Choice of Poster Presentations
Shota Fukuoka, Hiroki Hara, Naoki Takahashi, Takashi Kojima, et al
Conclusions: The combination of regorafenib 80mg plus nivolumab had a manageable safety profiles and encouraging anti-tumor activity in MSS GC and CRC pts, which warrants further investigations in a larger cohort. Updated biomarker analysis will be presented. Clinical trial information: NCT03406871
Rutika Mehta, Richard D. Kim, Neal Shah, Estrella M. Carballido, et al.
Methods: This is a single institutional phase II single arm two-stage design trial using the combination of TAS-102 and ramucirumab in advanced, refractory gastric or GEJ adenocarcinoma. Eligible patients include those with histologically confirmed gastric or GEJ adenocarcinoma that have received at least 1 prior line of treatment with performance status 0 or 1 and preserved organ function. Ramucirumab will be administered 8mg/kg every 2 weeks and TAS-102 at doses of 35 mg/m2 twice daily. Each cycle length will be 28 days. The primary endpoint is 6 month OS and secondary endpoints are safety, objective response rate and PFS. Fifteen patients will be enrolled in the first stage. If ≥ 7 of the 15 are alive at 6 months, an additional 10 patients will be enrolled in the second phase. Enrollment is currently ongoing. Clinical trial information: NCT03686488
Zev A. Wainberg, Harry H. Yoon, Daniel V.T. Catenacci, Shadia Ibrahim Jalal, et al.
Efficacy and safety of pembrolizumab (pembro) alone or in combination with chemotherapy (chemo) in patients (pts) with advanced gastric or gastroesophageal (G/GEJ) cancer: Long-term follow up from KEYNOTE-059.
Conclusions: These updated results demonstrate manageable safety, durable clinically meaningful activity of pembro in heavily pretreated pts, and promising efficacy of first-line pembro (alone or + chemo) in pts with advanced G/GEJ cancer. Clinical trial information: NCT02335411
Conclusions: Pembro significantly improved OS vs chemo as second-line therapy for advanced esophageal cancer with PD-L1 CPS ≥10, with a more favorable safety profile and stable and similar QOL. These data support pembro as a new second-line standard of care for esophageal cancer with PD-L1 CPS ≥10. Clinical trial information: NCT02564263
N = 107
N = 115
N = 85
N = 82
N = 22
N = 33
|12-mo OS, %||43||20||48||23||23||15|
|Median PFS (95% CI), mo||2.6||3.0||3.2||2.3||2.1||3.7|
|12-mo PFS, %||21||7||23||7||14||7|
|Median DOR (range), mo||9.3||7.7||9.3||7.7||Not reached||4.4|
|(2.1+ to 22.6+)||(4.3 to 16.8+)||(2.1+ to 18.8+)||(4.3 to 16.8+)||(6.5 to 22.6+)||(4.4-4.4)|
Yelena Yuriy Janjigian, Steven Brad Maron, Joanne F Chou, Amelia Gabler, et al.
Conclusions: Most pts (51%) remain on therapy, and so the primary endpoint should be reached by 6/19. Updated survival, correlative studies and will be presented. These promising preliminary safety and efficacy results led to initiation of a definitive phase III Keynote 811 trial. Clinical trial information: NCT02954536
Kohei Shitara, Toshihiko Doi, Hisashi Hosaka, Peter C. Thuss-Patience, et al.
Conclusions: FTD/TPI was safe and effective in pts aged ≥65 y, who had a higher incidence of moderate renal impairment vs the overall population. Clinical trial information: NCT02500043
||Age ≥65 y
|ITT population, n||337||170||154||74|
|Median OS, mo||5.7||3.6||6.2||5.4|
|HR (95% CI)||0.69 (0.56–0.85)||0.73 (0.52–1.02)|
|Median PFS, mo||2.0||1.8||2.2||1.8|
|HR (95% CI)||0.57 (0.47–0.70)||0.44 (0.32–0.61)|
|Safety population, n||335||168||153||72|
|Grade ≥3 AEs of any cause, %|
|Actions taken for any-cause/grade AEs, %|
aOccurring in ≥10% of pts in any group. bIncludes decreased neutrophil count. cIncludes decreased hemoglobin level. 1. Shitara K, et al. Lancet Oncol 2018.
Wasat Mansoor, Hendrik-Tobias Arkenau, MARIA ALSINA, Kohei Shitara, et al.
