Dr Garcia-Carbonero on the Phase 2b VIRAGE Trial in Metastatic PDAC

Rocio Garcia-Carbonero, MD, medical oncologist, coordinator, Gastrointestinal (GI) Tumor Unit, the Hospital Universitario Doce de Octubre, associate professor, Universitario Doce de Octubre, discusses the rationale for the phase 2b VIRAGE trial (NCT05673811) investigating nab-paclitaxel (Abraxane) and gemcitabine plus or minus VCN-01 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), highlighting which unmet needs may be met in this population with the initiation of this trial.

Garcia-Carbonero shared insights on this open-label, randomized investigation at the 

. Metastatic PDAC has a high fatality rate despite recent treatment advancements, and the field has seen minimal improvement in standard care over recent decades, she begins. Current treatment regimens offer only modest survival benefits, with overall survival for these patients rarely exceeding 1 year, Garcia-Carbonero explains.

To improve survival rates, it is essential to deepen the field’s understanding of the disease’s biology and develop innovative treatment strategies, according to Garcia-Carbonero. These strategies should aim to improve long-term survival, not just extend survival by a few weeks or months, she reports.

Garcia-Carbonero says she has high hopes for VCN-01 due to its unique mechanism of action, which differs from traditional chemotherapy. Unlike chemotherapy, which targets and kills cancer cells directly but often leads to temporary and limited responses, VCN-01 aims to induce a robust immune response against the cancer, Garcia-Carbonero states. By harnessing the body’s immune system to fight the tumor, investigators hope to achieve a more durable and sustained treatment response, she says.

The rationale behind this trial is based on the potential for immune-based therapy to provide longer-lasting effects than chemotherapy, she continues. If investigators can successfully stimulate the immune system to recognize and attack cancer cells, it could lead to significantly improved survival rates, she says. This approach might extend life expectancy beyond what is currently possible and improve the quality of life for patients by reducing the harsh adverse effects often associated with chemotherapy, Garcia-Carbonero concludes.

Videos

Rocio Garcia-Carbonero, MD, discusses the rationale for the phase 2b VIRAGE trial in patients with metastatic pancreatic cancer.

Rocio Garcia-Carbonero, MD, PhD, Universidad de Sevilla, discusses the quality of life results from the RAISE study.

The RAISE study was a phase III randomized, double-blind study of FOLFIRI plus ramucirumab or placebo in patients with metastatic colorectal cancer (mCRC) after first-line therapy with bevacizumab, oxaliplatin, or fluoropyrimidine.

Quality of life scores were calculated based on physical functioning, role functioning, emotional functioning, fatigue, appetite loss, and constipation. Results found that there was a transient worsening in quality of life for the FOLFIRI plus ramucirumab arm compared to the placebo plus FOLFIRI arm. However, differences in most quality of life scores were not significantly significant between the two arms.

Rocio Garcia-Carbonero, MD, PhD, Universidad de Sevilla, discusses the quality of life results from the RAISE study.

The RAISE study was a phase III randomized, double-blind study of FOLFIRI plus ramucirumab or placebo in patients with metastatic colorectal cancer (mCRC) after first-line therapy with bevacizumab, oxaliplatin, or fluoropyrimidine.

Rocio Garcia-Carbonero, MD, PhD

Articles

Dr Garcia-Carbonero on the Phase 2b VIRAGE Trial in Metastatic PDAC

Dr. Garcia-Carbonero on Quality of Life Impact of FOLFIRI Plus Ramucirumab in mCRC