GI CANCERS

A supplemental new drug application for lenvatinib as a frontline systemic treatment for patients with advanced hepatocellular carcinoma has been accepted by the FDA, acccording to a statement from Eisai, the company developing the therapy.

Manish A. Shah, MD, director of gastrointestinal oncology, Weill Cornell Medicine and New York-Presbyterian Hospital, discusses the differences between right- and left-sided colon cancer.

In the phase III KEYNOTE-177 trial, investigators are hoping to show that frontline treatment with the PD-1 inhibitor pembrolizumab (Keytruda) can improve progression-free survival compared with standard-of-care chemotherapy in patients with mismatch repair-deficient or microsatellite instability-high colorectal cancer.

Investigators aimed to evaluate the prognostic value of primary tumor location in patients with fully resected colon cancer, as well as its relationship to microsatellite instability-high (MSI-H), <em>RAS</em>, and <em>BRAF</em> mutational status, in a study presented at this year&#39;s World Congress on Gastrointestinal Cancer.

Davendra Sohal, MD, MPH, Department of Hematology and Medical Oncology, Cleveland Clinic, discusses the need for an ongoing study exploring mFOLFIRINOX versus gemcitabine and nab-paclitaxel (Abraxane) in patients with resectable pancreatic adenocarcinoma.

Heinz-Josef Lenz, MD, shares his excitement for&nbsp;findings from clinical studies on liquid biopsies, Immunoscore^&reg;, and primary tumor location in colorectal cancer.

Based on findings from the phase II KEYNOTE-059 study, pembrolizumab has been granted FDA approval for the treatment of patients with PD-L1&ndash;positive recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have received 2 or more&nbsp;lines of chemotherapy, including fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.

Charles S. Fuchs, MD, MPH, professor of Medicine, director, Yale Cancer Center, and physician-in-chief, Smilow Cancer Hospital, discusses what he envisions for the future treatment landscape of gastric cancer.

Peter W. T. Pisters, MD, MHCM, has been chosen as the next president of The University of Texas MD Anderson Cancer Center. Pisters has served as president and CEO of University of Health Network (UHN) of Toronto since 2015.

While currently-approved treatments for HCC are typically associated with responses rates of 10% or less, findings presented at the 11th Annual Conference of the ILCA, BLU-554, a potent and highly selective inhibitor of fibroblast growth factor receptor 4 (FGFR4), induced an overall response rate of 16% (95% CI, 6-31) in patients with FGF 19 IHC-positive HCC.

In updated phase III results, lenvatinib continued to be noninferior in overall survival compared with sorafenib for&nbsp;patients with unresectable hepatocellular carcinoma, and achieved significant improvements in progression-free survival, time to progression, and objective response rate compared with sorafenib.

Multidisciplinary findings across the field of hepatocellular carcinoma will be showcased at the 11th International Liver Cancer Association Annual Conference on September 15 to 17 in Seoul, South Korea. Abstracts already under discussion at this year&rsquo;s ILCA conference include pivotal research on VGEF inhibitors, immunotherapy regimens, and biomarkers.

Amit G. Singal, MD, MS, stressed that improvement for precision screening for hepatocellular carcinoma with the current screening techniques through its risk-stratifying approach.

Hepatocyte pERK-positive immunostaining and microvascular invasion were independent prognostic factors of recurrence-free survival for patients with hepatocellular carcinoma treated with adjuvant sorafenib. According to an analysis of the phase III STORM study presented at the 11th International Liver Cancer Association Annual Conference,&nbsp;a predictive biomarker for recurrence was not uncovered.

According to updated phase III results presented at the 11th Annual International Liver Cancer Association Conference,&nbsp;first-line therapy with Lenvatinib in the frontline setting continued to be noninferior in overall survival and achieve significant improvements in progression-free survival, time to progression, and objective response rate versus sorafenib for patients with unresectable hepatocellular carcinoma

Direct acting antivirals, a novel, oral hepatitis C therapy, is associated with a high response rate. DAAs are used in most patients being treated for hepatitis C, including those with decompensated cirrhosis. However, this treatment has been replaced by&nbsp;interferon-based therapy for patients with hepatitis C.

According to findings presented at the 11th Annual Conference on the International Liver Cancer Association in Seoul, South Korea, BLU-554 induced an overall response rate of 16% in patients with FGF 19 immunohistochemistry-positive hepatocellular carcinoma.&nbsp;BLU-554 is a potent and highly selective inhibitor of fibroblast growth factor receptor 4.

Excitement surrounds systemic therapies for hepatocellular carcinoma, with 1 new drug recently approved, 2 agents pending FDA decisions, and later-stage clinical trials for multiple therapies on the horizon.

Today, ABP-215, a biosimilar for bevacizumab developed by Amgen and Allergan, received FDA approval for the treatment of several different cancer types, making it the first biosimilar approved for the treatment of cancer.

The decision deadline on a biologics license application (BLA) for MYL-1401O, a trastuzumab (Herceptin) biosimilar co-developed by Mylan and Biocon, has been extended by 3 months, the FDA has announced. Under the new timeframe, a final decision is expected on or before December 3, 2017.

Mark S. Talamonti, MD, clinical professor, NorthShore University HealthSystem, discusses the learning curve for minimally invasive surgery in gastrointestinal cancers.

Antonia R. Sepulveda, MD, PhD, discusses&nbsp;the importance and utility of genetic testing in GI cancers, as well as noteworthy developments in microsatellite instability, <em>BRAF</em>, and <em>KRAS </em>testing in colorectal cancer.

Manuel Hidalgo, MD, shares his insight on the growth of genetic testing in CRC.<br /> &nbsp;

Manish A. Shah, MD,&nbsp;director of gastrointestinal oncology, Weill Cornell Medicine and New York-Presbyterian Hospital, discusses the decreasing incidence of colon cancer diagnosis in those over the age of 50.

In patients with heavily-pretreated microsatellite stable metastatic colorectal cancer (mCRC), treatment with CEA-TCB, an investigational CEA/CD3 bispecific antibody, showed a favorable safety profile and promising efficacy, with enhanced efficacy when combined with the PD-L1 inhibitor atezolizumab.

Dominik P. Modest, MD, discusses a retrospective, central evaluation of the FIRE-3 study to determine surgical treatment options, which explored the number of patients with metastatic colorectal cancer who had resectable disease during systemic first-line therapy.&nbsp;

Nivolumab (Opdivo) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Diane M. Simeone, MD, is stepping up to lead the new Pancreatic Cancer Center at NYU Langone. She has been a member of NYU Langone since March 2017, and will continue in her role as associate director of translational research at the Perlmutter Cancer Center.