贴一个大摩在Ash对亚盛的交流跟踪：
We hosted mgmt for a group breakfast at ASH yesterday. With olverembatinib (OLV) and lisaftoclax (LIS) launched in China, we believe AAPG is making good headway in bringing both programs to the global stage. Clearly, both carry unique attributes in their respective target indications. We continue to believe the approach and differentiation will deserve more credit over time.
On the heels of OLV’s Ph+ ALL POLARIS-1 and LIS’s China pivotal CLL/SLL presentations this weekend, our conversation focused on the differentiation in the competitive landscape, and mgmt’s latest thinking around the development strategy. Building on our fireside chat with the team this summer, we walked away with a refreshed outlook on its trajectory, as we see multiple inflection points from the ongoing global trials in the near term.
Below are the key takeaways from our discussion:
Olverembatinib’s Pivotal CML-CP Trial Is Expected to Have the Last-pt-in Next Year: The monotherapy pivotal Ph 3 POLARIS-2 in 3L CML-CP and 2L T315Im CML-CP is progressing well. Last-pt-in is on track around mid-2026. Given the trial has a 6-month MMR rate as the primary endpoint, a full readout is likely in late-2026 to early 2027, which in our view line up nicely with Takeda’s opt-in window.
Mgmt also provided a brief recap of the Ph+ ALL POLARIS-1 update that the team presented at ASH. Out of 53 evaluable pts, CR/CRi rate was 94% by the end of induction and the MRD-negative CR rate was 64%. Mgmt also spoke to the prospects in ALL and what a win looks like in the ALL market. OLV, in their view, is attractive with a strong response profile from the early cycles. It is also potentially attractive for elderly unfit pts who are seeking chemo-free option, or the pediatric population as a combo with low-intensity chemo.
Recapping Lisaftoclax’s Differentiated Edge: Mgmt walked through the key highlights from the pivotal R/R CLL/SLL data from China. As AAPG reiterates the unique attributes of LIS (e.g., no DDI with BTK or CD20, no TLS, only a 5-day ramp-up), mgmt also provided a recap of the latest strategy into other indications, such as AML and MDS. Notably, the absence of TLS will be an important differentiation driver. They believe commercial launch of LIS, if approved, will not require any hospital stay, easing a significant hurdle for adoption in the community setting.
Lisaftoclax Launch in China Is Off to a Good Start: LIS launch is going well with salesforce initially targeting 200 top centers in China before approval. Mgmt is hoping to expand its reach to 400 near-term, noting the expansion costs in China are relatively low and not cost prohibitive.