ShanghaiJune 9, 2026 /PRNewswire/ — The ASCO officially licensed meeting “2026 ASCO International Dialogue on Prostate Cancer: Featuring Licensed Content from ASCO®,” supported by Hengrui Medicine, has successfully concluded.
Long-Term Follow-Up Data from CHART Study Released, Chinese and U.S. Urology Experts Paint New Treatment Landscape at ASCO
The meeting invited Professor Dingwei Ye from Fudan University Shanghai Cancer Center to serve as the conference chair. International guests included Professor Stephen Freedland, Co-Chair of the ASCO Prostate Cancer Guidelines Panel and Professor of Urology at Cedars-Sinai Medical Center, and Professor Shilpa Gupta, Member of the NCCN Prostate Cancer Guidelines Panel and Director of the Genitourinary Medical Oncology Program at the Taussig Cancer Institute, Cleveland Clinic. Chinese guests included Professors Bo Dai and Yao Zhu from the Department of Urology at Fudan University Shanghai Cancer Center. Chinese and U.S. urology experts gathered at the Chicago studio for a high-level academic dialogue.
Keynote Presentations
Professor Yao Zhu (Fudan University Shanghai Cancer Center) delivered a keynote titled “Long-Term Follow-Up Survival Data from the Phase III Registration CHART Study of Rezvilutamide.” Professor Zhu noted that the CHART study is a Phase III registration clinical trial led by Chinese investigators and designed based on the disease characteristics of Chinese patients, with long-term follow-up data exceeding a median of 6 years.
Previously, the interim analysis of the CHART study, published in The Lancet Oncology in 2022, confirmed that compared to the control group, the rezvilutamide group significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC), along with rapid and potent PSA reduction: 94.4% of patients in the rezvilutamide group achieved PSA90, with a median time to response of only 29 days, and 68.7% of patients had PSA reduced to below 0.2 ng/mL. Subsequent post-hoc analyses further demonstrated that regardless of whether patients achieved PSA ≤ 0.2 ng/mL at 6 months of treatment, the rezvilutamide group showed significant improvements in OS and rPFS, with patients achieving PSA ≤ 0.2 ng/mL having even better OS and rPFS, further supporting the concept of early initiation of intensified treatment with next-generation androgen receptor pathway inhibitors (ARPI) for patients with high-volume mHSPC.
In terms of rPFS and other exploratory endpoints, the rezvilutamide group continued to show sustained benefits after a median follow-up of 6 years. The median rPFS in the rezvilutamide group reached 81.0 months, compared to 18.5 months in the bicalutamide group (HR=0.38), representing a 62% reduction in the risk of radiographic progression or death. Additionally, time to PSA progression, time to next skeletal-related event, and time to initiation of next-line anti-prostate cancer therapy were all significantly prolonged.
Regarding safety and quality of life, after a median follow-up of 6 years, no new safety signals were observed in the rezvilutamide group. The overall tolerability was good, and concomitant use of antithrombotic drugs, medications for gastric acid disorders, and lipid-modifying agents had minimal impact on safety. Patient-reported outcomes (PROs) indicated that compared to the control group, the rezvilutamide group improved patients’ quality of life, which was maintained over the long term.
In summary, the long-term follow-up data from the CHART study further confirm that the rezvilutamide regimen provides significant and durable survival benefits for patients with high-volume mHSPC, while maintaining a favorable safety profile and quality of life benefits during long-term treatment.
Panel Discussion
The panel discussion, moderated by Professor Bo Dai (Fudan University Shanghai Cancer Center), focused on topics including the design and results of the CHART study, its clinical implications and value, the international positioning of rezvilutamide, directions for academic publication, and future positioning in international guidelines and evidence requirements.
Topic 1: Clinical Significance of the Long-Term OS Results from the CHART Study
Both international professors expressed that the long-term OS results from the CHART study were “very impressive.” Professor Stephen Freedland acknowledged that since rezvilutamide has not yet been approved in the United States, clinical attention to the study in the U.S. has been relatively limited, but the existing data show remarkably strong efficacy. He specifically noted that the CHART study focused on a population with high-volume disease and a poorer prognosis, and its OS and rPFS results are clearly competitive compared to international studies like ARCHES and ENZAMET, strongly validating the value of intensified treatment in this population. He was particularly struck by the improvement in quality of life observed in the study — “Patients not only want to live longer, but also better” — and considered this a very important message. He expressed hope to see future efficacy and safety data for rezvilutamide in Western populations to verify cross-racial applicability.
Professor Gupta also agreed that the long-term OS data further strengthen the study’s persuasiveness, with rezvilutamide showing outstanding efficacy and safety in patients with high-volume disease. She also prospectively noted that rezvilutamide has potential application prospects for patients with low-volume disease, warranting further exploration through prospective studies.
