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424 Diseases |  |
809 Trials |
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809 Trials |  |
14393 News |  |
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- Homologous recombination deficiency (HRD) alterations as a predictor of responsiveness to combination pancreatic cancer in advanced pancreatic ductal adenocarcinoma (PDAC). () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2227;
HRD+ patients had longer durations of treatment on both 5-FU based therapy and Gemcitabine based combinations. These data challenges the importance of first line platinum therapy in HRD+ patients, and further exploration should be considered.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Favourable outcomes in locally advanced and metastatic pancreatic cancer treated with modified FOLFIRINOX as second-line chemotherapy. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2199;
This study is the largest retrospective review of second line mFOLFIRINOX chemotherapy for pancreatic cancer reported. It provides further evidence of the efficacy of second line mFOLFIRINOX for suitable patients with advanced pancreatic cancer and suggests ECOG 2 should not be a barrier to effective treatment in this group.
- Effect of dosimetric parameters on postoperative respiratory morbidity in locally advanced esophageal cancer treated with preoperative chemoradiotherapy (CRT). () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2194;
P2
It provides further evidence of the efficacy of second line mFOLFIRINOX for suitable patients with advanced pancreatic cancer and suggests ECOG 2 should not be a barrier to effective treatment in this group. We did not identify dosimetric factors that could predict the risk of postoperative respiratory morbidity after treatment with preoperative CRT with FOLFOX or Carboplatin-Paclitaxel.
- cisplatin / Generic mfg., gemcitabine / Generic mfg.
The impact of second-line treatment after fist-line cisplatin plus gemcitabine in advanced biliary tract cancers: A mono-institutional retrospective study. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2171;
Our results show that the second-line FOLFIRI regimen after a platinum-containing fist-line, was independently associated with improved OS. Given that the ABC-06 trial compared FOLFOX to ASC, a randomized trial of FOLFOX vs FOLFIRI as second-line would provide further information in this setting.
- Real-world data comparing FOLFIRINOX versus gemcitabine nab-paclitaxel as first-line treatment of metastatic pancreatic ductal adenocarcinoma patients in the United States. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2165;
Our retrospective cohort study demonstrated that FOLFIRINOX is associated with improved survival of approximately 2 months over Gem-Nab-P and is also associated with fewer post-treatments complications. A randomized controlled trial comparing these first line treatments is warranted to test the survival and post-treatment complications benefit of FOLFIRINOX over Gem-Nab-P.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Planned and actual dose reduction of standard or modified FOLFIRINOX in metastatic pancreatic cancer: A systematic review and meta-analysis. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2127;
Planned ‘modified’ FOLFIRINOX showed similar efficacy and reduced febrile neutropenia, compared to planned ‘standard’ regimen. This data can serve as a guidance in both prescribing FOLFIRINOX for clinicians and designing further studies for researchers in MPC.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., lenvatinib / Generic mfg.
Lenvatinib plus hepatic arterial infusion of modified FOLFOX regime(FOHAIC) in patients with BCLC stage C hepatocellular carcinoma. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2112;
This study demonstrated that lenvatinib plus FOHAIC had acceptable toxic effects and shown promising ORR, PFS and OS in BCLC stage C hepatocellular carcinoma. Warrants its further investigation in a large-scale trial.
- albumin-bound paclitaxel / Generic mfg.
Application of XCELSIOR, a nationwide real-world observational research protocol, to identify efficacious targeted therapy regimens in advanced pancreatic adenocarcinoma. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2092;
P=N/A
Application of this virtual platform to an emerging metastatic pancreatic adenocarcinoma dataset suggested biomarker-based molecular targeted therapies utilized at 3rd and 4th line have the potential to be efficacious. Further stratification and analyses will be performed as the data matures.
- A systemic review and meta-analysis of FOLFIRINOX vs gemcitabine plus nab-paclitaxel in the neoadjuvant treatment of localized pancreatic cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2070;
One limitation to our current study was that all included studies were designed retrospectively. Further randomized clinical trials are needed to explore the ideal neoadjuvant chemotherapy for PDAC.
- Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
A phase II, open-label, pilot study evaluating the safety and activity of liposomal irinotecan (Nal-IRI) in combination with 5-FU and oxaliplatin (NALIRIFOX) in preoperative treatment of pancreatic adenocarcinoma: NEO-Nal-IRI study. (Available On Demand; 163a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2031;
P2
Secondary endpoints include R0 resection rate, clinical, biochemical and radiological response rate and patient-reported quality of life during treatment as measured by the NCI validated FACT-G scale. Enrollment continues to a maximum of 28 evaluable pts to demonstrate a reduction in historical 30-day post-op complication rate.
- CEND-1 / Qilu Pharma, Cend Therapeutics
Phase Ib/IIa trial of CEND‐1 in combination with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colorectal, and appendiceal cancers (CENDIFOX). (Available On Demand; 162b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2030;
P1b/2a
Exploratory objectives include pathologic response, tissue immune response, EGFR expression, tumor tissue-to-plasma concentration of Panitumumab pre and post CEND-1 treatment. Enrollment to the CENDIFOX trial is currently ongoing.
- Lumakras (sotorasib) / Amgen
A phase Ib/II study of sotorasib combined with chemotherapy for second-line treatment of KRAS p. G12C–mutated advanced pancreatic cancer. (Available On Demand; 162a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2029;
The secondary endpoint to evaluate safety, and further evaluate efficacy in terms of disease control rate, duration of response, progression-free survival and overall survival. Correlative endpoints will determine biomarkers based on analysis of blood and/or tumor on study.
- albumin-bound paclitaxel / Generic mfg.
Sequential treatment with gemcitabine/nab-paclitaxel (GA) and FOLFIRINOX (FFX) followed by stereotactic MRI-guided adaptive radiation therapy (SMART) in patients with locally advanced pancreatic cancer (LAPC): GABRINOX-ART phase 2, multicenter trial. (Available On Demand; 160b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2026;
P2
Median follow-up, OS and PFS will be expressed as medians and rates with 95% CI while QoL will be explored by QLQ-C30 and QLQ-PAN26 analyses using the time to definitive deterioration. From 2021, we included 5 patients (NCT04570943).
- albumin-bound paclitaxel / Generic mfg.
Sequential first-line treatment with gemcitabine plus nab-paclitaxel (GA) followed by FOLFIRINOX (FFX) versus FFX alone in patients with metastatic pancreatic cancer (PC): GABRINOX-2 randomized phase 2 trial. (Available On Demand; 160a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2025;
P2
Multivariate analyses will use Cox proportional hazard model. Enrolment started in late 2021 and 3 patients were included so far.
- albumin-bound paclitaxel / Generic mfg.
A randomized phase II study of gemcitabine and nab-paclitaxel compared with 5-fluorouracil, leucovorin, and liposomal irinotecan in older patients with treatment-naïve metastatic pancreatic cancer (GIANT): ECOG-ACRIN EA2186—Trials in progress. (Available On Demand; 157b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2020;
P2
Additional endpoints of interest for older adults include: evaluation of risk factors identified through GA, and capturing toxicities of interest for this patient population (i.e. hospitalization, deterioration in PS, and falls). Correlative studies include assessment of pro-inflammatory biomarkers or aging in the blood (IL-6 and CRP) as well as imaging evaluation of sarcopenia and body composition as predictors of treatment tolerance.
- rucosopasem manganese (GC4711) / Galera Therap
GRECO-2: A randomized, phase 2 study of stereotactic body radiation therapy (SBRT) in combination with rucosopasem (GC4711) in the treatment of locally advanced or borderline resectable nonmetastatic pancreatic cancer. (Available On Demand; 157a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2019;
P2b
In a pilot phase 1/2 trial in patients with pancreatic cancer, avasopasem, a dismutase mimetic related to rucosopasem, nearly doubled median overall survival in patients receiving SBRT vs placebo plus SBRT...Materials/ GRECO-2 is a phase 2, multicenter, randomized, double-blind, placebo-controlled study (NCT04698915) to determine the effect of adding rucosopasem to SBRT on overall survival in patients with borderline resectable or locally advanced, unresectable nonmetastatic pancreatic cancer following initial chemotherapy with a FOLFIRINOX-based regimen or a gemcitabine doublet...Exploratory endpoints include PRO-CTCAE and CA19-9 normalization. This trial is now enrolling.
