#USA #San Diego #Ascentage Pharma #Multiple Myeloma #Lisaftoclax

Ascentage Pharma's Lisaftoclax Shines at ASH 2024

At the recent 66th American Society of Hematology (ASH) Annual Meeting held in San Diego, California, Ascentage Pharma presented compelling clinical data on its innovative Bcl-2 inhibitor, lisaftoclax (APG-2575). This drug is being evaluated for patients dealing with relapsed/refractory (R/R) multiple myeloma (MM) and immunoglobulin light-chain (AL) amyloidosis. The data shared has stirred significant interest due to its favorable implications for patients who have exhausted existing treatment options.

Context of ASH Annual Meeting

The ASH Annual Meeting is renowned as one of the largest gatherings in the hematology field, showcasing cutting-edge research and developments in the treatment of blood disorders. Ascentage Pharma’s presence was highlighted by various presentations, including oral reports focusing on several of its drug candidates like olverembatinib and APG-5918, alongside lisaftoclax.

Prof. Sikander Ailawadhi and Prof. Asher A. Chanan-Khan from Mayo Clinic led discussions on the clinical benefits associated with lisaftoclax. As reported, this treatment achieved a staggering 63.9% overall response rate (ORR) among 36 evaluated patients, with a 30.6% rate of very good partial remission (VGPR). Most notably, the median progression-free survival (PFS) was recorded at 9.7 months, signaling prolonged effectiveness compared to traditional therapies.

Efficacy and Safety Evidence

This open-label, multicenter Phase I/II trial emphasized the combination of lisaftoclax with established therapeutic agents. It was administered in daily doses alongside pomalidomide and dexamethasone or daratumumab, lenalidomide, and dexamethasone. The results indicated significant response rates even among patients heavily pretreated, which has been a considerable challenge in this patient population.

Alongside its promising efficacy, safety data also showed that high doses of lisaftoclax were well-tolerated, with no significant drug-drug interactions recorded. The side effects were limited and manageable, such as neutropenia and nausea, which aligns with the treatment expectations in oncology.

Insights from the Presenters

Prof. Ailawadhi noted, "Lisaftoclax has improved response rates and extended duration of response in R/R MM. This finding is especially crucial for patients who did not respond to prior treatments, including anti-CD38 antibodies. The safety profile also reassures us of lisaftoclax's potential as a targeted therapy."

Dr. Yifan Zhai, Chief Medical Officer at Ascentage, echoed these sentiments, highlighting the necessity for effective treatments in this area. He remarked on the urgent need to address clinical voids particularly among those with previous treatment failures involving proteasome inhibitors and immune-modulating therapies.

Broader Implications for the Field

These findings not only emphasize the clinical promise of lisaftoclax but also align with Ascentage Pharma's broader mission of developing comprehensive treatment solutions tailored to meet the pressing needs of patients worldwide. The company has demonstrated a strong commitment to accelerating its clinical development efforts, having already submitted a New Drug Application for lisaftoclax as a therapy for chronic lymphocytic leukemia in China.

Conclusion

Ascentage Pharma's advancements with lisaftoclax provide critical hope for patients battling difficult-to-treat malignancies like R/R MM. With ongoing trials and the pursuit of innovative therapies, the company stands at the forefront of enhancing treatment paradigms in hematological cancers. Future studies will be pivotal in confirming these encouraging results and potentially introducing a new standard of care for R/R MM patients.