LBA4 Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced non-squamous NSCLC in KEYNOTE-042
ConclusionFindings of this descriptive exploratory analysis suggest that pembrolizumab monotherapy should be considered as a standard first-line treatment option for PD-L1-positive advanced non-squamous NSCLC regardless of KRAS mutational status. These findings also suggest that a pembrolizumab-containing regimen is a clinically relevant comparator for studies of KRAS -targeted therapy given as first-line treatment of NSCLC. Table: LBA4With Any KRAS MutationWith KRAS G12C MutationWithout Any KRAS MutationPembro Mono-therapy (N = 30)Chemo-therapy (N = 39)Pembro Mono-therapy (N = 12)Chemo-therapy (N = 17)Pem...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
51P Oncologists ’ consideration of health-related quality of life in clinical practice for immune-checkpoint inhibitors-treated patients: An online patients community research
ConclusionAccording to patients, HRQoL consideration mostly relies on oncologists. Integration of HRQoL in clinical practice could be optimized by increasing frequency of dedicated interactions and by extending discussions to the less often addressed dimensions.Legal entity responsible for the studyCarenity.FundingBristol-Myers Squibb.DisclosureO. Wilczynski: Honoraria (institution): Bristol-Myers Squibb. A. Boisbouvier: Honoraria (institution), Full / Part-time employment: Bristol-Myers Squibb. L. Radoszycki: Honoraria (institution): Bristol-Myers Squibb. F-E. Cott é: Full / Part-time employment: Bristol-Myers Squibb. A-...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
91O A multi-center phase IIa trial to assess the safety and efficacy of BL-8040 (a CXCR4 inhibitor) in combination with pembrolizumab and chemotherapy in patients with metastatic pancreatic adenocarcinoma (PDAC)
ConclusionPreliminary data from the ongoing COMBAT study Cohort 2 with the triple combination of BL-8040, Pembrolizumab and chemo, show promising ORR (4/15) and DC (12/15) results. Median PFS and OS have not yet been reached.Clinical trial identificationNCT02826486.Legal entity responsible for the studyThe authors.FundingBiolinerx.DisclosureM. Hidalgo: Full / Part-time employment: Beth Israel Deaconess Medical Center; Full / Part-time employment: Harvard Medical School; Full / Part-time employment: Weill Cornell Medical College. V. Semenisty: Full / Part-time employment: Rambam Health Care Campus. B. Bockorny: Full / Part-...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
113P A phase I study of an anti-IDO1 inhibitor (LY3381916) as monotherapy and in combination with an anti-PD-L1 antibody (LY3300054) in patients with advanced cancer
ConclusionLY3381916 is safely administered as monotherapy and in combination with LY3300054. The 240mg dose QD is the RP2D for combination with PD-L1 in expansion cohorts.Clinical trial identificationNCT03343613.Editorial acknowledgementEditorial assistance was provided by Gina Moore, Syneos Health.Legal entity responsible for the studyEli Lilly and Company.FundingEli Lilly and Company.DisclosureB. O'Neil: Shareholder / Stockholder / Stock options: Eli Lilly and Company; Full / Part-time employment: Eli Lilly and Company. S. Jalal: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution):...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
LBA2 First-line durvalumab plus platinum-etoposide in extensive-stage (ES)-SCLC: Safety, pharmacokinetics (PK) and immunogenicity in CASPIAN
ConclusionIn CASPIAN, the incidence of ADA to D was low and the safety profile of D+EP was consistent with previous reports of both D and EP.Clinical trial identificationNCT03043872 (release date: February 6, 2017).Editorial acknowledgementMedical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Craig Turner, MSc, of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.Legal entity responsible for the studyAstraZeneca PLC.FundingAstraZeneca.DisclosureM. Özgüroğlu: Advisory / Consultancy, Advisory board participation: Jansse...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
159P Supportive roles of microglia in breast cancer brain metastases
ConclusionOur study shows that metastatic cancer cells may employ microglia to facilitate colonization of brain parenchyma. OPN production is elevated in cultured breast cancer cells and CNS breast cancer metastases. OPN can mediate interactions between microglia and metastatic cancer cells. Minocycline interferes with those interactions and may impair creating a metastatic niche and cancer progression.Legal entity responsible for the studyNencki Institute of Experimental Biology.FundingFoundation for Polish Science Team Tech Core Facility: Development of comprehensive diagnostics and personalized therapy in neuro-oncology...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
147P A personalised approach for anti-GITR-based immunotherapy in pre-clinical models of pancreatic ductal adenocarcinoma
ConclusionOur models recapitulate the immunological gene expression profiles observed in patient PDA samples making them a highly useful resource to study personalized immunotherapies. This integrated study highlights the importance of patient selection to maximize therapy benefit and spare immune related adverse events.Legal entity responsible for the studyThe authors.FundingBristol-Myers Squibb.DisclosureD. Cunningham: Research grant / Funding (self): Amgen; Research grant / Funding (self): Sanofi; Research grant / Funding (self): Merrimack; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): C...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
45P 5-AZA treatment induces cytotoxicity and in vitro expression of immunogenic NY-ESO-1 antigen in non-small lung cancer cell NCI-H1975
ConclusionOur study shows that 5-AZA cytotoxic effect would induce the expression of the immunogenic NY-ESO-1 antigen leading to activation of T cells mediated immune response. Our data infers the potential use of 5-AZA for lung cancer treatment.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
