Gastric Cancer

A look back at all the FDA news that occurred in the month of September.

Based on findings from the phase II KEYNOTE-059 study, pembrolizumab has been granted FDA approval for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have received 2 or more 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.

MYL-1401O, the trastuzumab (Herceptin) biosimilar manufactured by Mylan Pharmaceuticals, has been recommended for approval by the FDA's Oncologic Drugs Advisory Committee (ODAC) in a 16-0 vote.

Charles S. Fuchs, MD, MPH, professor of Medicine, director, Yale Cancer Center, and physician-in-chief, Smilow Cancer Hospital, discusses efficacy and safety results for pembrolizumab (Keytruda) monotherapy in patients with previously treated advanced gastric cancer.

In updated findings from the KEYNOTE-059 trial of pembrolizumab in advanced gastric or gastroesophageal junction (GEJ) cancer, the PD-1 inhibitor maintained signs of its clinical benefit in this patient population, which is encouraging as the indication is currently under consideration for approval with the FDA.

It’s been a busy month at the FDA. Here’s a look back at all the news in the oncology field to come out of the FDA during the month of May.

Pembrolizumab (Keytruda) has been granted a priority review by the FDA for the treatment of patients who have undergone at least 2 courses of chemotherapy for recurrent or advanced gastric or gastroesophageal junction adenocarcinoma.

Geoffrey Y. Ku, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the future of immune checkpoint inhibition in gastric and esophageal cancers.

Salah-Eddin Al-Batran, MD, medical oncologist and Director at the Institute of Clinical Cancer Research, Frankurt, Germany, discusses the findings of a study of paclitaxel with everolimus in gastric cancer.

In an analysis of 2 randomized trials,patients with advanced gastric or gastroesophageal juncture cancer derived a survival benefit from treatment with the monoclonal antibody ramucirumab, regardless of their age.<br /> &nbsp;

Continuing trastuzumab beyond progression may improve survival in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma who progress on first-line trastuzumab plus platinum-based chemotherapy.

Patients with malignant gastric outlet obstruction who received surgical palliation maintained their quality of life and improved solid food intake for at least 3 months after surgery.

A novel combination regimen of ramucirumab plus pembrolizumab demonstrated modest activity in patients with previously treated gastric or gastroesophageal juncture cancer.

Ian Chau, MD, discusses interim safety and clinical activity results in patients with advanced gastric or gastroesophageal junction adenocarcinoma from a multi-cohort phase I study of ramucirumab plus pembrolizumab.

According to findings from the phase III ONO-4538-12 trial, treatment with nivolumab (Opdivo) reduced the risk of death by 37% compared with placebo for patients with advanced gastric or gastroesophageal junction (GEJ) cancer following second or later-line chemotherapy.

Christophe Mariette, MD, PhD, surgical oncologist and professor of surgery, University Hospital of Lille in France, discusses a nationwide study investigating the impact of age and comorbidities on postoperative mortality after esophageal and gastric cancer surgery.

An expert panel, consisting of the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology&nbsp;issued comprehensive, evidence-based guidelines for clinicians and pathologists regarding the testing of HER2 status for patients with gastroesophageal adenocarcinoma.&nbsp;

The PD-1 inhibitor nivolumab extended overall survival versus placebo for patients who were refractory or intolerant to standard therapy&nbsp;with unresectable, advanced, or recurrent gastric cancer, according to topline data from the phase III ONO-4538-12 trial.

Newer agents, including immunotherapies and HER2 and VEGF-targeted therapies, are being investigated in gastric cancer, but the jury is still out on if these therapies will be beneficial, said David H. Ilson, MD, PhD, a medical oncologist at Memorial Sloan Kettering Cancer Center.<br /> &nbsp;

As gastric cancers continue to be classified into different subtypes, oncologists will now have the opportunity to improve treatment by determining which targeted agents are appropriate for which subtypes, said Howard S. Hochster, MD.<br /> &nbsp;

Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms at the University of Texas MD Anderson Cancer Center, discusses the most recent developments in diagnosing polycythemia vera.

Adam Bass, MD, assistant professor of medicine, Dana-Farber Cancer Institute, discusses the differentiation between the classes of gastric cancer.

Not all gastroesophageal junction cancers should be treated the same, according to Richard J. Bold, MD.

While the utilization of immunotherapy in gastric cancer may not be as clear cut as it is in melanoma or lung cancer, Zev Wainberg, MD, illustrates some trials where the therapy type is breaking through.

Adam Bass, MD, assistant professor of Medicine, Harvard Medical School, physician/scientist, Dana-Farber Cancer Institute, discusses the importance of individualizing treatments for patients with gastric/esophageal cancer.

Apatinib demonstrated an improvement in overall survival by 1.8 months and an acceptable toxicity profile compared to placebo as treatment for advanced gastric cancer.

Hendrik-Tobias Arkenau, MD, PhD, founding medical director, executive medical director, Sarah Cannon Research Institute UK, gives an overview of the JAVELIN trial in gastric cancer. He also discusses the safety profile of avelumab.

IMAB362, a novel chimeric IgG1 backbone antibody highly specific for CLDN18.2, extended median overall survival by 4.8 months when added to standard chemotherapy in patients with advanced gastric cancer.

Understanding how gastric and esophageal cancers are triggered and their genetic makeup is vital to developing and testing new therapies.