Found 19 Presentations For Request "LBA3"

Proffered Paper 1 – Gastrointestinal tumours, colorectal Proffered Paper session

Invited Discussant LBA30_PR and 522O (ID 6681)

Lecture Time
15:15 - 15:30
Speakers
  • Clara Montagut Viladot (Barcelona, Spain)
Location
Barcelona Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
28.09.2019
Time
14:45 - 16:15
Proffered Paper 1 – Gastrointestinal tumours, colorectal Proffered Paper session

Invited Discussant 523O and LBA31 (ID 6682)

Lecture Time
16:00 - 16:15
Speakers
  • Claus-Henning Koehne (Oldenburg, Germany)
Location
Barcelona Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
28.09.2019
Time
14:45 - 16:15
Proffered Paper 2 – Gastrointestinal tumours, colorectal Proffered Paper session

Invited Discussant LBA32, LBA33 and 524O (ID 6686)

Lecture Time
09:15 - 09:30
Speakers
  • Alfredo Falcone (Pisa, Italy)
Location
Barcelona Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
08:30 - 10:00
Proffered Paper 2 – Gastrointestinal tumours, colorectal Proffered Paper session

Invited Discussant LBA34 (ID 6689)

Lecture Time
09:45 - 10:00
Speakers
  • Andrew T. Chan (Boston, MA, United States of America)
Location
Barcelona Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
08:30 - 10:00
Proffered Paper 1 – Gastrointestinal tumours, colorectal Proffered Paper session

LBA30_PR - Analysis of circulating tumour DNA (ctDNA) from patients enrolled in the IDEA-FRANCE phase III trial: Prognostic and predictive value for adjuvant treatment duration (ID 5478)

Presentation Number
LBA30_PR
Lecture Time
14:45 - 15:00
Speakers
  • Julien Taieb (Paris, France)
Location
Barcelona Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
28.09.2019
Time
14:45 - 16:15

Abstract

Background

ctDNA has been recently suggested as a major prognostic factor in resected stage II and III colon cancer patients (pts)1,2. Its predictive value for adjuvant treatment intensity or duration is currently unknown. We have analyzed here ctDNA from pts enrolled in the IDEA-FRANCE trial3, its prognostic value and its predictive value for treatment duration (3 or 6 months).

Methods

ctDNA was tested by using the detection of 2 methylated markers (WIF1 and NPY) by digital droplet PCR accordingly to a method developed and validated for colorectal cancer 4-6. Comparisons for pts and tumour characteristics and DFS will be done between the ctDNA tested pts and the full study population and between ctDNA positive and negative pts. DFS has been analyzed in the 6 and 3M treatment arms according to ctDNA results. Subgroup analyses for high- and low-risk pts were pre-planned.

Results

Of the 1345/2010 pts that consented to the IDEA translational research program, with available blood sample for ctDNA testing, 805 have been sampled before chemotherapy start and fully analyzed. More PS 0 (77% vs 71%) and more T4 and/or N2 (28% vs 23%) were observed in the 805 pts studied here than in the 1205 pts left. 696 pts were found ctDNA- and 109 ctDNA + (13.5%). ctDNA+ pts were more often T4, poorly differentiated and with tumour perforation. 2-year DFS was 64% vs 82% in ctDNA+ and – pts, respectively (HR :1.75 (95%CI 1.25-2.45) p = 0.001). In multivariate analysis including Age, Gender, MSI, perforation, T stage, N stage and treatment arm, ctDNA was confirmed as an independent prognostic marker (adj.HR: 1.85 (95%CI 1.31 to 2.61) p < 0.001). Adjuvant treatment for 6 months was superior to 3 months in both ctDNA– (HR :0.69 (95%CI 0.52 to 0.93) p = 0.015) and ctDNA+ pts (HR: 0.50 (95%CI 0.27 to 0.95) p = 0.033). Interestingly ctDNA+ pts treated 6 months had a similar prognosis to ctDNA- pts treated 3 months.

Conclusions

In this first ctDNA assessment on a large series coming from a phase III clinical trial we found 13.5% of pts with ctDNA post-surgery. ctDNA was confirmed as an independent prognostic marker. In this series, 6 months of treatment seems better in both ctDNA+ and- pts. [1]Tie J, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer.Sci Transl Med. 2016 Jul 6;8(346):346ra92. [2]Schøler LV, et al. Clinical Implications of Monitoring Circulating Tumor DNA in Patients with Colorectal Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5437-5445. [3] André T, et al.Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, phase III Trial.J Clin Oncol. 2018 May 20;36(15):1469-1477. [4] Garrigou S, et al. A Study of Hypermethylated Circulating Tumor DNA as a Universal Colorectal Cancer Biomarker. Clin Chem. 2016;62:1129-1139. [5] Garlan F, et al. Early Evaluation of Circulating Tumor DNA as Marker of Therapeutic Efficacy in Metastatic Colorectal Cancer Patients (PLACOL Study). Clin Cancer Res.2017;23:5416-5425. [6] Bachet JB, et al. RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study. Ann Oncol. 2018May 1;29(5):1211-1219.

