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Found 4 Presentations For Request "duo-e LBA41"
LBA41 - Durvalumab (durva) plus carboplatin/paclitaxel (CP) followed by maintenance (mtx) durva ± olaparib (ola) as a first-line (1L) treatment for newly diagnosed advanced or recurrent endometrial cancer (EC): Results from the phase III DUO-E/GOG-3041/ENGOT-EN10 trial
- Shannon N. Westin (Houston, United States of America)
Abstract
Background
Combination of immunotherapy with CP led to improved progression-free survival (PFS) in patients (pts) with advanced EC. DUO-E (NCT04269200) evaluated addition of durva to standard 1L CP, followed by mtx durva ± ola, in pts with EC.
Methods
Pts with newly diagnosed FIGO Stage III/IV or recurrent EC and naïve to systemic treatment were randomised 1:1:1 to CP (CP + durva placebo [pbo] for 6 cycles followed by mtx durva pbo + ola pbo), CP + durva (CP + durva [1120 mg IV q3w] for 6 cycles followed by mtx durva [1500 mg IV q4w] + ola pbo), or CP + durva + ola (CP + durva for 6 cycles followed by mtx durva + ola [300 mg tablets bid]). Dual primary endpoints were PFS (investigator-assessed RECIST v1.1) in the intent-to-treat (ITT) population for CP + durva vs CP and CP + durva + ola vs CP; overall survival (OS) was a secondary endpoint. A multiple testing procedure with gatekeeping strategy was applied to PFS and OS. PFS by mismatch repair (MMR) status was a prespecified subgroup analysis.
Results
In the ITT population (N=718), CP + durva and CP + durva + ola showed statistically significant and clinically meaningful PFS benefit vs CP (Table). Interim OS data were immature (27.7%) yet with a trend towards benefit (CP + durva vs CP: HR [95% CI] 0.77 [0.56–1.07]; *Vs CP; †In censored patients.
Population Arm Median follow-up duration,† months PFS events, n/N (%) Median PFS, months HR* (95% CI) 12-/18-month PFS rate, % ITT CP 12.6 173/241 (71.8) 9.6 41.1/21.7 CP + durva 15.4 139/238 (58.4) 10.2 0.71 (0.57–0.89); 48.5/37.8 CP + durva + ola 15.4 126/239 (52.7) 15.1 0.55 (0.43–0.69); 61.5/46.3 dMMR CP 10.2 25/49 (51.0) 7.0 43.3/31.7 CP + durva 15.5 15/46 (32.6) Not reached 0.42 (0.22–0.80) 67.9/67.9 CP + durva + ola 19.2 18/48 (37.5) 31.8 0.41 (0.21–0.75) 70.0/62.7 pMMR CP 12.8 148/192 (77.1) 9.7 40.8/20.0 CP + durva 15.3 124/192 (64.6) 9.9 0.77 (0.60–0.97) 44.4/31.3 CP + durva + ola 15.2 108/191 (56.5) 15.0 0.57 (0.44–0.73) 59.4/42.0
Conclusions
DUO-E met both primary endpoints, showing statistically significant and clinically meaningful PFS improvement with the addition of durva to CP followed by maintenance durva ± ola vs CP alone. Mtx ola further improved PFS in pts with pMMR disease.
Clinical trial identification
D9311C00001; NCT04269200.
Editorial acknowledgement
Medical writing assistance was provided by Simone Boldt, PhD, at Cence, funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
This study was funded by AstraZeneca.
