What's Happening?
Phanes Therapeutics, a clinical-stage biotech company, has announced promising results from its Phase 2 trial of spevatamig (PT886) in combination with chemotherapy for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The data, presented at the ASCO GI 2026 symposium, highlights spevatamig's potential as a first-line treatment for patients with CLDN18.2 positive mPDAC. Spevatamig, an anti-CLDN18.2/CD47 bispecific antibody, demonstrated a favorable safety profile with no observed cases of cytokine release syndrome (CRS) or dose-limiting toxicities (DLTs). The trial involved 107 patients in the U.S., with 42 receiving the spevatamig and chemotherapy combination. The study reported a disease control rate (DCR) of 93% and an overall
response rate (ORR) of 40% in the 2 mg/kg weekly dosing regimen. The median progression-free survival was 7.3 months, and the median overall survival was 13.2 months, with data still maturing.
Why It's Important?
The positive results from the spevatamig trial are significant as they offer a potential new treatment option for patients with metastatic pancreatic cancer, a condition with limited effective therapies. The favorable safety profile and promising efficacy of spevatamig could lead to improved patient outcomes and survival rates. This development also underscores the potential of bispecific antibodies in oncology, particularly in enhancing innate immunity against solid tumors. The trial's success may encourage further research and investment in similar therapies, potentially accelerating the development of innovative cancer treatments. Additionally, the FDA's orphan drug and Fast Track designations for spevatamig highlight its potential impact on addressing unmet medical needs in pancreatic cancer treatment.
What's Next?
Phanes Therapeutics plans to continue the TWINPEAK study, with further data maturation expected from higher dosing regimens. The company is also exploring combinations of spevatamig with other cancer therapies, including immune-checkpoint inhibitors. As the trial progresses, Phanes may seek regulatory approval based on the final results, potentially bringing spevatamig to market as a new treatment option for mPDAC. The ongoing collaboration with Merck to study spevatamig in combination with pembrolizumab could further enhance its therapeutic potential. Stakeholders, including healthcare providers and patients, will be closely monitoring these developments, which could lead to significant advancements in pancreatic cancer treatment.