Clinical trial identification

NCT00958737.

Editorial acknowledgement

[1]Tie J, et al. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer.Sci Transl Med. 2016 Jul 6;8(346):346ra92.

[2]Schøler LV, et al. Clinical Implications of Monitoring Circulating Tumor DNA in Patients with Colorectal Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5437-5445.

[3] André T, et al.Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial.J Clin Oncol. 2018 May 20;36(15):1469-1477.

[4] Garrigou S, et al. A Study of Hypermethylated Circulating Tumor DNA as a Universal Colorectal Cancer Biomarker. Clin Chem. 2016;62:1129-1139.

[5] Garlan F, et al. Early Evaluation of Circulating Tumor DNA as Marker of Therapeutic Efficacy in Metastatic Colorectal Cancer Patients (PLACOL Study). Clin Cancer Res.2017;23:5416-5425.

[6] Bachet JB, et al. RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study. Ann Oncol. 2018May 1;29(5):1211-1219.

Legal entity responsible for the study

Gercor-Prodige.

Funding

Clinical trial: INCa, GERCOR; Translational project: ARC (Association de Recherche contre le Cancer, Paris, France).

Disclosure

J. Taieb: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: merck; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: amgen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Servier; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: pierre fabre; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Sanofi. D. Vernerey: Honoraria (self), Advisory / Consultancy: HalioDX; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Janssen. J. Bennouna: Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim. All other authors have declared no conflicts of interest.

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Proffered Paper 1 – Gastrointestinal tumours, colorectal Proffered Paper session

LBA31 - Bevacizumab plus chemotherapy versus chemotherapy alone as first-line treatment for patients with RAS mutant unresectable colorectal liver-limited metastases: A single center randomized control trial (ID 4839)

Presentation Number
LBA31
Lecture Time
15:45 - 16:00
Speakers
  • Jianmin Xu (shanghai, China)
Location
Barcelona Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
28.09.2019
Time
14:45 - 16:15

Abstract

Background

To assess the effects of bevacizumab plus chemotherapy as first-line treatment for RAS mutant unresectable colorectal liver metastases (CLMs).

Methods

From June 2013 to December 2017, patients with RAS mutant unresectable liver-limited metastases from colorectal cancer were randomly assigned to receive chemotherapy (mFOLFOX6 [modified fluorouracil, leucovorin,and oxaliplatin]) plus bevacizumab (arm A) or chemotherapy alone (arm B). The resectability of liver metastases was determined by a local multidisciplinary team. The primary end point was the rate of patients converted to resection for liver metastases. Secondary end points included tumor response, survival and toxicity. Block randomization method was used.

Results

The intent-to-treat population comprised 241 patients. 121 patients were randomly assigned to arm A and 120 to arm B. For all patients, 35.7% (86/241) had right-sided colon cancer; 47.3% (114/241) had primary tumour resection before randomization; 86.3% (208/241) had liver metastases more than three; 33.2 (80/241) with the diameter of liver metastases more than 5 cm; 78.4% (189/241) were bilobar metastases. The median follow-up time was 37.0 months for all patients. The R0 resection rates for liver metastases were 22.3% (27 of 121 patients) in arm A and 5.8% (7 of 120 patients) in arm B, with significant difference (P < 0.01). Patients in arm A had significantly better objective response rates (54.5% v 36.7%; P < 0.01), median PFS (9.5 v 5.6 months; P < 0.01) and median OS (25.7 v 20.5 months; P = 0.03) compared with those in arm B. Addition of bevacizumab was associated with more frequent proteinuria(9.9% v 3.3%; P = 0.04) and hypertension ( 8.3% v 2.5%; P < 0.05).

Conclusions

For patients with initially unresectable RAS mutant CLMs, bevacizumab combined with chemotherapy improved the resectability of liver metastases and improved response rates and survival compared with chemotherapy alone.

Clinical trial identification

NCT01972490.

Legal entity responsible for the study

Zhongshan Hospital.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Proffered Paper 2 – Gastrointestinal tumours, colorectal Proffered Paper session

LBA32 - Encorafenib plus cetuximab with or without binimetinib for BRAF V600E–mutant metastatic colorectal cancer: Expanded results from a randomized, 3-arm, phase III study vs the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC) (ID 4491)

Presentation Number
LBA32
Lecture Time
08:30 - 08:45
Speakers
  • Josep Tabernero (Barcelona, Spain)
Location
Barcelona Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
08:30 - 10:00

Abstract

Background

Encorafenib (ENCO) + binimetinib (BINI) + cetuximab (CETUX) significantly improved overall survival (OS, HR:0.52, P < 0.0001) and objective response rates (ORR, 26% vs 2%, P < 0.0001) in patients (pts) with BRAFV600E metastatic colorectal cancer (mCRC) compared with current standard of care. This analysis focuses on the triplet ((ENCO+CETUX+BINI) and doublet (ENCO+CETUX) arms.

