Cyramza (ramucirumab)

Taiho Pharmaceutical Co. Ltd.

A 63-year-old Japanese woman with stage IVB lung adenocarcinoma [programmed death ligand-1 (PD-L1) tumor proportion score 70%] received multiple lines of systemic therapy, including pembrolizumab-based chemoimmunotherapy, docetaxel plus ramucirumab, and subsequent cytotoxic regimens. The A763_Y764insFQEA mutation is uniquely sensitive to EGFR-TKIs, and comprehensive molecular testing can guide effective targeted therapy even in later treatment lines. Broader implementation of hybrid-capture-based assays may improve precision oncology outcomes for patients with rare EGFR alterations.

P2, N=37, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | N=72 --> 37 | Trial completion date: Apr 2031 --> Jun 2030 | Trial primary completion date: Apr 2028 --> Jun 2027

The primary endpoint is the objective response rate, which is assessed by a blinded independent central review. Translational research is planned to explore the predictive biomarkers and mechanisms of resistance to bemarituzumab by sequencing tumor DNA (PleSSiSion-Neo) and circulating tumor DNA (Guardant360), which are collected at multiple time points.

P2, N=278, Recruiting, AstraZeneca | Trial primary completion date: Mar 2027 --> Apr 2029

P1/2, N=500, Active, not recruiting, FBD Biologics Limited | Recruiting --> Active, not recruiting | N=150 --> 500

P2, N=168, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Jun 2026

IgG4+CD8+ Temra and VEGF-C levels at RAM+DOC initiation may serve as biomarkers of survival benefit. Trial Registration: UMIN-Clinical Trials Registry (UMIN000050478).

Trastuzumab first established HER2-targeted therapy in gastric cancer, but the failure of trastuzumab emtansine (T-DM1) led to a decade-long stagnation until the advent of trastuzumab deruxtecan (T-DXd), which demonstrated robust clinical activity and defined a new standard of care. While bevacizumab failed to improve survival, the anti-VEGFR2 antibody ramucirumab emerged as an effective second-line therapy. Immune checkpoint inhibitors, including nivolumab and pembrolizumab, have been incorporated into first-line treatment for PD-L1-positive disease based on landmark trials such as CheckMate 649 and KEYNOTE-811. More recently, the CLDN18.2-targeted antibody zolbetuximab has expanded therapeutic options for biomarker-selected patients. Concurrently, a diverse pipeline of immune-based strategies-such as TROP2-directed ADCs, bispecific antibodies, and CAR-T cell therapies-is undergoing active clinical development. Together, advances in biomarker-driven antibody therapeutics are accelerating personalized cancer care and improving clinical outcomes in patients with gastric cancer.

P2, N=56, Recruiting, SWOG Cancer Research Network | Trial completion date: May 2029 --> May 2028

P1/2, N=210, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Oct 2028 --> Oct 2030

Because of HER2 negative, 2 courses of ramucirumab plus paclitaxel was administered, but lung metastasis, increased liver metastasis, and ascites were detected...Nivolumab treatment was continued, and there has been no further disease progression at 83 months post-surgery. This case shows that disease control was achieved with nivolumab for liver, lung, and lymph node metastases following gastric cancer surgery, and long-term survival was attained with multimodal therapy.