#United States #San Diego #Blood Cancer #Taiho Oncology #Oral Therapies

Taiho Oncology's Commitment to Advancing Patient Care in Hematology

At the 66th American Society of Hematology (ASH) Annual Meeting, Taiho Oncology, Inc. unveiled significant findings from two key studies that focus on oral therapies targeting blood cancers, particularly myelodysplastic syndromes (MDS). Held from December 7-10, 2024, in San Diego, this annual gathering is renowned for presenting the latest advancements in hematology. The findings emphasize the commitment of Taiho Oncology to improve the treatment landscape for patients facing complex hematological disorders.

Study Highlights

Investigational Oral Therapy: ASTX030

In an oral presentation, researchers shared results from a Phase 1 dose escalation trial of an investigational combination therapy known as ASTX030, which features azacitidine and cedazuridine. This innovative treatment was designed to present a viable oral option for patients who traditionally might only have access to injectable therapies.

1. Study Design and Participants: The study enrolled 88 patients diagnosed with MDS and MDS/myeloproliferative neoplasms, including chronic myelomonocytic leukemia (CMML). They were subjected to a median of seven cycles of treatment. The trial's primary aim was to find optimal dosing that would provide similar pharmacokinetic exposure in patients receiving oral dosing compared to subcutaneous azacitidine.
2. Findings: The trial’s results showed that the combination of 20 mg of cedazuridine effectively inhibited the degradation of azacitidine, leading to enhanced drug bioavailability and achieving comparable exposure to that of subcutaneous injections. The recommended dosing for further evaluation in Phase 2 trials was established at 140 mg azacitidine along with 20 mg cedazuridine.
3. Efficacy and Safety: Patients demonstrated a median overall survival of 29.5 months, with a response rate revealing a complete response in 11% of participants. However, side effects were noteworthy, with 100% of participants encountering treatment-emergent adverse events, typically linked to myelosuppression.

Real-World Application: INQOVI®

In addition to the investigational treatment, a poster presentation highlighted a real-world study contrasting the clinical outcomes of patients treated with INQOVI® (decitabine and cedazuridine) versus traditional intravenous subcutaneous therapies. This real-world analysis utilized data from the ConcertAI electronic health records database and included 2,101 patients.
1. Survival Rates: Early data suggests that patients on INQOVI experienced a longer median real-world overall survival of 23.2 months compared to 19.0 months for patients treated with intravenous or subcutaneous HMAs.
2. Efficacy: Notably, acute myeloid leukemia (AML)-free survival was also higher in patients treated with INQOVI at 16.5 months versus 13.3 months among those on intravenous therapies. Furthermore, those administered INQOVI encountered a lower risk of transformation to AML and delays in subsequent treatments, indicating potential benefits in long-term management.

Experts Weigh In

Dr. Harold Keer, Chief Medical Officer at Taiho Oncology, expressed enthusiasm for the data presented, noting how oral therapies like ASTX030 and INQOVI could alleviate the burdens associated with treatment scheduling and administration.

Dr. Guillermo Garcia-Manero from The University of Texas MD Anderson Cancer Center underscored the promising implications of these oral therapies and echoed the anticipation for the forthcoming Phase 2 study results. Such dialogues at the ASH meeting reflect an ongoing effort within the medical community to optimize care for patients with MDS and related conditions.

Conclusion

Taiho Oncology's recent presentations signify a hopeful advancement in oral therapeutic options for patients battling blood cancers. As the field of hematology continues to progress, these studies pave the way for more patient-centric treatment paradigms that could revolutionize long-term management strategies for chronic hematological malignancies. These findings not only bolster the potential of oral therapies but also herald the promise of improved quality of life for those navigating their cancer journeys.