Nuvation Bio, a global oncology company tackling some of the toughest challenges in cancer treatment, has announced it has amended its exclusive license agreement with Daiichi Sankyo to include Japan rights for safusidenib.
The move gives Nuvation Bio full global development and commercialization control of the investigational drug and clears the path to expand its pivotal Phase 3 SIGMA study into Japan.
The amended agreement also grants Nuvation Bio access to all previously generated and future data to support publication of safusidenib results in IDH1-mutant glioma.
Safusidenib is a novel, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is currently being tested in the Phase 3 SIGMA study for maintenance treatment in patients with high-risk IDH1-mutant astrocytoma following standard-of-care therapy.
Early studies have shown encouraging results. In Phase 1 and Phase 2 single-arm studies, safusidenib demonstrated durable responses, prolonged progression-free survival, and tumor shrinkage across all IDH1-mutant glioma grades and treatment lines.
A Phase 1 study in Japan of 47 participants with recurrent or progressive gliomas showed clinical activity in both high- and low-grade tumors. Phase 2 data in 27 chemotherapy- and radiotherapy-naïve grade 2 patients, published in Neuro-Oncology in November 2025, confirmed these findings.
As of February 2026, 12 patients remain on treatment with a median follow-up of over five years. Nuvation Bio plans to present longer-term data at an upcoming medical meeting.
"We believe safusidenib has immense potential to address significant patient needs in IDH1-mutant glioma, and our current development plan focuses on patient groups with limited or no FDA-approved targeted treatment options," said David Hung, Founder, President, and CEO of Nuvation Bio.
"We are thrilled to now have the exclusive global development and commercialization rights to explore this investigational medicine's potential across these devastating brain tumors.
"With this agreement now final, we plan to expand the pivotal Phase 3 SIGMA study into Japan, continue to advance the robust global development of safusidenib, and pursue presentation and publication of longer-term data from the Phase 2 study to ensure the scientific community is up to date on these findings."
Yuki Abe, Head of R&D Division in Japan and Head of Research at Daiichi Sankyo, added, "The invention of new medicines is at the core of what we do at Daiichi Sankyo and safusidenib is a strong example of our expertise in science and technology.
"We continuously evaluate the best approach to accelerate the delivery of promising medicines to patients and we are confident that Nuvation Bio will carry this program forward, utilizing their strong expertise in clinical development and commercialization to explore the full potential of safusidenib for patients with IDH1-mutant glioma."
