Onconic Therapeutics has, for the first time, disclosed a complete response (CR) and a long-term survival case of more than three years observed in a phase 1b trial of its next-generation anticancer drug candidate Nesuparib (JPI-547) in patients with metastatic pancreatic cancer. A complete response means that all cancer lesions previously seen on imaging and other tests have disappeared.
Onconic Therapeutics said on the 22nd that it disclosed part of the phase 1b data from the phase 1b/2 trial of Nesuparib for patients with advanced or metastatic pancreatic cancer through the abstract of the American Society of Clinical Oncology (ASCO 2026). This is the first time it has disclosed clinical data in actual patients.
Nesuparib is a dual-target candidate that simultaneously inhibits DNA damage repair in cancer cells and cancer metastasis. Nonclinical data had previously been released through the American Association for Cancer Research (AACR) and international journals.
This analysis was based on data collected through Dec. 31 last year. In a total of 27 patients with metastatic or advanced pancreatic cancer, Nesuparib was administered in combination with the existing standard treatments GemAbraxane (gemcitabine plus Abraxane) or mFOLFIRINOX.
In the Nesuparib plus GemAbraxane (gemcitabine + Abraxane) combination group, the objective response rate (ORR, the proportion of patients whose tumors shrank by a defined threshold) was 53.8%, and the disease control rate (DCR, the proportion of patients whose cancer shrank or no longer grew) was 92.3%.
Notably, one patient achieved a complete response in which cancer cells in the target lesions completely disappeared, and that patient has survived for more than three years.
Positive results were also seen in survival metrics. In the Nesuparib plus GemAbraxane combination group, cancer had not grown or worsened in many patients as of the analysis cutoff, and the median overall survival was 14.2 months. The company noted that patient follow-up is still ongoing, so the actual survival may turn out to be longer.
In the combination group with another standard treatment, mFOLFIRINOX, tumor progression was suppressed and survival was extended as well. Nearly half of the patients showed tumor shrinkage, and the median overall survival was 18.5 months. This is assessed as a result suggesting potential improvement over existing treatments.
With GemAbraxane, currently used as a standard treatment for metastatic pancreatic cancer, the tumor response rate is known to be about 23%, with a median overall survival of 8.5 months. In contrast, the combination therapy with Nesuparib showed the potential for better outcomes than existing treatments in both tumor reduction and survival.
Pancreatic cancer is considered a representative hard-to-treat cancer, and complete responses are rare. With treatment options limited for pancreatic cancer at present, Nesuparib is being evaluated as presenting the potential for meaningful survival improvement compared with standard therapy.
The medical community is paying attention to Nesuparib's differentiated mechanism of action. Beyond pancreatic cancer, Nesuparib has received U.S. Food and Drug Administration (FDA) orphan drug designation (ODD) in gastric cancer, gastroesophageal junction cancer, and small cell lung cancer. In the market, there are also expectations that these clinical data could spark discussions on global out-licensing and joint development.
An Onconic Therapeutics official said, "Metastatic pancreatic cancer is a representative intractable cancer with limited treatment options," adding, "The complete response and the long-term survival over three years are meaningful results that show the potential to be first-in-class (an innovative new drug with a world-first mechanism of action)." The official added, "We plan to accelerate the ongoing phase 2 development."