Disclosure
S.N. Westin: Financial Interests, Institutional, Research Grant: AstraZeneca, AvengeBio, Bayer, Bio-Path, Clovis Oncology, GSK, Mereo, Novartis, Roche/Genentech, Zentalis; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Caris, Clovis Oncology, Eisai, EQRX, Gilead, GSK, ImmunoGen, Lilly, Merck, Mereo, Mersana, NGM Bio, Nuvectis, Roche/Genentech, SeaGen, Verastem, Vincerx, Zentalis, ZielBio. K.N. Moore: Financial Interests, Personal, Advisory Board: AstraZeneca, Aravive, Alkemeres, Blueprint Pharma, Eisai, Emd Serono, GSK/Tesaro, Genentech/Roche, Hengrui, Immunogen, IMab, Mereo, Myriad, Caris, Mersana, Novartis, Novocure, OncXerna, OncoNova, Tarveda, VBL Therapeutics, Clovis, Caris, Lilly, Nonvartis, Pannavance, Verastem, Zentalis, Merck; Financial Interests, Institutional, Advisory Board, advisory board work for gynecologic trial: Aadi; Financial Interests, Institutional, Advisory Board, work on clinical trial and planning for next trial: duality; Financial Interests, Personal, Full or part-time Employment: GOG Partners Associate Director; Financial Interests, Institutional, Full or part-time Employment: NRG Ovarian Cancer Chair; Financial Interests, Personal, Member of Board of Directors, not reimbursed: ASCO; Financial Interests, Institutional, Member of Board of Directors, not reimbursed: GOG Foundation; Financial Interests, Personal, Royalties: UP to Date; Financial Interests, Institutional, Coordinating PI, international CO-PI, local site PI: AstraZeneca; Financial Interests, Institutional, Coordinating PI: Immunogen, GSK/Tesaro, PTC Therapeutics, duality; Financial Interests, Institutional, Local PI: Lilly, Daiichi Sankyo, Regeneron, Artios, Bolt, verastem; Non-Financial Interests, Member of Board of Directors: GOG. J. Lee: Financial Interests, Personal, Invited Speaker: AstraZeneca, Takeda, MSD, Roche; Financial Interests, Personal, Advisory Board: Eisai, GI Innovation; Financial Interests, Institutional, Local PI: Alkermes, AstraZeneca, BergenBio, Cellid, Clovis Oncology, Eisai, GI Innovation, ImmunoGen, Janssen, Merck, Mersana, MSD, Novartis, OncoQuest, Roche, Seagen, Synthon; Financial Interests, Personal and Institutional, Local PI: BeiGene; Financial Interests, Personal, Steering Committee Member: AstraZeneca, OncoQuest, Seagen, ImmunoGen, MSD; Financial Interests, Institutional, Research Grant: ONO, Takeda. M. Sundborg: Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Speaker, Consultant, Advisor: GSK. J. de la Garza: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Merck, Seagen; Non-Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Other, DaVinci Robot proctor: Intuitive. T. Tillmanns: Financial Interests, Personal, Speaker, Consultant, Advisor: GSK, Eisai. F. Contreras Mejia: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Eli-Lilly, GSK, MSD, Novartis; Financial Interests, Personal, Advisory Board: BMS, Eli-Lilly, Janssen; Financial Interests, Personal, Expert Testimony: GSK, MSD. A.C. de Melo: Financial Interests, Institutional, Research Grant: Amgen, AstraZeneca, Bristol Myers Squibb, Clovis Oncology, GSK, Merck Sharp & Dohme, Novartis, Regeneron, and Roche; Financial Interests, Personal, Other, Honoraria for lectures: AstraZeneca, Bristol Myers Squibb, GSK, Merck Sharp & Dohme, Novartis, Roche, and Sanofi; Financial Interests, Personal, Advisory Board: AstraZeneca, Bristol Myers Squibb, GSK, Merck Sharp & Dohme, Novartis, and Roche. D. Klasa-Mazurkiewicz: Financial Interests, Personal, Other, Honoraria for lectures: AstraZeneca, GSK and Roche. C.A. Papadimitriou: Financial Interests, Personal, Other, Honoraria: Novartis, AstraZeneca, Genesis, MSD Oncology, Servier, WinMedica; Financial Interests, Personal, Advisory Role: Amgen, Astellas, BioPharma, Roche Hellas, AstraZeneca; Financial Interests, Institutional, Research Funding: Roche Hellas, WinMedica, Servier. M. Gil Martín: Financial Interests, Personal, Invited Speaker: MSD, AstraZeneca, GSK; Financial Interests, Personal, Other, Registration and attending scientific meetings: MSD, Clovis, GSK.. B. Brasiuniene: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Expert Testimony: AstraZeneca; Financial Interests, Personal, Other, Reimbursement of travel expenses: AstraZeneca; Non-Financial Interests, Personal, Advisory Board, Member of NSGO and NSGO-CTU scientific committee member: NSGO. C. Donnelly: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. X. Liu: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. E. Van Nieuwenhuysen: Financial Interests, Institutional, Advisory Board: Regeneron, Oncoinvent; Financial Interests, Institutional, Local PI: Regeneron, Oncoinvent, Roche, Seagen, Merck, Novartis; Financial Interests, Institutional, Steering Committee Member: AstraZeneca; Financial Interests, Institutional, Coordinating PI: AstraZeneca. All other authors have declared no conflicts of interest.
