Amplia Therapeutics Releases New Topline Data from ACCENT Narmafotinib Pancreatic Cancer Trial

Amplia Therapeutics (ASX: ATX) has released new topline data from an ongoing trial of its best-in-class selective FAK inhibitor narmafotinib on advanced pancreatic cancer.

The ACCENT clinical trial is investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of narmafotinib when used in combination with standard-of-care chemotherapies gemcitabine and Abraxane.

Latest data to 20 July has shown a progression free survival (PFS) of 7.6 months in trial participants, representing a two-month improvement over chemotherapy alone, and superior to the PFS obtained with the more aggressive (but less tolerated) FOLFIRINOX chemotherapy combination that attacks cancer cells in different ways.

Objective Response Rate

Narmafotinib’s objective response rate currently sits at 31%, significantly better compared to chemotherapy alone (23%), whilehe drug has also demonstrated a strong tolerability profile with adverse events being very similar in type and occurrence to those observed for chemotherapy.

Durability of response has been strong with seven patients having stayed on the trial for more than 12 months.

The mean days on trial for evaluable patients is 202 days and is substantially better than the 117 days the benchmark MPACT study reported for chemotherapy alone.

At the data cut-off date, 17 patients remained on trial.

Leading Cause of Death

Pancreatic cancer is the eighth most-diagnosed cancer in Australia and the nation’s third leading cause of cancer death.

While survival rates are increasing, it remains a serious diagnosis with an extremely poor prognosis.

Amplia is developing Narmafotinib as an inhibitor of FAK — a protein overexpressed in pancreatic cancer — and the treatment is gaining increasing attention for its role in solid tumours.

Quarterly Developments

The latest ACCENT results follow significant developments achieved in the trial during the three months to end June, with Amplia reporting a key activity threshold of 15 confirmed partial responses (PRs), demonstrating that the combination of narmafotinib with chemotherapy was superior to chemotherapy alone.

The company also announced that two trial participants had achieved pathological complete responses, with one patient experiencing a decrease in cancer lesion size over the course of treatment to the point where the lesions were no longer detectable.

Pathology showed a presumed residual tumour surgically removed from the second patient to be non-malignant tissue, meaning that the patient had achieved a pathological complete response.

This finding is extremely rare in metastatic pancreatic cancer sufferers, resulting in significant media attention for the patient and the hospital that had delivered the treatment.

Impressive Results

Amplia chief executive officer Dr Chris Burns said the trial continued to deliver impressive results.

“Data from our ACCENT trial of narmafotinib combined with chemotherapy continues to outperform chemotherapy alone across a variety of measures,” he said.

“A PFS of 7.6 months at this interim stage is a significant improvement on existing chemotherapy regimens and we expect to provide further positive updates as the trial matures.”

Dr Burns said the company was progressing a second trial of narmafotinib combined with FOLFIRINOX, with ethics approval for trial sites in the US and Australia received from the US Institutional Review Board during the June quarter.

Capital Raising

Post-quarter, Amplia launched a $27.5 million capital raising to support ongoing clinical activities and additional planned activities through to 2027.

The raising took the form of a $25m institutional placement and $2.5m share purchase plan and was supported by existing and new institutional and sophisticated investors in Australia and overseas.

Amplia finished the June quarter with a cash position of $7m, compared to $10.9m in the previous quarter, while net operating cash outflow totalled $3.9m, comprising $900,000 in administrative costs and $3m for research and development (R&D) activities primarily related to the ACCENT trial.

The company expects to receive a $3.8m R&D tax incentive refund in the next quarter, for the year ended March 2025.