnson: Financial Interests, Personal, Advisory Role: Otsuka; Financial Interests, Institutional, Advisory Role: Genentech/Roche; Financial Interests, Institutional, Advisory Role: Boehringer Ingelheim; Financial Interests, Institutional, Advisory Role: AstraZeneca; Financial Interests, Institutional, Advisory Role: Calithera Biosciences; Financial Interests, Institutional, Advisory Role: Merck; Financial Interests, Institutional, Advisory Role: Loxo; Financial Interests, Institutional, Advisory Role: Sanofi; Financial Interests, Institutional, Advisory Role: Mirati Therapeutics; Financial Interests, Personal, Advisory Role: Astellas Pharma; Financial Interests, Institutional, Advisory Role: Pfizer; Financial Interests, Institutional, Advisory Role: Guardant Health; Financial Interests, Institutional, Advisory Role: Ribon Therapeutics; Financial Interests, Institutional, Advisory Role: Incyte; Financial Interests, Institutional, Advisory Role: Abbvie; Financial Interests, Institutional, Advisory Role: Achilles Therapeutics; Financial Interests, Institutional, Advisory Role: Atreca; Financial Interests, Institutional, Advisory Role: GlaxoSmithKline; Financial Interests, Institutional, Advisory Role: Gritstone Oncology; Financial Interests, Institutional, Advisory Role: Janssen Oncology; Financial Interests, Institutional, Advisory Role: Lilly; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: Association of Community Cancer Centers (ACCC); Financial Interests, Institutional, Advisory Role: Amgen; Financial Interests, Institutional, Advisory Role: Bristol-Myers Squibb; Financial Interests, Institutional, Advisory Role: Daiichi Sankyo; Financial Interests, Institutional, Advisory Role: EMD Serono; Financial Interests, Institutional, Advisory Role: G1 Therapeutics; Financial Interests, Institutional, Advisory Role: WindMIL; Financial Interests, Institutional, Advisory Role: Checkpoint Therapeutics; Financial Interests, Institutional, Advisory Role: Eisai; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Abbvie; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Genentech; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Incyte; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Merck; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Pfizer; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Sanofi; Financial Interests, Institutional, Research Grant: EMD Serono; Financial Interests, Institutional, Research Grant: Kadmon; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Institutional, Research Grant: Mirati Therapeutics; Financial Interests, Institutional, Research Grant: Genmab; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Stem CentRx; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Checkpoint Therapeutics; Financial Interests, Institutional, Research Grant: Array BioPharma; Financial Interests, Institutional, Research Grant: Regeneron; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Hengrui Pharmaceutical; Financial Interests, Institutional, Research Grant: Lycera; Financial Interests, Institutional, Research Grant: BeiGene; Financial Interests, Institutional, Research Grant: Tarveda Therapeutics; Financial Interests, Institutional, Research Grant: Loxo; Financial Interests, Institutional, Research Grant: Abbvie; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Guardant Health; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: CytomX Therapeutics; Financial Interests, Institutional, Research Grant: Dynavax Technologies; Financial Interests, Institutional, Research Grant: Corvus Pharmaceuticals; Financial Interests, Institutional, Research Grant: Incyte; Financial Interests, Institutional, Research Grant: Genocea Biosciences; Financial Interests, Institutional, Research Grant: Gritstone Oncology; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: Genentech/Roche; Financial Interests, Institutional, Research Grant: Adaptimmune; Financial Interests, Institutional, Research Grant: Syndax; Financial Interests, Institutional, Research Grant: Neovia Oncology; Financial Interests, Institutional, Research Grant: Acerta Pharma; Financial Interests, Institutional, Research Grant: Takeda; Financial Interests, Institutional, Research Grant: Shattuck Labs; Financial Interests, Institutional, Research Grant: GlaxoSmithKline; Financial Interests, Institutional, Research Grant: Apexigen; Financial Interests, Institutional, Research Grant: Atreca; Financial Interests, Institutional, Research Grant: