TITAN Asian population data was released, and the deep decline of apatamide PSA was better than the global population

• Compared with the control group, the apatamide regimen significantly reduced the risk of death by 48% and improved the 4-year survival rate by 27.
  3%

• The lower the tumor burden of patients treated with apatamide regimens, the better the trend of benefit; Apatamide treatment with hyponeoplastic patients significantly reduces the risk of death by 66%, suggesting that "early initiation" of apatamide regimens maximizes patient benefit

Analysis of Asian population enrollment:

Of the 1052 patients included in the TITAN study, a total of 221 Asian patients (including 94 Chinese patients) received 1:1 treatment with apatamide + ADT and placebo + ADT
.
In terms of tumor burden among enrolled patients, the proportion of patients with high tumor burden in the Asian population was slightly higher than that of the global population (66.
7% vs.
61.
9%), and the proportion of patients with low tumor burden was 33.
3%.

The median follow-up was 42.
5 months
.

Asian Population Data Analysis:

The apatamide regimen allows patients to see a very pronounced decrease in PSA in a short period of time, which is more pronounced in the Asian population and better than the global population as a whole
.
The results showed that 73.
9% of mHSPC patients in the Asian population reduced PSA to less than 0.
2 ng/mL in less than
2 months after treatment with the apatamide regimen.

Figure 1: Proportion of patients with PSA falling below 0.
1 ng/mL and 0.
2 ng/mL in Asian populations (%)

Figure 2: Median time to different response endpoints to PSA with apatamide regimen in Asian populations

PSA deep descent can allow patients to quickly perceive the effectiveness of treatment options, improve treatment confidence, and reduce psychological pressure
.
The advantages of apatamide PSA deep descent have also been fully verified
in the real world.
In a real-world study [3] reported by AMCP Nexus in 2021^, it was shown that compared with new endocrine drugs such as abiraterone, apatamide can reduce the PSA depth to less than 0.
2ng/mL in more mHSPC patients, and the speed is also faster, achieving "better PSA depth reduction"
.

Figure 3: Real-world data on proportion of mHSPC patients with PSA90 and PSA falling below 0.
2 ng/mL (%)

Figure 4: Real-world data, time to median to PSA90 and PSA to less than 0.
2 ng/mL in mHSPC patients (months)

Apatamide PSA is deeply descended, allowing patients

"Live longer, live better"

At present, many studies have confirmed that the deep and rapid decline of PSA that can be achieved in the early stage of disease treatment can be used as a "strong predictor" of long-term survival benefits in patients ^[4-7].

Post-hoc analysis of the TITAN study also confirmed that patients with mHSPC with a reduction in PSA depth of less than 0.
2 ng/mL with the apatamide regimen had a better benefit from OS, with a significantly lower risk of death by 83 percent compared with those who did not achieve this goal (HR 0.
17, P<0.
0001) <b12>[8].

The released data of the TITAN Asian population also confirmed that Asian patients who achieved a PSA depth reduction of less than 0.
2 ng/mL on the apatamide regimen had significantly better OS than those who did not achieve this goal.
At the same time, the second progression-free survival (PFS2), radiographic progression-free survival (rPFS), time to castration resistance (TTCR), and time to PSA progression (TTPP) were significantly longer
than those who did not achieve this goal.

Figure 5: Patients with or without PSA ≤0.
2 ng/mL with apatamide regimen

At the same time, the post-hoc analysis of the TITAN study published in the 2022 ASCO-GU also confirmed that patients who achieved a decrease in PSA depth of less than 0.
2 ng/mL treated with the apatamide regimen had a lower risk of deterioration of physical health and a lower risk of progression of pain and fatigue intensity ^[9].

"Fast-acting, live longer, live better" is the wish
of all oncology patients.
Based on the excellent "PSA deep descent" advantage shown by apatamide in the above phase three clinical studies and real-world data, as well as the manageable safety profile, it currently includes the latest version of the Chinese Guidelines for the Diagnosis and Treatment of Urology and Andrological Diseases, the Chinese Society of Clinical Oncology (CSCO) guidelines, the European Urological Society (EAU) guidelines, and the National Comprehensive Cancer Network (NCCN).
), and authoritative guidelines for prostate cancer at home and abroad, including the guidelines of the American Academy of Urology (AUA), recommend apatamide regimens for the standard treatment
of patients with mHSPC and high-risk NM-CRPC with the highest level of evidence.

At present, both apatamide mHSPC and high-risk NM-CRPC can be reimbursed by medical insurance, and it is also the only new drug
in China that has achieved medical insurance coverage for mHSPC in the whole population.

Expert reviews

Corresponding author

Professor Huang Jian

Sun Yat-sen Memorial Hospital, Sun Yat-sen University