Methods

The BEACON CRC study was a randomized, 3-arm, phase 3 study which evaluated triplet or doublet vs. investigator’s choice of irinotecan or FOLFIRI + CETUX in 665 pts with BRAFV600E mCRC. The triplet vs doublet efficacy comparison was a secondary endpoint (not formally powered). Analyses included efficacy (OS, ORR, depth of response, and progression-free survival [PFS]), multivariate modeling, safety, and quality of life (QOL) assessments (EORTC QOL Questionnaire (QLQ C30), Functional Assessment of Cancer Therapy Colon Cancer, EuroQol 5D 5L, and Patient Global Impression of Change).

Results

224 and 220 pts were randomized to triplet and doublet, respectively. Median overall survival for triplet and doublet was 9.0 (95%CI: 8.0, 11.4) and 8.4 months (95%CI: 7.5, 11.0), respectively (HR:0.79 [95%CI: 0.59, 1.06]). ORR was 26% (95%CI: 18%, 35%) for triplet and 20% (95%CI: 13%,29%) for doublet. For pts with 1 prior therapy, ORR was 34% (95%CI: 23, 47) for triplet and 22% (95%CI: 14, 33) for doublet. Waterfall plots indicated that depth of response favored triplet. Grade 3+ adverse events (AE) were 58% in triplet and 50% in doublet. Rates of discontinuation due to an AE were similar (triplet: 7%; doublet: 8%), with median relative dose intensity maintained for both arms. There were no differences in QOL across 4 instruments. Some toxicities occurred less frequently with the triplet.

Conclusions

In BEACON CRC, triplet and doublet showed encouraging activity in BRAFV600E mCRC. Data suggest that the triplet offers improved efficacy vs doublet with some additional manageable toxicity and no impact on overall QOL. Further follow-up will better define the relative benefits of the regimens.

Clinical trial identification

NCT02928224.

Editorial acknowledgement

Editorial assistance was provided by JD Cox and Mayville Medical Communications, with funding from Array Biopharma.

Legal entity responsible for the study

Array BioPharma Inc.

Funding

Array BioPharma Inc.

Disclosure

J. Tabernero: Advisory / Consultancy: Bayer; Advisory / Consultancy: Boehringer; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: MSD; Advisory / Consultancy: Merck Serono; Advisory / Consultancy: Novartis; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Taiho; Advisory / Consultancy: Merrimack; Advisory / Consultancy: Peptomyc; Advisory / Consultancy: Rafael Pharmaceuticals; Advisory / Consultancy: Symphogen; Advisory / Consultancy: Chugai Pharma; Advisory / Consultancy: Ipsen; Advisory / Consultancy: Merus; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Seattle Genetics; Advisory / Consultancy: Array BioPharma; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BeiGene. A. Grothey: Honoraria (self): Elsevier; Honoraria (self): Aptitude Health; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Boston Biomedical; Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Advisory / Consultancy, Research grant / Funding (institution): Array BioPharma; Advisory / Consultancy: Guardant Health; Advisory / Consultancy, Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Eisai; Travel / Accommodation / Expenses: MSD; Travel / Accommodation / Expenses: Boehringer Ingelheim. E. Van Cutsem: Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy, Research grant / Funding (institution): Servier; Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution): Celgene; Advisory / Consultancy: MSD; Advisory / Consultancy, Research grant / Funding (institution): Merck KGaA; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: AstraZeneca; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Ipsen; Research grant / Funding (institution): Merck. R. Yaeger: Research grant / Funding (institution), Travel / Accommodation / Expenses: Array BioPharma; Research grant / Funding (institution): GSK; Research grant / Funding (institution): Novartis; Speaker Bureau / Expert testimony: Sysmex; Research grant / Funding (institution): Symphogen; Licensing / Royalties: Biocartis. H. Wasan: Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Merck KGaA; Honoraria (self), Speaker Bureau / Expert testimony: Celgene; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Sirtex Medical; Honoraria (self): Array BioPharma; Honoraria (self), Advisory / Consultancy: Shire; Honoraria (self): Genentech; Honoraria (self), Advisory / Consultancy: ERYTECH Pharma; Advisory / Consultancy: Roche; Advisory / Consultancy: Incyte; Speaker Bureau / Expert testimony: Servier; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): MSD. T. Yoshino: Research grant / Funding (institution): Chugai Pharma; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): Sumitomo Dainppon; Research grant / Funding (institution): GSK. J. Desai: Advisory / Consultancy, Research grant / Funding (institution): Eli Lilly; Advisory / Consultancy, Research grant / Funding (institution): Bionomics; Advisory / Consultancy: Eisai; Advisory / Consultancy, Research grant / Funding (institution): BeiGene; Advisory / Consultancy: Ignyta; Research grant / Funding (institution): Roche; Research grant / Funding (institution): GSK; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): MedImmune; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Ipsen. F. Ciardiello: Advisory / Consultancy, Research grant / Funding (institution): Genentech; Advisory / Consultancy, Research grant / Funding (institution): Merck KGaA; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy: Pfizer; Research grant / Funding (institution): Servier; Research grant / Funding (institution): Symphogen; Research grant / Funding (institution): MSD; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Ipsen. N. Steeghs: Research grant / Funding (institution): AstraZeneca/MedImmune; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): GSK; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Blueprint Medicines; Research grant / Funding (institution): AB Science; Research grant / Funding (institution): Deciphera; Research grant / Funding (institution): MSD; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Merus; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Incyte. H. Arkenau: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): GSK; Research grant / Funding (institution): Servier; Research grant / Funding (institution): Astellas; Research grant / Funding (institution): Array BioPharma; Research grant / Funding (institution), Travel / Accommodation / Expenses: Iovance; Full / Part-time employment: SCRI. A. Gollerkeri: Full / Part-time employment: Pfizer Inc.. M. Pickard: Full / Part-time employment: Pfizer Inc.. K. Maharry: Full / Part-time employment: Pfizer Inc.. J.L. Christy-Bittel: Full / Part-time employment: Pfizer Inc.. L. Anderson: Full / Part-time employment: Pfizer Inc.. S. Kopetz: Shareholder / Stockholder / Stock options: MolecularMatch; Research grant / Funding (institution), Shareholder / Stockholder / Stock options: Navire ; Advisory / Consultancy: Roche; Advisory / Consultancy, Research grant / Funding (institution): Genentech; Advisory / Consultancy, Research grant / Funding (institution): EMD Serono; Advisory / Consultancy: Merck; Advisory / Consultancy: Karyopharm; Advisory / Consultancy: Amal Therapeutics; Advisory / Consultancy: Symphogen; Advisory / Consultancy: Holy Stone; Advisory / Consultancy, Research grant / Funding (institution): Biocartis; Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Boehringer Ingelheim; Research grant / Funding (institution): Sanofi; Research grant / Funding (institution): Guardian Health; Research grant / Funding (institution): Array BioPharma; Research grant / Funding (institution): MedImmune. All other authors have declared no conflicts of interest.

