Rigel to Present Five Times at EHA2024 Hybrid Congress

Rigel Pharmaceuticals, Inc. recently showcased significant findings at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid, Spain. The presentations highlighted the efficacy of REZLIDHIA® (olutasidenib) in treating patients with relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML).

The oral presentation by Dr. Jorge E. Cortes, a key investigator of the Phase 2 trial, detailed five-year results demonstrating the drug's impact on heavily pretreated patients, including those previously treated with venetoclax. Dr. Cortes emphasized the importance of olutasidenib for patients with R/R mIDH1 AML, noting its potential for rapid and durable responses with a manageable safety profile. His findings also show that patients who had been treated with venetoclax exhibited consistent, durable responses, underscoring the clinical benefits of olutasidenib.

The study included 147 efficacy-evaluable patients, with 35% achieving complete remission (CR) or CR with partial hematologic recovery (CRh). The median duration for achieving CR/CRh was 1.9 months, and the median duration of CR/CRh was 25.3 months, with the longest duration ongoing at 54.6 months. The overall response rate was 48%, and the median overall survival was 11.6 months.

In additional analyses, olutasidenib showed notable effects on patients who struggled with prior venetoclax regimens. Among 12 such patients, 33% achieved CR/CRh, with a median duration of CR/CRh not yet reached and median overall survival at 16.2 months. Furthermore, olutasidenib demonstrated its efficacy as a bridge-to-transplant therapy. Out of 153 patients treated, 16 (11%) proceeded to allogeneic hematopoietic stem cell transplantation (HSCT), with a median overall survival not yet reached, indicating potential long-term benefits.

Poster presentations at the congress offered deeper insights into the safety and efficacy of olutasidenib across various patient subgroups. One study focused on elderly patients with R/R mIDH1 AML, demonstrating that 31% of those aged 75 and older achieved CR/CRh, with a median duration of 25.3 months. This suggests that olutasidenib can be beneficial even for older patients who have limited treatment options.

Another study centered on patients with mIDH1 AML secondary to myeloproliferative neoplasms (MPN). Data showed that olutasidenib was well-tolerated and effective in this subgroup, with six out of 15 patients achieving CR and a composite complete response rate of 53%. Additionally, the drug's safety and efficacy were consistent with earlier findings, making it a promising option for this difficult-to-treat population.

Rigel's CEO, Raul Rodriguez, expressed enthusiasm about these findings, emphasizing the drug's strong efficacy and durability across multiple AML patient populations. He highlighted the particularly compelling data in patients with mIDH1 AML secondary to MPN, who historically have had poor responses to existing treatments.

In summary, the new data presented at EHA 2024 reinforce the potential of REZLIDHIA® (olutasidenib) as a critical treatment for various mIDH1 AML patient populations, offering hope for those who have not responded to other therapies. The evidence supports its use not only as a standalone treatment but also as a bridge to potentially curative allogeneic HSCT, marking a significant advancement in AML care.