#United States #South San Francisco #Rigel Pharmaceuticals #REZLIDHIA #mIDH1 AML

Rigel Pharmaceuticals Shares Final Five-Year Data on REZLIDHIA®

Introduction
Rigel Pharmaceuticals, Inc., a biotechnology entity focused on hematologic disorders and cancer, has announced the publication of its final five-year data concerning REZLIDHIA® (olutasidenib) in the Journal of Hematology & Oncology. This pivotal data supports the effectiveness and safety profile of REZLIDHIA® in patients with relapsed or refractory mutant isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML).

Key Findings
The latest findings shed light on two additional years of efficacy and safety data, following the original three-year report. REZLIDHIA® has showcased durable responses and a consistent safety profile in patients, including those previously treated with venetoclax regimens. According to Dr. Jorge E. Cortes, Phase 2 trial investigator, the medication has become crucial for patients dealing with the challenging circumstances of R/R mIDH1 AML.

The extensive results cover a range of critical points:

• - Out of 147 patients evaluated for effectiveness, a total of 35% achieved either complete remission (CR) or complete remission with partial hematologic recovery (CRh), with a median duration of CR/CRh lasting 25.3 months.
• - The overall response rate (ORR) registered at 48% and the median overall survival (OS) continued at 11.5 months.
• - 39% of patients previously dependent on red blood cell transfusions achieved independence for at least 56 days, while 41% gained platelet independence, showcasing the drug's remarkable impact on patient health.
• - Among patients who responded overall, a significant 66% saw results within two months of treatment.

Notably, patients with one to two prior regimens exhibited a higher response rate than those with three or more, underlining the importance of therapy duration for optimal results. Of particular significance was the data around patients R/R to venetoclax, where 33% achieved CR/CRh, further expanding the potential landscape of treatment options for this demographic.

Future Directions
Rigel Pharmaceuticals is exploring olutasidenib in other areas where mIDH1 mutations may play a role, including partnerships with notable institutions. In alignment with this, they have recently activated a fifth clinical study in conjunction with MD Anderson, aimed at assessing olutasidenib in combination therapies targeting myeloid malignancies.

Conclusion
The publication titled "Olutasidenib for Mutated IDH1 Acute Myeloid Leukemia Final Five-Year Results From the Phase 2 Pivotal Cohort" emphasizes the positive impact olutasidenib can have on patients combating R/R mIDH1 AML. With ongoing studies and collaborations, Rigel Pharmaceuticals is committed to innovating treatment avenues for this prevalent form of cancer. Furthermore, as statistics estimate approximately 22,010 new cases of AML by 2025 in the U.S., advancing therapeutic options remains critical for enhancing patient care and quality of life.