- ivaltinostat (CG-745) / CrystalGenomics
A phase 1b/2, dose-escalation, randomized, multicenter study of maintenance (maint) ivaltinostat (ival) plus capecitabine (cap) or capecitabine monotherapy in patients (pts) with metastatic pancreatic adenocarcinoma (PDAC) whose disease has not progressed on first-line FOLFIRINOX chemotherapy (CT). (Available On Demand; 156a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2017;
Background: The mainstay of treatment (TX) for pts with advanced or mPDAC consists of CT, with FOLFIRINOX and gemcitabine (gem)/nab-paclitaxel currently representing the front-line standards of care...Of note, ival 250 mg/m2 represents the RP2D identified in prior clinical studies of this agent both as monotherapy in solid tumors and in comb with gem/erlotinib in advanced PDAC pts...Assuming an accrual duration of 18 mos and a dropout/lost to follow-up rate of 10%, the estimated total number of pts in the randomized ph2 portion is 52 (26 per arm). Enrollment is expected to being in spring 2022 across 25 U.S. sites.
- Lonsurf (trifluridine/tipiracil) / Servier, Otsuka
Study protocol of an open-label, single-arm, phase II trial investigating the efficacy and safety of trifluridine/tipiracil combined with irinotecan as a second-line therapy in patients with cholangiocarcinoma (TRITICC). (Available On Demand; 153b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2012;
P2
Gemcitabine/Cisplatin has been the standard of care in the first-line therapy of BTC for a decade...Currently, 3 out of the planned 6 German study sites are opened for recruitment and 6 patients have been enrolled. The primary study endpoint is estimated to be evaluated in 2023.
- Herceptin (trastuzumab) / Roche, emavusertib (CA-4948) / Curis, Dr. Reddy's
Phase I trial of CA-4948, an IRAK4 inhibitor, in combination with FOLFOX/PD-1 inhibitor +/- trastuzumab for untreated unresectable gastric and esophageal cancer. (Available On Demand; 149b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2004;
P1
During Dose Escalation, we will investigate CA-4948 in combination with FOLFOX/nivolumab by BOIN algorithm evaluating 4 different dose levels...Cohort B will investigate CA-4948 in combination with FOLFOX/pembrolizumab and trastuzumab...Secondary objectives are to determine the preliminary efficacy of the combination. Correlative studies to evaluate pharmacodynamic effects and to identify biomarkers associated with disease response are planned.
- Keytruda (pembrolizumab) / Merck (MSD)
First-line lenvatinib plus pembrolizumab plus chemotherapy in esophageal squamous cell carcinoma: LEAP-014 trial in progress. (Available On Demand; 149a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2003;
P3
In part 2 (main study), approximately 850 patients will be randomly assigned 1:1 to induction with pembrolizumab plus lenvatinib plus chemotherapy (FP or mFOLFOX6 [Q2W for 6 cycles {IV oxaliplatin 85 mg/m2 plus bolus IV 5-FU 400 mg/m2 plus continuous IV 5-FU 2400 mg/m2 plus IV leucovorin 400 mg/m2 or IV levoleucovorin 200 mg/m2}]) followed by consolidation with pembrolizumab plus lenvatinib (arm 1) or pembrolizumab plus chemotherapy (FP or mFOLFOX6; arm 2)...In part 2, the dual primary end points are overall survival and progression-free survival (per RECIST v1.1 assessed by blinded independent central review [BICR]); secondary end points include objective response rate and duration of response (per RECIST v1.1 assessed by BICR) and safety and tolerability. Enrollment in this trial is ongoing.