Topic 2: Interpreting the CHART Study Design and OS Benefit
Regarding whether the lack of pre-specified crossover and the bicalutamide comparator affect the interpretation of OS, Professor Freedland stated that this is not an issue because the absence of crossover is statistically advantageous for observing the most genuine OS difference. However, this by no means implies that patients in the control group did not receive subsequent effective treatment — in fact, a large number of control group patients received standard treatments such as abiraterone after disease progression. The study was not a “no-treatment control,” so the OS results still hold significant clinical meaning, concluding that “the data are already very robust.”
Professor Gupta added that at the time the CHART study was initiated, bicalutamide was a reasonable comparator. The study was essentially a head-to-head comparison between two active drugs with a solid real-world background, and the subsequent treatment information accurately reflects real-world practice. Therefore, she does not believe the comparator setting diminishes the study’s value.
Topic 3: Future International Positioning of Rezvilutamide
Professor Freedland stated that if future studies can confirm its efficacy in Western populations is consistent with that in Asian populations, while demonstrating superior safety compared to existing ARPIs, particularly in reducing central nervous system (CNS)-related toxicities, rezvilutamide has the full potential to become a preferred option among ARPIs. Additionally, he believes the application scope of rezvilutamide should not be limited to high-volume mHSPC but could also be expanded to earlier disease stages such as biochemical recurrence.
Professor Gupta, considering the real-world complexity of drug selection, pointed out the need to comprehensively evaluate factors such as age, comorbidities, drug interactions, CNS toxicity, dosing convenience, and insurance accessibility. Using existing drugs as examples, she explained: elderly patients require special attention to cognitive and CNS toxicities; darolutamide has garnered attention for its favorable safety profile, but its twice-daily dosing may affect compliance; and apalutamide requires caution regarding drug interactions. She believes that if rezvilutamide can achieve a better balance between efficacy and safety in the future, it will hold a significant competitive advantage.
Topic 4: Academic Value and Publication Directions of the CHART Study’s Long-Term OS Data
Professor Gupta believes the long-term OS results from the CHART study have high academic value and are worthy of submission to high-impact journals. She noted that the long-term OS data itself, the real-world subsequent treatment information provided in the study, and the quality of life results together constitute publication strengths.
Professor Freedland strongly agreed and further emphasized that PRO data should be a highlight of future publications. Echoing his earlier focus on quality of life, he specifically noted that “patients not only lived longer but also with better quality, which is crucial,” and suggested further analysis of patient baseline symptoms, pain changes, and other information to enhance the clinical persuasiveness of the study.
Topic 5: CNS Toxicity and Real-World Drug Selection
Professor Freedland cautioned that ARPI-related CNS toxicity warrants high vigilance in the real world, especially for elderly and frail patients, and that toxicity manifestations in clinical trials and real-world settings may differ. If rezvilutamide can further confirm lower CNS toxicity, it would constitute a significant clinical advantage.
Professor Gupta added from a U.S. clinical practice perspective that precisely because the U.S. has multiple ARPI options, physicians tend to make more nuanced treatment decisions based on safety differences. Real-world patients often have more comorbidities and concomitant medications, making the accumulation of long-term real-world safety data crucial.
Topic 6: Global Significance of the CHART Study in the PSMA PET Era
Addressing concerns about whether PSMA PET might diminish the global impact of the CHART study, Professor Gupta offered a measured analysis. She acknowledged that PSMA PET can detect low-volume disease earlier, but patients with high-volume disease remain widespread, especially in China, where the proportion of patients with high-volume disease at initial diagnosis is still high. Therefore, the results of the CHART study have significant practical implications for this population. She also noted that the benefits observed in high-volume patients do not negate the potential benefits for low-volume patients, and future exploration could include MDT models, more precise dose management, and earlier disease applications.
Topic 7: Positioning of Rezvilutamide in International Guidelines and Future Evidence Needs
Professor Gupta pointed out that incorporating rezvilutamide into international guidelines still awaits regulatory approval, but the CHART study has already provided an important impetus for global prostate cancer treatment. Future accumulation of data from Western patients is needed, and cross-racial studies will help enhance international recognition.
Professor Freedman prospectively noted that the current mHSPC treatment landscape in the U.S. is rapidly evolving. If rezvilutamide plans to enter Western markets, traditional randomized controlled designs may face challenges due to ethical constraints, potentially requiring exploration of innovative study designs. He concluded the discussion with a core consensus — “The CHART study has fully demonstrated that rezvilutamide is an effective and promising ARPI.”
Meeting Summary
Professor Dingwei Ye summarized the meeting. He stated that taking the opportunity of the 2026 ASCO meeting, in-depth and constructive exchanges were held with Chinese and international opinion leaders in the field of prostate cancer regarding the long-term follow-up data from the CHART study. The long-term follow-up exceeding a median of 6 years from the CHART study strongly confirms the sustained survival benefits of the rezvilutamide regimen for patients with high-volume mHSPC, and the long-term safety and quality of life data are equally encouraging.
The successful convening of this ASCO meeting also fully demonstrates Hengrui Medicine’s research and development capabilities and innovative strength in the field of prostate cancer. As international data for rezvilutamide continues to accumulate, it is anticipated that it will benefit more patients worldwide in the near future.