FDA Approves Tarceva for Advanced Pancreatic Cancer Treatment

The FDA has approved Tarceva in combination with gemcitabine chemotherapy for advanced pancreatic cancer treatment. Tarceva is the first drug to show significant improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer. Tarceva is also approved for use in patients with advanced non-small cell lung cancer.

Actuate Therapeutics, Inc. (NASDAQ: ACTU) announced the topline results from their Phase 2 trial (Actuate-1801 Part 3B) for the treatment of previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial showed statistically significant improvements in median overall survival (OS) and one-year survival rates for patients receiving a combination treatment of elraglusib and gemcitabine/nab-paclitaxel (GnP) compared to GnP alone. The data will be presented in an oral session at the American Society of Clinical Oncology (ASCO) annual meeting on May 31, 2025.

The Phase 2 trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). The primary endpoint for this study is median overall survival, with OS summarized throughout the study by estimates of 1-year survival. Secondary endpoints are Disease Control Rates (DCR), Objective Response Rates (ORR), Progression-Free Survival (PFS), and Adverse Events (AE).

The study's results suggest that elraglusib may address unmet needs in mPDAC treatment, highlighting its potential as a promising therapy. The combination treatment resulted in increased OS, 1-year survival rate, DCR, and ORR compared to GnP alone. The data will be presented by Devalingam Mahalingam, MD, PhD, of Northwestern University Feinberg School of Medicine, at the ASCO annual meeting.

Actuate will also host a KOL event on May 31, 2025, to review the findings, featuring discussions with key opinion leaders in the field. The KOL event will be held at 6:30 PM CDT and will be accessible via live webcast.

The positive results from the Phase 2 trial provide further evidence of elraglusib's potential as a promising emerging therapy for treating metastatic pancreatic ductal adenocarcinoma. However, it is essential to note that the results are from a Phase 2 trial, which may have limited regulatory and commercial implications compared to larger Phase 3 studies. The company has also indicated that they face "substantial doubt" regarding their ability to continue as a going concern, which could hinder further development or commercialization of elraglusib.

References:
[1] https://www.nasdaq.com/articles/actuate-therapeutics-reports-phase-2-trial-success-showing-improved-survival-metastatic