ShanghaiJune 1, 2026 /PRNewswire/ — During the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, Eli Lilly and Company announced for the first time the results of the global Phase III LIBRETTO-432 clinical study: the study met its primary endpoint, demonstrating that selpercatinib as adjuvant therapy showed a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) compared to placebo in patients with stage II–IIIA RET fusion-positive non-small cell lung cancer (NSCLC) (HR=0.17, 95% CI: 0.06–0.51; p=0.0003), reducing the risk of disease recurrence or death by 83%. Consistent benefits were also observed in patients with stage IB–IIIA disease. The related study was simultaneously published in the New England Journal of Medicine (NEJM).
The LIBRETTO-432 study is the first global Phase III randomized, controlled study to achieve positive results in the adjuvant treatment of RET fusion-positive NSCLC. The study was led by Professor Yi-Long Wu from Guangdong Provincial People’s Hospital as the principal investigator and was selected for the Plenary Session of the 2026 ASCO Annual Meeting. Professor Wu is also a co-first author of the NEJM paper. It is worth emphasizing that Chinese research centers contributed nearly half of the global enrollment, providing critical support for the successful completion of the study.
Chinese Leadership at the Forefront: Advancing Research in Early-Stage Treatment of RET Fusion-Positive NSCLC
RET fusion is a rare oncogenic driver alteration in lung cancer, occurring in approximately 1%-2% of NSCLC patients[1,2,3]. For a long time, even after curative surgery or radiotherapy, these early-stage patients have faced a high risk of recurrence[4,5,6], yet lacked targeted precision adjuvant treatment options, representing a significant unmet clinical need.
In an exclusive interview, Professor Yi-Long Wu stated: “The core treatment goal for early-stage RET fusion-positive lung cancer patients is to improve long-term survival and minimize the risk of recurrence. Our original intention in conducting this study was to translate the successful experience from advanced-stage treatment to earlier stages, enabling more early-stage patients to reduce their risk of disease recurrence. The positive results of the LIBRETTO-432 study provide important clinical research evidence for RET-targeted adjuvant therapy and offer key evidence-based support for exploring further improvements in patients’ long-term outcomes, including the potential for cure.”
Professor Wu further explained that the LIBRETTO-432 study, building on the successful experience of selpercatinib in advanced-stage treatment and drawing on established models of targeted adjuvant therapy for other targets, determined the research direction of extending precision targeted therapy to early-stage disease[7,8]. The study design fully integrated Chinese clinical practice experience, marking the first time in the RET target field that patients who received curative-intent radiotherapy were included in the study population, breaking the limitation of previous similar studies that only covered surgical patients. Additionally, the Chinese team excelled in enrollment execution. Two centers, the Chengdu Third People’s Hospital and the Guangdong Lung Cancer Institute, contributed nearly one-third of the global cases, while Chinese research centers overall completed nearly half of the enrollment, laying a solid foundation for the study’s timely completion.
Discussing the academic value of the study, Professor Wu emphasized that the results hold significant academic importance, having been selected for the Plenary Session of the 2026 ASCO Annual Meeting and published in the New England Journal of Medicine (NEJM). Given that the number of Plenary Session reports at the ASCO Annual Meeting is typically limited each year, this underscores the study’s importance in the international oncology field.
Leveraging this achievement, China is expected to advance the regulatory filing for the adjuvant treatment indication of selpercatinib for RET fusion-positive NSCLC ahead of other countries globally. This marks a significant leap for Chinese oncology clinical research from international participation to global leadership in the rare target field, providing a Chinese model for early-stage precision treatment of rare-target tumors worldwide. As China’s clinical research capabilities continue to improve, an increasing amount of Chinese wisdom and strength will lead global pharmaceutical innovation, bringing more treatment options to more patients.
Collaborative Synergy Empowering: Driving Chinese Pharmaceutical Innovation Towards a Historic Leap
Commenting on the success of the LIBRETTO-432 study, Dr. Li Wang, Senior Vice President of Eli Lilly and Company and Head of Lilly China Drug Development and Medical Affairs Center, stated that the study is the inevitable result of deep collaboration and complementary strengths between Lilly China and top Chinese researchers, and a vivid practice of both parties’ commitment to the principle of “science-driven, patient-centric.”
When discussing the successful collaboration experience, Dr. Wang noted that Professor Yi-Long Wu, leveraging his extensive clinical experience accumulated in research on lung cancer targets such as EGFR and ALK, provided invaluable guidance for the study. From the development of patient selection criteria to the choice of the control group, every detail embodied the professional insights of Chinese researchers, laying a solid foundation for the study’s success. At the same time, Chinese research centers demonstrated extremely high execution efficiency, undertaking nearly half of the global patient enrollment. Furthermore, through in-depth discussions with the global research team, they contributed significant Chinese wisdom to the interpretation of the study results, directly aiding the academic presentation of the findings.
Regarding the historic leap this study has propelled for China, Dr. Wang emphasized that over the past decade, China’s pharmaceutical innovation ecosystem has undergone fundamental changes, moving from “following” to a new stage of global synchronization and partial leadership. The LIBRETTO-432 study may help China become the first country globally to submit a regulatory application for the adjuvant treatment indication of selpercatinib for RET fusion-positive NSCLC. This stems from three core factors: first, the continuous optimization of China’s pharmaceutical innovation ecosystem; second, the profound professional expertise of Chinese researchers and efficient communication between Chinese and international teams; and third, China’s outstanding contributions across the entire process, including study enrollment, design, implementation, and data interpretation. This breakthrough breaks the traditional inertial thinking of “applications first in Europe and the US, with China following.”
May 2026 coincides with the 150th anniversary of Eli Lilly and Company. Lilly has always adhered to its original aspiration of “health first,” and the LIBRETTO-432 study is a concrete practice of this commitment. Dr. Wang stated that in the future, Lilly will continue to deepen collaboration with top Chinese researchers. On one hand, it will expand its oncology product pipeline, committed to introducing novel therapeutic modalities such as antibody-drug conjugates and radionuclide drugs to China to fill unmet clinical needs. On the other hand, leveraging China’s achieved 100% global R&D integration advantage, and building on the fact that Chinese researchers already participate in 70% of global advisory committees, Lilly will further increase their representation, promoting the transformation of more Chinese researchers from “patient enrollment contributors” to “intellectual leaders,” growing into global principal investigators. At the same time, Lilly will not limit itself to registration studies in the future but will strive to explore conducting more early-stage and translational research in China, helping China stand at the forefront of international pharmaceutical innovation, fulfilling its long-term commitment to Chinese patients, and contributing Chinese strength to global pharmaceutical and healthcare endeavors.
Statement: Selpercatinib has not yet been approved in China for the adjuvant treatment indication for RET fusion-positive NSCLC. If you wish to learn more about disease-related knowledge, please consult a healthcare professional. This content is supported by Lilly China. Approval number: CMAT-32924
References:
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3. Takeuchi K. Discovery stories of RET fusions in lung cancer: a mini-review. Front Physiol 2019; 10: 216. |
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4. Grass GD, Naghavi AO, Abuodeh YA, et al. Analysis of relapse events after definitive chemoradiotherapy in locally advanced non–small-cell lung cancer patients. Clin Lung Cancer. 2019;20(1):e1-e7. |