- bemarituzumab (AMG 552) / Amgen, Opdivo (nivolumab) / Ono Pharma, BMS
Trial in progress: Phase 1b/3 study of bemarituzumab + mFOLFOX6 + nivolumab versus mFOLFOX6 + nivolumab in previously untreated advanced gastric and gastroesophageal junction (GEJ) cancer with FGFR2b overexpression (FORTITUDE-102). (Available On Demand; 148a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2001;
P1b, P3
Primary endpoint for Part 2 is OS; secondary endpoints include PFS, OR, and safety. The concurrent phase 3 FORTITUDE-101 study (NCT05052801) will evaluate bemarituzumab + mFOLFOX6 vs placebo + mFOLFOX6.
- bemarituzumab (AMG 552) / Amgen
Trial in progress: Phase 3 study of bemarituzumab + mFOLFOX6 versus placebo + mFOLFOX6 in previously untreated advanced gastric or gastroesophageal junction (GEJ) cancer with FGFR2b overexpression (FORTITUDE-101). (Available On Demand; 147b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2000;
P1b, P3
Tumor responses and PFS will be assessed locally per RECIST v1.1. The concurrent phase 1b/3 FORTITUDE-102 study (NCT05111626) will evaluate the efficacy and safety of bemarituzumab + mFOLFOX6 + nivolumab versus placebo + mFOLFOX6 + nivolumab.
- Opdivo (nivolumab) / Ono Pharma, BMS
EA2183: A phase III study of consolidative radiotherapy in patients with oligometastatic HER2-negative esophageal and gastric adenocarcinoma. (Available On Demand; 146b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1998;
P3
Stratification factors include number of metastatic sites, choice of immunotherapy with relation to PD-L1 CPS, as well as time of registration to the protocol (before or after systemic therapy initiation). Enrollment to the study is ongoing.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Do we need postoperative chemotherapy after preoperative FOLFIRINOX in resected borderline or locally advanced pancreatic cancer? A retrospective analysis. (Available On Demand; 135) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1986;
We observed a trend in the N+ population for a survival benefit. Peri-Op FFX was associated with longer survival than Gemcitabine Post-Op regimen.
- Tedopi (OSE 2101) / OSE Immunotherapeutics, Opdivo (nivolumab) / Ono Pharma, BMS
A randomized, non-comparative, phase II study of maintenance OSE2101 vaccine alone or in combination with nivolumab (nivo) or FOLFIRI after induction with FOLFIRINOX in patients (Pts) with advanced pancreatic ductal adenocarcinoma (aPDAC): First interim results of the TEDOPAM GERCOR D17-01 PRODIGE 63 STUDY. (Available On Demand; 133) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1984;
P2
Maintenance OSE2101 monotherapy showed a favorable safety profile and encouraging time to strategy failure warranting further evaluation. OSE2101 + nivo was associated with poorer outcomes leading to close Arm C. Following IDMC recommendation, the study is ongoing with the new design (maintenance FOLFIRI vs. FOLFIRI + OSE2101).
- Evaluation of stage IV pancreatic adenocarcinomas based on mutational profiling of tumors. (Available On Demand; 125) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1976;
Most patients continue to be treated with conventional chemotherapy despite a sizeable group with targetable mutations. Further work is needed to identify targeted therapies for the more common mutations in PDAC given their impact on overall survival.
- Mutational landscape of pancreatic adenocarcinoma identified by prospective clinical sequencing in a nationwide cancer network. (Available On Demand; 123) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1974;
Access to the TAPUR trial allowed for an increase in the patients identified for targeted immunotherapy between 2013 and 2019, although overall use remained low for PDAC. Further research is needed to identify therapies based on the more commonly mutated genes given their association with overall survival.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Resectable pancreatic adenocarcinoma neo-adjuvant FOLF(IRIN)OX-based chemotherapy: A multicenter, non-comparative, randomized, phase II trial (PANACHE01-PRODIGE48 study). (Available On Demand; 120) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1971;
P2
The feasibility and efficacy of the mFOLFIRINOX neoadjuvant chemotherapy is confirmed regarding completion of therapeutic sequence and oncological outcomes. These results confirm the rationale for ongoing clinical trials, PREOPANC3 and Alliance AO21806.
