462PA phase I open-label, non-randomized study of recombinant super-compound interferon (rSIFN-co) in patients with advanced solid tumours
ConclusionsThe RP2D of rSIFN-co was 30ug (1.6  × 107IU) 3x/week for 21days followed by 7 days ’ rest. Anti-tumour activity seen in heavily pre-treated advanced solid tumor patients. especially in HCC. Future plans involve combinations with other immunotherapies.Clinical trial identificationNCT02387307.Legal entity responsible for the studySichuan Huiyang Life Science and Technology Corporation.FundingSichuan Huiyang Life Science and Technology Corporation.DisclosureAll authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

240PUnravelling the biological characteristics of MammaPrint extreme risk subgroups
ConclusionsOur preliminary findings give additional insights into the biological processes associated with extreme MP groups, which might open new avenues for therapeutic intervention in breast cancer.Legal entity responsible for the studyAgendia Inc.FundingAgendia Inc.DisclosureR. Bhaskaran: Full / Part-time employment: Agendia Inc. C. Griffioen: Full / Part-time employment: Agendia Inc. D. Wehkamp: Full / Part-time employment: Agendia Inc. L. Mittempergher: Full / Part-time employment: Agendia Inc. A.M. Glas: Full / Part-time employment: Agendia Inc. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

6PDThe mutational signature of spontaneously developing tumours in MLH1-/- mice: Potential consequences for immunotherapeutic approaches
ConclusionsThe present study is the first reporting results of a comparison between different spontaneously developing tumors as models for MMR-D driven tumorigenesis. Additionally to identifying ARID1A as causative mutation hotspot, this comprehensive characterization of the mutational landscape may be a good starting point to predict antigens for vaccination approaches.Legal entity responsible for the studyThe authors.Fundinggerman research foundation (DFG); grant number: MA5799/2-1.DisclosureAll authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

1134PMonalizumab in combination with cetuximab in patients (pts) with recurrent or metastatic (R/M) head and neck cancer (SCCHN) previously treated or not with PD-(L)1 inhibitors (IO): 1-year survival data
ConclusionsIn a cohort of 40 patients of heavily pretreated SCCHN patients, monalizumab and cetuximab combination demonstrated high response rate, good duration of response, and promising PFS and OS as well as good safety profile. An additional R/M SCCHN cohort of 40 patients who received both platinum-based chemotherapy and IO is being enrolled in this study.Clinical trial identificationNCT02643550.Legal entity responsible for the studyInnate Pharma.FundingInnate Pharma.DisclosureR.B. Cohen: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Innate Pharma; Honoraria (self), Advisory / Consul...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

1582PEstimating the cost and survival impact of new aNSCLC therapies in Canada with the iTEN model
ConclusionsNew therapies for aNSCLC are likely to increase the survival and average cost of treatment in Canada.Legal entity responsible for the studyThe authors.FundingAstraZeneca Canada.DisclosureP.K. Cheema: Honoraria (self), Advisory / Consultancy: AstraZeneca Canada, BI, BMS, Roche, Pfizer, Novartis, Takeda and Merck,. W.K. Evans: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca Canada, AbbVie, Astellas, BMS, Eisai, Lilly, Janssen, Gilead, Takeda, Boehringer Ingelheim, Roche and Celgene. R. Burkes: Honoraria (self), Advisory / Consultancy: AstraZeneca Canada. R. Sangha: Honorari...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

241PResidual cancer burden as a prognostic factor in a large series of neoadjuvant chemotherapy. Subgroup analysis per molecular surrogated subtypes
ConclusionsIn our large series the RCB is reproducible as a surrogate of survival special in those chemo sensitive tumors such as Her2 and triple negative ones.Legal entity responsible for the studyThe authors.FundingHas not received any funding.DisclosureAll authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

463PEvaluation of pharmacodynamic (PD) biomarkers in advanced cancer patients treated with oxidative phosphorylation (OXPHOS) inhibitor, OPC-317 (OPC)
ConclusionsWe identified novel tumor/blood PD biomarkers with clear evidence of target modulatory effects at clinically tolerable doses of OPC. With validation, they can aid the clinical development of OXPHOS inhibitors as a novel class of cancer therapy.Clinical trial identificationNCT03158324.Legal entity responsible for the studyOtsuka Pharmaceutical Co. Ltd.FundingOtsuka Pharmaceutical Co. Ltd.DisclosureD.S. Tan: Honoraria (self): Roche; Honoraria (self), Research grant / Funding (institution): Bayer; Honoraria (self): MSD; Honoraria (self): Genmab; Honoraria (self), Research grant / Funding (institution): AstraZeneca;...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

7PDSynergistic anti-cancer activity of auranofin with anti-PD-L1 therapy in triple negative breast cancer
ConclusionsOur data provides a novel therapeutic strategy using auranofin in combination with anti-PD-L1 antibody for TNBCs and warrants further clinical investigation for TNBC patients. Since the success rate of anti-PD-L1 therapy is very low in TNBC patients, our data provides a novel strategy to use auranofin with anti-PD-L1 therapy to that may enhance the efficacy of immune checkpoint therapy in TNBC patients.Legal entity responsible for the studyThe authors.FundingCure Cancer Australia& Can Too Foundation Project grant [ID 1147230] to Prahlad Raninga National Health& Medical Research Council (NH&MRC) Progr...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

