Amplia (ASX:ATX) Surges 80% After Rare Pancreatic Cancer Responses

Survival Up 2.6 Months, AACR Is the Next Catalyst

Amplia Therapeutics released results from its ACCENT Phase 1b trial, sending the share price up 80%.

The key number was median overall survival, which improved by 2.6 months from the standard 8.5 months. That matters because NALIRIFOX was approved by the FDA based on a median overall survival of 11.1 months, so Amplia is now showing a level of benefit that starts to look clinically relevant in a disease where survival gains are usually hard won.

Who is Amplia

Amplia is an Australian biotech developing drugs that target a protein called FAK. This protein is overexpressed in a number of cancers, particularly pancreatic cancer, and helps tumours survive treatment. The company’s lead drug, narmafotinib, is designed to inhibit FAK activity and is being tested in combination with standard chemotherapy, gemcitabine and Abraxane, in patients with advanced pancreatic cancer through the ACCENT trial.

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About pancreatic cancer

That matters because pancreatic cancer is one of the deadliest forms of cancer and is notoriously difficult to treat. Standard chemotherapy delivers a median survival of around 8.5 months, so even modest extensions in survival can be meaningful. NALIRIFOX, a different chemotherapy combination, was approved on the basis of a median overall survival of 11.1 months, which shows how important a 2.6-month extension can be in this setting.

What were the results and why are they important

One of the most striking outcomes from the study was the five complete responses. That means CT scans confirmed the disappearance of all measurable tumours and any visible spread, with no new lesions appearing for at least two consecutive months.

In pancreatic cancer, it is extremely rare. Standard chemotherapy achieves complete responses in only around 0.2% of patients, while Amplia reported 7.8%. That is roughly 39x higher than the benchmark for chemotherapy alone.

The objective response rate, which captures all patients whose tumours shrank meaningfully, was also strong. At 35.9%, Amplia’s ORR was above the MPACT chemotherapy benchmark of 23% and almost identical to the NAPOLI-3 trial result of 36.2%.

The clinical validation step

All clinical response data before this announcement had been assessed by doctors at each trial site. Amplia has now had all scans independently reviewed by an external laboratory using RECIST 1.1, which is the international standard for measuring tumour response. That matters because it is the same methodology regulators expect to see in registration-enabling data.

There are also still four patients remaining on study, with one patient now approaching 24 months, which means the data set may continue to improve as follow-up matures.

The next thing for investors to watch is Amplia’s presentation of the detailed ACCENT data, including further analysis from the independent central read, at AACR, the world’s most prestigious cancer research conference. Being selected for AACR is an important signal because it puts the data in front of global oncology experts, potential partners, and institutional investors.