- |||||||||| Imfinzi (durvalumab) / AstraZeneca
Durvalumab (MEDI 4736) with extended neoadjuvant regimens in rectal cancer: A randomised phase II trial (PRIME-RT). (On Demand | Level 1, West Hall; Poster Board No. Q4) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_944; P2 Eligible patients are randomised to Arm A: short course radiotherapy (25 Gray in 5 fractions) with concomitant durvalumab, followed by durvalumab and FOLFOX chemotherapy, or Arm B: long course chemoradiotherapy (50 Gray to primary tumour, 45 Gray to elective nodes, in 25 fractions with capecitabine) with concomitant durvalumab followed by FOLFOX and durvalumab...Clinical trial: NCT04621370; ISRCTN18138369. Clinical trial information: ISRCTN18138369.
- |||||||||| Avastin (bevacizumab) / Roche, Tecentriq (atezolizumab) / Roche
NRG-GI004/SWOG-S1610: Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) study—A randomized phase III study of atezolizumab (atezo) monotherapy versus mFOLFOX6/bevacizumab/atezo in the first-line treatment of patients (pts) with deficient DNA mismatch repair (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (mCRC). (On Demand | Level 1, West Hall; Poster Board No. N20) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_921; P=N/A, P3 A recent randomized trial subgroup analysis of 8 pts with dMMR metastatic colon cancer treated with FOLFOXIRI+bev+atezo, with the first patient having progression ~16 mos (AtezoTRIBE)...Support: U10CA180868, -180822, -180888, UG1CA189867, U24CA196067; Genentech, Inc. Clinical trial information: NCT05080673.
- |||||||||| Recentin (cediranib) / AstraZeneca, Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, Avastin (bevacizumab) / Roche
The HORIZON III retrospective exploratory analysis: HER2 expression amplification in colorectal cancer. (On Demand | Level 1, West Hall; Poster Board No. K16) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_857; P2/3 The demographic characteristics of patients with analyzable samples were representative of the entire HORIZON III study population; however, further assessment of KRAS status and other clinicopathological characteristics is needed. These data may inform future clinical development and support selection of patients with CRC who are likely to benefit from HER2 targeting therapies.
- |||||||||| Avastin (bevacizumab) / Roche
A meta-analysis of bevacizumab’s cardiovascular risks in patients treated for colorectal cancer. (On Demand | Level 1, West Hall; Poster Board No. F10) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_777; When BVZ was used as an add-on therapy to FOLFOX regimens for colorectal cancer, it was associated with about five times higher odds of developing hypertension (Grade 3 or more) in the treatment group with BVZ. Previous RCTs have demonstrated that BVZ add-on therapy to the standard regime is safe and without significant risk of toxicity.
- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer
Burden of illness in metastatic colorectal cancer. (On Demand | Level 1, West Hall; Poster Board No. C8) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_717; Later lines of therapy are associated with substantial HCRU and costs. >
- |||||||||| Cyramza (ramucirumab) / Eli Lilly
Randomized, phase II selection study of ramucirumab and paclitaxel versus FOLFIRI in refractory small bowel adenocarcinoma: SWOG S1922. (Available On Demand; Poster Board No. Q19) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_669; P2 This is randomized, phase II, selection design clinical trial of FOLFIRI (5-fluorouracil, leucovorin and irinotecan) every two weeks or ramucirumab D1,15 and paclitaxel D1,8,15 every 4 weeks with the primary endpoint of progression-free survival (PFS)...Key eligibility criteria include having mismatch repair proficient/microsatellite stable small bowel adenocarcinoma (ampullary location excluded); metastatic or locally advanced unresectable disease; prior fluoropyrimidine and/or oxaliplatin therapy; no prior treatment with irinotecan, ramucirumab, or taxanes; no recent bleeding, blood clots, or bowel perforation/fistula; and Zubrod performance status of 0/1...The design provides a 90% probability of selecting the more active arm, assuming a hazard ratio of 1.4, if both arms meet this threshold. This trial is open and, as of September 1, 2021, 21 of 94 planned patients have been enrolled.
- |||||||||| albumin-bound paclitaxel / Generic mfg.
Updates to NeoOPTIMIZE: An open-label, phase II trial and biomarker discovery platform to assess the efficacy of adaptive switching of modified FOLFIRINOX (mFFX) or gemcitabine/nab-paclitaxel (GA) as a neoadjuvant strategy for patients with resectable/borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinoma (PDAC). (Available On Demand; Poster Board No. Q12) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_662; P2 Sixty patients (n = 40 resectable/BRCP; n = 20 locally advanced unresectable [uLAPC]) will be enrolled to receive 2 months of preoperative mFFX (oxaliplatin, 85 mg/m2; folinic acid, 400 mg/m2; irinotecan, 150 mg/m2; 5-FU, 2400 mg/m2), then restaging by a multidisciplinary tumor board (multiD-TB)...To date, the trial has enrolled 19 patients: 8 resectable, 7 BRCP, and 4 uLAPC. Clinical trial information: NCT04539808.
- |||||||||| albumin-bound paclitaxel / Generic mfg.
An adaptive approach to neoadjuvant therapy to maximize resection rates for pancreatic adenocarcinoma: A phase II trial. (Available On Demand; Poster Board No. Q7) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_657; P2 Recent US national cooperative group trials have demonstrated the safety and feasibility of neoadjuvant chemotherapy (PMID 33475684, PMID 35834226), and also show that the two frontline regimens, FOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin) and gemcitabine/nab-paclitaxel (GnP), are comparable in this setting...Key translational correlatives will include serial circulating tumor DNA assessment and extensive tumor molecular profiling. Clinical trial information: NCT04594772.
- |||||||||| Solucin (177Lu-edotreotide) / ITM Isotopen Technologien Munchen
Genetic profiling analysis design of well-differentiated aggressive grade 2 and 3 gastroenteropancreatic neuroendocrine tumors in the phase III randomized controlled COMPOSE trial. (Available On Demand; Poster Board No. P13) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_643; P3 In the prospective, randomized, controlled, open-label, multi-center, Phase III COMPOSE trial, the radiolabeled somatostatin analogue 177Lu-edotreotide will be compared to approved standard of care with everolimus, CAPTEM or FOLFOX in patients with well-differentiated aggressive grade 2 and 3 (Ki-67 index 15−55%), somatostatin receptor positive GEP-NETS...The aim of this analysis is to develop software that would integrate genetic data with structural and functional imaging, histopathology and phenotype information for implementation into clinical practice. Clinical trial information: NCT04919226.
|