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Proffered Paper 2 – Gastrointestinal tumours, colorectal Proffered Paper session

LBA33 - Lefitolimod vs standard of care (SOC) for patients with metastatic colorectal cancer (mCRC) responding to first-line standard treatment: Results from the randomized phase III IMPALA trial (ID 5016)

Presentation Number
LBA33
Lecture Time
08:45 - 09:00
Speakers
  • Ramon Salazar (Hospitalet de Llobregat, Spain)
Location
Barcelona Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
08:30 - 10:00

Abstract

Background

The TLR9 agonist lefitolimod broadly activates the innate and adaptive immune system. Based on encouraging data from the randomized phase II IMPACT trial, lefitolimod was evaluated in this phase III trial as switch maintenance treatment in patients with mCRC who have responded to first-line therapy.

Methods

The international, multicenter, open-label phase III IMPALA trial was conducted including the AIO, TTD and GERCOR cooperative groups and recruited 549 patients across 8 European countries. Patients who had an objective response to any standard first-line induction therapy (5FU/FA or CAPE, plus OX or IRI, alone or plus antiVEGF or antiEGFR) were randomized to receive either lefitolimod monotherapy (experimental arm) or local standard of care (control arm). After first progression, patients started re-induction therapy, with those in the experimental arm continuing lefitolimod on top.

Results

Demographics and baseline characteristics were well balanced between the study arms. Median duration of follow up was 35 months. The primary endpoint overall survival (OS) was not met: median OS was 22.0 and 21.9 months in the lefitolimod and control group, respectively (p = 0.2765; HR = 1.12; 95% CI 0.91 - 1.38). Progression free survival, event-free rates, pre-defined sub-group analyses including molecular and immunological parameters for OS did also not indicate a benefit. In comparison with the control arm treatment with lefitolimod was generally well tolerated. Rates of grade 3, 4 and 5 toxicities were 6.3, 1.9 and 0%, respectively and no new safety signals or autoimmune events were identified while immune activation was confirmed in peripheral blood.

Conclusions

Lefitolimod did not show superiority to standard of care as a single agent maintenance treatment in patients with mCRC. Limited add-on toxicity confirmed the favorable safety and tolerability profile of lefitolimod. Hence, and given its mode of action, lefitolimod will be evaluated in combination with other anti-cancer immunotherapies.

Clinical trial identification

NCT02077868.

Legal entity responsible for the study

Mologen AG.

Funding

Mologen AG.

