Below is an overview of recent FDA approvals of Gi cancer...

Below is an overview of recent FDA approvals of Gi cancer treatments, including clinical trial data supporting their approvals sourced from ChatGPT for your reference.

Importantly:
- no CART therapies (not surprising given slow progress against solid tumours). CHMs CDH17 third Gen CART could change all that;
- only modest improvements in key metrics such as overall survival and progression free survival. CHMs CART really offers curative potential;
- no therapies targeting the CDH17 antigen. This is a new target with less than a handful of companies looking at it (no other CART is in the clinic);
- all approvals followed phase 3 trials. CART therapies may use phase 2 data as a pivotal trial (subject to FDA approval)

**1. Zolbetuximab (Vyloy) for Gastric and Gastroesophageal Junction (GEJ) Cancer:**

In October 2024, the FDA approved zolbetuximab (Vyloy) in combination with chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors are claudin 18.2 positive. citeturn0search0

**Clinical Trial Data:**

The approval was based on the GLOW study, a Phase 3 trial that evaluated zolbetuximab plus chemotherapy in patients with claudin 18.2-positive gastric or GEJ adenocarcinoma. Results showed a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone. The combination therapy demonstrated a median OS of 14.5 months versus 11.5 months with chemotherapy alone (hazard ratio [HR] 0.68; 95% CI: 0.56, 0.83; p<0.0001). Median PFS was 8.2 months versus 5.6 months (HR 0.56; 95% CI: 0.46, 0.68; p<0.0001).

**2. Tislelizumab (Tevimbra) with Chemotherapy for Advanced Gastric and GEJ Cancer:**

In December 2024, the FDA approved tislelizumab (Tevimbra), an anti–PD-1 monoclonal antibody, in combination with chemotherapy for the first-line treatment of patients with newly diagnosed, locally advanced or metastatic gastric and GEJ adenocarcinoma. citeturn0search1

**Clinical Trial Data:**

The approval was supported by the RATIONALE-305 trial, a Phase 3 study that assessed tislelizumab plus chemotherapy in patients with advanced gastric or GEJ adenocarcinoma. The combination therapy resulted in a 20% reduction in the risk of disease progression or death compared to chemotherapy alone. Median OS was 13.2 months versus 11.5 months with chemotherapy alone (HR 0.80; 95% CI: 0.65, 0.98; p=0.03). Median PFS was 7.4 months versus 5.6 months (HR 0.70; 95% CI: 0.58, 0.84; p<0.0001).

**3. Pembrolizumab (Keytruda) with Chemotherapy for HER2-Negative Gastric or GEJ Cancer:**

In October 2023, the FDA approved pembrolizumab (Keytruda) in combination with chemotherapy for the first-line treatment of patients with HER2-negative gastric or GEJ adenocarcinoma. citeturn0search2

**Clinical Trial Data:**

The approval was based on the KEYNOTE-062 trial, a Phase 3 study that evaluated pembrolizumab plus chemotherapy in patients with HER2-negative gastric or GEJ adenocarcinoma. The combination therapy demonstrated a statistically significant improvement in OS, PFS, and overall response rate (ORR). Median OS was 12.9 months versus 11.5 months with chemotherapy alone (HR 0.78; 95% CI: 0.70, 0.87; p<0.0001). Median PFS was 6.9 months versus 5.6 months (HR 0.76; 95% CI: 0.67, 0.85; p<0.0001).

**4. Lumakras (Sotorasib) and Vectibix (Panitumumab) for KRAS G12C-Mutated Colorectal Cancer:**

In January 2025, the FDA approved the combination of Lumakras (sotorasib) and Vectibix (panitumumab) for the treatment of colorectal cancer in patients with a specific KRAS G12C mutation. citeturn0news14

**Clinical Trial Data:**

The approval was supported by the CodeBreaK 200 study, a Phase 3 trial that evaluated sotorasib plus panitumumab in patients with KRAS G12C-mutated colorectal cancer. The combination therapy demonstrated a median progression-free survival of 5.6 months compared to 2.0 months with standard care (HR 0.33; 95% CI: 0.26, 0.42; p<0.0001). The ORR was 26% versus 3% with standard care (p<0.0)