Promising Early Results in Amplia Therapeutics' Pancreatic Cancer Trial
ATX (ATX) Share Update July 2024 Thursday 25th
Amplia Therapeutics Reports Promising Results in Pancreatic Cancer Trial
Amplia Therapeutics Limited (ASX: ATX) has announced encouraging early results from its Phase 2a ACCENT trial, which investigates the efficacy of narmafotinib in combination with standard chemotherapy for advanced pancreatic cancer.
Instant Summary:
- 50% of required patient responses in the initial enrolment stage confirmed.
- Three patients show confirmed partial responses with at least a 30% decrease in tumor size.
- Two additional patients have sustained stable disease.
- Three more confirmed partial responses needed to complete trial enrolment.
Trial Progress and Results
Amplia Therapeutics Limited has reported that three patients in its Phase 2a ACCENT trial have shown confirmed partial responses, defined as at least a 30% decrease in tumor size sustained over two months. This early success is a significant milestone in the trial, which aims to evaluate the efficacy of narmafotinib in combination with standard chemotherapy for advanced pancreatic cancer.
Of the six patients assessed at the four-month mark, two additional patients have recorded sustained stable disease. This means that 50% of the required patient responses in the initial enrolment stage have now been confirmed. The trial protocol mandates that at least six of the first 26 patients enrolled achieve this level of response before proceeding to complete enrolment.
Next Steps and Future Plans
Amplia CEO and MD Dr. Chris Burns expressed optimism about the trial's progress, stating, 'To be reporting that three confirmed partial responses have been observed so early in this stage of the trial is extremely encouraging. We are well on track to reach the efficacy threshold of six confirmed partial or complete responses by the end of this quarter, which will then allow us to restart the trial to recruit the full cohort of fifty patients.'
The company recently completed the enrolment of the first 26 patients in the trial as part of the industry-standard Simon’s Two-Stage Trial design. Once six confirmed partial or complete responses are obtained, an additional 24 patients will be enrolled, bringing the total to 50 patients for the trial.
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 preclinical data and is currently being assessed in an open-label Phase 2a trial in combination with gemcitabine and Abraxane. The primary endpoints of the ACCENT trial are Objective Response Rate (ORR) and Duration on Trial (DOT), with secondary endpoints including Progression Free Survival (PFS) and Overall Survival (OS).
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 aims to assess the drug's efficacy in combination with standard chemotherapy.
The early positive results from the ACCENT trial are likely to boost investor confidence in Amplia Therapeutics. The confirmation of partial responses in patients could lead to increased interest in the company's stock, as it demonstrates the potential efficacy of narmafotinib in treating advanced pancreatic cancer. This development may also attract further investment and partnerships in the biopharmaceutical sector.
Investor Reaction:
Analysts have reacted positively to the news, noting the significance of achieving early confirmed partial responses. Investors are optimistic about the potential for narmafotinib to become a valuable treatment option for advanced pancreatic cancer, a disease with limited effective therapies.
Conclusion:
Investors should keep a close eye on further updates from Amplia Therapeutics as the ACCENT trial progresses. The company's ability to meet its efficacy thresholds and complete enrolment will be crucial in determining the long-term success of narmafotinib. Continued positive results could significantly impact the company's stock and position in the market.