World GI Congress: New Data, New Hope

OncLive Chairman,

Mike Hennessy

Several studies presented at the 2015 ESMO World Congress on Gastrointestinal (GI) Cancer offered new promise for patients. The new data covered both established and emerging therapeutics.

In updated results from the phase Ib KEYNOTE-012 trial, the PD-1 inhibitor pembrolizumab had an overall response rate of 22% in patients with recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction. Also in immunotherapy, adding the investigational agent IMM-101 to gemcitabine showed promising activity while maintaining quality of life in patients with advanced pancreatic cancer.

Results from the phase III RECOURSE trial (page 30) showed a similar survival benefit, regardless of KRAS status, with the oral nucleoside TAS- 102 in patients with KRAS wild-type or mutated metastatic colorectal cancer (CRC). The FDA is currently reviewing a new drug application for TAS-102 as a treatment for patients with refractory metastatic CRC (mCRC), with an approval decision scheduled by December 19, 2015.

In contrast to the RECOURSE results, mutational status was predictive of efficacy with second-line cetuximab in patients with mCRC in the phase II CAPRI-GOIM trial. Participants whose tumors had no mutations in KRAS, NRAS, BRAF, and/or PIK3CA genes experienced significantly prolonged progression-free survival by continuing cetuximab as part of a second-line regimen compared with chemotherapy alone.

Two studies confirmed the benefit of the multikinase inhibitor regorafenib, which is FDA-approved for patients with pretreated mCRC based on results from the CORRECT trial. Findings from a large expanded access program confirmed the overall survival (OS) data from CORRECT, and the CONCUR trial confirmed the OS benefit from CORRECT in Asian patients.

Another promising development coming out of the World GI meeting was a discussion on how novel agents that are revolutionizing the treatment of the hepatitis C virus could also have a significant impact on prevention and treatment outcomes in hepatocellular carcinoma.

For additional insight on the latest groundbreaking developments in GI cancers and all other tumor types go to OncLive.com. And as always, thank you for reading.