386MO - Trastuzumab duocarmazine versus physician's choice therapy in pre-treated HER2-positive metastatic breast cancer: Final results of the phase III TULIP trial
- Philippe G. Aftimos (Anderlecht, Belgium)
Abstract
Background
Trastuzumab duocarmazine (T-Duo, SYD985) is a HER2-targeting antibody-drug conjugate comprised of trastuzumab bound to the DNA alkylating agent duocarmazine with a drug-antibody ratio of 2.4 to 2.8. TULIP is a randomized, international, multicenter, phase 3 study in patients with pre-treated HER2-positive metastatic breast cancer (MBC). The initial analysis of the primary endpoint progression free survival (PFS) showed a clinically meaningful and statistically significant difference in favor of T-Duo versus physician's choice (PC) (Saura
Methods
The TULIP trial randomly assigned patients with HER2-positive locally advanced or MBC with ≥2 previous HER2-targeting MBC regimens or pretreated with T-DM1, in a 2:1 ratio between T-Duo (1.2 mg/kg q3w) and PC. PC could be either trastuzumab combined with capecitabine or vinorelbine or eribulin or lapatinib plus capecitabine. The primary endpoint was PFS by blinded, independent, central review. Key secondary endpoints are PFS by investigator, OS, overall response rate, QoL, duration of response and safety.
Results
A total of 291 patients were randomized to the T-Duo group and 146 to the PC group. At the data cut off, the median follow-up of the T-Duo and PC groups were 35.6 months and 32.0 months, respectively. Median OS was 21.0 months in the T-Duo group and 19.5 months in the PC group. The hazard ratio was 0.87 (95% CI 0.68, 1.12) p=0.236. The 1-year survival estimate was 70% in the T-Duo group and 68% in the PC group. The primary endpoint PFS (7.0 vs 4.9 months, HR 0.63, p=0.002) and other secondary efficacy outcomes did not change in this analysis compared to the initial analysis. No new safety findings were observed with longer follow-up.
Conclusions
T-Duo showed a meaningful and statistically significant improvement in PFS in patients with pre-treated HER2-positive MBC. The final OS results confirm a trend towards a numerically prolonged OS (statistically non-significant) in the T-Duo group compared with PC group. Safety was aligned with the primary analysis, with no new signals identified.
Clinical trial identification
NCT03262935, Eudract 2017-001994-18.
Legal entity responsible for the study
Byondis B.V.
Funding
Byondis B.V.
Disclosure
P.G. Aftimos: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Macrogenics, Roche, Novartis, Amcure, Servier, G1 Therapeutics, Radius, Deloitte, Menarini, Gilead, Novartis, Eisai, Lilly; Financial Interests, Personal, Invited Speaker: Synthon, Amgen; Financial Interests, Institutional, Research Grant: Roche. N. Turner: Financial Interests, Personal, Advisory Board: AstraZeneca, Lilly, Novartis, Pfizer, Roche/Genentech, GSK, Zentalis pharmaceuticals, Repare therapeutics, GSK, Relay therapeutics, Gilead, Inivata, Guardant, Exact Sciences; Financial Interests, Institutional, Funding: AstraZeneca, Pfizer, Roche/Genentech, Merck Sharpe and Dohme, Invitae, Inivata, Personalis, Natera; Financial Interests, Institutional, Other, provision of materials: BioRad; Financial Interests, Institutional, Other, Provision of assays: Guardant Health. J. O'Shaughnessy: Financial Interests, Personal, Advisory Board: Abbvie, Agendia, Amgen, Aptitude Health, AstraZeneca, Bristol Myers Squibb, Celgene, Eisai, G1 Therapeutics, Genentech, Immunomedics, Ipsen Biopharmaceuticals, Lilly, Merck, Myriad, Novartis, Ondonate, Pfizer, Puma, Prime Oncology, Roche, Seattle Genetics, Syndax, Carrick Therapeutics, Daiichi Sankyo, Gilead Sciences, Ontada, Pierre Fabre Pharmaceuticals, Samsung