Disclosure

D. Cunningham: Advisory / Consultancy: Celgene; Advisory / Consultancy: MedImmune; Advisory / Consultancy: Bayer; Advisory / Consultancy: 4SC; Advisory / Consultancy: Clovis; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Janssen; Advisory / Consultancy: Merck. R. Salazar: Advisory / Consultancy: VCN-BCN; Advisory / Consultancy: Agendia; Advisory / Consultancy: Guardant Health; Advisory / Consultancy, Research grant / Funding (institution): Roche Diagnostics; Advisory / Consultancy: Ferrer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Prizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy: Ipsen; Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): Roche Farma; Advisory / Consultancy: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: AZD; Speaker Bureau / Expert testimony: Celgene; Leadership role, Shareholder / Stockholder / Stock options: Sace Medhealth; Research grant / Funding (institution): Novartis Farmaceutica; Research grant / Funding (institution): PsiOxus Therapeutics Ltd; Research grant / Funding (institution): VCN Biosciences; Research grant / Funding (institution): Mologen. A. Sobrero: Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck; Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Celgene; Advisory / Consultancy, Speaker Bureau / Expert testimony: Sanofi; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Takeda. M.P. Ducreux: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Celgene; Research grant / Funding (self): Chugai; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Merck Serono; Honoraria (self), Advisory / Consultancy: Novartis; Research grant / Funding (self): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Roche; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy: Servier; Spouse / Financial dependant: Sandoz. E. Van Cutsem: Advisory / Consultancy: Astellas; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Celgene; Advisory / Consultancy: Incyte; Advisory / Consultancy, Research grant / Funding (institution): Lilly; Advisory / Consultancy, Research grant / Funding (institution): MSD; Advisory / Consultancy, Research grant / Funding (institution): Merck Serono; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy, Research grant / Funding (institution): Servier; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Ipsen. C. Tournigand: Advisory / Consultancy: Bayer; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi. V. Molnar: Full / Part-time employment: Mologen AG. M. Starke: Full / Part-time employment: Mologen AG. M. Baumann: Leadership role: Mologen AG. E. Wiegert: Advisory / Consultancy: Mologen AG. M. Schmidt: Full / Part-time employment: Mologen AG. D. Arnold: Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self): Amgen; Advisory / Consultancy: MSD; Advisory / Consultancy: Merck Serono; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy: Servier; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy: Terumo; Honoraria (self): Astellas; Honoraria (self): Biocompatibles; Honoraria (self), Advisory / Consultancy: Sirtex; Advisory / Consultancy: Boston Scientific; Honoraria (self): ArtTempi Media; Honoraria (self): PRiME Oncology; Honoraria (self): TRM Oncology; Advisory / Consultancy: IQVIA / Quintiles; Advisory / Consultancy: FlatIron. All other authors have declared no conflicts of interest.

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Proffered Paper 2 – Gastrointestinal tumours, colorectal Proffered Paper session

LBA34 - MIRACLE: Green tea extract versus placebo for the prevention of colorectal adenomas: A randomized, controlled trial (ID 1890)

Presentation Number
LBA34
Lecture Time
09:30 - 09:45
Speakers
  • Thomas Seufferlein (Ulm, Germany)
Location
Barcelona Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
30.09.2019
Time
08:30 - 10:00

Abstract

Background

Prevention of colorectal adenomas (CA) is likely to prevent colorectal cancer (CRC). Nutri- or chemoprevention of CRC is not yet established. NSAIDs show some benefit but also increase the bleeding risk. Agents with a more favourable benefit/risk ratio are desirable. Preclinical and small clinical trials suggest that epigallocatechingallate (EGCG), a major polyphenol in green tea, has a good safety profile and antineoplastic effects in the large bowel, but there are no data from large trials. MIRACLE enrolled 1001 patients to examine the effect of a three year intake of ECGC on the recurrence of CA after polypectomy.

Methods

Double-blinded, placebo-controlled trial, 41 recruiting German centers, recruitment 12/2011-6/2015. Patients aged 50-80 years who underwent polypectomy within the last 6 months and tolerated EGCG well during a one month run-in were randomized to standardized decaffeinated EGCG (150 mg bid) or placebo for 3 years. Primary endpoint: Incidence of metachronous CA at the 3 year follow-up colonoscopy. Secondary endpoints: Occurrence, number, localization, size, histological subtype of CA, frequency of CRC and biomarker. Strata: Study center and intake of low-dose aspirin (≤100 mg/d).

Results

Clinical parameters were well balanced between the groups. Primary endpoint was analysed in the modified ITT set (modITT; n = 309 patients in EGCG, n = 323 in placebo group giving informed consent and undergoing 3 year follow up colonoscopy in the requested time frame). n = 102 patients in the EGCG and n = 103 in the placebo group were excluded due to missing follow up colonoscopy. Incidence of one or more CA after 3 year of placebo or EGCG 150 mg bid was 55.7 % and 51.1%, respectively (one sided adj. P = 0.077, adj. RR 0.904) in the modITT. In the per protocol set constituting all modITT patients completing the study without major protocol violations the respective figures were 54.3 % in the placebo and 48.3% in the EGCG group (one sided adj. P = 0.058, adj. RR 0.883). There were no safety issues and no major differences in AEs between EGCG and placebo during the randomized phase.

Conclusions

300 mg EGCG per day was well tolerated and showed a trend towards a preventive effect on CA in the large bowel though not statistically significant.

