GI Innovation's next-generation immuno-oncology therapy candidate GI-101A (drug name efdelikofusp alfa) showed meaningful anticancer activity even in patients whose cancer failed to respond to standard treatment.
The company released on the 22nd that it will deliver an oral presentation of the phase 1/2 results for GI-101A monotherapy and in combination with Keytruda at the American Society of Clinical Oncology (ASCO 2026).
The presentation will be given on the 30th (local time) by Lee Jeryeon, a medical oncologist at Asan Medical Center. The results will be disclosed in the "Developmental Therapeutics—Immunotherapy" session.
In the GI-101A monotherapy arm, a complete response (CR, cancer has disappeared to the point of not being visible on imaging) was confirmed in a bladder cancer patient who had not responded to existing immunotherapies.
The patient maintained a state of complete disappearance of cancer for 5.8 months, and the progression-free survival (PFS, the period during which the disease does not worsen and remains controlled) was 13.9 months.
This is more than twice as long as the average PFS of about 6 months for Padcev, Astellas Pharma's bladder cancer treatment currently used as a standard therapy.
A partial response (PR, a meaningful reduction in tumor size) was also confirmed in a patient with malignant mesothelioma who had not responded to existing immunotherapies, and the response lasted more than 5.6 months.
The combination therapy of GI-101A and MSD's immunotherapy Keytruda was conducted in a total of 48 patients. Antitumor activity was observed across multiple tumor types, including renal cell carcinoma (ccRCC), urothelial carcinoma, squamous non-small cell lung cancer (squamous NSCLC), cutaneous squamous cell carcinoma, pancreatic cancer, and cervical cancer. Antitumor activity means that after treatment, cancer growth is suppressed or tumor size decreases.
In renal cell carcinoma, which included the largest number of patients, the objective response rate (ORR, the proportion of patients whose tumors shrank by a certain threshold) was 40%, and the disease control rate (DCR, the proportion of patients whose cancer shrank or no longer grew) was 70%. Notably, about 70% of these were patients who were refractory to existing immunotherapies. The duration of response was confirmed to be at least 16.7 months, and treatment is still ongoing.
Yoon Nari, vice president of GI Innovation (head of clinical and business development), said, "GI-101A showed a trend of increasing anticancer activity with higher doses," and added, "Since the abstract submission, additional encouraging data have been confirmed in terms of response rate (ORR) and durability of response." She added, "We expect meaningful results to continue in the on-site presentation at ASCO."