Bioepis, Sanofi. E. van den Tweel: Financial Interests, Personal, Full or part-time Employment, Clinical Project Leader: Byondis B.V.. M. Oesterholt: Financial Interests, Personal, Full or part-time Employment, Clinical Project leader: Byondis BV. S. Escrivá-de-Romaní: Financial Interests, Personal, Advisory Board: Roche, Daiichi Sankyo/AstraZeneca, Seagen, Pierre-Fabre, COR2ED; Financial Interests, Personal, Invited Speaker: Roche, Daiichi Sankyo/AstraZeneca, Pfizer, Seagen, Novartis; Financial Interests, Personal, Other, Travel grants: Pfizer, Kern; Financial Interests, Institutional, Local PI: Roche, Synthon, Byondis, Lilly, MedSIR, Zymeworks, Daiichi Sankyo/AstraZeneca, SOLTI. N. Quenel Tueux: Financial Interests, Personal, Advisory Board: Pfizer, Astra Zenica, Daiichi; Financial Interests, Personal, Other, Support for congresses: Novartis, Lilly, MSD, Seagen, Gilead, Astra Zenica, Daiichi. T.J.Y. Tan: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Everest Medicines (Singapore) Pte Ltd, DKSH; Financial Interests, Personal, Invited Speaker: DKSH, AstraZeneca, Novartis, MSD; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Local PI: Roche, Novartis, AstraZeneca, Daiichi Sankyo, Genentech, Sanofi; Non-Financial Interests, Member: ASCO; Other, Conference sponsorship: DKSH, AstraZeneca, Novartis. J. Lim: Financial Interests, Personal, Advisory Board: Pfizer, Novartis, AstraZeneca, DKSH, MSD, Everest Medicine; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD; Financial Interests, Institutional, Local PI: Synthon pharmaceuticals, Daiichi, Taiho pharmaceuticals; Financial Interests, Institutional, Funding: CTI biopharma. S. Ladoire: Financial Interests, Personal, Advisory Board, advisory board: Pfizer, Novartis, AstraZeneca, Sanofi, Daiichi, Gilead, Menarini-Stemline; Financial Interests, Personal, Advisory Board, advisory board, expert testimony: Astellas; Financial Interests, Personal, Advisory Board, expert testimony, invited speaker: Janssen, Ipsen; Financial Interests, Personal, Invited Speaker, invited speaker: BMS, Seagen, Exact Science; Financial Interests, Personal, Invited Speaker, invited speaker, expert testimony: Lilly; Financial Interests, Institutional, Research Grant, research grant: Novartis, Eisai, BMS. A.C. Armstronh: Financial Interests, Personal, Advisory Role: AstraZeneca, MSD, Gilead; Financial Interests, Personal, Stocks/Shares, Spousal Shares: AstraZeneca; Financial Interests, Institutional, Research Funding, to institution: AstraZeneca; Non-Financial Interests, Personal, Other, Clinical lead: RCOG Breast Cancer and Pregancy Guideline; Non-Financial Interests, Personal, Other, Clinical Advisor: NICE Menopause Guideline (update). A. Stradella: Financial Interests, Personal, Advisory Board, Advisory about CAPITELLO 291 trial: AstraZeneca; Financial Interests, Personal, Advisory Board, Advisory on new activities for residents: Novartis; Financial Interests, Personal, Invited Speaker, Trastu-Deruxtecan clinical case meeting: Daiichi; Financial Interests, Personal, Invited Speaker, meeting on new data on cyclin inhibitors: Novartis. G.V. Bianchi: Financial Interests, Personal, Advisory Board: Novartis, Lilly, Roche, AstraZenica/Daiichi, MSD, Seagen. M.A. Colleoni: Financial Interests, Institutional, Research Grant: Roche; Non-Financial Interests, Leadership Role, CO-Chair Scientific Committee: International Breast Cancer Study Group. K. Punie: Financial Interests, Institutional, Advisory Board: AstraZeneca, Novartis, Roche, Vifor Pharma, Eli Lilly, Pierre Fabre, McCann Health, Roularta, Teva, Gilead Sciences, Pfizer, Gilead, MSD; Financial Interests, Institutional, Invited Speaker: Pfizer, Roche, Novartis, Eli Lilly, Mundi