Clinical trial identification

NCT01360320.

Legal entity responsible for the study

Martin-Luther-Universität Halle-Wittenberg, Germany.

Funding

German Cancer Aid (Stiftung Deutsche Krebshilfe).

Disclosure

All authors have declared no conflicts of interest.

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Proffered Paper 1 – Gastrointestinal tumours, non-colorectal Proffered Paper session

Invited Discussant LBA38_PR and LBA39 (ID 6697)

Lecture Time
14:30 - 14:45
Speakers
  • Arndt Vogel (Hannover, Germany)
Location
Madrid Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
27.09.2019
Time
14:00 - 15:30
Proffered Paper 1 – Gastrointestinal tumours, non-colorectal Proffered Paper session

LBA38_PR - CheckMate 459: A randomized, multi-center phase III study of nivolumab (NIVO) vs sorafenib (SOR) as first-line (1L) treatment in patients (pts) with advanced hepatocellular carcinoma (aHCC) (ID 6572)

Presentation Number
LBA38_PR
Lecture Time
14:00 - 14:15
Speakers
  • Thomas Yau (Hong Kong, Pokfulam, Hong Kong PRC)
Location
Madrid Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
27.09.2019
Time
14:00 - 15:30

Abstract

Background

SOR is approved as 1L therapy for pts with aHCC, but there is still an unmet need to prolong survival and improve tolerability. This phase III study compared clinical efficacy and safety of NIVO with SOR as 1L therapy in pts with aHCC.

Methods

Systemic therapy–naive pts aged ≥18 years with aHCC were randomized 1:1 to NIVO (240 mg IV Q2W) or SOR (400 mg oral BID). Primary endpoint was overall survival (OS). Additional endpoints were objective response rate (ORR) and progression-free survival (PFS) by blinded independent central review per RECIST v1.1, efficacy by tumor programmed death ligand 1 (PD-L1) expression, and safety.

Results

743 pts with aHCC were randomized to NIVO (n = 371) or SOR (n = 372) with minimum follow-up of 22.8 months at data cutoff. OS did not meet the predefined threshold of statistical significance (HR 0.84, P = 0.0419). Median OS (mOS) was 16.4 mo for NIVO and 14.7 mo for SOR (HR 0.85 [95% CI: 0.72–1.02]; P = 0.0752). Clinical benefit was observed across predefined subgroups, including hepatitis infection status, presence of vascular invasion and/or extrahepatic spread, and region (Asia vs non-Asia). ORR was 15% for NIVO (14 pts with complete response [CR]) and 7% for SOR (5 pts with CR; Table). Grade 3/4 treatment-related adverse events were reported in 81 pts (22%) in the NIVO arm and 179 pts (49%) in the SOR arm and led to discontinuation in 16 (4%) and 29 (8%) pts, respectively. No new safety signals were observed with NIVO. 140 pts (38%) in the NIVO arm and 170 pts (46%) in the SOR arm received subsequent therapy. Additional OS analyses and patient-reported outcomes will be presented to support the benefit of NIVO.

Efficacy results

NIVOSOR
n = 371n = 372
Median OS (95% CI), mo16.4 (13.9–18.4)14.7 (11.9–17.2)
12-mo OS rate, % (95% CI)59.7 (54.4–64.6)55.1 (49.8–60.1)
24-mo OS rate, % (95% CI)36.8 (31.8–41.8)33.1 (28.3–38.0)
Median PFS, mo (95% CI)3.7 (3.1–3.9)3.8 (3.7–4.5)
ORR, n (%)57 (15)26 (7)
BOR, n (%)
Complete response14 (4)5 (1)
Partial response43 (12)21 (6)
ORR by baseline tumor PD-L1 expression, n/n (%)
PD-L1 ≥1%20/71 (28)6/64 (9)
PD-L1 <1%36/295 (12)20/300 (7)

Conclusions

Though the primary endpoint of OS did not achieve statistical significance vs SOR, NIVO showed clinically meaningful improvements in OS, ORR, and CR rate as 1L treatment for aHCC. NIVO demonstrated a favorable safety profile consistent with previous reports.

Clinical trial identification

NCT02576509.

Editorial acknowledgement

Writing and editorial assistance was provided by Andrea L. Hammons of Parexel International (Waltham, MA, USA) and funded by Bristol-Myers Squibb.

Legal entity responsible for the study

Bristol-Myers Squibb.

Funding

Bristol-Myers Squibb.