242PClinical validation of CanAssist breast in a Spanish cohort
ConclusionsCAB performs well in stratifying risk of recurrence in this Spanish cohort with the data matching performance shown earlier with the mix of Asian and Caucasian patients. In the absence of any inter-mediate risk category in CAB, it offers a cost effective alternative to existing prognostic tests providing definitive results to plan treatment of early stage breast cancer patients.Legal entity responsible for the studyManjiri M. Bakre.FundingHas not received any funding.DisclosureM. Bakre: Leadership role, Full / Part-time employment, Officer / Board of Directors, CEO and Founder: OncoStem Diagnostics Pvt Limted. (...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

1135PUpdated results of a phase II study evaluating accelerator-based boron neutron capture therapy (AB-BNCT) with borofalan(10B) (SPM-011) in recurrent squamous cell carcinoma (R-SCC-HN) and recurrent and locally advanced non-SCC (R/LA-nSCC-HN) of the head and neck
ConclusionsThese data suggest that AB-BNCT with borofalan(10B) emerges as a promising treatment option for pts with R –SCC- HN or R/LA-nSCC-HN with no other treatment option.Clinical trial identificationJapicCTI-194640.Legal entity responsible for the studySumitomo Heavy Industries, Ltd, Stella Pharma Corporation.FundingFukushima prefectural subsidy for development and testing of global cutting-edge medical devices.DisclosureK. Hirose: Research grant / Funding (self), Travel / Accommodation / Expenses: Sumitomo Heavy Industries, Ltd; Travel / Accommodation / Expenses: Stella Pharma Corporation. K. Ono: Advisory / Consult...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

1583PSMARCA4 deficient non-small cell lung cancer (NSCLC): A comprehensive genomic profiling (CGP) study
ConclusionsSMARCA4d NSCLC is characterized by pleomorphic histology, TTF1- IHC and significant reduction in targetable driver mutations in genes such as EGFR, ALK, ROS1 and NTRK1-3. Despite new evidence that SMARCA4d tumors can respond to cell cycle inhibitors such as palbociclib, the CDK4/6 mutation frequencies is not increased in this tumor subset. Higher TMB levels in SMARCA4d NSCLC suggests strong potential for immunotherapy benefit, but the significantly enriched STK11 GA frequency may reduce overall response rates to checkpoint inhibitors.Legal entity responsible for the studyFoundation Medicine.FundingFoundation Med...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

464PPharmacokinetic (PK) assessment of BT1718: A phase I/II a study of BT1718, a first in class bicycle toxin conjugate (BTC), in patients (pts) with advanced solid tumours
ConclusionsBT1718 is a first in class BTC which is generally well tolerated at the present dose level. Current plasma and tumor PK data are consistent with proposed preclinical mechanism of tumor targeted toxin delivery.Clinical trial identificationNCT03486730.Legal entity responsible for the studyCancer Research UK.FundingCancer Research UK and BicycleRD Limited.DisclosureN. Cook: Advisory / Consultancy: Tarveda Therapeutics; Advisory / Consultancy: Epigene Therapeutics. U. Banerji: Advisory / Consultancy: Astellas; Advisory / Consultancy: Novartis; Advisory / Consultancy: Karus Therapeutics; Advisory / Consultancy: Phoen...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

8PDAutomatic interpretation of cancer genomes creates the largest repository of tumour genetic driver events
ConclusionsAll the results and framework are available online to the cancer genomics research community atwww.intogen.org, which we envision can support a broad range of oncology use cases.Legal entity responsible for the studyInstitute for Research in Biomedicine (IRB, Barcelona).FundingMinisterio de Educaci ón y Ciencia de España (SAF-2015-R-66084 and RTI2018-094095-B-I00) Instituto Nacional de Bioinformática (INB) - PT17/0009/0013.DisclosureAll authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

243PMeta-analysis on association of pathological complete response with long-term survival outcomes in triple-negative breast cancer
ConclusionsThis study confirms the strong association between pCR and survival outcomes in TNBC based on evidence synthesis from both clinical and real-world settings. In addition, this study suggests potential survival benefit of subsequent adjuvant therapy for TNBC patients who received neoadjuvant therapy.Legal entity responsible for the studyMerck& Co., Inc.FundingMerck& Co., Inc.DisclosureP.A. Fasching: Advisory / Consultancy: Merck& Co., Inc. M. Huang: Full / Part-time employment: Merck& Co., Inc. J. Cort és: Advisory / Consultancy: Merck& Co., Inc. J. Zhao: Full / Part-time employment: Merck&...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research

1136PPhase III KEYNOTE-048 study of first-line (1L) pembrolizumab (P) for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Asia vs non-Asia subgroup (subgrp) analysis
ConclusionsP vs E showed favorable OS in Asia and non-Asia subgrps, regardless of PD-L1 status; responses were durable, particularly among all non-Asia subgrps; safety was favorable. P+C vs E showed favorable OS in pts with CPS ≥20 in Asia and non-Asia subgrps regardless of PD-L1 status, durable responses, and similar safety.Clinical trial identificationNCT02358031.Editorial acknowledgementDoyel Mitra, PhD, and Dana Francis, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA), funded by Merck Sharp& Dohme Corp., a subsidiary of Merck& Co., Inc., Kenilworth, NJ, USA.Legal entity responsible for the studyMe...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research