On April 1, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported the company has amended its existing exclusive license agreement for safusidenib with Daiichi Sankyo (TSE :4568) to include Japan rights, effectively securing exclusive global development and commercialization rights of the investigational medicine. The agreement, as amended, enables Nuvation Bio to expand its ongoing pivotal SIGMA study of safusidenib into Japan, and provides rights to all previously generated and future data to support further publication of safusidenib results in IDH1-mutant glioma.
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Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1 that is currently being evaluated in the ongoing Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care.
In Phase 1 and Phase 2 single arm studies, safusidenib has shown encouraging efficacy signals across all IDH1-mutant glioma grades and treatment lines, including durable responses and prolonged progression-free survival that show tumor shrinkage and disease control. In the Phase 1 study in Japan of 47 participants with recurrent or progressive IDH1-mutant glioma with enhancing (predominantly high-grade) and non-enhancing (predominantly low-grade) tumors, safusidenib showed clinical activity in both populations. Data from a Phase 2 study in Japan of safusidenib in 27 patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma was published online in the November 2025 issue of Neuro-Oncology. The data published reflected a March 10, 2023 data cut-off. As of February 2026, 12 patients in the study remain on treatment with safusidenib with a median follow-up of over 5 years. Nuvation Bio plans to present longer-term data from the Phase 2 study at a future 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. 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," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "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."
"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," said Yuki Abe, Ph.D., Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "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."
About IDH1-Mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH1-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors.
About Safusidenib
Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1. In Phase 1 and Phase 2 clinical studies, safusidenib delayed disease progression and provided durable responses across grades and risk groups with a favorable risk-benefit profile.
About the SIGMA (G203) Study
SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. Data is anticipated to be available in 2029.
A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. Data is anticipated to be available in 2027.
(Press release, Nuvation Bio, APR 1, 2026, https://www.prnewswire.com/news-releases/nuvation-bio-announces-acquisition-of-japan-rights-to-safusidenib-from-daiichi-sankyo-302730492.html [SID1234664134])