Disclosure

T. Yau: Honoraria (institution), Advisory / Consultancy: Bristol-Myers Squibb. R.S. Finn: Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (self): Bayer; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eisai; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eli-Lilly; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Merck; Honoraria (self), Speaker Bureau / Expert testimony: Novartis; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (self): Pfizer; Honoraria (self), Speaker Bureau / Expert testimony: Roche/ Genentech. A. Cheng: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Ono Pharmaceutical; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Nucleix Ltd.; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche/Genentech; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: IQVIA; Advisory / Consultancy: Merck Sharp Dohme; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bayer Yakuhin; Speaker Bureau / Expert testimony: Amgen Taiwan; Advisory / Consultancy: Ispen; Advisory / Consultancy: Bayer Schering Pharma; Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eisai; Advisory / Consultancy: Merck Serono; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis. P. Mathurin: Honoraria (self), Speaker Bureau / Expert testimony: Ipsen; Honoraria (self), Speaker Bureau / Expert testimony: Eisai; Honoraria (self), Speaker Bureau / Expert testimony: MSD; Honoraria (self), Speaker Bureau / Expert testimony: Bayer Healthcare ; Honoraria (self), Speaker Bureau / Expert testimony: AbbVie; Honoraria (self), Speaker Bureau / Expert testimony: Gilead; Honoraria (self), Speaker Bureau / Expert testimony: Servier; Honoraria (self), Speaker Bureau / Expert testimony: Sanofi. J. Edeline: Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Speaker Bureau / Expert testimony: MSD; Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Speaker Bureau / Expert testimony: IPSEN; Honoraria (self), Speaker Bureau / Expert testimony: Eisai; Honoraria (self), Speaker Bureau / Expert testimony: Bayer; Travel / Accommodation / Expenses: Amgen. M. Kudo: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eisai; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Advisory / Consultancy: Ono; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Medico’s Hirata; Research grant / Funding (institution): Otsuka; Research grant / Funding (institution): Taiho; Research grant / Funding (institution): Astellas Pharma; Research grant / Funding (institution): Chugai; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): EA Pharma; Research grant / Funding (institution): Takeda; Research grant / Funding (institution): Gilead. J.J. Harding: Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Speaker Bureau / Expert testimony: Eisai; Honoraria (self), Speaker Bureau / Expert testimony: Exelexis; Honoraria (self), Speaker Bureau / Expert testimony: Elly Lilly ; Honoraria (self), Speaker Bureau / Expert testimony: CytomX; Honoraria (self), Speaker Bureau / Expert testimony: QED. P. Merle: Advisory / Consultancy: Bayer; Advisory / Consultancy, Research grant / Funding (institution): IPSEN; Advisory / Consultancy: Eisai; Advisory / Consultancy: Lilly; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Merck; Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy: AstraZeneca. O. Rosmorduc: Honoraria (self): Bayer; Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy: Sirtex; Honoraria (self): Eisai. L. Wyrwicz: Research grant / Funding (self): Bristol-Myers Squibb; Research grant / Funding (self): Beigene; Research grant / Funding (self): Eisai. E. Schott: Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Bayer. S.P. Choo: Honoraria (self), Speaker Bureau / Expert testimony: Bayer; Honoraria (self), Speaker Bureau / Expert testimony: Lilly; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Honoraria (self), Advisory / Consultancy: Sirtex; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Ipsen. R.K. Kelley: Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Adaptimmune; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Exelixis; Honoraria (self), Speaker Bureau / Expert testimony, IDMC membership: Genentech/Roche; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Regeneron; Research grant / Funding (institution): AstraZeneca. D. Begic: Full / Part-time employment: Bristol-Myers Squibb. J. Neely: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. J. Anderson: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. B. Sangro: Advisory / Consultancy: Adaptimmune; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy: BTG; Advisory / Consultancy: H3 Biomedicine; Advisory / Consultancy, Speaker Bureau / Expert testimony: Ipsen; Advisory / Consultancy: Lilly; Advisory / Consultancy: Merck; Advisory / Consultancy: Onxeo; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Sirtex Medical; Advisory / Consultancy: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Terumo. All other authors have declared no conflicts of interest.

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Proffered Paper 1 – Gastrointestinal tumours, non-colorectal Proffered Paper session

LBA39 - Randomised efficacy and safety results for atezolizumab (Atezo) + bevacizumab (Bev) in patients (pts) with previously untreated, unresectable hepatocellular carcinoma (HCC) (ID 3502)

Presentation Number
LBA39
Lecture Time
14:15 - 14:30
Speakers
  • Michael Lee (Chapel Hill, United States of America)
Location
Madrid Auditorium (Hall 2), Fira Gran Via, Barcelona, Spain
Date
27.09.2019
Time
14:00 - 15:30

Abstract

Background

Pts with unresectable HCC have few treatment (tx) options. Checkpoint inhibitors and combination approaches with anti-VEGFs are emerging as potential new tx options. Here we report the first randomised dataset evaluating atezo (anti-PD-L1) as monotherapy vs the combination of atezo + bev (anti-VEGF; Arm F) as well as updated single-arm atezo + bev data (Arm A) from a Ph 1b study.

Methods

Arms F and A of the Ph 1b study GO30140 enrolled systemic tx-naïve pts with unresectable HCC. Arm F pts were randomised 1:1 to atezo + bev or atezo monotherapy and received atezo 1200 mg IV q3w, bev 15 mg/kg IV q3w until unacceptable toxicity or loss of clinical benefit. Arm A pts received atezo + bev. Primary endpoints were progression free survival (PFS; Arm F) and objective response rate (ORR, Arm A) by independent review facility (IRF)-assessed RECIST 1.1, and safety (Arms F and A).