- Keytruda (pembrolizumab) / Merck (MSD)
KRAS wild-type pancreatic ductal adenocarcinoma: Molecular and therapeutic opportunities. (Available On Demand; 116) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1967;
The molecular profile of KRAS wt PDAC is highly heterogeneous and difficult to generalize. Novel approaches (e.g., basket trials) are needed to develop therapy for this rare PDAC subgroup.
- AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / Jiangsu Hengrui Pharma
Hepatic artery infusion chemotherapy (HAIC) combined with apatinib and camrelizumab for hepatocellular carcinoma (HCC) in BCLC stage c: A prospective, single-arm, phase II trial (TRIPLET study). (Available On Demand; 93) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1944;
P2
The triplet treatment of HAIC, apatinib and camrelizumab showed promising clinical benefits and acceptable safety for BCLC Stage C HCC. Further confirmatory randomized controlled trial is about to get underway.
- Herceptin (trastuzumab) / Roche
Trastuzumab plus FOLFOX for gemcitabine/cisplatin refractory HER2-positive biliary tract cancer: A multi-institutional phase II trial of the Korean Cancer Study Group (KCSG-HB19-14). (Available On Demand; 83) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1934;
P2
For HER2-positive BTC, 2nd- or 3rd-line trastuzumab plus FOLFOX exhibited a promising efficacy with acceptable toxicity, warranting further investigations. Targeted NGS analyses with ctDNAs from pre-treatment and post-progression liquid biopsies are ongoing.
- Keytruda (pembrolizumab) / Merck (MSD)
A phase II study of perioperative mFOLFOX plus pembrolizumab combination in patients with potentially resectable adenocarcinoma of the esophageal, gastroesophageal junction (GEJ) and stomach. (Available On Demand; 35) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1887;
P2
The preliminary benefit data are very encouraging with ypRR of 93%, ypCR of 19 %, and the long-time survival. The data support the combination of chemotherapy and Immune checkpoint inhibitor at perioperative setting.
- Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
FOLFOX versus FOLFOX plus nivolumab and ipilimumab administered in parallel or sequentially versus FLOT plus nivolumab administered in parallel in patients with previously untreated advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction: A randomized phase 2 trial of the AIO. (Available On Demand; 31) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1883;
P2
FOLFOX plus dual checkpoint inhibition administered in parallel is associated with an increase in toxicity but not activity. This portion of the moonlight trial does not generate a signal for further trials on FOLFOX plus nivo and ipi for adenocarcinoma of stomach and GEJ.
- Cyramza (ramucirumab) / Eli Lilly
Perioperative ramucirumab in combination with FLOT versus FLOT alone for resectable esophagogastric adenocarcinoma (RAMSES/FLOT7) with high rate of signet cell component: Final results of the multicenter, randomized phase II/III trial of the German AIO and Italian GOIM. (Available On Demand; 30) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1882;
P2/3
In this phase II trial, the addition of ramucirumab to perioperative FLOT significantly improved R0-resection rates and slightly prolonged DFS without an impact on path response or overall survival. FLOT-RAM is feasible and safe, when type I tumors are excluded.
- tremelimumab (CP-675206) / AstraZeneca, Pfizer, Imfinzi (durvalumab) / AstraZeneca
The PRODIGE 59-DURIGAST trial: A randomized phase II study evaluating FOLFIRI plus durvalumab and FOLFIRI plus durvalumab plus tremelimumab in second-line treatment of patients with advanced gastric or gastro-esophageal junction adenocarcinoma. (Available On Demand; 24) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1876;
P2
FDT combination demonstrates a clinically relevant efficacy never before achieved with a median PFS of 6 months and should be evaluated in a phase III trial. Updated results including PFS according to centralized review and PD-L1 status will be presented during ASCO meeting.
