‘Unprecedented’ response seen with narmafotinib in pancreatic cancer trial
Adding drug to chemo led to no detectable cancer on scans for some patients
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Adding Amplia Therapeutics‘ experimental drug narmafotinib to standard chemotherapy led to complete responses — meaning no detectable cancer on imaging scans for at least two months — in a small percentage of patients with advanced pancreatic cancer in an ongoing clinical trial.
These new data come from the Phase 1b/2a ACCENT trial (NCT05355298), underway in Australia and South Korea. The trial is testing narmafotinib in combination with gemcitabine and Abraxane (nab-paclitaxel) as a first-line treatment for people with pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer, that is metastatic, or has spread.
According to Amplia, this level of complete response — observed in more than 7% of participants — is “unprecedented” for this patient population.
“These latest data from the ACCENT trial clearly demonstrate the significant clinical benefit of narmafotinib,” Chris Burns, PhD, CEO and managing director of Amplia, said in a company press release announcing these and other new data highlights.
“The unprecedented 7.8% rate of [CRs] in the first line setting provides new hope for patients with this very aggressive cancer and provides further strong support for the benefit that narmafotinib can bring when combined with other treatment modalities,” Burns said.
The company said it has been selected to present data from the study at an upcoming scientific meeting in California.
Narmafotinib, also known as AMP945, is an oral therapy designed to inhibit FAK, a protein found at high levels in pancreatic cancers and thought to support cancer cell growth, spread, and survival. By selectively blocking this protein in cancer cells and the surrounding tissue, the therapy is believed to make cancer cells more susceptible to chemotherapy.
Trial tested narmafotinib in patients whose cancer had spread
The open-label ACCENT study was designed to test whether narmafotinib can indeed improve responses to treatment in people receiving first-line treatment for metastatic PDAC, meaning the tumor had spread from the pancreas to other parts of the body.
It is being conducted across two parts. In the Phase 1b part, researchers tested four increasing doses of narmafotinib in combination with chemotherapy to evaluate safety and determine the optimal dose for further study. In the Phase 2a portion, the selected dose (400 mg) is being tested in a larger group of patients to assess its effectiveness.
According to Amplia, a total of 64 participants received the 400 mg dose across the two parts. As of the latest data cutoff in mid-March, four were still in the study, and one was approaching two years of follow-up.
Among all patients, five had a complete response, and one had a pathological complete response — an extremely rare outcome in this patient population, in which there are no signs of live tumor tissue in lesions removed during surgery.
Combining complete and partial responses, a total of 35.9% of patients on the 400 mg dose had an objective response to treatment, meaning they experienced at least a partial reduction in tumor size, according to new analyses.
The company said these numbers are based on analyses of all trial data done by a central lab. Amplia had previously reported findings based on assessments by investigators at each site, but those had failed to identify four complete responses and one partial response. Those additional data have now been included in the results to date.
Combo treatment also led to longer median survival times
Additionally, the median survival time for patients in the study was 11.1 months, according to the data. That’s about two months longer than the median survival time expected for patients using chemotherapy alone, Amplia said.
The company said is slated to present full data from the study at the American Association of Cancer Research (AACR) meeting in San Diego next month.
“We look forward to presenting a detailed analysis of the ACCENT trial at the forthcoming AACR conference,” Burns said.
Amplia is also conducting another Phase 1/2 trial, called AMPLICITY (NCT07026279), that’s evaluating narmafotinib in combination with a four-drug chemotherapy regimen known as FOLFIRINOX in patients with metastatic PDAC. That trial is recruiting participants at sites in the U.S. and Australia.
