Prostate cancer is one disease area where the treatment environment has been improving with the increasing number of treatment options listed for health reimbursement benefits.

Recently, Pluvicto (vipivotide tetraxetan), a radioligand therapy with a new mechanism of action, has emerged and is attracting attention as a viable new standard of care.

Although the prescription is still in its early stages in Korea, it is already expanding its influence in the global market.

At a meeting with Dailypharm, SeungJu Lee, Professor of Urology; Byung-Yong Sim, Professor of Oncology; and Hyuk-Jin Yoon, Professor of Nuclear Medicine at Catholic University St.Vincent’s Hospital, expressed their views on how the new treatment option Pluvicto is expected to provide a new option for patients who are not responding to existing treatments.


Prostate cancer has been ranked as the leading cancer among men in recent years, and its diagnosis rate has been increasing due to the aging population and westernization, as well as active PSA (Prostate Specific Antigen) screening.

Metastatic castration-resistant prostate cancer (mCRPC) is estimated to account for 20-30% of all prostate cancer patients.

Its prognosis is favorable if detected early, as its 5-year survival rate exceeds 90%, but if the disease has already metastasized by the time of diagnosis and become mCRPC, the prognosis differs significantly from that of early-stage prostate cancer, as it cannot be cured with drugs.

“Ten years ago, there was no way to cure mCRPC other than androgen deprivation therapy, but the introduction of antiandrogens had improved the condition and response of the patients,” said Professor Seung-Ju Lee. ”However, as even these treatments can lead to resistance, so we are looking forward to the development of further therapies.”

Professor Byung-Yong Sim said, “In the treatment of mCRPC patients, patients are forced to move on to the next line of treatment due to resistance and eventually are left to receive chemotherapy. However, since most prostate cancer patients are elderly, there is also an issue that they cannot receive chemotherapy properly.”

Radioligand therapy emerges for mCRPC...multidisciplinary care is key

One such option is Pluvicto, a radioligand therapy (RLT).

#i2The drug was approved by the Ministry of Food and Drug Safety Korea in May for the treatment of adult patients with PSMA-positive mCRPC who had previously received ARPI therapy and taxane-based chemotherapy.

In other words, the drug is expected to become a new treatment option for patients who have had a poor prognosis despite receiving existing therapies.

“Previously, anticancer drugs were administered systemically through pills or injections, which then reached the cancer cells, but radioligand therapy’s mechanism of action allows radioactive substances to find and enter the target,” said Professor Lee. ”It is an effective treatment option that aligns with the characteristics of prostate cancer that can be administered with less impact on other cells.”

It is also expected to be effective in terms of resistance, which is one of the challenges that exist with mCRPC treatment.

“Continued treatment can lead to resistance, but Pluvicto selectively binds to prostate-specific membrane antigen (PSMA), which increases during the process of developing resistance to existing treatments,” said Professor Hyuk-Jin Yoon. ”Before treatment, patients can be tested with a radiopharmaceutical called PSMA PET-CT to determine their suitability in advance, allowing for more effective treatment.”

However, due to the complex mechanism of RLT, multidisciplinary care is essential during the patient screening process.

For this reason, only a few hospitals in Korea, including St. Vincent's Hospital, are currently able to prescribe Pluvicto.

“Collaboration for RLT is only possible in hospitals that are large enough and are equipped with the facilities to handle nuclide materials,” said Professor Sim. ”We are forging multidisciplinary care, supported by a nuclear medicine department equipped with the scale to use radiotherapy materials related to bone metastases, and other departments screening the right patients.”

“Pluvicto is administered in 6 cycles at 6-week intervals, and when you come to the hospital, you visit all 3 departments together,” he said. ”The whole body blood test is done by the oncology department, and the prostate is also related to urinary problems, so the urology department checks each of these problems and provides total care.”

So how does Pluvicto actually work? While it's still early days for the drug and is hard to definitely say, the evaluation on-site is that has been shown to be effective in relieving bone pain.

“A decrease in PSA levels by more than 50% is an important indicator of response, which can take as early as 2 weeks or as long as 4 weeks if the response is slow, so it's still too early to tell,” said Professor Yoon. ”However, one of the patients we recently treated was satisfied with the elimination of bone pain after the first treatment and is continuing onto the second treatment.”

Pluvicto shows promise, but its high cost remains a challenge

Aside from its therapeutic benefits, its high price tag is likely to be a hurdle like in many other new drugs. Currently, 6 cycles of Pluvicto are estimated to cost around KRW 200 million.

Without reimbursement constraints, it is estimated that around 10% of men with castration-resistant prostate cancer (mCRPC), which accounts for 20-30% of all metastatic prostate cancer, would be eligible for Pluvicto. The number may be further reduced when screening eligible patients with PSMA PET-CT.

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“A lot of people could be helped if they didn't consider the price. Patients are highly interested in the drug, and we have visitors who received information about PSMA PET-CT and the list of hospitals that can treat it in patient advocacy groups, cafes, etc.”

“There are some prostate cancer patients who are in good physical condition even though they have undergone all chemotherapy and hormonal treatments and have seen no effect. In such cases, Pluvicto would be a good option despite its high cost.”

In the long run, however, the challenge will be its reimbursement. Professor Lee predicts that the reimbursement discussions will be made with the accumulation of prescription experience.

“Reimbursement discussions have not been very active at academic conferences because Pluvicto is still new. Once we have a year or two of patient prescription experience, demand will also rise, and once there is demand, reimbursement discussions will be made one way or another.”

“In urology, I think the introduction of Pluvicto will serve as momentum to the evolution of prostate cancer treatment, along with robotic surgery and antihormonal drugs,” added Professor Lee. ”I think the basis of the change is PSMA PET-CT, which will be a game-changer in diagnosis, and I think the related treatments will become an important issue that will attract the attention of academics for the next 2-3 years.”