Amplia Therapeutics Sees Promising Results in Pancreatic Cancer Trial
ATX (ATX) Share Update August 2024 Monday 5th
Amplia Therapeutics Announces Positive Results in Pancreatic Cancer Trial
Amplia Therapeutics Limited (ASX: ATX) has announced that a fourth patient in their Phase 2a ACCENT trial for advanced pancreatic cancer has shown a confirmed partial response, bringing the company closer to meeting the criteria for expanding the trial.
Instant Summary:
- Fourth patient in ACCENT trial shows confirmed partial response.
- Total of four responders in the first cohort of 26 patients.
- Only two more confirmed responses needed to proceed with the second cohort.
- ACCENT trial explores narmafotinib in combination with standard chemotherapy.
- Interim analysis expected to be completed by the end of this quarter.
Trial Progress and Results
Amplia Therapeutics Limited has reported that a fourth patient enrolled in their Phase 2a ACCENT trial for advanced pancreatic cancer has shown a confirmed partial response. This development follows the previously reported three partial responses in the first cohort of 26 patients.
The ACCENT trial is designed to assess the efficacy of narmafotinib, a FAK inhibitor, in combination with standard-of-care chemotherapy (gemcitabine and Abraxane®). The trial requires at least six confirmed partial or complete responses in the first cohort to proceed with the recruitment of an additional 24 patients for the second cohort. With this latest response, only two more are needed to meet this criterion.
Understanding the Responses
A 'confirmed partial response' in this context means that there is at least a 30% decrease in the overall size of tumor lesions, sustained over a two-month period, with no new tumor lesions. A 'confirmed complete response' refers to the total absence of tumor lesions over the same period.
Dr. Chris Burns, CEO and MD of Amplia, expressed optimism about the trial's progress, stating that the activity of narmafotinib remains consistent with previous clinical and preclinical data. The company aims to complete the interim analysis by the end of this quarter.
About Narmafotinib and the ACCENT Trial
Narmafotinib (AMP945) is Amplia's best-in-class inhibitor of the protein FAK, which is over-expressed in pancreatic and other cancers. The drug has shown promising data in preclinical studies and is currently in an open-label Phase 2a trial. The ACCENT trial, entitled 'A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety, and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients,' aims to evaluate the drug's efficacy and safety.
The first stage of the trial (Phase 1b) was completed in November 2023 and identified a 400 mg oral daily dose of narmafotinib as safe and well-tolerated. The current Phase 2a stage focuses on drug efficacy, with primary endpoints being Objective Response Rate (ORR) and Duration on Trial (DOT), and secondary endpoints including Progression Free Survival (PFS) and Overall Survival (OS).
The positive results from the ACCENT trial are likely to boost investor confidence in Amplia Therapeutics. The confirmation of partial responses indicates that narmafotinib could be an effective treatment for advanced pancreatic cancer, potentially leading to increased interest and investment in the company. The completion of the interim analysis and the subsequent recruitment of the second cohort could further validate the drug's efficacy and expand its market potential.
Investor Reaction:
Analysts are expected to react positively to the news, given the high unmet need for effective treatments in advanced pancreatic cancer. The sustained tumor reduction observed in patients could be seen as a significant milestone, potentially leading to a rise in Amplia's stock price. However, investors will likely await the completion of the interim analysis and further trial results before making substantial investment decisions.
Conclusion:
Investors should keep a close eye on Amplia Therapeutics as the ACCENT trial progresses. The promising results so far indicate that narmafotinib could become a valuable treatment option for advanced pancreatic cancer. As the company moves towards completing the interim analysis and potentially expanding the trial, there could be significant opportunities for growth and investment.