OncoMed; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Immunocore; Financial Interests, Institutional, Research Grant: Jounce Therapeutics; Financial Interests, Institutional, Research Grant: University of Michigan; Financial Interests, Institutional, Research Grant: WindMIL; Financial Interests, Institutional, Research Grant: TCR2 Therapeutics; Financial Interests, Institutional, Research Grant: Arcus Biosciences; Financial Interests, Institutional, Research Grant: Ribon Therapeutics; Financial Interests, Institutional, Research Grant: BerGenBio; Financial Interests, Institutional, Research Grant: Calithera Biosciences; Financial Interests, Institutional, Research Grant: Tmunity Therapeutics, Inc.; Financial Interests, Institutional, Research Grant: Seven and Eight Biopharmaceuticals; Financial Interests, Institutional, Research Grant: Rubius Therapeutics; Financial Interests, Institutional, Research Grant: Curis; Financial Interests, Institutional, Research Grant: Silicon Therapeutics; Financial Interests, Institutional, Research Grant: Dracen; Financial Interests, Institutional, Research Grant: PMV Pharma; Financial Interests, Institutional, Research Grant: Artios. T. Doi: Financial Interests, Institutional, Principal Investigator: Lilly; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Daiichi Sankyo; Financial Interests, Institutional, Principal Investigator: Sumitomo Dainippon; Financial Interests, Institutional, Principal Investigator: Taiho; Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Institutional, Principal Investigator: Merck Serono; Financial Interests, Institutional, Principal Investigator: Janssen; Financial Interests, Institutional, Principal Investigator: Boehringer Ingelheim; Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: Abbvie; Financial Interests, Institutional, Principal Investigator: IQVIA; Financial Interests, Institutional, Principal Investigator: Eisai; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Abbvie; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Astellas. S.A. Piha-Paul: Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Institutional, Research Grant: Abbvie; Financial Interests, Institutional, Research Grant: Aminex; Financial Interests, Institutional, Research Grant: Biomarin; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb; Financial Interests, Institutional, Research Grant: Cerulean Pharma; Financial Interests, Institutional, Research Grant: Chugai Pharma; Financial Interests, Institutional, Research Grant: Curis; Financial Interests, Institutional, Research Grant: Five Prime Therapeutics; Financial Interests, Institutional, Research Grant: Genmab; Financial Interests, Institutional, Research Grant: GlaxoSmithKline; Financial Interests, Institutional, Research Grant: Helix BioPharma; Financial Interests, Institutional, Research Grant: Incyte; Financial Interests, Institutional, Research Grant: Jacobio; Financial Interests, Institutional, Research Grant: MedImmune; Financial Interests, Institutional, Research Grant: Medivation; Financial Interests, Institutional, Research Grant: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pieris Pharmaceuticals; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Principa Biopharma; Financial Interests, Institutional, Research Grant: Puma Biotechnology; Financial Interests, Institutional, Research Grant: RAPT Therapeutics; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Taiho Oncology; Financial Interests, Institutional, Research Grant: Tesaro; Financial Interests, Institutional, Research Grant: TransThera Biosciences; Financial Interests, Institutional, Research Grant: XuanZhu; Financial Interests, Institutional, Research Grant: Amphivena Therapeutics; Financial Interests, Institutional, Research Grant: Alkermes; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: ABM Therapeutics, Inc.; Financial Interests, Institutional, Research Grant: Acepodia, Inc.; Financial Interests, Institutional, Research Grant: ENB Therapeutics; Financial Interests, Institutional, Research Grant: Gene Quantum; Financial Interests, Institutional, Research Grant: Silverback Therapeutics; Financial Interests, Institutional, Research Grant: NCI/NIH P30CA016672. S. Sen: Financial Interests, Personal, Full or part-time Employment: Roche/Genentech; Financial Interests, Personal, Stocks/Shares: Roche/Genentech; Financial Interests, Institutional, Research Grant: Loxo; Financial Interests, Institutional, Research Grant: Exelixis; Financial