LBA5 KRAS mutational status and efficacy in KEYNOTE-189: Pembrolizumab (pembro) plus chemotherapy (chemo) vs placebo plus chemo as first-line therapy for metastatic non-squamous NSCLC
ConclusionBased on this descriptive exploratory analysis, pembrolizumab plus pemetrexed and a platinum should be a standard first-line treatment for pts with metastatic non-squamous NSCLC regardless of KRAS mutation status. Table: LBA5With Any KRAS MutationWith KRAS G12C MutationWithout Any KRAS MutationPembro + Chemo (N = 59)Placebo + Chemo (N = 30)Pembro + Chemo (N = 26)Placebo + Chemo (N = 11)Pembro + Chemo (N = 145)Placebo + Chemo (N = 55)ORR, % (95% CI)40.726.750.018.247.610.9(28.1-54.3)(12.3-45.9)(29.9-70.1)(2.3-51.8)(39.2-56.0)(4.1-22.3)PFS, median, mo (95% CI)9 (7-14)5 (5-9)11 (6-18) 5 (5-N...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
52P Chronic and late-onset toxicities from immune checkpoints inhibitors (ICIs): Analysis of the publications leading to ICIs approval between 2011 and 2019
ConclusionDescription of toxicity in publications of clinical trials of ICIs is often suboptimal especially in terms of duration and long-term sequelae. Future efforts should focus on capturing the real impact of irAEs on patients ’ QoL to better define treatments value.Legal entity responsible for the studyThe authors.FundingHas not received any funding.DisclosureG. Valabrega: Honoraria (self): Roche; Honoraria (self): Amgen; Honoraria (self): AstraZeneca; Honoraria (self): PharmaMar; Honoraria (self): Tesaro. M. Aglietta: Honoraria (self): Tesaro; Honoraria (self): Roche; Honoraria (institution): AstraZeneca. M. Di Mai...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
130O Association of long non-coding RNA biomarkers with clinically immune subtype and prediction of immunotherapy in patients with cancer
ConclusionWe suggested immunotherapy for patients in Immune-Functional Class, especially for those in high CTL Immune-Active Class. Multiomics comprising lncRNA score, PD-L1 expression and TMB could accurately predict immunotherapy efficacy.Legal entity responsible for the studyHerui Yao.FundingGrants from the National Natural Science Foundation of China (81372819, 81572596, U1601223), the Natural Science Foundation of Guangdong Province (2017A030313828), the Guangzhou Science and Technology Program (201704020131), the Sun Yat-Sen University Clinical Research 5010 Program (2018007).DisclosureAll authors have declared no co...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
160P Novel arginase inhibitor alone and in combination with an immune check point inhibitor reduces tumour growth in murine experimental gliomas
ConclusionThese results demonstrate that arginase is a key mediator of immuno suppression in gliomas, and inhibiting Arg1 shifts the immune response toward a pro-inflammatory environment. Our results suggest that combining OAT-1746 with other immunotherapies may improve responses in glioblastoma.Legal entity responsible for the studyMolecular Neurobiology, Nencki Institute of Experimental Biology.FundingProject DIMUNO: “Development of new cancer therapies based on selective antitumour immunomodulators”, co-financed by the National Centre for Research and Development.DisclosureAll authors have declared no conflicts of i...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
LBA3 Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo as first-line (1L) treatment (tx) for advanced non-small cell lung cancer (aNSCLC): CheckMate 227 - part 2 final analysis
ConclusionCheckMate 227 Part 2 did not meet the primary endpoint of OS for NIVO + chemo vs chemo in NSQ NSCLC. Descriptive analyses showed longer OS with NIVO + chemo in all randomized pts and SQ NSCLC. No new safety signals were observed.Clinical trial identificationNCT02477826; Release date: June 23, 2015.Editorial acknowledgementWriting and editorial assistance was provided by Namiko Abe, PhD, of Caudex, funded by Bristol-Myers Squibb.Legal entity responsible for the studyBristol-Myers Squibb.FundingBristol-Myers Squibb.DisclosureL. Paz-Ares: Honoraria (self): Roche, MSD, Lilly, Novartis, Boehringer Ingelheim, AstraZene...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
35O Phase I clinical trial of PD-1 knockout anti-MUC1 CAR-T cells in the treatment of patients with non-small cell lung cancer
ConclusionOur data suggests that the treatment with PD-1 disrupted anti- MUC1-CAR cells is safe and well tolerated by all NSCLC patients. Importantly no CRS was indicated in all cases. The efficacy of this unique combined therapy was still inconclusive and will be explored in our next phase study.Clinical trial identificationNCT03525782.Legal entity responsible for the studyGuangzhou Anjie Biomedical Technology Co. Ltd.FundingGuangzhou Anjie Biomedical Technology Co. Ltd.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
LBA1 Clinical efficacy of atezolizumab (atezo) in biomarker subgroups by SP142, SP263 and 22C3 PD-L1 immunohistochemistry (IHC) assays and by blood tumour mutational burden (bTMB): Results from the IMpower110 study
ConclusionPt subgroups defined as PD-L1 –high by all 3 IHC assays (SP142, 22C3, SP263) had similar OS and PFS benefit with atezo, despite the different assay sensitivities and scoring algorithms. Enrichment in clinical benefit, favouring atezo, was also seen in bTMB positive subgroups. Atezo monotherapy is a potential new 1L tx option f or pts with PD-L1–high NSCLC. Table: LBA1SubgroupMedian OSHRaa (95% CI)AtezoChemonmonmoVENTANA SP142 (n = 554)TC1/2/3 or IC1/2/3 WT27717.527714.10.83(0.65, 1.07)TC3 or IC3 WT10720.29813.10.59(0.40, 0.89)Dako 22C3 (n = 534)22C3 BEP26817.526614.10.82(0.64, 1.06)≥ 50% TPS134...
Source: Annals of Oncology - December 15, 2019 Category: Cancer & Oncology Source Type: research
