119P Final results of phase II trial (MIRACULUM) of the novel PD-1 inhibitor prolgolimab in patients with advanced melanoma
ConclusionBoth dosing regimens of prolgolimab (1  mg/kg Q2W and 3 mg/kg Q3W) have durable antitumor activity and a manageable safety profile in patients with advanced melanoma.Clinical trial identificationNCT03269565.Legal entity responsible for the studyBIOCAD.FundingBIOCAD.DisclosureS. Tjulandin: Advisory / Consultancy, Speaker Bureau / Expert testimony: BIOCAD. M. Fedyanin: Advisory / Consultancy, Speaker Bureau / Expert testimony: BIOCAD. L. Demidov: Advisory / Consultancy, Speaker Bureau / Expert testimony: BIOCAD. V. Moiseyenko: Research grant / Funding (institution): BIOCAD. S. Protsenko: Advisory / Consultancy,...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

58P Risk factors for immune related adverse events: A retrospective study
ConclusionThis study helped distinguish potential risk factors for irAE, like the female gender and history of allergies. Autoimmune disorders are already reported as risk factores. However the small sample isn't enough for us to draw accurate conclusions. More prospective trials are waranted in this setting.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 - December 15, 2019 Category: Cancer & Oncology Source Type: research

38P Obtaining tumour-specific T cells in a mouse melanoma model
ConclusionWe have developed a new method to obtain potential TSL from tumor nodules. Future experiments will be directed to compare their repertoires with B16F0-specific T-cells.Legal entity responsible for the studyThe authors.FundingMinistry of Education and Science of the Russian Federation (grant No 14.W03.31.0005).DisclosureAll authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

101P Results of the NLG2105 phase I trial using the IDO pathway inhibitor indoximod, in combination with radiation and chemotherapy, for children with newly diagnosed DIPG
ConclusionAdding indoximod-based immunotherapy to conventional radiation and chemotherapy for up-front therapy of children with DIPG appears to be well tolerated with improved outcomes.Clinical trial identificationNLG2105, NCT02502708.Legal entity responsible for the studyNewLink Genetics Corporation.FundingNewLink Genetics Corporation, Alex's Lemonade Stand Foundation, Cannonball Kids cancer Foundation, Beloco Foundation, Eli ’s Block Party Foundation, Hyundai Hope on Wheels Foundation, Northern Nevada Children’s Cancer Research Foundation, CAM Fund, Press On Foundation.DisclosureT.S. Johnson: Research grant / Funding...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

76P Real-world data analysis of PD-L1 expression and overall survival (OS) in advanced non-small cell lung cancer (aNSCLC)
ConclusionThis study used administrative claims and lab test data allowing examination of effectiveness of PEM-based vs. NoICI therapy for aNSCLC. As in clinical trials, this analysis suggests OS benefit for PEM-based vs NoICI. Further analysis with longer follow-up will better assess OS benefit by TPS score.Legal entity responsible for the studyUnitedHealth Group.FundingHas not received any funding.DisclosureJ. Staib: Shareholder / Stockholder / Stock options, Full / Part-time employment: UnitedHealth Group; Shareholder / Stockholder / Stock options: Bristol Myers Squibb; Shareholder / Stockholder / Stock options: Merck; ...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

24P Multiple KRAS mutations detected by cancer related DNA in patients with resected pancreas adenocarcinoma during treatment with TG01/GM-CSF and gemcitabine (CT TG01-01)
ConclusionThe great majority of patients with PAC have multiple KRAS mutations; in addition, mutations changed during the course of the study. Single mutation vaccines and small molecules targeting single mutations are therefore unlikely to be effective while therapies targeting a mix of KRAS mutations (TG01) may be more beneficial.Clinical trial identificationCT TG01-01; EudraCT: 2012-002400-40.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 - December 15, 2019 Category: Cancer & Oncology Source Type: research

166P Insights in the mode of action of a T cell bispecific antibody in tumour bearing mice
ConclusionChanges observed in tumour bearing mice upon treatment with a tumour-targeted TCB suggest an early engagement of tumour resident T cells resulting in cytokine release locally and systemically within 2h after treatment, with homing and extravasation of inflammatory cells into the tumour progressively increasing 24h to 48h after treatment. This course of events is believed to be translatable to patients treated with TCBs.Legal entity responsible for the studyRoche Glycart AG.FundingRoche Glycart AG.DisclosureA.M. Giusti: Full / Part-time employment: Roche Glycart AG. J. Sam: Full / Part-time employment: Roche Glyca...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