Interests, Institutional, Research Grant: BioAtla; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Epizyme; Financial Interests, Institutional, Research Grant: Fujifilm; Financial Interests, Institutional, Research Grant: GlaxoSmithKline; Financial Interests, Institutional, Research Grant: Tesaro; Financial Interests, Institutional, Research Grant: Synthorx; Financial Interests, Institutional, Research Grant: Xencor; Financial Interests, Institutional, Research Grant: Cyteir; Financial Interests, Institutional, Research Grant: Turning Point Therapeutics; Financial Interests, Institutional, Research Grant: Abbisko; Financial Interests, Institutional, Research Grant: Oncorus. T. Shimizu: Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: Chugai Pharma; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Taiho Pharmaceutical; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Takeda; Financial Interests, Personal, Other, Honoraria: Boehringer Ingelheim; Financial Interests, Personal, Other, Honoraria: Chugai Pharma; Financial Interests, Personal, Other, Honoraria: Ono Pharmaceutical; Financial Interests, Personal, Other, Honoraria: Taiho Pharmaceutical; Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb; Financial Interests, Institutional, Research Grant: Takeda/Millennium; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Five Prime Therapeutics; Financial Interests, Institutional, Research Grant: PharmaMar; Financial Interests, Institutional, Research Grant: 3D Medicines; Financial Interests, Institutional, Research Grant: SymBio Pharmaceuticals; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Incyte; Financial Interests, Institutional, Research Grant: Chordia Therapeutics; Financial Interests, Institutional, Research Grant: Astellas Pharma. B. Cheng: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo, Inc.. N. Yoshizuka: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo, Inc.. N. Okamoto: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo, Inc.; Financial Interests, Personal, Stocks/Shares: Daiichi Sankyo, Inc.; Financial Interests, Personal, Stocks/Shares, An Immediate Family Member: Daiichi Sankyo, Inc.; Financial Interests, Personal, Stocks/Shares, An Immediate Family Member: Takeda; Financial Interests, Personal, Stocks/Shares, An Immediate Family Member: Astellas Pharma. Y. Okuda: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo, Co., LTD. X. Qian: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo, Inc.; Financial Interests, Personal, Other, Equity Ownership: Daiichi Sankyo, Inc.. G. Serbest: Financial Interests, Personal, Full or part-time Employment: Daiichi Sankyo, Inc.. W.E. Brady: Financial Interests, Personal, Full or part-time Employment: Sarah Cannon; Financial Interests, Personal, Full or part-time Employment, (Spouse) Employment: State University of New York at Buffalo; Financial Interests, Personal, Other, (Spouse) Consultancy (Includes expert testimony): Fred Hutchinson Cancer Center. M.R. Patel: Financial Interests, Institutional, Research Grant: Daiichi Sankyo, Inc.. J.C. Bendell: Financial Interests, Institutional, Advisory Role: Gilead Sciences; Financial Interests, Institutional, Advisory Role: Genentech/Roche; Financial Interests, Institutional, Advisory Role: Bristol-Myers Squibb; Financial Interests, Institutional, Advisory Role: Five Prime Therapeutics; Financial Interests, Institutional, Advisory Role: Lilly; Financial Interests, Institutional, Advisory Role: Merck; Financial Interests, Institutional, Advisory Role: MedImmune; Financial Interests, Institutional, Advisory Role: Celgene; Financial Interests, Institutional, Advisory Role: EMD Serono; Financial Interests, Institutional, Advisory Role: Taiho Pharmaceutical; Financial Interests, Institutional, Advisory Role: Macrogenics; Financial Interests, Institutional, Advisory Role: GlaxoSmithKline; Financial Interests, Institutional, Advisory Role: Novartis; Financial Interests, Institutional, Advisory Role: OncoMed; Financial Interests, Institutional, Advisory Role: Leap Therapeutics; Financial Interests, Institutional, Advisory Role: TG Therapeutics; Financial Interests, Institutional, Advisory Role: AstraZeneca; Financial Interests, Institutional, Advisory Role: Boehringer Ingelheim; Financial Interests, Institutional, Advisory Role: Daiichi Sankyo; Financial Interests, Institutional, Advisory Role: Bayer; Financial Interests, Institutional, Advisory Role: Incyte; Financial Interests, Institutional, Advisory