Pharma, MSD, Medscape; Financial Interests, Institutional, Other, Consultancy: Roche; Financial Interests, Personal, Other, Consultancy: Gilead, Novartis, MSD, Roche; Financial Interests, Personal, Invited Speaker: Sanofi, AstraZeneca, Exact Sciences, Focus Patient, Pfizer, Gilead Sciences; Financial Interests, Personal, Advisory Board: Seagen, AstraZeneca, Pfizer; Financial Interests, Personal, Ownership Interest: Need Inc.; Financial Interests, Institutional, Funding: Sanofi; Financial Interests, Institutional, Trial Chair: MSD; Non-Financial Interests, Other, Committee member: ESMO Young Oncologists Committee; Non-Financial Interests, Leadership Role, Vice President: Belgian Society of Medical Oncology BSMO; Non-Financial Interests, Other, Committee Member: ESMO Resilience Task Force; Non-Financial Interests, Leadership Role: EORTC Breast Cancer Task Force Steering Committee Member; Non-Financial Interests, Institutional, Product Samples, Drug provision for academic research: Gilead Sciences; Non-Financial Interests, Advisory Role: Commission personalized medecine Federal Government Belgium; Non-Financial Interests, Advisory Role, External Scientific Advisor: European Medicine Agency. X. Song: Financial Interests, Personal, Advisory Board: EMD, BMS, Novartis, Pfizer, merck; Financial Interests, Institutional, Local PI: AstraZeneca, BMS, Gilead, Novartis, Pfizer, Roche, Seagen. N. Koper: Financial Interests, Personal, Full or part-time Employment, VP Clinical Development: Byondis B.V.. C. Saura Manich: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Bristol Meyers Squibb, Daiichi Sankyo, Eisai, Exact Sciences, Exeter Pharma, F. Hoffmann - La Roche Ltd, Gilead, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Philips, Piere Fabre, PintPharma, Puma, Roche Farma, Sanofi-Aventis, SeaGen, Zymeworks, Genentech, Innoup, Millenium, Pharmalex Spain SLU; Financial Interests, Personal, Other, SC: Byondis B.V., Glaxo, Macrogenics, Menarini, Merus, Synthon Biopharpaceuticals; Financial Interests, Institutional, Research Grant: AstraZeneca, Bayer Pharma, Boehringer Ingelheim, Bristol Myers Squibb (BMS), Cytomx Therapeutics, Daiichi Sankyo, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Genentech, GSK, Immunomedics, Innoup Farma, Macrogenics, Menarini Ricerche, Merus, Novartis, Pfizer, Puma, Roche, Sanofi-Aventis, Seattle Genetics; Financial Interests, Institutional, Coordinating PI: Byondis B.V.; Non-Financial Interests, Member: Spanish Society of Medical Oncology (SEOM), American Society for Clinical Oncology (ASCO), Geicam (Spanish Breast Cancer Research Group), European Society for Medical Oncology (ESMO), Sinology Society of the Official College of Physicians of Barcelona (COMB); Non-Financial Interests, Member, Junta Directiva y Comité Científico: SOLTI group (Academic research group in breast cancer). All other authors have declared no conflicts of interest.
Invited Discussant LBA41 and LBA42
- Domenica Lorusso (Rome, Italy)
132MO - Molecular profiling of 991 prospectively recruited rare cancers patients in EUROPE: First results of ARCAGEN – an EORTC-SPECTA and EURACAN study
- Marie Morfouace (Darmstadt, Germany)
Abstract
Background
Within the EORTC-SPECTA platform, the ARCAGEN collaborative study between EORTC and EURACAN was initiated in June 2019 and aimed to assess the prevalence of genomic alterations, high tumor mutational burden (TMB) and microsatellite instability (MSI), as well as actionability in patients diagnosed with advanced rare cancers (defined with an incidence<6/105/y).
Methods
Patients with a rare adult solid tumor of one of the 10 domains or EURACAN in advanced phase were proposed for the ARACAGEN study as part of the SPECTA program.