Conclusions: FTD/TPI showed a manageable safety profile and efficacy benefit in pts with mGEJC in the TAGS trial, despite heavier pretreatment of the FTD/TPI than the placebo group. Clinical trial information: NCT02500043
|ITT population, n||337||170||98||47|
|Median OS, mo||5.7||3.6||4.8||3.5|
|HR (95% CI)||0.69 (0.56–0.85)||0.75 (0.50–1.11)|
|Median PFS, mo||2.0||1.8||1.9||1.8|
|HR (95% CI)||0.57 (0.47–0.70)||0.60 (0.41–0.88)|
|Safety population, n||335||168||97||46|
|Grade ≥3 AEs of any cause, %|
|AEs of any grade or cause, %|
|Leading to dosing modification||58||22||54||24|
|Leading to treatment discontinuation||13||17||9||11|
aOccurring in ≥10% of pts in any group. bIncludes decreased neutrophil count. cIncludes decreased hemoglobin level.
1. Shitara K, et al. Lancet Oncol 2018.
Maria Alsina, Josep Tabernero, Kohei Shitara, Toshihiko Doi, et al.
Conclusions: During the treatment period, HRQoL remained stable for most functional and symptom scales in both arms, suggesting that HRQoL is largely maintained with FTD/TPI. Treatment with FTD/TPI was associated with a positive trend toward a lower risk of QoL deterioration than placebo across all scales. Changes in QoL were informative for patients ‘expected ECOG status. Clinical trial information: NCT02500043
Rui-Hua Xu, Feng Wang, Xiao-Li Wei, Fenghua Wang, et al.
Conclusions: In a pooled analysis, FTD/TPI was well tolerated with a consistent safety profile in pts with mGC/mGEJC or mCRC. The most frequent AEs were hematologic and GI, which were managed with dosing delays/dose reductions. Clinical trial information: NCT02500043; NCT01607957
(n = 335)
(n = 168)
(n = 533)
(n = 265)
|Any gr, %||Gr ≥3, %||Any gr, %||Gr ≥3, %||Any gr, %||Gr ≥3, %||Any gr, %||Gr ≥3, %|
|Actions taken for any-cause AEs|
TRAEs, treatment-related AEs.
Ken Masuda, Hirokazu Shoji, Kengo Nagashima, Shun Yamamoto, et al.
Conclusions: Development of irAEs was associated with clinical benefit for AGC patients receiving nivolumab monotherapy.
Sylvie Lorenzen, Peter C. Thuss-Patience, Claudia Pauligk, Eray Goekkurt, et al.
FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab for patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction as second-line therapy: Interim safety and efficacy results from the phase II RAMIRIS Study (AIO-STO-0415) of the German Gastric Group at AIO.
Conclusions: The interim safety analysis of the RAMIRIS trial has demonstrated feasibility of the combination of FOLFIRI and ramucirumab. Docetaxel pre-treated pts had higher ORR and DCR when ramucirumab is combined with FOLFIRI, instead of paclitaxel. EudraCT: 2015-005171-24. Clinical trial information: NCT03081143
Seung Kim, Sung Yong Oh, Se Hoon Park, Kyung Kim, et al.
Conclusions: This is the first study to demonstrate a clinically robust correlation between stromal-based signature and response to anti-angiogenesis inhibitor in GC. Clinical trial information: 02628951.
Brian D. Badgwell, Mariela A. Blum, Naruhiko Ikoma, Xuemei Wang, et al.
Conclusions: Laparoscopic HIPEC with mitomycin, cisplatin, and paclitaxel appears safe at intraperitoneal doses of 30 mg, 200 mg, and 60 mg/m2, respectively. Although electrolyte abnormalities are common, systemic toxicity of this therapy is modest. Survival rates are promising, supporting further research into intraperitoneal therapy for stage IV gastric cancer. Clinical trial information: NCT03330028
Salah-Eddin Al-Batran, Claudia Pauligk, Ralf Hofheinz, Sylvie Lorenzen, et al.
Perioperative atezolizumab in combination with FLOT versus FLOT alone in patients with resectable esophagogastric adenocarcinoma: DANTE, a randomized, open-label phase II trial of the German Gastric Group of the AIO and the SAKK.
