Safusidenib Shows 44% Response Rate and Long-Term Disease Control in Nuvation Bio Phase 2 Study
Positive Results Highlight Potential to Delay Chemoradiation in Glioma Patients
Fresh results from Nuvation Bio’s Phase 2 study of safusidenib are putting the spotlight on new possibilities for treating grade 2 IDH1-mutant glioma—a challenging brain cancer most often diagnosed in adults in their 30s and 40s. The company has reported a robust objective response rate (ORR) of 44% and nearly 88% progression-free survival at two years, raising hope for a therapeutic approach that could postpone the need for traditional chemoradiation and its long-term toxicities.
Durable Responses Seen: Key Phase 2 Data at a Glance
| Study Population | ORR | 24-Month Progression-Free | Median Follow-Up (months) | Grade =3 Adverse Events |
|---|---|---|---|---|
| 27 (IDH1-mutant grade 2 glioma, no prior therapy except surgery/biopsy) | 44% | 87.9% | 28 | 18.5% |
The Phase 2 open-label, single-arm trial enrolled 27 patients who had not yet received chemotherapy or radiotherapy. Safusidenib—a novel, brain-penetrant oral inhibitor of mutant IDH1—was evaluated for its ability to control tumor progression and minimize the need for immediate chemoradiation. Notably, at the March 10, 2023 data cut-off, the median duration of response and progression-free survival (PFS) were not reached due to a lack of progression events, further underscoring the therapy’s long-term benefit.
Regulatory Progress and Upcoming Pivotal Phase 3 Trial
The results supported favorable interactions with the FDA, allowing Nuvation Bio to align on plans for converting the ongoing G203 trial into a pivotal Phase 3 study focused on high-grade gliomas. Importantly, the new protocol sets PFS as the primary endpoint, which could potentially serve as the basis for full approval in this setting. As of September 15, 2025, twelve patients from the initial cohort remained on safusidenib treatment, signaling lasting clinical benefit and paving the way for more mature long-term data.
Adverse Events: Safety Data Remain Manageable
Adverse events observed during the study were mostly mild or moderate, with just 18.5% of patients experiencing grade 3 or higher events. No fatal (grade 5) events were recorded. While a Good Clinical Practice noncompliance issue was identified in initial adverse event collection, the final safety analysis is based on a strict, protocol-adherent re-collection and re-evaluation, aiming for high data integrity.
Potential to Shift the Standard of Care for Glioma
Safusidenib’s ability to produce durable tumor responses and high progression-free rates could mark a step-change in treating IDH1-mutant gliomas. For many patients, delaying or even reducing exposure to chemoradiation could have major quality of life implications—especially given the risks associated with long-term adjuvant therapies. Experts, including Dana-Farber Cancer Institute’s Dr. David Reardon, highlight the need for options that go beyond existing IDH inhibitors, which still leave a gap in disease durability and patient outcomes.
What Comes Next?
With a pivotal global Phase 3 trial underway and further long-term data to come, investors and clinicians alike will be watching closely. Should results continue on this trajectory, safusidenib may soon provide an alternative pathway for those living with this tough-to-treat cancer. As always, ongoing data and regulatory updates will determine whether safusidenib fulfills its promise as a new standard for patients facing IDH1-mutant glioma.
Contact Information:
If you have feedback or concerns about the content, please feel free to reach out to us via email at support@marketchameleon.com.
About the Publisher - Marketchameleon.com:
Marketchameleon is a comprehensive financial research and analysis website specializing in stock and options markets. We leverage extensive data, models, and analytics to provide valuable insights into these markets. Our primary goal is to assist traders in identifying potential market developments and assessing potential risks and rewards.
NOTE: Stock and option trading involves risk that may not be suitable for all investors. Examples contained within this report are simulated and may have limitations. Average returns and occurrences are calculated from snapshots of market mid-point prices and were not actually executed, so they do not reflect actual trades, fees, or execution costs. This report is for informational purposes only, and is not intended to be a recommendation to buy or sell any security. Neither Market Chameleon nor any other party makes warranties regarding results from its usage. Past performance does not guarantee future results. Please consult a financial advisor before executing any trades. You can read more about option risks and characteristics at theocc.com.
The information is provided for informational purposes only and should not be construed as investment advice. All stock price information is provided and transmitted as received from independent third-party data sources. The Information should only be used as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments and trading strategies. The Company does not guarantee the accuracy, completeness or timeliness of the Information.
Disclosure: This article was generated with the assistance of AI