Results
Within 3.5 years, 991 patients were enrolled within 14 countries in Europe, 918 were evaluable, receiving a molecular profile (92.60% success rate), with a median turn-around time of 13.25 days [range 11.5-17]. Molecular profiling was preferentially performed on FFPE material (FoundationOne, 73.5%), if not feasible, liquid biopsy was used as a rescue (FoundationOne Liquid, 26.5%). The 3 most common histotypes were cancer of unknown primary (CUP, 103, 11.2%), mesothelioma (80, 8.7%), cholangiocarcinoma (72, 7.8%). Clinically relevant molecular alterations were identified in 606 patients (66%), with top alterations seen in
Conclusions
Close to 50% of patients with rare cancers received a therapeutic recommendation based on molecular characterization, a majority within clinical trials. Molecular characterization should be recommended routinely for rare cancers in advanced phase.
Clinical trial identification
SPECTA NCT02834884.
Legal entity responsible for the study
EORTC.
Funding
Hoffman-La Roche.
Disclosure
M. Morfouace: Financial Interests, Personal, Other, Employee: Merck Healthcare. J. Oliveira: Financial Interests, Personal, Other, Advisory board, Invited Speaker: AstraZeneca, Roche, Novartis, Janssen; Financial Interests, Personal, Invited Speaker: GSK, BMS, MSD, Bayer; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Institutional, Funding, Investigator Initiated Clinical Trial funding: AstraZeneca. B. Brasiuniene: Financial Interests, Personal, Other, lecture, advisory board, publications, expert testimony; reimbursement of travel expenses: sia ; Financial Interests, Personal, Writing Engagement, editor work in the local journal: UAB; Financial Interests, Personal, Advisory Board, lecture - speaker, expert testimony; reimbursement of travel expenses: AstraZeneca Lietuva UAB; Financial Interests, Personal, Invited Speaker, lecture-speaker: Merck Serono UAB; Financial Interests, Personal, Advisory Board, lecture-speaker, writing engagement, expert testimony: ElI Lilly Lietuva UAB; Financial Interests, Personal, Advisory Board, Meeting, Conference, Scientific Programme Organization, Search for the Speakers, Chair of The Meeting, Speaker: Nacionalinis mokymų centras VŠĮ; Financial Interests, Personal, Invited Speaker, Lecture Presentation: Sevier pharma; Financial Interests, Personal, Invited Speaker, Invited Speaker, Writing Engagement: Baltmeda UAB; Financial Interests, Personal, Invited Speaker, Lecture, Speaker, Expert Testimony: Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker, Invited Speaker (chair of the season): Esmo; Financial Interests, Personal, Invited Speaker: Medison Pharma Lithuania; Financial Interests, Personal, Local PI, working in clinical trials: Novartis Pharma AG; Financial Interests, Personal and Institutional, Coordinating PI, Working with Clinical Trial: EORTC; Financial Interests, Personal, Local PI, working with clinical trial: Ergomed, AstraZeneca Lietuva UAB; Financial Interests, Personal, Steering Committee Member, SC member for ENGOT-EN10 clinical trial DUO-E: AstraZeneca; Financial Interests, Personal and Institutional, Local PI, Work with Clinical Trial: Labcorp Drug development; Financial Interests, Personal and Institutional, Local PI, Work with Clinical Trials: NSGO, PSI CRO AG; Non-Financial Interests, Member: Lithuanian Society of Oncologist; Non-Financial Interests Member, Member of Gynecological Cancer Group and Melanoma Group: EORTC; Non-Financial Interests, Member, member of NSGO and NSGO-CTU Scientific Committee Member: NSGO - Nordic Society of Gynecological oncology; Non-Financial Interests, Member: The society of Lithuanian medical oncologists; Non-Financial Interests, Member of ESMO and POWG of ESMO: ESMO; Other, Assoc. Prof position: Vilnius University of Lithuania Faculty of Medicine. L. Greillier: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, BMS, MSD, Novartis, Sanofi, Takeda, Roche; Financial Interests, Personal, Invited Speaker: Lilly, Pfizer; Financial Interests, Institutional, Local PI: AstraZeneca, AbbVie, BMS, MSD, Novartis, Takeda, Pfizer, PharmaMar; Financial Interests, Institutional, Coordinating PI: Sanofi; Financial Interests, Personal, Local PI: Roche. H.J. Klumpen: Financial Interests, Institutional, Invited Speaker, Current Treatments of Cholangiocarcinoma: Medtalk; Financial Interests, Institutional, Invited Speaker, PODCAST on treatment of HCC: CCO; Financial Interests, Institutional, Advisory Board: Janssen, AstraZeneca; Financial Interests, Institutional, Local PI, IMBRAVE 050: ROCHE; Financial Interests, Institutional, Local PI, FIGHT 302: INCYTE; Financial Interests, Institutional, Local PI, LEAP 012: MSD; Financial Interests, Institutional, Local PI, TAS120: Taiho; Financial Interests, Institutional, Local PI, COMPETE, COMPOSE: ITM Solucin GmbH; Financial Interests, Institutional, Local PI, KEYNOTE 966: MSD; Financial Interests, Institutional, Local PI, COSMIC 312: Exelixis; Other, Subdomain leader G5.1: EURACAN; Other, In the Netherlands: Member National Guideline Committee For Biliary Tract Cancer; Other, in the Netherlands: Member of the National guideline committee for HCC. L.F.L. Licitra: Financial Interests, Personal, Advisory Board, for Expert Opinion in Advisory Boards: AstraZeneca, Bayer, BMS, Eisai, MSD, Merck–Serono, Boehringer Ingelheim, Hoffmann-La Roche Ltd, Novartis, Roche, Debiopharm International SA, Sobi, Incyte Biosciences Italy srl, Doxa Pharma srl, Amgen, Nanobiotics and GSK; Financial Interests, Institutional, Research Grant, Funds received by my institution for clinical studies and research activities in which I am involved: AstraZeneca, BMS, Boehringer Ingelheim, Celgene International, Eisai, Exelixis, Debiopharm International SA, Hoffmann-La Roche Ltd, IRX Therapeutics, Medpace, Merck–Serono, Merck Healthcare KGaA, MSD, Novartis, Pfizer, Roche, Buran. N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi, Gilead; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer Ingelheim, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Non-Financial Interests, Officer, International Thymic Malignancy Interest Group, President: ITMIG; Other, Family member is an employee: AstraZeneca. J.A. Gietema: Financial Interests, Institutional, Research Grant, Research grant paid to the institution UMCG: Roche, Siemens, AbbVie. W. de Herder: Financial Interests, Personal, Advisory Board: Novartis, Ipsen; Financial Interests, Personal, Invited Speaker: Novartis, Ipsen; Non-Financial Interests, Leadership Role, Chairman EURACAN Domain 4 Rare Cancer of the Neuroendocrine System: EU. E. Kapiteijn: Financial Interests, Institutional, Advisory Board: BMS, Novartis, Pierre Fabre, Merck, Delcath, Bayer, Lilly; Financial Interests, Institutional, Coordinating PI: BMS, Pierre-Fabre, Delcath. A. Idbaih: Financial Interests, Personal, Advisory Board, Advisory board: Novocure, Leo Pharma, Boehringer Ingelheim, Novartis; Financial Interests, Institutional, Local PI, Clinical research: Enterome, Bristol Myers Squibb; Financial Interests, Institutional, Coordinating PI, Clinical research: Carthera; Financial Interests, Institutional, Local PI, Basic/Translational research: Carthera; Financial Interests, Institutional, Local PI, Basic and Translational research: Sanofi, Nutrithéragène, Servier, Transgene; Other, Travel Funding: Carthera, Leo Pharma, Novocure, Enterome. I.L. Ray-Coquard: Financial Interests, Personal, Advisory Board: Roche, GSK, AstraZeneca, Mersana, Deciphera, Amgen, Oxnea, Merck Sereno, Agenus, Novartis, Macrogenics, Clovis, EQRX, Adaptimmune, Eisai, SUTRO, BMS, Adaptimmune, Daiichi Sankyo; Financial Interests, Institutional, Other, COLIBRI translational research: BMS; Financial Interests, Institutional, Advisory Board, translational research NEOPREMBROV trial: MSD; Non-Financial Interests, Principal Investigator: PAOLA1; Non-Financial Interests, Other, President: GINECO. J. Blay: Financial Interests, Personal, Advisory Board: Bayer, Deciphera, GSK, Roche; Financial Interests, Personal, Invited Speaker: PharmaMar; Financial Interests, Institutional, Invited Speaker: MSD, MSD; Financial Interests, Personal, Other, Member of The Supervisory Board: Innate Pharma; Financial Interests, Institutional, Funding: MSD, BMS, Deciphera; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, Bayer, GSK, Novartis, OSE pharma. All other authors have declared no conflicts of interest.