Role: Apexigen; Financial Interests, Institutional, Advisory Role: Array BioPharma; Financial Interests, Institutional, Advisory Role: Sanofi; Financial Interests, Institutional, Advisory Role: ARMO BioSciences; Financial Interests, Institutional, Advisory Role: Ipsen; Financial Interests, Institutional, Advisory Role: Merrimack; Financial Interests, Institutional, Advisory Role: Oncogenex; Financial Interests, Institutional, Advisory Role: FORMA Therapeutics; Financial Interests, Institutional, Advisory Role: Arch Oncology; Financial Interests, Institutional, Advisory Role: Prelude Therapeutics; Financial Interests, Institutional, Advisory Role: Phoenix Biotech; Financial Interests, Institutional, Advisory Role: Cyteir; Financial Interests, Institutional, Advisory Role: Molecular Partners; Financial Interests, Institutional, Advisory Role: Innate Pharma; Financial Interests, Institutional, Advisory Role: Torque; Financial Interests, Institutional, Advisory Role: Tizona Therapeutics, Inc.; Financial Interests, Institutional, Advisory Role: Janssen; Financial Interests, Institutional, Advisory Role: Tolero Pharmaceuticals; Financial Interests, Institutional, Advisory Role: TD2; Financial Interests, Institutional, Advisory Role: Amgen; Financial Interests, Institutional, Advisory Role: Seattle Genetics; Financial Interests, Institutional, Advisory Role: Moderna Therapeutics; Financial Interests, Institutional, Advisory Role: Tanabe Research; Financial Interests, Institutional, Advisory Role: Beigene; Financial Interests, Institutional, Advisory Role: Continuum Clinical; Financial Interests, Institutional, Advisory Role: Cerulean Pharma; Financial Interests, Institutional, Advisory Role: Kyn Therapeutics; Financial Interests, Institutional, Advisory Role: Bicycle Therapeutics; Financial Interests, Institutional, Advisory Role: Relay Therapeutics; Financial Interests, Institutional, Advisory Role: Evelo Therapeutics; Financial Interests, Institutional, Advisory Role: Fusion Pharmaceuticals; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Merck; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche/Genentech; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Celgene; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Daiichi Sankyo; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Gilead Sciences; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Bristol-Myers Squibb; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Lilly; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: MedImmune; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Taiho Pharmaceutical; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Novartis; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: OncoMed; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Boehringer Ingelheim; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: ARMO BioSciences; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Ipsen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: FORMA Therapeutics; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Genentech/Roche; Financial Interests, Institutional, Research Grant: Incyte; Financial Interests, Institutional, Research Grant: Gilead Sciences; Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb; Financial Interests, Institutional, Research Grant: Leap Therapeutics; Financial Interests, Institutional, Research Grant: AstraZeneca/MedImmune; Financial Interests, Institutional, Research Grant: Boston Biomedical; Financial Interests, Institutional, Research Grant: GlaxoSmithKline; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Array BioPharma; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical; Financial Interests, Institutional, Research Grant: Celgene; Financial Interests, Institutional, Research Grant: OncoMed; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: Apexigen; Financial Interests, Institutional, Research Grant: Kolltan Pharmaceuticals; Financial Interests, Institutional, Research Grant: SynDevRx; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Macrogenics; Financial Interests, Institutional, Research Grant: Five Prime Therapeutics; Financial Interests, Institutional, Research Grant: EMD Serono; Financial Interests, Institutional, Research Grant: TG Therapeutics; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Forty Seven; Financial Interests, Institutional, Research Grant: Stem CentRx; Financial Interests, Institutional, Research Grant: Onyx; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: Takeda; Financial Interests, Institutional, Research Grant: Abbott/AbbVie; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Celldex; Financial Interests, Institutional, Research Grant: Agios; Financial Interests, Institutional, Research Grant: ARMO BioSciences; Financial Interests, Institutional, Research Grant: CytomX Therapeutics; Financial Interests, Institutional, Research Grant: Nektar; Financial Interests, Institutional, Research Grant: Ipsen; Financial Interests, Institutional, Research Grant: Merrimack; Financial Interests, Institutional, Research Grant: Tarveda Therapeutics; Financial Interests, Institutional, Research Grant: Tyrogenex; Financial Interests, Institutional, Research Grant: Oncogenex; Financial Interests, Institutional, Research Grant: Marshall Edwards; Financial Interests, Institutional, Research Grant: Pieris Pharmaceuticals; Financial Interests, Institutional, Research Grant: Mersana; Financial Interests, Institutional, Research Grant: Calithera Biosciences; Financial Interests, Institutional, Research Grant: Blueprint Medicines; Financial Interests, Institutional, Research Grant: Gritstone Oncology; Financial Interests, Institutional, Research Grant: Evelo Therapeutics; Financial Interests, Institutional, Research Grant: FORMA Therapeutics; Financial Interests, Institutional, Research Grant: Forty Seven; Financial Interests, Institutional, Research Grant: EMD Serono; Financial Interests, Institutional, Research Grant: Merus; Financial Interests, Institutional, Research Grant: Jacobio; Financial Interests, Institutional, Research Grant: eFFECTOR Therapeutics; Financial Interests, Institutional, Research Grant: Novocure; Financial Interests, Institutional, Research Grant: Sorrento Therapeutics; Financial Interests, Institutional, Research Grant: Arrys Therapeutics; Financial Interests, Institutional, Research Grant: TRACON Pharma; Financial Interests, Institutional, Research Grant: Sierra Oncology; Financial Interests, Institutional, Research Grant: Innate Pharma; Financial Interests, Institutional, Research Grant: Prelude Therapeutics; Financial Interests, Institutional, Research Grant: Arch Oncology; Financial Interests, Institutional, Research Grant: Harpoon therapeutics; Financial Interests, Institutional, Research Grant: Phoenix Biotech; Financial Interests, Institutional, Research Grant: Unum Therapeutics; Financial Interests, Institutional, Research Grant: Vyriad; Financial Interests, Institutional, Research Grant: Harpoon therapeutics; Financial Interests, Institutional, Research Grant: cyteir; Financial Interests, Institutional, Research Grant: Molecular Partners; Financial Interests, Institutional, Research Grant: Innate Pharma; Financial Interests, Institutional, Research Grant: ADC Therapeutics; Financial Interests, Institutional, Research Grant: Torque; Financial Interests, Institutional, Research Grant: Tizona Therapeutics, Inc.; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: BeiGene; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Millenium Pharamceuticals; Financial Interests, Institutional, Research Grant: ImClone Systems; Financial Interests, Institutional, Research Grant: Acerta Pharma; Financial Interests, Institutional, Research Grant: Rgenix; Financial Interests, Institutional, Research Grant: Bellicum Pharmaceuticals; Financial Interests, Institutional, Research Grant: Arcus Biosciences; Financial Interests, Institutional, Research Grant: Gossamer Bio; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Tempest Therapeutics; Financial Interests, Institutional, Research Grant: Shattuck Labs; Financial Interests, Institutional, Research Grant: Synthorx; Financial Interests, Institutional, Research Grant: Revolution Medicines; Financial Interests, Institutional, Research Grant: Bicycle Therapeutics; Financial Interests, Institutional, Research Grant: Zymeworks; Financial Interests, Institutional, Research Grant: Relay Therapeutics; Financial Interests, Institutional, Research Grant: Evelo Therapeutics; Financial Interests, Institutional, Research Grant: Scholar Rock; Financial Interests, Institutional, Research Grant: NGM Biopharmaceuticals; Financial Interests, Institutional, Research Grant: Numab; Financial Interests, Institutional, Research Grant: AtlasMedx; Financial Interests, Institutional, Research Grant: Treadwell Therapeutics. All other authors have declared no conflicts of interest.

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