Methods: This is a large, multinational, prospective, multicenter, randomized, investigator-initiated, open label phase II trial. Patients with locally advanced, potentially resectable adenocarcinoma of the stomach and GEJ (≥cT2 and/or N-positive) without distant metastases are enrolled. Eligibility status is centrally evaluated. Patients are randomized 1:1 to 4 pre-operative 2-week cycles (8 weeks) of FLOT (Docetaxel 50 mg/m²; Oxaliplatin 85 mg/m²; Leucovorin 200 mg/m²; 5-FU 2600 mg/m²) followed by surgery and 4 additional cycles of FLOT plus atezolizumab at 840 mg every 2 weeks, followed by a total of 8 additional cycles of atezolizumab at 1200 mg every 3 weeks as monotherapy (arm A) or FLOT alone (arm B). Primary endpoint is time to disease progression or relapse after surgery (PFS/DFS) as assessed by the Kaplan-Meier-Method. The statistical design is based on a target HR of 0.68, a power of 0.8, and a significance level of p< 0.05 (1-sided log rank test). A total of 295 patients will be randomized. Main secondary endpoints are rates of centrally assessed pathological regression (rates of complete and nearly complete pathological regression), overall survival, R0 resection, and safety. Recruitment started in Sept 2018; by February 2019, a total of 27 patients have been randomized. Clinical trial information: NCT03421288
Anica Högner, Kirstin Breithaupt, Alexander Stein, Axel Hinke, et al.
Methods:The RAP trial (AIO-STO-0218, registered at ClinicalTrials.gov) is a single arm multicenter phase II trial. A total of 59 patients with metastatic or locally advanced gastric or gastro-esophageal junction adenocarcinoma, ECOG 0–1, who progressed after having received first-line therapy with platinum and fluoropyrimidine doublet with or without anthracycline, docetaxel or trastuzumab within the last six months will receive avelumab and ramucirumab on day 1, 15 and paclitaxel on day 1, 8 and 15 of a 28-day cycle until disease progression (RECIST v1.1), intolerable toxicity, withdrawal of consent or at a maximum treatment of 1 year. The primary endpoint is the overall survival rate (OSR) at 6 months. Sample size calculation is based on a Simon 2-stage design with a one-sided alpha error of 10% and a power of 80%, an expected OSR at 6 months of ≥ 65% and a 0 hypothesis ≤ 50%. Secondary endpoints include OS, OSR at 12 months, PFS, safety and tolerability, duration of response. Ethics commission approved the study protocol in January 2019. Updated patient accrual will be presented. Clinical trial information: AIO-STO-0218.
Robin Kate Kelley, Ann-Lii Cheng, Fadi S. Braiteh, Joong-Won Park, et al.
Phase 3 (COSMIC-312) study of cabozantinib (C) in combination with atezolizumab (A) versus sorafenib (S) in patients (pts) with advanced hepatocellular carcinoma (aHCC) who have not received previous systemic anticancer therapy.
Methods: This international, randomized, open-label phase 3 trial (NCT03755791) is evaluating the efficacy and safety of C+A vs S as first-line treatment for aHCC. Eligibility criteria include age ≥18 years, BCLC stage B or C, Child-Pugh A, ECOG PS 0 or 1, and measurable disease per RECIST 1.1. Patients are randomized 6:3:1 to an experimental arm of C (40 mg qd) + A (1200 mg infusion q3w), a control arm of S (400 mg bid), and an exploratory arm of C monotherapy (60 mg qd). 640 pts are planned at ~200 sites globally. Randomization is stratified by disease etiology (HBV [with or without HCV], HCV [without HBV], or other), region (Asia, other), and the presence of extrahepatic disease and/or macrovascular invasion (yes, no). OS and progression-free survival are coprimary endpoints and objective response rate is a secondary endpoint. Additional endpoints include safety, pharmacokinetics, and correlation of biomarker analyses with clinical outcomes. Enrollment in COSMIC-312 is ongoing. Clinical trial information: NCT03755791
Masatoshi Kudo, Kenta Motomura, Yoshiyuki Wada, Yoshitaka Inaba, et al.
Conclusions: The preliminary safety of avelumab + axitinib in HCC is manageable and consistent with the known safety profiles of avelumab and axitinib when administered as monotherapies. This study demonstrates antitumor activity of the combination in HCC. Follow-up is ongoing. Clinical trial information: NCT03289533
N = 22
N = 22
|Confirmed ORR, % (n)*||13.6 (3)||31.8 (7)|
|Median PFS, mo*||5.5||3.8|
|6-mo PFS rate, %*||35.1||30.9|
*per investigator assessment.
Yung-Jue Bang, Makoto Ueno, David Malka, Hyun Cheol Chung, et al.