- Imfinzi (durvalumab) / AstraZeneca
Durvalumab (D) and PET-directed chemoradiation (CRT) after induction FOLFOX for esophageal adenocarcinoma: Final results. (Available On Demand; 17) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1869;
P1/2
PD-L1 CPS≥1 and higher TMB may be associated with MPR. TLG is a novel PET variable that should be studied prospectively.
- albumin-bound paclitaxel / Generic mfg.
Sequential nab-paclitaxel/gemcitabine followed by modified FOLFOX for first-line metastatic pancreatic cancer: The SEQUENCE trial. (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1862;
P1/2
Nab-P/Gem-mFOLFOX showed significantly higher clinical activity than the standard nab-P/Gem treatment, with a manageable safety profile. This regimen represents a feasible and efficient new option for first-line treatment of mPDAC.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., gemcitabine / Generic mfg.
Randomized phase III trial of induction chemotherapy followed by chemoradiotherapy or chemotherapy alone for nonresectable locally advanced pancreatic cancer: First results of the CONKO-007 trial. (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1861;
P3
Pts with R0 CRM - resections had a better prognosis compared to patients with either R0 CRM+ or incomplete or without surgery. However, this effect on resectability did not translate into a statistically significant PFS or OS benefit in the whole cohort.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg., gemcitabine / Generic mfg.
Adapted physical activity in patients (Pts) with advanced pancreatic cancer (APACaP): Results from a prospective national randomized GERCOR trial. (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1860;
P=N/A
A total of 313 Pts (median age: 64 years; men: 55%, ECOG PS 0-1: 93%; metastatic: 77%; FOLFIRINOX: 78%, gemcitabine-based: 13%) were included from 11/2014 to 10/2020 (standard arm: n = 157, APA arm: n = 156)... APA in combination with usual care improved several dimensions of HRQoL in Pts with aPDAC receiving first-line CTx.
- Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, Takeda
NET-02: A multicenter, randomized, phase II trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients (pts) with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (PD-EP-NEC). (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1857;
A recognised first-line (1L) treatment for advanced disease is etoposide/platinum-based chemotherapy; there is no standard second-line (2L) treatment (area of unmet need). nal-IRI/5-FU, but not docetaxel, met the primary endpoint (exceeding the threshold for efficacy), with manageable toxicity, and warrants evaluation in a phase III trial.
- Bylantra (devimistat) / Rafael Pharma, Ono Pharma
Phase 3, multicenter, randomized study of CPI-613 with modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) as first-line therapy for patients with metastatic adenocarcinoma of the pancreas (AVENGER500). (Available On Demand; 10) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1851;
P3
The addition of CPI-613 to mFFX failed to show significant improvements of ORR, PFS or OS. The mFFX in the test arm that had the lowest prospectively tested doses of FFX was without compromise on PFS or OS and may be considered as a reference for future FFX administration.
- Preoperative chemoradiation (CRT) with carboplatin (CBP)/paclitaxel (PCL) (CP) or with 5-fluorouracil (FU)/oxaliplatin (OX) (Fx) for esophageal or junctional cancer: A randomized phase 2 trial. (Available On Demand; 3) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1841;
P2
Following randomization (balanced by ECOG PS 0 vs 1-2, stage II vs III, squamous-cell (SCC) vs adenocarcinoma (ADK), center), pts received CP (AUC2 CBP plus PCL 50mg/m² / week x 5 weeks), or Fx (FU 400 mg/m² bolus Day 1, then FU 1600 mg/m² continuous infusion over 2 days, plus OX 85 mg/m², and Folinic acid 200 mg/m², 2-h infusion, Day 1; 3 cycles every 2 weeks). When combined to preoperative radiation therapy at 41.4Gy, both regimens (CP and Fx) provided short-term benefit on R0 resection; however, CP is associated with a severe postoperative morbidity rate higher than expected.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with FOLFOX to improve outcomes of patients with hepatocellular carcinoma with microvascular invasion: A prospective multicenter, phase 3, randomized, controlled clinical trial. (Available On Demand; 2) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1840;
P3
Background: To report the efficacy and safety of postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with FOLFOX (5- fluorouracil, leucovorin, and oxaliplatin) in hepatocellular carcinoma (HCC) patients with microvascular invasion (MVI). Postoperative adjuvant HAIC with FOLFOX significantly improved the survival benefits with acceptable toxicities in HCC patients with MVI.
