Abstracts highlighting developments of novel agents for the treatment of colorectal and pancreatic cancer will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress, to be held from September 27 to October 1, 2019, in Barcelona, Spain, the largest oncology conference in Europe which is expected to be attended by approximately 25,000 clinicians, researchers and representatives of the pharmaceutical and biotechnology sector.
The first study involves arfolitixorin and investigational agent being studied in an ongoing pivotal/registration-based trial in metastatic colorectal cancer (mCRC). The drug is studies versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.
“The abstract [to be] presented as a poster [during the upcoming annual meeting of the European Society of Medical Onclogoy] highlights the design and execution to date of the AGENT study,” noted Roger Tell, MD, Ph.D, chief medical officer of Isofol Medical.
“The study evaluating the effectiveness of arfolitixorin, in combination with other drugs, compared to current standard treatment for patients affected by mCRC. The AGENT study is important, as very few new drugs have been introduced to the mCRC treatment landscape in the last decade, including no new early-line therapies. With the preliminary hopeful results we have achieved with arfolitixorin in our ongoing Phase I/II study (ISO-CC-005),” Tell added.
The AGENT study is a multicentre, randomized, parallel-group Phase III clinical study evaluating arfolitixorin as a new experimental therapy for the treatment of mCRC in first-line treatment. The study is recruiting patients at approximately 70 global sites.
Josep Tabernero, MD, Ph,D, head of the Medical Oncology Department at the Vall d’Hebron Barcelona Hospital Campus, and Director of the Vall d’Hebron Institute of Oncology, is the study’s coordinating investigator and Heinz-Josef Lenz, MD, FACP, Professor of Medicine and Preventive Medicine, Section Head of GI Oncology in the Division of Medical Oncology and Co-Director, Gastrointestinal Cancers Program, at the Keck School of Medicine of the University of Southern California, Los Angeles, US, is the principal investigator in North America.
During the 2019 annual ESMO meeting Cindy Neuzillet, MD, Ph.D, head of digestive medicine at the Department of Medical Oncology, Institut Curie in Saint-Cloud, is expected to present a new treatment protocol (PRODIGE trial) combining chemotherapy, immunotherapy and a therapeutic vaccine.
The trial is conducted in 28 hospitals in France, being part of the Unicancer centers as well as a number of public/private hospitals.
“There are very few treatment options available for patients with pancreatic cancer, and most of these treatment options are not very effective,” noted Neuzillet.
“Unfortunately, some of the advanced therapeutic innovations such as targeted therapies or immunotherapy have not shown a major improvement or survival benefit,” she added.
Neuzillet’s poster presentation discusses a clinical trial which aims to delay progression of the disease while maintaining an acceptable health related quality of life for patients.
The clinical trial includes patients whose disease is controlled by the FOLFIRINOX. Once chemotherapy is complete, these patients are divided into three groups: some of the patients continue to chemotherapy (FOLFIRI), others receive a therapeutic vaccine OSE2101 (Tedopi®; OSE Immunotherapeutics), and the last group of patients is treated with nivolumab (Opdivo®; Bristol‑Myers Squibb) an immunotherapy.
“Administering nivolumab when the disease is (still) controlled by chemotherapy may, potentaiil, be a more effective approach than administering it to patients for whom the treatment has (already) failed,” Neuzillet, explained.
She also noted that chemotherapy will again be included in the event of disease progression.
As part of the trial, biopsies and blood tests will be performed to monitor cancer progression and exploring heterogeneity of tumors and biomarkers associated with efficacy, or resistance to, the investigational treatment.
Trials and presentations
|Abstract #||Title||Speaker||Type of Presentation||Location||Date/Time|
|664TiP||Open label phase III study of arfolitixorin vs leucovorin in mFOLFOX-6 for first-line treatment of metastatic colorectal cancer: AGENT||Sebastian Stintzing||Poster Display session||Poster Area (Hall 4), Fira Gran Via, Barcelona, Spain||29 July 2019|
Time: 12:00 – 13:00
|1592TiP||ATALANTE-1 randomized phase III trial, OSE-2101 versus standard treatment as second or third line in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients (ID 2352)||Enriqueta Felip (Barcelona, Spain)||Poster Display session||Poster Area (Hall 4), Fira Gran Via, Barcelona, Spain||28 September 2019|
Time: 12:00 – 13:00
|830TiP||A randomized phase II study of maintenance therapy with multiepitope vaccine tedopi (OSE2101) ± nivolumab or FOLFIRI after induction chemotherapy (CT) with FOLFIRINOX in patients (Pts) with advanced pancreatic ductal adenocarcinoma (aPDAC) (TEDOPaM – PRODIGE 63 GERCOR study) (ID 1563)||Cindy Neuzillet (Clichy, France)||Poster Display session||Poster Area (Hall 4), Fira Gran Via, Barcelona, Spain||29 September 2019|
Time: 12:00 – 13:00