Conclusions: Pembro provides durable antitumor activity, regardless of PD-L1 expression, and manageable toxicity in a subset of pts with advanced BTC. Clinical trial information: NCT02054806 and NCT02628067
Vaibhav Sahai, Tyler Howard Buckley, Kent A. Griffith, Mark Zalupski;
Methods: Key eligibility criteria include histologically confirmed advanced, unresectable biliary carcinoma (intra- or extra-hepatic and gallbladder) with progression or intolerance of first-line systemic therapy (excluding irinotecan and PD-1/PD-L1 antibody), measurable disease per RECIST v1.1, ECOG PS 0-1, Child Pugh A or B7, and absence of autoimmune disease or chronic steroid use. Primary objective of the phase Ib portion is to determine the recommended phase 2 dose, and of the phase II portion is to evaluate the median progression-free survival. Secondary objectives include evaluation of objective response rate per immune related (ir)RECIST, median OS and safety in this patient population. Exploratory objectives include identification of biomarker predictors of response and mechanisms of resistance through serial biopsies and blood collection (pre, on and post therapy), including sequential whole exome/transcriptomic analysis and immune cell subset analysis (tissue and blood). Therapy includes nal-irinotecan 70 mg/m2, leucovorin 200 (dose level -1) or 400 mg/m2 (dose level 0), 5-fluouracil 2400 mg/m2 IV over 46 hours, and nivolumab 240 mg on day 1 every 2 weeks for 6 months. In the absence of disease progression, pts may continue therapy for up to 2 years. Accrual goal is 30 evaluable pts. Using a null hypothesis value of median PFS of 2.9 months, and an alternative hypothesis of 5.0 months, this ongoing study has > 80% power, with a two-sided alpha of 0.05 to identify treatment efficacy of study arm. Clinical trial information: NCT03785873
Gilbert Spizzo, Alberto Puccini, Joanne Xiu, Richard M. Goldberg, et al.
Conclusions: BRCA mutations are found in a significant subgroup of biliary tract tumors and are associated with an immunogenic tumor profile. These data provide rationale for trials testing PARP inhibitors in combination with immunotherapy and targeted therapies in patients with BRCA-mutant biliary tract cancers that are MSS.
Andreas Seeber, Alberto Puccini, Joanne Xiu, Richard M. Goldberg, et al.
Conclusions: BRCA mutations are found in a significant subgroup of pancreatic ductal adenocarcinoma and these carcinomas are associated with an immunogenic tumor profile. These data suggest evaluating PARP inhibitors in combination with immunotherapy in patients with BRCA-mutant pancreatic adenocarcinoma especially in tumors that are MSS.
Davendra Sohal, Danika L. Lew, Syed A. Ahmad, Namita Gandhi, et al.
Conclusions: This is the first-ever NCTN study of periop CTx for resectable PDA. Accrual was brisk, establishing feasibility. Ineligible cases after central radiology review highlight quality control and physician education imperatives for neoadjuvant PDA trials. Preop CTx safety and resection rates are encouraging. Follow up for OS is ongoing. Clinical trial information: NCT02562716
L. Daniel Muldoon, Jared Hirsch, Gabriela Dieguez, Paul Cockrum;
Conclusions: Mean total Parts A and B (excluding professional) costs for common 1L-3L regimens varied from less than $15,000 to greater than $30,000. 90-day survival rates for common regimens varied between 1L (86%) to 3L (68%).
L. Daniel Muldoon, Jared Hirsch, Gabriela Dieguez, Paul Cockrum;
Conclusions: The mean monthly cost increased by LOT for m-PANC FDA-approved/NCCN category 1 regimens. Interestingly, Part A inpatient costs decreased in 2L and 3L, while Part B drug costs other than chemotherapy were comparable.
Federico Longo, Oscar Alfredo Castillo Trujillo, Juan José Serrano Domingo, Roberto Martin Huertas, et al.
Conclusions: In our study, advanced PDAC patients treated with Folfirinox were younger and had a better performance status than those treated with NabPacGem. We found no differences in survival between both treatments when adjusting by ECOG and age.
|Variable||HR (PFS)||p||HR (OS)||p|
|ECOG 2**||2.04||0.003||4.68||< 0.001|
(*Folfirinox as the reference, **ECOG 0 as the reference).
Jong-Chan Lee, Dong Woo Shin, Se Yeol Yang, Min Jae Kim, et al.
Conclusions: In this study using K-PaC registry in Korea, FOLFIRINOX and GNP showed comparable efficacy and toxicity. In the subgroup analysis, sequential treatment did not showed significant difference, but GNP showed a better trend in the group of peritoneal seeding.