Results

In Arm F, 60 pts were randomised to atezo + bev (Group F1) and 59 pts to atezo (Group F2). Arm F showed a statistically significant improvement in the primary endpoint median PFS for atezo + bev vs atezo (5.6 vs 3.4 mo, HR 0.55, 80% CI, 0.40 – 0.74, P = 0.0108). Any-Gr TRAEs occurred in 41 (68%) F1 pts and 24 (41%) F2 pts; Gr 3-4 TRAEs occurred in 12 (20%) F1 pts and 3 (5%) F2 pts. There were no Gr 5 TRAEs in Arm F. For the 104 pts in Arm A, primary endpoint ORR was 36% (37 pts) with 76% ongoing. Any-Grade (Gr) tx-related adverse events (TRAEs) occurred in 91 (88%) pts; Gr 3-4 TRAEs occurred in 41 (39%) pts. Gr 5 TRAEs were seen in 3 (3%) pts.

Conclusions

By meeting its primary endpoint of improved PFS for atezo + bev vs atezo alone, Arm F showed the single-agent contribution of atezo and bev to the overall tx effect. With longer follow up, Arm A highlights the clinically meaningful and durable responses of atezo + bev. Coupled with a tolerable safety profile, these data suggest that atezo + bev is a promising first-line tx option for unresectable HCC.

Clinical trial identification

NCT02715531.

Editorial acknowledgement

Medical writing assistance was provided by Steffen Biechele, PhD, of Health Interactions and funded by F. Hoffmann-La Roche, Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche, Ltd.

Funding

F. Hoffmann-La Roche, Ltd.

Disclosure

M. Lee: Research grant / Funding (self): Amgen; Research grant / Funding (self): Bristol-Myers Squibb ; Research grant / Funding (self): Pfizer; Research grant / Funding (self): EMD Serono; Research grant / Funding (self): Genentech/Roche. C. Hsu: Honoraria (institution), Advisory / Consultancy: BMS; Honoraria (institution), Advisory / Consultancy: Ono Pharmaceutical; Honoraria (institution), Research grant / Funding (self): MSD; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: AZ; Advisory / Consultancy: Roche. S. Stein: Advisory / Consultancy: Genentech; Advisory / Consultancy: BMS; Advisory / Consultancy: Eisai; Advisory / Consultancy: Bayer; Advisory / Consultancy: Exelixis. W. Verret: Full / Part-time employment: Genentech/Roche. S. Hack: Shareholder / Stockholder / Stock options, Full / Part-time employment: Genentech/Roche. J. Spahn: Shareholder / Stockholder / Stock options, Full / Part-time employment: Genentech/Roche. B. Liu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Genentech/Roche. H. Abdullah: Full / Part-time employment: Genentech/Roche. R. He: Speaker Bureau / Expert testimony: Bayer; Speaker Bureau / Expert testimony: BMS; Speaker Bureau / Expert testimony: Eisai Inc.; Speaker Bureau / Expert testimony: Exelixis Inc; Advisory / Consultancy, Research grant / Funding (institution): Merck & Co; Advisory / Consultancy: AZ. K. Lee: Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self): Bayer; Honoraria (self): Eisai; Honoraria (self): Ono Pharmaceuticals; Honoraria (self), Speaker Bureau / Expert testimony: Roche; Honoraria (self): Samsung Bioepis; Speaker Bureau / Expert testimony: Eli Lilly. All other authors have declared no conflicts of interest.

LBA39

Arm F
IRF RECIST 1.1
IRF HCC mRECIST
F1 Atezo + Bev (n = 60)F2 Atezo (n = 59)aF1 Atezo + Bev (n = 60)F2 Atezo (n = 59)a
Median follow-up, mo6.66.76.66.7
Median PFS, mo 95% CI5.6b 3.6 – 7.43.4b 1.9 – 5.25.6 3.6 – 7.43.4 1.9 – 5.2
HR0.55b0.54
80% CI0.40 – 0.74 P = 0.01080.40 – 0.74
Arm A: Atezo + Bev
n = 104
IRF RECIST 1.1IRF HCC mRECIST
Median follow-up, mo12.4
Confirmed ORR, n (%)37 (36)b41 (39)
95% CI (%)26 – 4630 – 50
Complete Response (CR), n (%)12 (12)16 (15)
Partial Response (PR), n (%)25 (24)25 (24)
On-going response, n (%)28 (76)28 (68)
DCR (CR + PR + SD), n (%)74 (71)74 (71)
Median DOR, moNENE
95% CI11.8 – NE11.8 – NE
Median PFS, mo7.37.3
95% CI5.4 – 9.95.4 – 9.9

DCR, disease control rate; DOR, duration of response; NE, not estimable; SD, stable disease. Data cut off: 14 June 2019.

1 randomised pt did not receive atezo.

Primary endpoint.

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