“Korean patients in the ASCENT-04 trial were happy to be in the trial, even if assigned to the placebo arm.”

A breast cancer specialist I met last week at the American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago, said so.

I felt disturbed. “Being happy to be included in the placebo arm” wasn't just a clinical trial story. It reveals the reality of Korean cancer patients who have no choice but to turn to clinical trials in search of treatment and the medical and industrial ecosystem intertwined with it.

The global phase 3 ASCENT-04 study presented at ASCO 2025 was highlighted as a study that could change the paradigm of first-line treatment for metastatic triple-negative breast cancer. The study, which compared the combination of the immuno-oncology drug Keytruda (pembrolizumab) and the TROP-2-targeting antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) to the conventional combination of Keytruda plus chemotherapy in patients with PD-L1-positive metastatic triple-negative breast cancer, was successful.

Median progression-free survival (mPFS) in the trial arm was 11.2 months, significantly longer than the 7.8 months in the control arm. The risk of disease progression or death was reduced by 35 percent, and progression-free survival at six and 12 months was 72 percent vs. 48 percent and 63 percent vs. 33 percent, respectively. Based on these results, academics believe that the first-line standard of care for metastatic triple-negative breast cancer will likely shift from Keytruda plus chemotherapy to Keytruda plus Trodelvy shortly.

However, the reality in Korea is different. Even the existing combination of Keytruda plus chemotherapy is not yet covered by health insurance. Although recognized as a standard of care, it remains out of reach for many Korean patients due to cost. This has led to a situation where patients can only receive standard treatment by participating in clinical trials, and even if they are assigned to the placebo group, they have to be grateful to receive treatment. The term “medically advanced country” is a misnomer.

This lagging reimbursement system threatens more than patients' right to survive. It also casts a large shadow on Korea's industrial future, which aspires to be a drug development powerhouse.

Lack of access to treatment makes it impossible to participate in clinical trials for follow-up treatments. For example, patients who do not receive the global standard of care as a first-line treatment will not be able to meet the enrollment criteria for later-stage drug trials, distorting the drug development ecosystem.

A case in point is the development of lung cancer drugs. While Tagrisso (osimertinib), a third-generation EGFR TKI, was being used as a first-line treatment in most countries worldwide, Korea delayed reimbursement for first-line treatment by about four years. As a result, Korean patients still had to try first-generation drugs first, and the resulting resistance variant, called T790, became a primary therapeutic target.

The problem didn't end there. Korean companies developing fourth-generation EGFR TKIs naturally focused on finding candidates with the “T790” mutation. They designed new drugs based on disease characteristics that were different from those of international patients. Since the “T790” variant is rarely encountered in the global clinical setting, where Tagrisso is used in first-line treatment, the success of new drugs targeting it was limited from the start.

"Any drug development that starts in a skewed clinical setting is doomed to failure from the start," one lung cancer expert told this reporter at the time. The lack of a standard of care creates a “double jeopardy” that not only reduces patient survival but also reduces drug development success.

It's time for a shift in perception. Clinical and research settings are not separate. Clinical trials are ultimately conducted in real-world settings. If that environment is not aligned with global standards, the drug discovery ecosystem will be distorted.

If the government is serious about becoming a “drug discovery powerhouse,” the first step is to normalize the standard of care. Reimbursement policy is not just an administrative procedure; it is a lifeline for patients and a rudder for the industry. It's time for the government to recognize its weight.