- Damage-associated molecular patterns (DAMPS) in patients with advanced cancer undergoing systemic treatment. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1790;
Signals of ICD were not observed in these patients. HMGB1 variation was not significant while plasma concentration of S100A8 significantly decreased after treatment, more markedly in those patients who experienced tumor response.
- autogene cevumeran (RG6180) / Roche
Phase I trial of adjuvant autogene cevumeran, an individualized mRNA neoantigen vaccine, for pancreatic ductal adenocarcinoma. (Available On Demand; 172) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1562;
P1
Vaccine induced neoantigen-specific immunity preliminarily correlates with improved PDAC outcome. Further clinical trials in PDAC are warranted.
- Tyvyt (sintilimab) / Eli Lilly, Avastin (bevacizumab) / Roche
PD-1 blockade boosted chemo-target therapy in cT4NxM0 pMMR/MSS colorectal cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1548;
Neoadjuvant Sintilimab combined with Bevacizumab and mFOLFOX6 was associated with few side effects, did not delay surgery and lead to a striking 56% and 78% complete and major pathological response. Stroma down-regulation of CD3 or CD3/CD4 expression was related to pCR.
- 5-fluorouracil / Generic mfg., oxaliplatin / Generic mfg., leucovorin calcium / Generic mfg.
Evaluation of circulating tumor cells in stage III colorectal cancer patients under three or six months of adjuvant therapy. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1546;
To conclude, the current study indicates that 3 months of adjuvant treatment is at least as efficacious as 6 months in eliminating CTCs. However, the increase of both the rate and number of positive CTCs after three months of treatment might highlight the emergence of resistant cancer cell clones.
- Avastin (bevacizumab) / Roche
A single center phase 2 study of anti-PD-1 antibody plus bevacizumab and FOLFIRI as second-line treatment for patients with MSI-H metastatic colorectal cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1538;
P2
Patients receive FOLFIRI (iritecan 180mg/m2, leucovorin 400mg/m2, fluorouracil 400mg/m2 bolus, fluorouracil 2400mg/m2 46-48 hours), anti-PD-1 antibody (Nivolumab 240mg, or Pembromab 200mg, or Terriprizumab 240mg), and bevacizumab (5mg/kg)... Anti-PD-1 antibody plus bevacizumab and FOLFIRI demonstrated promising activity as second-line treatment for patients with MSI-H metastatic colorectal cancer.
- 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
From bench to bedside and back: prognostic groups of Phase 2 study of second-line FOLFIRI-aflibercept in prospectively stratified, RAS wild type, anti-EGFR resistant, metastatic colorectal cancer patients: The DISTINCTIVE trial—A GISCAD study. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1513;
P=N/A
Our results showed the prognostic role of the combination of hematologic parameters and VEGFR2 levels + RBC count in RAS WT anti-EGFR resistant mCRC pts treated with FOLFIRI-Aflibercept. These findings represent a promising association of translational and clinical factors in predicting survival in the specific study population.
- Vectibix (panitumumab) / Amgen, Takeda
Development and validation of a predictive score to identify K-Ras wild-type (WT) metastatic colorectal cancer (mCRC) patients who are likely to benefit from Panitumumab (P) treatment. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1505;
P3
Based on CEA, ALP, LDH and platelet baseline levels, this easily applicable predictive score might be helpful to accurately select K-Ras WT mCRC patients who would benefit from P treatment. Further work is required to validate this approach in prospective cohorts of patients.