US-based biopharma, Actuate Therapeutics’s elraglusib reduced the risk of death by 37% in a Phase I/II metastatic pancreatic cancer trial.
The randomised Phase I/II trial (NCT03678883) evaluated elraglusib, a GSK-3 beta inhibitor, in combination with gemcitabine/nab-paclitaxel (GnP) for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial additionally saw the one-year survival rate double in the treatment arm, reaching 43.6% in the treatment arm when compared with the control arm of GnP alone which saw a one-year survival rate of 22.5%, meeting its primary endpoint.
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At the same time, the company added that the 18 and 24-month survival rates also saw a benefit of 20.9% vs 0% and 16.7% vs 0% in the elraglusib-GnP combination vs GnP arms respectively. As of the trial’s 15 November cut-off, 38% of patients were still alive in the elraglusib-GnP combination arm vs 19% in the GnP control arm. Meanwhile, regarding safety endpoints, researchers observed similar treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in both arms.
Based on the Phase I/II data, the company is looking to initiate a pivotal, Phase III study. More data from the Phase I/II study is due in H1 2025.
Daniel Schmitt, president and chief executive officer of Actuate, said: “These interim results are highly encouraging and underscore the transformative potential of elraglusib in the treatment of metastatic pancreatic cancer.
“The improvement in median and overall long-term survival, disease control rate and overall response rate compared to GnP alone, combined with elraglusib’s favourable risk-benefit profile, offers the possibility of improved outcomes for patients with limited treatment alternatives.
Following the 17 December announcement the company’s stock value rose from $8.69 per share the day before, up to a high of $10.09 per share before settling back down.
Andrew Mazar, Actuate’s scientific co-founder and chief operating officer, said: “Pancreatic cancer is one of the most aggressive and lethal cancers with less than 5% survival rate in the US at 5 years. We are encouraged by consistent evidence of significant clinical benefit and anti-tumour activity in the elraglusib combination arm across multiple endpoints in this study.”
Elsewhere in the field of cancer treatments, Cardiff Oncology has announced positive initial data from its randomised Phase II clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Meanwhile, Lisata Therapeutics has completed the enrolment of subjects for the Phase Ib/IIa CENDIFOX study to assess its investigational drug, certepetide.
