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.

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.