Topline Results of Phase III BURAN Trial Evaluating Buparlisib (AN2025) in Combination with Paclitaxel for Recurrent or Metastatic HNSCC
2025/05/30Tokyo Japan, May.30, 2025 –Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, Japan; President: Atsuhiro Wakumoto; hereinafter "Nippon Kayaku") today noted that Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a global clinical-stage biotechnology company focused on the development of innovative targeted and immune-modulating cancer therapies, announced topline results from its Phase III BURAN trial evaluating buparlisib (AN2025), a PI3K inhibitor, in combination with paclitaxel for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The study did not achieve statistical significance for the primary endpoint of improving overall survival (OS) compared to paclitaxel alone. The safety profile of buparlisib was consistent with previous findings, with no new safety signals observed. Detailed results will be presented by our partner Adlai Nortye at an upcoming medical conference.
Nippon Kayaku is deeply grateful to the patients, investigators, and research teams whose commitment and contributions made this global study possible, especially for the clinical sites in Japan. Our ex-Japan partner Adlai Nortye will continue to analyze the data to better understand the findings and to inform future drug development in HNSCC.”
While the BURAN outcome is disappointing, Nippon Kayaku remains confident to other development programs, including taletrectinib is currently under new drug application reviewed by PMDA. Nippon Kayaku also have first proposal right to opt in two additional programs from Adlai Nortye’s promising early-stage programs, including AN4005 (oral anti-PD-L1), AN8025 (tri-specific immune-oncology modulator), and AN9025 (pan-RAS(ON) inhibitor), together with their emerging candidates in Japan territory. Nippon Kayaku remain confident to address significant unmet needs across multiple tumor types and deliver transformative therapies to patients in Japan.
The impact of this matter is not significant on our consolidated FY2026 full-year forecasts.
About Phase III BURAN Trial
The BURAN study is a randomized (2:1), open-label Phase III study to assess the treatment effect of buparlisib in combination with paclitaxel compared to weekly paclitaxel alone in patients with recurrent and metastatic HNSCC that have progressed after anti-PD-(L)1-based treatment. A total of 487 patients were enrolled globally. The primary endpoint of the trial was overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), and duration of response (DoR). This Phase III trial builds on positive Phase II data, where the buparlisib-paclitaxel combination demonstrated improvements in ORR, PFS, and OS compared to paclitaxel alone. Notably, these Phase II findings preceded the establishment of anti-PD-(L)1 therapies as the cornerstone treatment for recurrent/metastatic HNSCC.
About Collaboration between Nippon Kayaku and Adlai Nortye
Nippon Kayaku has option right to exclusive license Buparlisib in Japan for commercialization, development and manufacture. Nippon Kayaku also has first proposal right to opt in two additional programs from Adlai Nortye in Japan territory.
About Nippon Kayaku
Nippon Kayaku was founded in 1916 as the first industrial explosives manufacturer in Japan. We have developed products to meet the needs of the time by utilizing, combining and transforming our core technologies in the company’s main areas, explosives, dyes, pharmaceuticals and resins. Nippon Kayaku has contributed to realizing a sustainable society through its four businesses of Functional Chemicals, Pharmaceuticals, Safety Systems, and Agrochemicals.
In the Pharmaceuticals Business, Nippon Kayaku specializes in anticancer drugs and other cancer-related products, handling a range of products from new drugs to biosimilars and generics. It strives to provide trustworthy information crucial for understanding anticancer drugs to medical institutions.
Please visit the company website at https://www.nipponkayaku.co.jp/english/ for more information.
About Adlai Nortye
Adlai Nortye (NASDAQ: ANL) is a global clinical-stage company focused on the development of innovative targeted and immune-modulating cancer therapies, with global R&D centers in the U.S. and China. The company is advancing multiple drug candidates including AN4005, an oral small molecule PD-L1 inhibitor, AN8025, a multifunctional fusion protein acting as a T cell and antigen-presenting cell (“APC”) modulator, and AN9025, an oral small molecule pan-RAS(ON) inhibitor.
For further information, please contact:
Nippon Kayaku Co., Ltd.
Corporate Communications Division,
Tel. +81 3 6731 5237