59P Checkpoint inhibitors and conventional therapy for central nervous system lymphoma
ConclusionNivo is a safe and efficient option in some pts with CNS lymphoma. Appropriateness, timing and optimal regimen of nivo therapy should be determined in prospective trials.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 - December 15, 2019 Category: Cancer & Oncology Source Type: research

120P Combination of triptorelin with nivolumab in ICI resistant advanced melanoma
ConclusionThe association of triptorelin to nivolumab was well tolerated and yielded partial response in two patients.Legal entity responsible for the studyDebiopharm International S.A.FundingDebiopharm International S.A.DisclosureC. Robert: Advisory / Consultancy: Novartis, Bristol-Myers Squibb, MSD, Roche, Sanofi, Amgen, Pierre Fabre. F.J. Lejeune: Honoraria (self): Debiopharm International SA. C. Lebb é: Honoraria (self): Roche, Bristol-Myers Squibb, Novartis, MSD, Amgen, Pierre Fabre, Pfizer, Incyte; Advisory / Consultancy: Roche, Bristol-Myers Squibb, Novartis, MSD, Amgen; Travel / Accommodation / Expenses: Bristol-M...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

9P Overall assessment of tumour-infiltrating lymphocytes in early-stage nasopharyngeal carcinoma
ConclusionIn early-stage of NPC, assessment of TILs has a significant prognostic value that can be useful to identify cases with aggressive behavior. Further studies are necessary to validate the importance of TILs in larger cohorts of early NPC.Legal entity responsible for the studyAlhadi Almangush.FundingHas not received any funding.DisclosureThe author has declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

102P Results from a phase II trial of pembrolizumab (P) plus gemcitabine (Gem) in patients (pts) with HER2-negative advanced breast cancer (ABC): GEICAM/2015-04 (PANGEA-Breast) study
ConclusionP can be safely combined with Gem, the combination did not meet the efficacy objective in terms of ORR but 22.2% pts were on treatment ≥ 6 mo.Clinical trial identificationNCT03025880.Legal entity responsible for the studyGEICAM Spanish Breast Cancer Group.FundingMSD.DisclosureJ. Cruz: Honoraria (self), Advisory / Consultancy: Glaxo; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pharmamar; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advis...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

136P Profiling the tumour immune microenvironment in pleomorphic dermal sarcomas suggests its potential effectiveness for immunotherapy
ConclusionWe provide the initial comprehensive immune-phenotype profiling of PDS and two representative cases that were successfully treated with immune-checkpoint inhibitor for the first time. These results will aid in further assessment of PDS cases and formulate the qualification criteria for immunotherapy in individuals presenting this rare skin malignancy.Legal entity responsible for the studyUniversity Hospital Cologne.FundingEFRE 2018 (ImmunePredict).DisclosureAll authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

150P Intratumoural MDSC recruitment by chemotherapeutic agent, 5-FU offsets the anti-tumor activity of immune-checkpoint inhibitor in HCC
ConclusionThis study illustrated that anti-PD-L1 monotherapy enriched tumor-infiltrating T lymphocytes and NK cells, possibly accounting for the deferred tumor growth. However, the accumulation of myeloid cells in 5-FU treated mice hinders the anti-tumor activity of anti-PD-L1 from this orthotopic HCC mouse model. Therefore, low dose of 5-FU may initiate immunosuppressive mechanism to alter the effectiveness of anti-PD-L1 in HCC.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 - December 15, 2019 Category: Cancer & Oncology Source Type: research

25P Analysis of NGS-based blood immune cell RNA signatures for colorectal cancer detection
ConclusionThis study shows that measuring specific immune cell type by RNA signatures correlate with traditional cell counting methods, enabling the extraction of valuable clinical information from blood transcriptomic data. This data suggests that both blood myeloid and T cells RNA signatures are promising biomarkers for CRC detection. Further biomarker development would require the optimization of the RNA signatures to validate and increase their diagnostic power.Legal entity responsible for the studyNovigenix.FundingNovigenix.DisclosureS. Morgenthaler: Advisory / Consultancy: Novigenix. L. Ciarloni: Shareholder / Stockh...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research

77P The characteristics of long-lasting responders to PD-1 inhibitor in advanced non-small cell lung cancer patients
ConclusionLong-lasting response of PD-1 inhibitor was particularly characterized by high tumor shrinkage in patients who had response to PD-1 inhibitors.Legal entity responsible for the studyThe authors.FundingHas not received any funding.DisclosureY. Okuma: Research grant / Funding (institution): Takeda; Research grant / Funding (institution): Chugai. Y. Goto: Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eli Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Chugai; Advisory / Consul...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research