New Pancreatic Cancer Drug Approved, Boosting K-Bio Development Competition

The global market for pancreatic cancer treatments is experiencing significant activity following the U.S. Food and Drug Administration's (FDA) approval of a drug that nearly doubles the average survival time for patients. As the treatment paradigm shifts from chemotherapy to targeted therapies, competition among domestic biotech companies in developing these treatments is expected to intensify.

According to industry sources, on August 26, the FDA approved Lasonk (active ingredient: darasofit) from Revolution Medicines as a treatment for metastatic pancreatic cancer. In a Phase 3 clinical trial (RASolute 302), the drug increased the median survival time from the standard chemotherapy of 6.7 months to 13.2 months, reducing the risk of death by 60%.

With the FDA's approval of Lasonk, market growth is anticipated to accelerate. Industry analysts project that the global pancreatic cancer treatment market will expand from approximately 6 trillion won this year to 19.5 trillion won by 2034.

This trend is expected to invigorate development efforts among domestic companies. Jeil Pharmaceutical's subsidiary, Onconic Therapeutics, has been developing the targeted cancer drug Nesupaparib since 2021. In June, the company gained attention by announcing results from a Phase 1b trial at the American Society of Clinical Oncology (ASCO), which showed complete responses and long-term survival cases exceeding 40 months in metastatic pancreatic cancer patients.

Currently, clinical trials for four indications, including pancreatic cancer, endometrial cancer, ovarian cancer, and gastric cancer, are underway in South Korea. The company is also preparing to submit an Investigational New Drug (IND) application to the FDA, aiming to enter Phase 2 trials in the U.S. by the end of the year. The company aims to establish itself as a first-line treatment for pancreatic cancer, leveraging regulatory benefits such as conditional approval and fast-track designation.

Prestige Biopharma is conducting a Phase 1/2a study for its pancreatic cancer candidate PBP1510 (Urenistamab). PBP1510 targets PAUF (Pancreatic Adenocarcinoma Up-regulated Factor), a factor expressed in pancreatic cancer. The Phase 1 trial, which evaluated safety and initial anti-tumor effects in patients with advanced metastatic pancreatic cancer, has been completed, and data analysis is ongoing as the company prepares to enter Phase 2a.

ABL Bio is targeting the first-line treatment market for gastric cancer with its bispecific antibody ABL111, developed in collaboration with China's iMap. ABL111 is designed to enhance anti-cancer effects by simultaneously targeting claudin 18.2, a protein highly expressed in gastric cancer cells, and 4-1BB, a protein that activates immune cells. A global Phase 3 trial for gastric cancer is set to begin in December, with plans to expand indications to include pancreatic and biliary cancers.

Ligand Pharmaceuticals is entering the pancreatic cancer market with its antibody-drug conjugate (ADC) targeting CLDN18.2, LCB02A. Recently, it received approval for a Phase 1/2a trial in the U.S. targeting CLDN18.2-positive solid tumors, including gastric, gastroesophageal junction, and pancreatic cancers, with plans to enroll up to 191 participants across the U.S., South Korea, and Canada.

However, there is growing concern over drug pricing. Lasonk is priced at $39,800 for a 30-day supply in the U.S., amounting to approximately $480,000 annually. This high pricing has drawn both praise as a 'new standard of care' and criticism as a symbol of 'inflation in cancer drug prices.'

Mark Goldsmith, CEO of Revolution Medicines, stated, "Today marks a historic advancement for patients with metastatic pancreatic cancer, demonstrating the results of over a decade of research into RAS-driven diseases."