Gastric Cancer

Results from the phase 3 KEYNOTE-062 study appear mixed for both pembrolizumab monotherapy versus chemotherapy and pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Results presented during the 2022 Gastrointestinal Cancers Symposium showed that 58.6% of evaluable patients experienced complete regression and fibrosis with no tumor cells.

Updated survival results from the phase 2 DESTINY-Gastric01 trial reveal the survival benefit of trastuzumab deruxtecan HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma.

A study of cinrebafusp alfa is underway to evaluate its safety and efficacy in combination with other therapies in patients with gastric or gastroesophageal junction cancers.

The novel checkpoint inhibitor, evorpacept induced responses in patients with head and neck squamous cell carcinoma and gastric cancer when used in combination with anticancer therapy and chemotherapy in a phase 1b study.

Data from the phase 3 CheckMate-649 trial showed that the combination therapy of nivolumab and chemotherapy showed a sustained survival benefit in patients with advanced gastric, gastroesophageal junction (GEJ), or esophageal cancer, in contrast to the combination of nivolumab and ipilimumab.

The combination of nivolumab/ipilimumab did not significantly improve OS compared with chemotherapy in patients with advanced gastric, gastroesophageal junction, or esophageal cancer.

In Western patients with HER2-positive gastric/gastroesophageal junction cancer Fam-trastuzumab deruxtecan-nxki as a second-line treatment elicited a 38% confirmed objective response rate.

In patients with advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression, the addition of toripalimab to platinum-based chemotherapy demonstrated significantly improved survival outcomes.

Limited responses as a second-line treatment for patients with locally advanced or metastatic gastric or gastroesophageal junction cancer were seen with Linagliptin plus atezolizumab.

The FDA has granted an orphan drug designation to TST001, an anti-Claudin18/2 monoclonal antibody, for the treatment of gastric cancer or gastroesophageal junction.

Pembrolizumab has been voluntarily withdrawn from the North American market as a treatment option for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

“We observed much more deeper responses and more meaningful responses [in the treatment arm] compared with the placebo arm, in which 15% of the population had deep responses of ≥ 80%."

The combination of paclitaxel and GSK2636771 showed encouraging antitumor activity and a manageable toxicity profile and in patients with PTEN-deficient advanced gastric cancer who progressed after first line chemotherapy.

An FDA Oncologic Drugs Advisory Committee meeting resulted in continued approval for 4 of 6 indications that were discussed, although all 6 indications did not demonstrate clinical benefit in confirmatory studies. The meeting, held April 27-29, evaluated anti–PD-1/PD-L1 drugs that received accelerated approvals through the FDA’s accelerated approval program, a nearly 30-year-old initiative to expedite the approval process.

The treatment landscape for gastric cancer is evolving. The use of biomarkers and implementation of testing to improve outcome later on in the course of treatment are being more important.

The latest updates on gastric and esophageal cancers focus on greater use of biomarkers, next-generation sequencing (NGS), and immunotherapies.

The FDA has granted orphan drug designation to the first-in-class ruthenium-based small molecule, BOLD-100, for the treatment of patients with gastric cancer.

The FDA has granted accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction cancer.

Here is a look back at the FDA happenings from the month of April 2021.

The FDA’s Oncologic Drugs Advisory Committee has voted 6 to 2 against the continued approval of pembrolizumab as indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 who experienced disease progression on or after 2 or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2-targeted therapy.

The FDA has approved nivolumab in combination with certain chemotherapies for the initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

For the treatment of patients with HER2-amplified gastric cancers in addition to those with HER2 moderate-, low-, and non-expressing disease, trastuzumab deruxtecan has shown to be an effective therapeutic option.

The FDA has granted an orphan drug designation to ARX788 for the treatment of patients with HER2-positive gastric cancer, according to a press release from developer Ambrx.

In an interview with Targeted Oncology, Markus Moehler, MD, PhD, reviewed the potentially practice-changing data from the phase 3 CheckMate 649 clinical trial.