Gastric Cancer

Pembrolizumab plus lenvatinib showed a safety profile consistent with previous reports evaluating the combination.

John Marshall, MD, discussed zolbetuximab, which the FDA recently approved for patients with CLDN18.2–positive locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma.

Zolbetuximab’s targeted action, combined with manageable adverse effects, positions it as a promising therapy for advanced gastric cancer.

Additional genetic testing measures and targeted therapies may improve outcomes for patients with diverse molecular subgroups of gastric cancers.

Data from the SPOTLIGHT and GLOW trials reveal that zolbetuximab increased survival in patients with CLDN18.2-positive gastric or GEJ adenocarcinoma.

The incorporation of zolbetuximab in addition to chemotherapy has shown benefit in patients with Claudin 18.2–positive gastric cancers in clinical trials.

Data from the phase 3 SPOTLIGHT trial and the phase 3 GLOW trial supported the approval of zolbetuximab plus chemotherapy in this indication.

Data from the GLOW and SPOTLIGHT trials support the European Commission’s approval of zolbetuximab for patients with CLDN18.2-positive gastric cancer.

Second-line fruquintinib plus paclitaxel did not sustain sufficient efficacy for patients with advanced gastric or GEJ adenocarcinoma to support approval in China.

The addition of neoadjuvant S-1 also reduced the risk of death compared with adjuvant therapy alone in the phase 3 PRODIGY trial.

Enrollment will soon begin for the dose-expansion portion of the ongoing phase 1 trial assessing EO-3021 in CLDN18.2-positive tumors.

Combining evorpacept with trastuzumab, ramucirumab, and paclitaxel appeared to be well tolerated among patients enrolled on the phase 2 ASPEN-06 trial.

Frontline zolbetuximab plus chemotherapy is one step closer to approval by the European Commission for select patients with advanced gastric/GEJ cancer.

The FDA has set a new Prescription Drug User Fee Act date of November 9, 2024, for zolbetuximab in this gastric cancer population.

Higher response rates with T-DXd occurred in patients with gastric cancer and plasma HER2 amplification in circulating tumor DNA in the DESTINY-Gatric01 trial.

The primary end point of overall survival was met in the KEYNOTE-811 trial assessing pembrolizumab in HER2-positive gastrointestinal cancer.

Using FOLFIRI as a doublet with durvalumab or a triplet with durvalumab and tremelimumab yielded positive safety in gastric/GEJ cancers.

Findings from the phase 3 CheckMate 649 trial support nivolumab plus chemotherapy as a standard frontline therapy for patients with gastric, gastroesophageal junction, and esophageal adenocarcinoma.

Data from the phase 3 RATIONALE 305 trial support the biologics license application for tislelizumab plus chemotherapy in advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Over half of the patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma achieve a major pathological complete response following treatment with sintilimab plus FLOT in a phase 2 trial.

Findings from the FRUTIGA study support fruquintinib plus paclitaxel as a promising second-line treatment for those with advanced gastric or gastroesophageal junction adenocarcinoma following prior chemotherapy.

Risk-reducing total gastrectomy is associated with short-term and long-term physical and emotional AEs in patients with pathogenic or likely pathogenic germline CDH1 P/LP variants.

Investigators observe a benefit with durvalumab plus neoadjuvant chemotherapy among subgroups of patients regardless of microsatellite instability status in the phase 3 MATTERHORN trial.

Combining ASKB589 with capecitabine, capecitabine, and sintilimab leads to no treatment discontinuation due to adverse effects among patients with gastric or gastroesophageal junction cancer in a phase 1/2 trial.

The FDA cannot approve the application for zolbetuximab in advanced or metastatic gastric or gastroesophageal junction adenocarcinoma due to unresolved issues following a pre-license inspection of a third-party manufacturing site.

In Europe, pembrolizumab is now available as a treatment in combination with fluoropyrimidine-/platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, as well as in combination with gemcitabine/cisplatin for locally advanced biliary tract carcinoma.

Approval of PD-L1 IHC 22C3 pharmDx may also identify patients with non–small cell lung cancer and other malignancies who may benefit from treatment with pembrolizumab.

Only patients with PD-L1–positive tumors may receive treatment with pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastroesophageal junction adenocarcinoma following the FDA’s amendment.

CHM 2101 will be assessed as part of a phase 1A/B clinical study in a population of patients diagnosed with advanced colorectal cancer, gastric cancer, and neuroendocrine cancer.

CMG901 demonstrated a well-tolerated safety profile in patients with CLDN18.2-positive, advanced gastric/gastroesophageal junction cancer.